Country readiness in responding to COVID-19 Vaccine-Related Events (VREs) in Malawi: a mixed methods readiness assessment April—May, 2023

Country readiness in responding to COVID-19 Vaccine-Related Events (VREs) in Malawi: a mixed methods readiness assessment April—May, 2023 | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Country readiness in responding to COVID-19 Vaccine-Related Events (VREs) in Malawi: a mixed methods readiness assessment April—May, 2023 Save Kumwenda, Mphatso Nyamasauka, Davis Makupe, Sandra Machiri, and 5 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7041748/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract The Malawi Ministry of Health and partners developed a comprehensive COVID-19 VRE response plan in 2022. We explored MoH readiness to implement the plan by assessing the availability of VRE-related documents describing overall process of identifying, reporting, investigating, and coordinating a VRE response; and assessing the strengths, weaknesses and recommendations for improvements in the current system. We conducted a cross-sectional mixed methods assessment among MoH staff involved in VRE response at national, district, and health facilities levels using a survey and a semi-structured interview guide in ten districts in Malawi during April—May, 2023. Availability of ten VRE-related documents was assessed and visually confirmed. We assessed the count of each of the survey findings by district and zone. Ten key themes pertaining to VRE identification, reporting, investigation and response were explored in 109 Key Informant Interviews (KIIs) and six Focus Group Discussions (FGDs). Of the 109 KIIs, 91% of those interviewed worked at District or Health Facility levels. We conducted 6 FGDs at the Health Facility level. We analyzed 74 survey responses. More than 60% of respondents reported having access to VRE-related documentation, but less than 10% reported access to non-AEFI VRE related guidance. KII and FGD respondents identified existing processes for AEFI-related VREs, but noted the lack of training, coordination and budgetary support for non-AEFI VRE activities. Optimal deployment of Malawi’s COVID-19 VRE response plan will require expanded training opportunities, sustained funding and improved coordination across all levels of the health system and between surveillance and communications functions. Vaccine related events (VREs) vaccination community engagement feedback training adverse effect following immunization and Malawi VRE response plan vaccine safety preparedness Figures Figure 1 Figure 2 1.0 Background Vaccination has been shown to be an effective means of preventing infectious diseases and sustaining healthy populations. However, inadequate identification and response to vaccine-related events (VREs) can negatively affect the confidence in a vaccination program ( 1 ) and subsequently undermine efforts to achieve and sustain optimal vaccination coverage ( 2 – 5 ). VREs include two broad categories: Adverse Events Following Immunization (AEFI) VREs and non-AEFI VREs, which include a new assessment or experimental data related to vaccines, press report or local rumor, suspension of vaccine, recall of vaccine or the replacement of a vaccine. AEFIs are reported through passive and active surveillance by healthcare workers while non-AEFI VREs are mainly reported by news organizations, social media monitoring, or community informants ( 6 ). While AEFI surveillance systems are well-established globally ( 7 ), the broader conceptualization of VREs has been developed more recently by WHO, with guidance published in 2013 ( 1 ), antigen-specific guidance for polio vaccine in 2022 ( 8 ) and for COVID-19 vaccine in 2020 ( 9 ). A VRE response system consists of a formalized process for identifying, reporting, investigating and responding to VREs in an integrated manner across health system levels and between vaccine safety focal points and health promotion teams. Despite the availability of guidance, gaps in training and cost have been attributed to delays in transitioning from AEFI surveillance into a unified system to detect and response to VREs ( 10 ). In Malawi, recent declines in childhood immunization rates as well as suboptimal COVID-19 vaccination coverage indicate a need to bolster existing systems and potentially identify challenges related to VRE reporting and response ( 11 , 12 )( 13 ). Low COVID-19 vaccination coverage has been attributed to the spread of mis- and dis-information, rumors, information voids, and poor response to vaccine related events ( 12 , 14 ) . In 2022, the Malawi Ministry of Health formalized its VRE response system and published a COVID-19 VRE response plan, disseminating it to focal points in all zones and districts in the country ( 6 ). This plan synthesizes guidance on AEFI surveillance, COVID-19 vaccine adverse events monitoring and surveillance in Malawi, and vaccine safety and VRE communication plans to provide a framework for distinguishing between known, perceived, and theoretical safety concerns that emerge following vaccination and with the goal of ensuring that information reaches various audiences including affected families and communities quickly ( 15 ). Thus far, no assessment has been conducted to evaluate Malawi’s readiness to implement the COVID-19 VRE response plan. Our objective is to assess Ministry of Health readiness and ability to identify, report, investigate and respond to both types of VREs (AEFI and non-AEFI) in the initial period following the development of Malawi’s national plan in 2022. Our three primary aims were to: 1) document the availability of VRE-related documents and document VRE reporting and response activities; and 2) describe the overall process of identifying, reporting and investigating VREs and coordinating response; and 3) assess the strengths, weaknesses, and recommendations for improvement of the current VRE reporting and response system. From these findings, we aim to provide insights on the strengths and weaknesses of the current COVID-19 VRE response system, identify needs for enhancing effective VRE response activities, and offer a model to other countries introducing VRE response plans. 2.0 Methods 2.1 Assessment setting and design This cross-sectional mixed-methods readiness assessment was conducted in ten districts, drawing from each of Malawi’s three Regions (North, Central and South) during April—May, 2023. To ensure geographic representation and to be able to report findings by region, we purposively selected two districts in each of the five health zones, including the district that houses the zonal headquarters (Fig. 1 ). For the quantitative component of this assessment, we collected data from each health facility and district health office on the availability of VRE-related documents, the frequency and types of AEFIs and non-AEFI VREs reported by district, and the frequency of investigations and causality assessment meetings. For the qualitative component, we conducted key informant interviews (KIIs) with national and zonal coordinators, Integrated Disease Surveillance and Response (IDSR) focal points, and Health Promotion coordinators and focus group discussions (FGDs) with Health Facility staff and Health Surveillance Assistants to understand the current process for VRE identification, reporting, investigation and response as well as perspectives on the strengths, weaknesses, and capacities of the current system. Table 1 describes the location and role of participants as well as key thematic areas discussed in each group. 2.2 Inclusion criteria and sampling In each district, we purposively sampled participants from the District Health Office, the District hospital or Central hospital, and Health Facilities. For the capital city of Lilongwe, we sampled participants from the Central Hospital, Health Facilities, and National-level stakeholders. Inclusion criteria for participants included a role as a Health Worker involved in the immunization program at a National, District, and Health Facility level, being at least 18 years of age, willingness to have the discussion recorded and providing written informed consent to participate in the assessment. KII and FGD sample sizes were set with the expectation of reaching saturation in themes, with overall estimated sample size of 176 participants. We sought to quantitatively assess the availability of VRE-related documents by surveying the AEFI focal point or their designee at each site of qualitative data collection. 2.3 Data collection and management Data was collected using a pre-programmed checklist on Kobo Collect to assess the availability of VRE-related documents, the reported use of these documents in the event of a VRE, the presence of teams to investigate VREs, and the most recent number and types of AEFIs and non-AEFI VREs reported at each district and health facility visited. The VRE-related documents included a list of reportable AEFIs, guidelines for AEFI reporting, guidelines for AEFI investigation, guidelines for AEFI causality assessment, agenda from the most recent AEFI investigation meeting, minutes from the most recent COVID-19 causality assessment committee meeting, a community assessment plan or protocol, report or findings of previously conducted assessment, social media monitoring Standard Operating Procedures (SOP)/guidelines, social listening reports, crisis and risk communication plan and communication materials development plan. We conducted semi-structured interviews with participants at the National level in English; District and Health Facility semi-structured interviews and focus groups were conducted using in English or Chichewa, depending on the preference of participants. Data collectors used a KII guide, FGD guide, and checklist to guide the discussion. We collected audio recordings of the interviews and discussions, and transcribed them, and translated the Chichewa transcriptions into English. No individually identifying information was collected. 2.4 Measures and Analysis Responses to the quantitative elements were summed to the District level and reported by Region. Mzuzu and Rumphi Districts comprise the North Region; Dedza, Kasungu, Lilongwe, Salima Districts comprise the Central Region, and Blantyre, Mangochi, and Nsanje Districts comprise the South Region Districts included in this assessment. The quantitative analysis reported on the availability of VRE-related documents, with response options yes or no to the demonstration of document availability at the site. A visual confirmation of the documents was required before a data collector indicated the availability of a given document on the quantitative assessment. The use of VRE-related documents was self-reported as ever used or never used for each document. The availability of a team to investigate VREs was self-reported as yes or no. AEFI type (serious local reaction, seizure, abscess, sepsis, fever, headache, and other) and frequency were measured using the AEFI reporting forms in the six months preceding the assessment (November 2022—March 2023) for each Health Facility. WHO standard definitions were used in the classification of adverse events following immunization ( 16 ). Non-AEFI VREs reported were summed by District and reported by Region, along with a qualitative description for each. When the documents were applicable to both AEFIs and non-AEFI VREs, the overarching term VRE was used. When AEFI-specific elements, processes, or documents were mentioned, we describe these as AEFI. We calculated the count and proportion of all documents available for each VRE document type by District and Region, and then compared the proportion of all documents available by region using a chi-square test, with significance at p-value less than 0.05. We summed total number of AEFIs reported by type in the previous six months for each of the three Regions. All quantitative analyses were conducted using IBM SPSS Version 20 ( 17 ). For the qualitative analysis, researchers collectively identified themes based on the interview and discussion guides and conducted an inductive thematic analysis of transcripts both manually and with Nvivo 14. 2.5 Data Quality Assurance The research design was presented to research committees in the ten districts before submission to the National Health Research Ethics Committee which also reviewed it. All comments from the committees were discussed by authors and necessary revisions were made. The main revisions were on the target districts to be by zone and also suggestions on who to be interviewed at a health facility. After ethical approval, we recruited and trained data collectors. The data collectors had a minimum qualification of a university degree in Environmental Health, Medicine, Nursing and Social Sciences. These assisted in translating the tools, which were already translated to local language by authors before submission for ethical review, back to English to check if they were accurate and consistent. The tools were thereafter pre-tested in Chiradzulu in Southern Malawi. During data collection, the first author supervised the data collection process. Challenges met during each day of data collection were discussed and resolved before the next day. During data cleaning, questionnaires with more than 10% missing data were not included in the analysis. 2.6 Ethical Considerations Permission to conduct this assessment was sought and obtained from all the ten districts. The permission letters together with the protocol were sent and approved by the National Health Research Ethics committee (Protocol #23/02/3178). The Human Subjects Office at the Global Health Center at the US Centers for Disease Control and Prevention (CDC) reviewed this protocol for a non-research determination. Written informed consent was obtained from all health workers who participated in this study. 3.0 Results We conducted a total of 109 KIIs, of which 9.2% (10/109) were with National coordinators, 22.9% (25/109) with District-level EPI coordination, 19.3% (21/109) with District-level surveillance representatives, and 6.4% (7/109) with those involved in District-level health promotion activities (Table 2 ). Six FGDs were conducted on VRE identification, reporting, investigation, and response; each included between six to eight Health Workers. We collected quantitative data from 103 participants involved in VRE reporting, of which 74 surveys (71.8%) were of sufficient quality to be retained in the analysis. Of the responses analyzed, 29.9% (22/74) came from Health Facilities in the Central Region, 28.3% (21/74) from the North Region, and 41.8% 31/77) from the South Region. Thirty-three percent (24/74) were from District hospitals and the remaining 67% (50/74) were from Health Facilities (Table 3 ). Table 1 KII and FGD participants by role and region North Central South Total Coordination (National, zonal) 1 8 1 10 EPI Coordination 5 8 12 25 Integrated Disease Surveillance and Response (IDSR) Coordination 4 7 10 21 Health Promotion Coordination 1 4 2 7 Health Facility staff 9 13 21 43 Health Surveillance Assistant 2 0 1 3 Total 22 40 47 109 Table 2 Respondents to the quantitative survey by role and region North Central South Total EPI Coordination 7 8 13 28 IDSR Coordination 5 5 6 16 Health Facility staff 8 11 11 30 Total 20 24 30 74 3.1 Availability of documents, teams and VREs reported by Region All respondents showed data collectors a list of reportable AEFIs, and more than 50% could produce guidelines for AEFI reporting available in their facility (Table 4 ). However, less than 50% of respondents could produce guidelines for AEFI investigation, guidelines for causality assessment, or if minutes from a recent COVID-19 causality assessment meeting had been recorded. More than 60% of survey respondents in Central and South Regions and 47% in North Region reported that their health facilities had a team available that could investigate VREs (Table 3 ). Furthermore, staff from over 75% of health facilities reported that their health facility had a team that could respond to AEFI VREs after an investigation and over 59% of respondents in each Region reported that their Health Facility team had the capacity to respond to non-AEFI VREs. There was no significant difference in availability of teams in VRE investigation and response across regions (p > 0.05). Table 3 VRE Documentation and Self-reported Investigation Capacity by Region Central, n = 22 (%) North, n = 21 (%) South, n = 31 (%) Chi-square (p-value) Proof of document availability at site List of reportable AEFIs 22 (100) 21 (100) 31 (100) NA Guideline for AEFI Reporting 17 (77.3) 11 (52.4) 23 (74.2) 3.801 (0.150) Guideline for AEFI Investigation 6 (27.3) 7 (33.3) 15 (48.4) 2.692 (0.260) Guideline for AEFI Causality assessment 4 (18.2) 3 (14.3) 1 (3.2) 3.352 (0.187) Agenda for the most recent AEFI investigation meeting 5 (22.7) 8 (38.1) 17 (54.8) 5.577 (0.062) Minutes for the recent AEFI causality assessment meeting 1 (4.5) 2 (9.5) 1 (3.2) 1.016 (0.602) Social media monitoring SOP/Guidelines 2 (9.1) 0 (0) 2 (6.5) Social listening reports 3 (13.6) 5 (23.8) 6 (19.4) Crisis and Risk communications plan 3 (13.6) 0 (0) 1 (3.2) Community engagement plan 9 (40.9) 8 (38.1) 5 (16.1) 4.764 (0.092) Reported capacity to complete activities at site Distinguishes between serious and non-serious VRE 14 (63.6) 15 (71.4) 23 (74.1) 0.705 (0.703) Investigates VRE 14 (63.6) 10 (47.6) 20 (64.5) 1.709 (0.425) Assesses causality for VREs deemed not serious 5 (22.7) 2 (9.5) 3 (9.7) 2.274 (0.425) Responds to AEFI VRE after investigation 20 (90.9) 16 (76.2) 27 (87.1) 2.001 (0.368) Responds to non-AEFI VREs 13 (59.1) 14 (66.7) 22 (71.0) 0.814 (0.666) Respondents from all Regions reported using the AEFI reporting form to record at least one VRE in the previous six months. Respondents from all regions identified non-AEFI VREs (Table 4 ). Table 4 VRE reported by health facility across all antigens by type and by region from November 2022—March 2023 Central (N = 22) N (%) North (N = 21) N (%) South (N = 31) N (%) Serious local reaction 1 (4.5) 7 (33.3) 5 (16.1) Seizures 0 (0.0) 2 (9.5) 7 (22.6) Abscess 17 (77.3) 13 (61.9) 26 (83.9) Sepsis 0 (0.0) 2 (9.5) 5 (16.1) Headache 3 (13.6) 8 (38.1) 15 (48.4) Fever 18 (81.8) 17 (81.0) 23 (74.2) Other AEFI 3 (13.6) 2 (9.5) 2 (6.4) Non-AEFI VREs 3 (13.6) 3 (14.3) 8 (25.8) The other mentioned AEFIs were thrombocytopenia (reported twice in Central Regions), upper respiratory infection (reported twice in Northern and Southern Regions) and anaphylactic shock (reported once in Central Region). The commonly reported VREs were mainly AEFIs including severe local reaction to injections followed by fever, abscess, and headache. 3.2 Qualitative Findings: Process for identifying, reporting, investigating, and responding to VREs KII respondents described the overall process for identifying, reporting, and investigating VREs and response coordination. Conversely, non-AEFI VRE elements, documents and processes were explicitly identified as such. VRE communication and reporting system began at community level, where community members reported VREs to their respective Health Surveillance Assistants (HSAs) or Village Health Committees or volunteers (VHCs) or directly to the Health Facility staff. The VHCs report to the Health Facilities through senior HSAs or healthcare workers. The first healthcare worker to receive notification of a VRE is the person who is then responsible for completing a VRE (commonly known as AEFI assessment form in health facilities) reporting form and sending either to a clinician or their immediate supervisor for further assessment. If the VRE is determined not to be serious, the cases are reported but not referred to the District; they are dealt with by the health workers at the health facility. Health facility staff recorded VREs on paper forms, known as AEFI reporting forms, but they typically transmitted these forms digitally to District focal points via WhatsApp. “In terms of coordination, I can say is ok, for the people who have been trained on how to detect a VRE case, they are able to link. When clinician has seen a case, he is able to link with an HSA to say here is a case we need to report. We use the technical guides in training of the community, religious and health care workers.” ( Health care worker, South Region) If the VRE is classified as serious, the report is then sent to the District EPI coordinator and IDSR coordinator who can make determination or refer to the Zonal and National-level Expanded Program on Immunization (EPI) Unit. The EPI Unit can investigate the VRE and make a determination or can refer the VRE to the Causality Assessment Committee (CAC) (Fig. 2 ). The CAC is a component of Pharmacy and Medical Review Association responsible for medicine safety and quality. Following the decision of the National Causality Committee, these findings are transmitted to the EPI Unit at national level, then to the Zonal office and District VRE investigation committee, and finally to the Health Facility staff who reported the VRE for follow up with the case, caregivers of the case, and community. When the causality assessment is made at a lower level of the health system, the findings are meant to be conveyed back to the community using a similar process as the national causality committee determination. Most of the Health Facility staff queried had experience reporting AEFIs to the District EPI coordinator and to the National EPI division, but none reported that these AEFIs were then escalated to the PMRA Causality Assessment Committee (CAC) for causality assessment. 3.3 VRE reporting: Strengths and Weakness identified Thematic responses on the VRE system are outlined in Table 5 . All respondents explained that they use both paper based and WhatsApp via mobile phones for reporting VREs to the next level of the health system. Health facilities staff noted that they reported VREs using paper forms but submitted the forms electronically to the District via WhatsApp. At District level, the data is then entered into District Health Information System 2 (DHIS 2) through the Health Information Management System (HIMS). However, district-level difference in reporting processes were observed, notably that the District VRE investigation committee frequently bypassed the Zonal office and sent VRE investigation requests directly to the National EPI unit. Table 5 Key issues and findings identified through KIIs and FGDs by District November 2022—March 2023 Main Themes Key issue Key findings Verbatim examples Districts mentioned Documentation for VRE planning, identification, reporting and response List of reportable AEFIs is available in almost all health facilities and AEFI reporting forms “ Here, we have a list reportable AEFIs and also the AEFI reporting forms”. Nsanje, Salima, Blantyre, Mangochi, Dedza, Mangochi, Mzuzu, Rumphi, Lilongwe, Kasungu Social listening is done in some districts and reports are generated “The social listening reports are very useful to us, and we always encourage speaking out on these issues because when going with interventions in the community, the issues that has been presented are incorporated so that the fears and challenges that may be there are cleared out .” Rumphi, Mangochi, Kasungu VRE plan not available “We do not have a VRE plan” Lilongwe, Mzuzu, Dedza, Rumphi, Salima, Zomba No documentation for rumours and community engagement “For rumours, we utilize the opportunity when there are local leader’s meetings. These are informal and not documented”. Mzuzu, Nsanje, Mangochi, Zomba, Kasungu, Dedza, Lilongwe, Rumphi COVID-19 VRE plan available “Yes, I have a copy of the COVID-19 VRE plan for Malawi”. Lilongwe Committees for VRE response Causality assessment is done at national level. It is done by the Medicine Safety and Quality Monitoring Committee (MSQMC) at national level “ Of course I can say, at the district we don’t have the causality assessment team, in fact ours we do just the investigations. Causality assessment is done at national level”. All the ten districts including PMRA The health centres do not have VRE investigation committees. “Once the VRE has been identified as serious here at health centre, we report to the district for investigations”. All the ten districts Health Centres are willing to establish VRE investigation committees “Despite not having an investigation committee, we are able and ready to investigate”. Kasungu, Dedza, Rumphi VRE response Coordination and reporting Formal structures for coordination and reporting available from health centre level “I know that the guidelines are there talk on how we should organize ourselves, prepare for the investigations, things that would need to be investigated, seek help, report to the administration, etc. These are some of the things I can remember”. All ten districts Coordination and reporting of VRE by-passes the zonal coordinators “As a zone we don’t respond to AEFIs because we are not directly involved since the reports go straight to the national but the strength that we have is that we do capacity building by playing a supervisory role to see how things are going about and provide expertise”. Mzuzu, Salima, Lilongwe Community listening There are no formal structures for community listening are not available; however, others use Health Advisory Committees, Community Health Action Groups and others like hotlines “We do not have formal written procedures for community listening and reporting….”. Dedza, Kasungu, Lilongwe, Mangochi, Mzuzu, Nsanje, Rumphi, Salima, Zomba HSAs are supposed to do community listening “ Each and every HSA is supposed to conduct community assessment and listening activities in their areas. We give our micro plans to the [Senior HAS] SHSA who compiles them and make a plan for the facility”. Blantyre, Zomba, Mzuzu Media engagement Mainly done at District Level and National Level by HPO. Health centre engagement is done after getting permission from the district “Media engagement is only done at national and district level by going through the health education unit which has a spokesperson who talks on behalf of the Ministry of Health”. Mzuzu, Mangochi, Dedza, Zomba VRE response plan All did not have the VRE plan except one officer in Lilongwe and Blantyre districts who had the COVID-19 VRE plan “I got the COVID-19 VRE plan during the meeting…”. Lilongwe, Blantyre COVID-19 VRE plan is similar to what could be the plan for all antigens “VREs plan for COVID-19 vaccination needs to be inclusive of all the other vaccines……”. Zomba, Nsanje, Salima, Mangochi, Lilongwe Challenges in VRE response Delayed or no feedback form the district and national level on VRE investigations “The challenge is that feedback is not there in most cases unless if it’s a special case…”. All Community misinformation and myths Community misinformation and myths “Some myths and misinformation affect vaccine uptake in the district”. Lilongwe, Mangochi, Mzuzu, Dedza, Nsanje, Zomba Health facility training, coordination, and hesitation to report Difficult for HSAs to report AEFIs from cases they themselves vaccinated “Some clients find it easy to report the VRE to HSAs but the HSAs sometimes do not report to use especially if they were the ones administering the vaccination”. Lilongwe, Blantyre, Zomba Blame game between health worker cadres for low detection and reporting of VREs “…some cadres accuse others of causing VRE and also of not reporting them”. Mzuzu, Kasungu, Mangochi and Zomba Lessons Learnt Health Advisory Committee (HAC) helps in solving misinformation “During community meetings to discuss VREs, we involve HAC members because they stay in the community and are easily understood”. Nsanje, Salima, Rumphi, Mzuzu, Blantyre, Dedza, Mangochi, Zomba Need to use non-technical language during media engagement, community engagement meeting and also during training of health workers “In addition to that, sometimes the media changes the meaning of the message that was intended for the communities because some messages are presented in technical terms…”. Salima, Mangochi, Zomba, Mzuzu, Lilongwe, Dedza, Rumphi Solution to allowance culture is by holding meetings in communities “The community have great expectations that they will get allowances whenever they attend a community listening session outside their village”. Dedza Respondents noted that the VRE reporting process was challenging due to resource constraints and data management issues. Delays in transmitting reports to the district level were attributed to inadequate staff with the authorization to report VREs, limited transportation resources to transmit paper-based reports to District level, uneven and expensive mobile network coverage to transmit electronic VRE reports to District level. Furthermore, respondents highlighted that these paper reports are not always documented and stored in easily-accessible registries, leading to increased risk of losing documentation pertaining to the VRE. Additionally, some Health Workers expressed fear of reprimand or blame for reporting VREs against themselves or fellow workers regardless of the reason for the event. Health Facility-level respondents noted challenges in both the identification of VREs at the community-level and reporting at the Health Facility level. A Health Worker in the Central Region added that the challenges start from the community level and HSAs because AEFIs are considered as normal outcomes and not reported to the Health Workers: “ The people in the communities are not able to identify VREs especially AEFIs. I remember this other time, I went to the field, I found a mother and she told me not to vaccinate the child on the spot I wanted and she showed me the spot where she wanted her child to be vaccinated. When I asked the reason, she showed an abscess which had healed. And when I asked her how the child got that, the mother said that after the child received the vaccine, the child developed that and the mother took the child to a private clinic where they blew up the abscess. This means that the mother did not consider that a VRE, had it been the mother reported to the facility, it would have been recorded in the VRE form ” (Health care worker, Central Region). KII with a health care worker in the South Region indicated that not all the staff are familiar with the reporting system, inadequate coordination among health care workers to record VREs, and suboptimal referral practices to appropriate personnel for recording and investigation. “When the challenge is on the vaccine, then reports go to the district office but when there are AEFIs caused by the vaccine administrator like abscess, they are dealt with at the facility and later we meet the concerned personnel and inform them on proper administration of vaccines” (Health worker, South Region). Health Workers from Central and South Regions reported instances that Health Workers provided treatment for AEFIs without recording these AEFIs on the reporting forms. Furthermore, the respondents expressed a need to train VHCs on the VREs. However, there were respondents from each of the Regions who indicated that there no challenges with VRE coordination and reporting. “We are trying to have health talks but also Continuous Professional Development meetings where we can discuss issues on pharmacovigilance so that every clinician and nurse should know what to do where and where to report in case, they meet such a case. Especially on the issue of reporting we don't have a clear system so sometimes you feel like for you to start the reporting system, you waste time but if it is a proper reporting system it's easier to do” (Health care worker, South Region). Although the process for VRE reporting is meant to go from District to Zone and National level, actual reporting often bypasses Zonal offices and respondents reported circumstances where Zonal staff received notification of VREs in their Zone following the receipt of a National-level investigation and response. “Don’t even bother because we don’t have database so we need to ask from the national office. I can’t say I will extract from DHIS 2 because it only gives numbers and not all details on type of VREs but I know there is need to have a database that one can easily access information from of course with rights,” (Health care worker, North Region). 3.3 Opportunities to Strengthen VRE Investigations Following the identification of a VRE, health workers are responsible for referring the case to the HSAs, who document the VRE on official reporting forms and either investigating the VRE or referring the case to the relevant health worker for assessment. Some health workers reported that they did not know the steps required to complete the VRE investigation process. One respondent explained that although EPI coordinators participate in VRE investigation teams, the infrequency of investigations leads to a lack of experience and subsequent uncertainty on how to undertake an investigation. “I know that the guidelines are there talk on how we should organize ourselves, prepare for the investigations, things that would need to be investigated, seek help, report to the administration, etc. These are some of the things I can remember. Maybe because we haven’t had a serious VRE case requiring an investigation so I think my team members cannot know all these steps as well. It can be a very tough issue if we can have an VRE case requiring investigation today ” (Health Worker, North Region ). Respondents in the North, Central and South Regions noted that the responsibility for distinguishing serious and minor VREs was not consistently assigned. One health worker in Central Region noted that HSAs were responsible for distinguishing, while another in Central Region indicated that the health worker was responsible for this determination, and a third respondent could not determine the role responsible for this decision. “We don’t have that team which distinguishes the VREs because when VRE comes usually it’s the clinician who is the first contact, sometimes the clinician asks the EPI focal or SHSA to discuss about the VRE and if it’s serious it’s referred to higher level and minor ones are observed at the health facility ” (Health care worker, South Region). Health Workers in each Region noted that that serious AEFIs had been detected in their health facility, with symptoms ranging from paralysis to seizures, abscess and convulsions. However, some respondents noted that there had not been any serious AEFIs reported for the past six months or have never registered any serious AEFI case. Health Workers in the Central Region added that when there is a serious AEFI and the facility cannot handle it, the patients are referred to the medical short stay at the Regional hospital, for advanced diagnostics. The investigations are done at District level and the findings are documented and sent to National EPI office. One Health Worker described the investigation process from District level: “ When the case was reported to the [District Health Officer], we followed up that case…. We wanted to understand what happened to the child, what vaccine did the child receive, batch number of the vaccine, what time was the child vaccinated, after vaccination what happened up until the parents reported to the hospital. The investigations were conducted in 2 days, the first day they went to investigate at the health centre then the second day they went to the health center then thereafter to the village ” (Health care worker, South Region). 3.4. Causality Assessment on the reported serious AEFIs Respondents from seven Districts reported that their Districts had not established District-level causality assessment committees; thus, causality assessment could not occur at the district level. District-level respondents from all three Regions further explained that they are only responsible for investigations and that causality assessments are conducted at National level by the Ministry of Health, WHO, pharmacovigilance and other key stakeholders. “Of course, I can say, at the district we don’t do the causality assessment and we do not have that team, in fact ours we do just the investigations” (Health Worker, South Region). 3.5 Responding to VREs Respondents at all levels of the health system emphasized the importance of sharing the results of an investigation and causality assessment with community members to build and sustain trust between the community and the health system. Following an investigation or upon receiving the results of a causality assessment, the DHO is responsible for calling the facility in-charge or EPI focal person, who then shares the findings with the case, the caregivers of the case, and surrounding community. While most respondents did not report experience with responding to non-AEFI VRE investigations, one respondent from the North Region reported that investigation findings from two non-AEFI VREs had been addressed by the District-level Health Education team. Respondents from Health Facilities noted infrequent dissemination of investigations and causality assessments from either the National level or the Districts. One FGD participant in Central Region attributed these inconsistencies to the lack of formal processes for responding to VREs: “I remember there was one woman whose child had an AEFI where the injection site got hardened and darkened, she went to the HSA in the community who referred the client to the Clinician here and after the Clinician examined the child he said the injection site has recovered therefore no medication was required so she was sent home. The HSA later followed the client to her home and provided some health talk to those surrounding” (Health Worker in Central Region) For serious AEFIs, respondents noted that the investigations are supposed to start within 24 hours if reported directly to the facility and 72 hours if identified in the community. However, respondents in Central Region noted that investigations typically did not begin until two weeks after the identification of a serious AEFI. Investigation delays were attributed to lack of clinical staff availability, inadequate supplies of stationary and AEFI reporting forms, lack of allowances, and no dedicated fuel for transport of the AEFI reporting forms. Respondents suggested that timeliness of investigations could be improved with faster identification and reporting of VREs to the District and National level. “When a serious VRE is investigated, it goes from a facility level, to district and then national level. It is at the national level where it is delayed because the national level comes and conducts its own investigation” (Health Worker, South Region). Key informants noted that investigation findings were meant to be transmitted to the community, but this feedback did not often reach the community. “The challenge is that feedback [from the CAC] is not there in most cases unless if it’s a special case, for example when COVID-19 vaccine was just initiated there was feedback in most cases that were being reported and the reason could be because there were a lot of rumors (Non AEFIs) so it was one way of clearing the rumor and also the VREs were new to health workers. For routine immunization, feedback was not frequently done” (Health care worker, South Region). 3.5 Considerations for non-AEFI VREs: Community and social listening Respondents in all three Regions highlighted the absence of guidance documents and assessments on community and social listening at the District and Health Facility-level. However, respondents in both the North and South Regions asserted that community assessment and microplanning activities were ongoing, led by HSAs. In addition, one respondent from South Region noted that HSAs also routinely receive social reports from community members and during Health Facility interactions. “ Each and every HSA is supposed to conduct assessment activities in their areas. We give our micro plans to the [Senior HAS] SHSA who compiles them and make a plan for the facility. On reports, every HSA writes a report when they find a VRE case and give it to the SHSA ” (Health Worker, North Region). Community listening sessions varied by District, with some noting that these sessions are regularly conducted during bi-monthly outreach sessions or by mobile phones and others reporting no activities in the previous six months. “These outreach clinics are done once or twice a month. As a facility, we do not have community listening tools but rather we get information through personal mobile phones as other community members have our phone numbers and they contact us anytime” ( Health Worker, South Region ) Health Facilities staff reported community listening conduits, including community meetings with local leaders, Facebook pages, Community Health Action groups (CHAG), Health Advisory Committee (HAC), Area Development Committee (ADC), Village Health Committees (VHCs), Village Development Committees (VDC), suggestion boxes, Health promoters, an ombudsman office at the facility and encouraging community to report anything to the nearest Health Facility or the HSAs in their catchment area. Supplemental resources during the COVID-19 pandemic supported community listening through a phone hotline, community listening sessions, or radio call-in shows. “Sometimes we have panel discussions on community radios, we have three community radios … so sometimes we utilize these to have panel discussions where the community are given time to ask questions through phone calls and we respond to them immediately or we just give the message via the radio and I give my number so that in case someone has a question should call directly to me and be explained to individually” (Health Worker, South Region). Most respondents stated that their Health Facilities do not produce or have access to social listening reports. Three respondents, one from Central Region and two from South Region, noted that their District developed social listening reports. Each described a process of sharing social listening reports at District level with the HPO, DHO, and HMIS focal points, then disseminated either the social listening report or a strategy to address the VREs identified to HACs. Most respondents indicated that informal social listening channels existed to address rumors through community engagement with local leaders, religious leaders and influential leaders, HAC, VDC, health education services like health talks, and community interface meetings. “We utilize the opportunity when there are local leader’s meetings. [He] invites HSAs to his meetings and at some point… said that he wants his chiefs to be exemplary by getting vaccinated in their vaccination sites. Apart from this we established a committee known as Champions committee composed of chiefs, youths, women who got vaccinated of COVID-19 vaccine specifically all the 2 doses or booster. So, their main role is to sensitize the community on COVID-19 vaccine and dispelling all the rumors surrounding the vaccine” (Health Worker, Central Region). 3.7 Coordination mechanism A well-functioning VRE response system requires strong coordination between both community members and the health system as well as within health system structures. In particular, health Facility and District-level coordination between surveillance and communication focal points requires strengthening for effective VRE response. Respondents noted several opportunities for strengthening coordination between the surveillance and communication structures. The respondent in the Central Region noted that training on VREs had only included HSAs and recommended expanding training offerings on VRE to the relevant communications and health promotions focal points. Some respondents highlighted the availability and use of an overarching crisis and risk management plan as a crucial element of their successful coordination across stakeholders, while others cited the absence of this plan in their district as a barrier to proactive coordination. Some respondents noted that their district team developed risk communication plans on an as-needed basis to tailor planning for the specific issue arising. These plans are implemented through local key stakeholders such as local leaders and can included dedicated resources for community engagement. In addition, these plans include components to equip volunteers: “We do capacity building to either volunteers or healthcare workers such as HSAs. Sometimes we even go beyond HSAs to other cadres like clinicians and nurses depending on what issue we are handling” ( Health Worker, Central Region). 3.8 Media Engagement VRE responses can also involve media engagement, either through the Health Education Unit at national level or the Health Education Promotion and District Information officer at District level. The Health Education Unit has a guideline that outlines what to expect and how to communicate whenever something new has happened. It also guides on the channels of communication and engagement that can be employed. All the Health Education and Health Promotion officers interviewed stated that they monitor the media and develop communications messages to rapidly respond to potential VREs. Media engagement also occurs through community radio Q&A programs or media visits to Health Facilities or District offices. The Health Education Unit in the Ministry of Health conducts community mobilization, sensitization and produces promotional materials. Respondents identified a variety of funding sources to support VRE response. In South Region, a respondent noted COVID-19 VRE plan implementation was supported with funding from international organizations, while another respondent from Central Region noted funding from Kamuzu University of Health Sciences. Others stated that their plans were either unfunded or that no funded source had been identified. 4.0 Discussion We assessed Malawi’s system readiness to implement a COVID-19 VRE response plan using a mixed methods assessment in ten Districts representing all three Regions. We found that elements of the VRE response plan were being implemented, particularly pertaining to the subset of AEFI-related VREs. To strengthen the AEFI-related structures, respondents recommended expanded training for AEFI identification and reporting among HSA and Health Promotions staff at Health Facility level, including incentivizing AEFI reporting to overcome fear and reprimand. Delays in reporting, investigation and feedback to the Health Facility and community were identified as crucial challenges in the current system. Respondents highlighted the unmet need to implement cohesive VRE response plan framework at District and Health Facility level, particularly with regards to community and social listening, VRE investigation feedback to community, and communication between surveillance and communication pillars. Respondents also highlighted the need to strengthen the identification and response to non-AEFI VREs. To achieve a fully functioning VRE response system, respondents recommended strengthening and standardizing the safety surveillance and infoveillance systems, including the investigation flow process feedback. To address reporting delays, there is a need to consider and use appropriate technologies for the rapid transmission for sensitive records. To achieve and sustain optimal system functioning, there is a need to invest in the sustained funding for VRE systems, particularly for community listening and community feedback mechanisms. These findings add to the literature by identifying system needs to implement a VRE response system in low- and middle- income countries. Similar concerns of reprisal were identified by Health Workers in Kenya ( 18 ) and highlight the need for both positive incentives to report VREs and regular training and mentorship to support Health Worker competencies in identifying VREs ( 19 ). The challenges in terms of providing feedback and incomplete investigations were also reported in Zimbabwe, however, partnership between institutions involved in immunizations and the regulatory authority was reported to have improved the surveillance ( 20 ). Phone applications have been successfully piloted to reduce delays in AEFI reporting and response in Germany ( 21 ); technological solutions like this could be further explored in lower resource settings. System assessments in Nigeria and Kenya also identified budget constraints as a key barrier to successful implementation of these systems ( 18 , 19 , 22 ). More research is needed to identify options to increase and sustain investment in VRE systems. Strengths and Limitations One key strength lies is the breadth of respondent perspectives, with over 100 health workers interviewed, representing ten Districts from the Health Facility to National level. It is the first assessment to evaluate Malawi’s readiness to implement a VRE response system, and the first VRE system readiness evaluation of which we are aware in an LMIC. However, several limitations should be considered. First, this assessment was cross-sectional and thus only represents the immediate time period following the development of Malawi’s VRE response plan, when COVID-19 funding was still available in country but before widespread dissemination of the plan itself. The ten Districts were purposively selected; however, they included respondents from ten Districts in each of Malawi’s three Regions. As a qualitative assessment, these findings are not meant to be representative of the health system overall; instead they provide in-depth thematic identification of key challenges in the VRE response system. 5.0 Conclusion This system readiness assessment identified the need to strengthen processes and communication within the health system and with the community. By fully implementing Malawi’s VRE response plan, Malawi’s health system can more readily identify, report, investigate and respond to VREs, safeguarding population health and bolstering confidences in vaccination. Declarations Author contribution Save Kumwenda (SK) reviewed the protocol, data collection tools, collected data, conducted data analysis and produced the first draft and participated in revising the manuscript for final submission, Mphatso Nyamasauka (MN) collected data, conducted the qualitative data analysis and helped in writing draft manuscript, Davis Makupe (DM) participated in data collection, conducted qualitative data analysis and participated in draft manuscript writing, Sandra Machiri (SM) reviewed the protocol, helped in drafting the manuscript, Nenani Chisema (NC) participated in protocol development, data collection and drafting of the manuscript, Mavuto Thomas (MT) helped in community mobilization, data collection and participated in draft manuscript writing, Rhoda Chado (RC) assisted community mobilization for data collection, data analysis and participated in draft manuscript writing, Alvin Phiri (AP) helped in reviewing the protocol, data collection and participated in draft manuscript writing, and Atupele Kapito (AK) led the protocol development, data analysis, data collection and draft manuscript writing. Acknowledgements The authors wish to thank all participants for sharing their rich experiences with Vaccine-Related Event response in all levels of the health system. We also wish to thank the data collectors, particularly Dr. Robert Thindwa, Nyokase Phiri Msiska, Chrissy Soda, Brian Kapito, Daisy Mtonga, Mavuto Yesaya and Thoko Makuwira for their efforts to recruit and interview participants. We extend thanks to the US-CDC team for technical and financial support including Jane Gidudu, Nuadum Muriel Konne, Sandra Kiplagat, and Kimberly E. Bonner. Funding: This assessment was funded by the Centers for Disease Control and Prevention. Clinical trial number: Not Applicable. Competing interests: All authors declare no conflicts of interested pertinent to this manuscript; all have provided their conflict-of-interest disclosures. Confirmation about methods: All authors confirm that all methods were carried out in accordance with relevant guidelines and regulations. Data Availability Data in form of transcripts, recordings and excel file is available upon request to the corresponding author. Ethical approval and consent to participate Before data was collected the study was cleared by the National Health Research Ethics committee (Protocol #23/02/3178). All subjects provided an informed written consent before participating in the study. Consent to publish All authors signed their consents to publish this manuscript and all subjects provided an informed written consent to participate in the study which included information that the data provided might be published after analysis. References Vaccine safety events. managing the communications response : a guide for ministry of health EPI managers and health promotion units. Copenhagen: World Health Organisation, Regional Office for Europe; 2013. Nnaji CA, Owoyemi AJ, Amaechi UA, Wiyeh AB, Ndwandwe DE, Wiysonge CS. Taking stock of global immunisation coverage progress: the gains, the losses and the journey ahead. Int Health. 2021;13(6):653–7. Christou-Ergos M, Wiley KE, Leask J. Willingness to receive a vaccine is influenced by adverse events following immunisation experienced by others. Vaccine. 2023;41(1):246–50. Motta M, Stecula D. The Effects of Partisan Media in the Face of Global Pandemic: How News Shaped COVID-19 Vaccine Hesitancy. Political Communication. 2023;40(5):505–26. Ni YH, Xu ZH, Wang J. Understanding vaccine hesitancy with PCV13 in children: Results of a survey in Shanghai, China. PLoS ONE. 2023;18(4):e0284810. Ministry of Health Z. COVID 19 Vaccine Related Events Response Plan (2022–2024). 2023. WHO. Global manual on surveillance of adverse events following immunization. Geneva; 2016. GPEI. Novel Oral Polio Vaccine Type 2 (nOPV2) Vaccine Related Event (VRE) Response Plan. 2022. WHO. WHO COVID-. 19 vaccines risk communication plan 2020 [Available from: https://www.who.int/groups/global-advisory-committee-on-vaccine-safety/topics/covid-19-vaccines/risk-communication-plan Nana Akosua A, Daniel W, Samuel Tamti C, Samuel Tomilola O, Enyonam D, Patrick A, et al. Barriers and strategies to improve vaccine adverse events reporting: views from health workers and managers in Northern Ghana. BMJ Public Health. 2025;3(1):e001464. Lubanga AF, Bwanali AN, Munthali L, Mphepo M, Chumbi GD, Kangoma M, et al. Malawi vaccination drive: An integrated immunization campaign against typhoid, measles, rubella, and polio; health benefits and potential challenges. Hum Vaccin Immunother. 2023;19(2):2233397. Africa CDC - COVID-19 Daily Updates: Africa CDC. 2023 [Available from: https://africacdc.org/covid-19/ UNICEF Wa. Estimates of immunization coverage in Malawi: 2022 2023 [Available from: Ao Q, Egolet RO, Yin H, Cui F. Acceptance of COVID-19 Vaccines among Adults in Lilongwe, Malawi: A Cross-Sectional Study Based on the Health Belief Model. Vaccines (Basel). 2022;10(5). WHO. Vaccine Safety Events: Managing the Communications REsponse. Copenhagen; 2013. WHO. Adverse Event Following Immunization AIDE-MÉMOIRE ON CAUSALITY ASSESSMENT. Geneva, Switzerland: World Health Organization. SPSS. SPSS Statistics 20. 2020. Masika CW, Atieli H, Were T, Knowledge. Perceptions, and Practice of Nurses on Surveillance of Adverse Events following Childhood Immunization in Nairobi, Kenya. Biomed Res Int. 2016;2016:3745298. Omoleke SA, Bamidele M, de Kiev LC. Barriers to optimal AEFI surveillance and documentation in Nigeria: Findings from a qualitative survey. PLOS Glob Public Health. 2023;3(9):e0001658. Nyambayo P, Manyevere R, Chirinda L, Zifamba E, Marekera S, Nyamandi T, et al. Descriptive Study of the Adverse Events Following Immunization (AEFIs) Surveillance System in Zimbabwe. Research Square; 2022. Nguyen MTH, Ott JJ, Caputo M, Keller-Stanislawski B, Klett-Tammen CJ, Linnig S, et al. User preferences for a mobile application to report adverse events following vaccination. Pharmazie. 2020;75(1):27–31. Omoleke SA, Getachew B, Isyaku A, Aliyu AB, Mustapha AM, Dansanda SM, et al. Understanding and experience of adverse event following immunization (AEFI) and its consequences among healthcare providers in Kebbi State, Nigeria: a qualitative study. BMC Health Serv Res. 2022;22(1):741. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7041748","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":502534699,"identity":"afd9ab4a-782d-4159-937e-4e9063da1297","order_by":0,"name":"Save 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Health","correspondingAuthor":false,"prefix":"","firstName":"Alvin","middleName":"","lastName":"Phiri","suffix":""},{"id":502534707,"identity":"be3faeb5-f153-4e60-86bf-61cdc27d3aea","order_by":8,"name":"Atupele Kapito","email":"","orcid":"","institution":"Kamuzu University of Health Sciences","correspondingAuthor":false,"prefix":"","firstName":"Atupele","middleName":"","lastName":"Kapito","suffix":""}],"badges":[],"createdAt":"2025-07-03 23:53:13","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7041748/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7041748/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":89558758,"identity":"6ca5f35f-0421-4a53-8721-2d72f3d39747","added_by":"auto","created_at":"2025-08-21 09:58:15","extension":"jpeg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":452751,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eDistricts included in VRE system readiness assessment, April—May 2023\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSource: https://d-maps.com/carte.php?num_car=4780\u0026amp;lang=en\u003c/p\u003e","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-7041748/v1/a68821c53ab5490bc2f1cc9a.jpeg"},{"id":89558757,"identity":"77b44bc0-7c81-424f-8508-3ae6193605db","added_by":"auto","created_at":"2025-08-21 09:58:15","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":77561,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eVRE reporting, Investigation and response process, Malawi\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"floatimage2.png","url":"https://assets-eu.researchsquare.com/files/rs-7041748/v1/4a1d0793204cea064a203865.png"},{"id":94645651,"identity":"93fef3be-a73b-4e86-aa64-222f8522d3b5","added_by":"auto","created_at":"2025-10-29 08:39:14","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1769830,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7041748/v1/223a348c-b55b-4826-aa11-bca1e413e15b.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Country readiness in responding to COVID-19 Vaccine-Related Events (VREs) in Malawi: a mixed methods readiness assessment April—May, 2023","fulltext":[{"header":"1.0 Background","content":"\u003cp\u003eVaccination has been shown to be an effective means of preventing infectious diseases and sustaining healthy populations. However, inadequate identification and response to vaccine-related events (VREs) can negatively affect the confidence in a vaccination program (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) and subsequently undermine efforts to achieve and sustain optimal vaccination coverage (\u003cspan additionalcitationids=\"CR3 CR4\" citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e). VREs include two broad categories: Adverse Events Following Immunization (AEFI) VREs and non-AEFI VREs, which include a new assessment or experimental data related to vaccines, press report or local rumor, suspension of vaccine, recall of vaccine or the replacement of a vaccine. AEFIs are reported through passive and active surveillance by healthcare workers while non-AEFI VREs are mainly reported by news organizations, social media monitoring, or community informants (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eWhile AEFI surveillance systems are well-established globally (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e), the broader conceptualization of VREs has been developed more recently by WHO, with guidance published in 2013 (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e), antigen-specific guidance for polio vaccine in 2022 (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) and for COVID-19 vaccine in 2020 (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). A VRE response system consists of a formalized process for identifying, reporting, investigating and responding to VREs in an integrated manner across health system levels and between vaccine safety focal points and health promotion teams. Despite the availability of guidance, gaps in training and cost have been attributed to delays in transitioning from AEFI surveillance into a unified system to detect and response to VREs (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eIn Malawi, recent declines in childhood immunization rates as well as suboptimal COVID-19 vaccination coverage indicate a need to bolster existing systems and potentially identify challenges related to VRE reporting and response (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e)(\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). Low COVID-19 vaccination coverage has been attributed to the spread of mis- and dis-information, rumors, information voids, and poor response to vaccine related events (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e) .\u003c/p\u003e\u003cp\u003eIn 2022, the Malawi Ministry of Health formalized its VRE response system and published a COVID-19 VRE response plan, disseminating it to focal points in all zones and districts in the country (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). This plan synthesizes guidance on AEFI surveillance, COVID-19 vaccine adverse events monitoring and surveillance in Malawi, and vaccine safety and VRE communication plans to provide a framework for distinguishing between known, perceived, and theoretical safety concerns that emerge following vaccination and with the goal of ensuring that information reaches various audiences including affected families and communities quickly (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eThus far, no assessment has been conducted to evaluate Malawi\u0026rsquo;s readiness to implement the COVID-19 VRE response plan. Our objective is to assess Ministry of Health readiness and ability to identify, report, investigate and respond to both types of VREs (AEFI and non-AEFI) in the initial period following the development of Malawi\u0026rsquo;s national plan in 2022. Our three primary aims were to: 1) document the availability of VRE-related documents and document VRE reporting and response activities; and 2) describe the overall process of identifying, reporting and investigating VREs and coordinating response; and 3) assess the strengths, weaknesses, and recommendations for improvement of the current VRE reporting and response system. From these findings, we aim to provide insights on the strengths and weaknesses of the current COVID-19 VRE response system, identify needs for enhancing effective VRE response activities, and offer a model to other countries introducing VRE response plans.\u003c/p\u003e"},{"header":"2.0 Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003e2.1 Assessment setting and design\u003c/h2\u003e\u003cp\u003eThis cross-sectional mixed-methods readiness assessment was conducted in ten districts, drawing from each of Malawi\u0026rsquo;s three Regions (North, Central and South) during April\u0026mdash;May, 2023. To ensure geographic representation and to be able to report findings by region, we purposively selected two districts in each of the five health zones, including the district that houses the zonal headquarters (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eFor the quantitative component of this assessment, we collected data from each health facility and district health office on the availability of VRE-related documents, the frequency and types of AEFIs and non-AEFI VREs reported by district, and the frequency of investigations and causality assessment meetings. For the qualitative component, we conducted key informant interviews (KIIs) with national and zonal coordinators, Integrated Disease Surveillance and Response (IDSR) focal points, and Health Promotion coordinators and focus group discussions (FGDs) with Health Facility staff and Health Surveillance Assistants to understand the current process for VRE identification, reporting, investigation and response as well as perspectives on the strengths, weaknesses, and capacities of the current system. Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e describes the location and role of participants as well as key thematic areas discussed in each group.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec4\" class=\"Section2\"\u003e\u003ch2\u003e2.2 Inclusion criteria and sampling\u003c/h2\u003e\u003cp\u003eIn each district, we purposively sampled participants from the District Health Office, the District hospital or Central hospital, and Health Facilities. For the capital city of Lilongwe, we sampled participants from the Central Hospital, Health Facilities, and National-level stakeholders. Inclusion criteria for participants included a role as a Health Worker involved in the immunization program at a National, District, and Health Facility level, being at least 18 years of age, willingness to have the discussion recorded and providing written informed consent to participate in the assessment. KII and FGD sample sizes were set with the expectation of reaching saturation in themes, with overall estimated sample size of 176 participants. We sought to quantitatively assess the availability of VRE-related documents by surveying the AEFI focal point or their designee at each site of qualitative data collection.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec5\" class=\"Section2\"\u003e\u003ch2\u003e2.3 Data collection and management\u003c/h2\u003e\u003cp\u003eData was collected using a pre-programmed checklist on Kobo Collect to assess the availability of VRE-related documents, the reported use of these documents in the event of a VRE, the presence of teams to investigate VREs, and the most recent number and types of AEFIs and non-AEFI VREs reported at each district and health facility visited. The VRE-related documents included a list of reportable AEFIs, guidelines for AEFI reporting, guidelines for AEFI investigation, guidelines for AEFI causality assessment, agenda from the most recent AEFI investigation meeting, minutes from the most recent COVID-19 causality assessment committee meeting, a community assessment plan or protocol, report or findings of previously conducted assessment, social media monitoring Standard Operating Procedures (SOP)/guidelines, social listening reports, crisis and risk communication plan and communication materials development plan.\u003c/p\u003e\u003cp\u003e We conducted semi-structured interviews with participants at the National level in English; District and Health Facility semi-structured interviews and focus groups were conducted using in English or Chichewa, depending on the preference of participants. Data collectors used a KII guide, FGD guide, and checklist to guide the discussion. We collected audio recordings of the interviews and discussions, and transcribed them, and translated the Chichewa transcriptions into English. No individually identifying information was collected.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec6\" class=\"Section2\"\u003e\u003ch2\u003e2.4 Measures and Analysis\u003c/h2\u003e\u003cp\u003eResponses to the quantitative elements were summed to the District level and reported by Region. Mzuzu and Rumphi Districts comprise the North Region; Dedza, Kasungu, Lilongwe, Salima Districts comprise the Central Region, and Blantyre, Mangochi, and Nsanje Districts comprise the South Region Districts included in this assessment.\u003c/p\u003e\u003cp\u003eThe quantitative analysis reported on the availability of VRE-related documents, with response options yes or no to the demonstration of document availability at the site. A visual confirmation of the documents was required before a data collector indicated the availability of a given document on the quantitative assessment. The use of VRE-related documents was self-reported as ever used or never used for each document. The availability of a team to investigate VREs was self-reported as yes or no. AEFI type (serious local reaction, seizure, abscess, sepsis, fever, headache, and other) and frequency were measured using the AEFI reporting forms in the six months preceding the assessment (November 2022\u0026mdash;March 2023) for each Health Facility. WHO standard definitions were used in the classification of adverse events following immunization (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e). Non-AEFI VREs reported were summed by District and reported by Region, along with a qualitative description for each. When the documents were applicable to both AEFIs and non-AEFI VREs, the overarching term VRE was used. When AEFI-specific elements, processes, or documents were mentioned, we describe these as AEFI.\u003c/p\u003e\u003cp\u003eWe calculated the count and proportion of all documents available for each VRE document type by District and Region, and then compared the proportion of all documents available by region using a chi-square test, with significance at p-value less than 0.05. We summed total number of AEFIs reported by type in the previous six months for each of the three Regions. All quantitative analyses were conducted using IBM SPSS Version 20 (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e). For the qualitative analysis, researchers collectively identified themes based on the interview and discussion guides and conducted an inductive thematic analysis of transcripts both manually and with Nvivo 14.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec7\" class=\"Section2\"\u003e\u003ch2\u003e2.5 Data Quality Assurance\u003c/h2\u003e\u003cp\u003e The research design was presented to research committees in the ten districts before submission to the National Health Research Ethics Committee which also reviewed it. All comments from the committees were discussed by authors and necessary revisions were made. The main revisions were on the target districts to be by zone and also suggestions on who to be interviewed at a health facility. After ethical approval, we recruited and trained data collectors. The data collectors had a minimum qualification of a university degree in Environmental Health, Medicine, Nursing and Social Sciences. These assisted in translating the tools, which were already translated to local language by authors before submission for ethical review, back to English to check if they were accurate and consistent. The tools were thereafter pre-tested in Chiradzulu in Southern Malawi. During data collection, the first author supervised the data collection process. Challenges met during each day of data collection were discussed and resolved before the next day. During data cleaning, questionnaires with more than 10% missing data were not included in the analysis.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\u003ch2\u003e2.6 Ethical Considerations\u003c/h2\u003e\u003cp\u003ePermission to conduct this assessment was sought and obtained from all the ten districts. The permission letters together with the protocol were sent and approved by the National Health Research Ethics committee (Protocol #23/02/3178). The Human Subjects Office at the Global Health Center at the US Centers for Disease Control and Prevention (CDC) reviewed this protocol for a non-research determination. Written informed consent was obtained from all health workers who participated in this study.\u003c/p\u003e\u003c/div\u003e"},{"header":"3.0 Results","content":"\u003cp\u003eWe conducted a total of 109 KIIs, of which 9.2% (10/109) were with National coordinators, 22.9% (25/109) with District-level EPI coordination, 19.3% (21/109) with District-level surveillance representatives, and 6.4% (7/109) with those involved in District-level health promotion activities (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). Six FGDs were conducted on VRE identification, reporting, investigation, and response; each included between six to eight Health Workers.\u003c/p\u003e\u003cp\u003e We collected quantitative data from 103 participants involved in VRE reporting, of which 74 surveys (71.8%) were of sufficient quality to be retained in the analysis. Of the responses analyzed, 29.9% (22/74) came from Health Facilities in the Central Region, 28.3% (21/74) from the North Region, and 41.8% 31/77) from the South Region. Thirty-three percent (24/74) were from District hospitals and the remaining 67% (50/74) were from Health Facilities (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eKII and FGD participants by role and region\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"5\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNorth\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eCentral\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eSouth\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eTotal\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCoordination (National, zonal)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e10\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eEPI Coordination\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e12\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e25\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eIntegrated Disease Surveillance and Response (IDSR) Coordination\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e10\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e21\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHealth Promotion Coordination\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e7\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHealth Facility staff\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e9\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e13\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e21\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e43\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHealth Surveillance Assistant\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e3\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTotal\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e22\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e40\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e47\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e109\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eRespondents to the quantitative survey by role and region\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"5\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNorth\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eCentral\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eSouth\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eTotal\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eEPI Coordination\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e13\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e28\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eIDSR Coordination\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e16\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHealth Facility staff\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e11\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e11\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e30\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTotal\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e20\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e24\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e30\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e74\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cdiv id=\"Sec10\" class=\"Section2\"\u003e\u003ch2\u003e3.1 Availability of documents, teams and VREs reported by Region\u003c/h2\u003e\u003cp\u003eAll respondents showed data collectors a list of reportable AEFIs, and more than 50% could produce guidelines for AEFI reporting available in their facility (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e). However, less than 50% of respondents could produce guidelines for AEFI investigation, guidelines for causality assessment, or if minutes from a recent COVID-19 causality assessment meeting had been recorded. More than 60% of survey respondents in Central and South Regions and 47% in North Region reported that their health facilities had a team available that could investigate VREs (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). Furthermore, staff from over 75% of health facilities reported that their health facility had a team that could respond to AEFI VREs after an investigation and over 59% of respondents in each Region reported that their Health Facility team had the capacity to respond to non-AEFI VREs. There was no significant difference in availability of teams in VRE investigation and response across regions (p\u0026thinsp;\u0026gt;\u0026thinsp;0.05).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eVRE Documentation and Self-reported Investigation Capacity by Region\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"5\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eCentral, n\u0026thinsp;=\u0026thinsp;22 (%)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eNorth, n\u0026thinsp;=\u0026thinsp;21 (%)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eSouth, n\u0026thinsp;=\u0026thinsp;31 (%)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eChi-square (p-value)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colspan=\"5\" nameend=\"c5\" namest=\"c1\"\u003e\u003cp\u003eProof of document availability at site\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eList of reportable AEFIs\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e22 (100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e21 (100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e31 (100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eNA\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGuideline for AEFI Reporting\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e17 (77.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e11 (52.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e23 (74.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e3.801 (0.150)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGuideline for AEFI Investigation\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e6 (27.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e7 (33.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e15 (48.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e2.692 (0.260)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGuideline for AEFI Causality assessment\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e4 (18.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e3 (14.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e1 (3.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e3.352 (0.187)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAgenda for the most recent AEFI investigation meeting\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e5 (22.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e8 (38.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e17 (54.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e5.577 (0.062)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMinutes for the recent AEFI causality assessment meeting\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1 (4.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e2 (9.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e1 (3.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e1.016 (0.602)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSocial media monitoring SOP/Guidelines\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e2 (9.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0 (0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e2 (6.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSocial listening reports\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e3 (13.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e5 (23.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e6 (19.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCrisis and Risk communications plan\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e3 (13.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0 (0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e1 (3.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCommunity engagement plan\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e9 (40.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e8 (38.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e5 (16.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e4.764 (0.092)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"5\" nameend=\"c5\" namest=\"c1\"\u003e\u003cp\u003e\u003cb\u003eReported capacity to complete activities at site\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDistinguishes between serious and non-serious VRE\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e14 (63.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e15 (71.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e23 (74.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.705 (0.703)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eInvestigates VRE\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e14 (63.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e10 (47.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e20 (64.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e1.709 (0.425)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAssesses causality for VREs deemed not serious\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e5 (22.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e2 (9.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e3 (9.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e2.274 (0.425)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eResponds to AEFI VRE after investigation\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e20 (90.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e16 (76.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e27 (87.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e2.001 (0.368)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eResponds to non-AEFI VREs\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e13 (59.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e14 (66.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e22 (71.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.814 (0.666)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eRespondents from all Regions reported using the AEFI reporting form to record at least one VRE in the previous six months. Respondents from all regions identified non-AEFI VREs (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eVRE reported by health facility across all antigens by type and by region from November 2022\u0026mdash;March 2023\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"4\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eCentral (N\u0026thinsp;=\u0026thinsp;22)\u003c/p\u003e\u003cp\u003eN (%)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eNorth (N\u0026thinsp;=\u0026thinsp;21)\u003c/p\u003e\u003cp\u003eN (%)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eSouth (N\u0026thinsp;=\u0026thinsp;31)\u003c/p\u003e\u003cp\u003eN (%)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSerious local reaction\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e1 (4.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e7 (33.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e5 (16.1)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSeizures\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e0 (0.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e2 (9.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e7 (22.6)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAbscess\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e17 (77.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e13 (61.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e26 (83.9)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSepsis\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e0 (0.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e2 (9.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e5 (16.1)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHeadache\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e3 (13.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e8 (38.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e15 (48.4)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eFever\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e18 (81.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e17 (81.0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e23 (74.2)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eOther AEFI\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e3 (13.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e2 (9.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e2 (6.4)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNon-AEFI VREs\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e3 (13.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e3 (14.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e8 (25.8)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eThe other mentioned AEFIs were thrombocytopenia (reported twice in Central Regions), upper respiratory infection (reported twice in Northern and Southern Regions) and anaphylactic shock (reported once in Central Region). The commonly reported VREs were mainly AEFIs including severe local reaction to injections followed by fever, abscess, and headache.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\u003ch2\u003e3.2 Qualitative Findings: Process for identifying, reporting, investigating, and responding to VREs\u003c/h2\u003e\u003cp\u003eKII respondents described the overall process for identifying, reporting, and investigating VREs and response coordination. Conversely, non-AEFI VRE elements, documents and processes were explicitly identified as such. VRE communication and reporting system began at community level, where community members reported VREs to their respective Health Surveillance Assistants (HSAs) or Village Health Committees or volunteers (VHCs) or directly to the Health Facility staff. The VHCs report to the Health Facilities through senior HSAs or healthcare workers. The first healthcare worker to receive notification of a VRE is the person who is then responsible for completing a VRE (commonly known as AEFI assessment form in health facilities) reporting form and sending either to a clinician or their immediate supervisor for further assessment. If the VRE is determined not to be serious, the cases are reported but not referred to the District; they are dealt with by the health workers at the health facility. Health facility staff recorded VREs on paper forms, known as AEFI reporting forms, but they typically transmitted these forms digitally to District focal points via WhatsApp.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;In terms of coordination, I can say is ok, for the people who have been trained on how to detect a VRE case, they are able to link. When clinician has seen a case, he is able to link with an HSA to say here is a case we need to report. We use the technical guides in training of the community, religious and health care workers.\u0026rdquo; (\u003c/em\u003eHealth care worker, South Region)\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eIf the VRE is classified as serious, the report is then sent to the District EPI coordinator and IDSR coordinator who can make determination or refer to the Zonal and National-level Expanded Program on Immunization (EPI) Unit. The EPI Unit can investigate the VRE and make a determination or can refer the VRE to the Causality Assessment Committee (CAC) (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). The CAC is a component of Pharmacy and Medical Review Association responsible for medicine safety and quality.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eFollowing the decision of the National Causality Committee, these findings are transmitted to the EPI Unit at national level, then to the Zonal office and District VRE investigation committee, and finally to the Health Facility staff who reported the VRE for follow up with the case, caregivers of the case, and community. When the causality assessment is made at a lower level of the health system, the findings are meant to be conveyed back to the community using a similar process as the national causality committee determination. Most of the Health Facility staff queried had experience reporting AEFIs to the District EPI coordinator and to the National EPI division, but none reported that these AEFIs were then escalated to the PMRA Causality Assessment Committee (CAC) for causality assessment.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\u003ch2\u003e3.3 VRE reporting: Strengths and Weakness identified\u003c/h2\u003e\u003cp\u003eThematic responses on the VRE system are outlined in Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e. All respondents explained that they use both paper based and WhatsApp via mobile phones for reporting VREs to the next level of the health system. Health facilities staff noted that they reported VREs using paper forms but submitted the forms electronically to the District via WhatsApp. At District level, the data is then entered into District Health Information System 2 (DHIS 2) through the Health Information Management System (HIMS). However, district-level difference in reporting processes were observed, notably that the District VRE investigation committee frequently bypassed the Zonal office and sent VRE investigation requests directly to the National EPI unit.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab5\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 5\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eKey issues and findings identified through KIIs and FGDs by District November 2022\u0026mdash;March 2023\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"4\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMain Themes Key issue\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eKey findings\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eVerbatim examples\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eDistricts mentioned\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"4\" rowspan=\"5\"\u003e\u003cp\u003eDocumentation for VRE planning, identification, reporting and response\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eList of reportable AEFIs is available in almost all health facilities and AEFI reporting forms\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u0026ldquo;\u003cem\u003eHere, we have a list reportable AEFIs and also the AEFI reporting forms\u0026rdquo;.\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eNsanje, Salima, Blantyre, Mangochi, Dedza, Mangochi, Mzuzu, Rumphi, Lilongwe, Kasungu\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eSocial listening is done in some districts and reports are generated\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;The social listening reports are very useful to us, and we always encourage speaking out on these issues because when going with interventions in the community, the issues that has been presented are incorporated so that the fears and challenges that may be there are cleared out\u003c/em\u003e.\u0026rdquo;\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eRumphi, Mangochi, Kasungu\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eVRE plan not available\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u0026ldquo;We do not have a VRE plan\u0026rdquo;\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eLilongwe, Mzuzu, Dedza, Rumphi, Salima, Zomba\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNo documentation for rumours and community engagement\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;For rumours, we utilize the opportunity when there are local leader\u0026rsquo;s meetings. These are informal and not documented\u0026rdquo;.\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eMzuzu, Nsanje, Mangochi, Zomba, Kasungu, Dedza, Lilongwe, Rumphi\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eCOVID-19 VRE plan available\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u0026ldquo;Yes, I have a copy of the COVID-19 VRE plan for Malawi\u0026rdquo;.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eLilongwe\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e\u003cp\u003eCommittees for VRE response\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eCausality assessment is done at national level. It is done by the Medicine Safety and Quality Monitoring Committee (MSQMC) at national level\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u0026ldquo;\u003cem\u003eOf course I can say, at the district we don\u0026rsquo;t have the causality assessment team, in fact ours we do just the investigations. Causality assessment is done at national level\u0026rdquo;.\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eAll the ten districts including PMRA\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eThe health centres do not have VRE investigation committees.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;Once the VRE has been identified as serious here at health centre, we report to the district for investigations\u0026rdquo;.\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eAll the ten districts\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eHealth Centres are willing to establish VRE investigation committees\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;Despite not having an investigation committee, we are able and ready to investigate\u0026rdquo;.\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eKasungu, Dedza, Rumphi\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eVRE response Coordination and reporting\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eFormal structures for coordination and reporting available from health centre level\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u003cem\u003e \u0026ldquo;I know that the guidelines are there talk on how we should organize ourselves, prepare for the investigations, things that would need to be investigated, seek help, report to the administration, etc. These are some of the things I can remember\u0026rdquo;.\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eAll ten districts\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eCoordination and reporting of VRE by-passes the zonal coordinators\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;As a zone we don\u0026rsquo;t respond to AEFIs because we are not directly involved since the reports go straight to the national but the strength that we have is that we do capacity building by playing a supervisory role to see how things are going about and provide expertise\u0026rdquo;.\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eMzuzu, Salima, Lilongwe\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eCommunity listening\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eThere are no formal structures for community listening are not available; however, others use Health Advisory Committees, Community Health Action Groups and others like hotlines\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;We do not have formal written procedures for community listening and reporting\u0026hellip;.\u0026rdquo;.\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eDedza, Kasungu, Lilongwe, Mangochi, Mzuzu, Nsanje, Rumphi, Salima, Zomba\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eHSAs are supposed to do community listening\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u0026ldquo;\u003cem\u003eEach and every HSA is supposed to conduct community assessment and listening activities in their areas. We give our micro plans to the [Senior HAS] SHSA who compiles them and make a plan for the facility\u0026rdquo;.\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eBlantyre, Zomba, Mzuzu\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMedia engagement\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMainly done at District Level and National Level by HPO. Health centre engagement is done after getting permission from the district\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;Media engagement is only done at national and district level by going through the health education unit which has a spokesperson who talks on behalf of the Ministry of Health\u0026rdquo;.\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eMzuzu, Mangochi, Dedza, Zomba\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eVRE response plan\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eAll did not have the VRE plan except one officer in Lilongwe and Blantyre districts who had the COVID-19 VRE plan\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;I got the COVID-19 VRE plan during the meeting\u0026hellip;\u0026rdquo;.\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eLilongwe, Blantyre\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eCOVID-19 VRE plan is similar to what could be the plan for all antigens\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;VREs plan for COVID-19 vaccination needs to be inclusive of all the other vaccines\u0026hellip;\u0026hellip;\u0026rdquo;.\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eZomba, Nsanje, Salima, Mangochi, Lilongwe\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eChallenges in VRE response\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eDelayed or no feedback form the district and national level on VRE investigations\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;The challenge is that feedback is not there in most cases unless if it\u0026rsquo;s a special case\u0026hellip;\u0026rdquo;.\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eAll\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCommunity misinformation and myths\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eCommunity misinformation and myths\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;Some myths and misinformation affect vaccine uptake in the district\u0026rdquo;.\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eLilongwe, Mangochi, Mzuzu, Dedza, Nsanje, Zomba\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eHealth facility training, coordination, and hesitation to report\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eDifficult for HSAs to report AEFIs from cases they themselves vaccinated\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;Some clients find it easy to report the VRE to HSAs but the HSAs sometimes do not report to use especially if they were the ones administering the vaccination\u0026rdquo;.\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eLilongwe, Blantyre, Zomba\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eBlame game between health worker cadres for low detection and reporting of VREs\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;\u0026hellip;some cadres accuse others of causing VRE and also of not reporting them\u0026rdquo;.\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eMzuzu, Kasungu, Mangochi and Zomba\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e\u003cp\u003eLessons Learnt\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eHealth Advisory Committee (HAC) helps in solving misinformation\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;During community meetings to discuss VREs, we involve HAC members because they stay in the community and are easily understood\u0026rdquo;.\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eNsanje, Salima, Rumphi, Mzuzu, Blantyre, Dedza, Mangochi, Zomba\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNeed to use non-technical language during media engagement, community engagement meeting and also during training of health workers\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;In addition to that, sometimes the media changes the meaning of the message that was intended for the communities because some messages are presented in technical terms\u0026hellip;\u0026rdquo;.\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eSalima, Mangochi, Zomba, Mzuzu, Lilongwe, Dedza, Rumphi\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eSolution to allowance culture is by holding meetings in communities\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;The community have great expectations that they will get allowances whenever they attend a community listening session outside their village\u0026rdquo;.\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eDedza\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eRespondents noted that the VRE reporting process was challenging due to resource constraints and data management issues. Delays in transmitting reports to the district level were attributed to inadequate staff with the authorization to report VREs, limited transportation resources to transmit paper-based reports to District level, uneven and expensive mobile network coverage to transmit electronic VRE reports to District level. Furthermore, respondents highlighted that these paper reports are not always documented and stored in easily-accessible registries, leading to increased risk of losing documentation pertaining to the VRE. Additionally, some Health Workers expressed fear of reprimand or blame for reporting VREs against themselves or fellow workers regardless of the reason for the event.\u003c/p\u003e\u003cp\u003eHealth Facility-level respondents noted challenges in both the identification of VREs at the community-level and reporting at the Health Facility level. A Health Worker in the Central Region added that the challenges start from the community level and HSAs because AEFIs are considered as normal outcomes and not reported to the Health Workers:\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u0026ldquo;\u003cem\u003eThe people in the communities are not able to identify VREs especially AEFIs. I remember this other time, I went to the field, I found a mother and she told me not to vaccinate the child on the spot I wanted and she showed me the spot where she wanted her child to be vaccinated. When I asked the reason, she showed an abscess which had healed. And when I asked her how the child got that, the mother said that after the child received the vaccine, the child developed that and the mother took the child to a private clinic where they blew up the abscess. This means that the mother did not consider that a VRE, had it been the mother reported to the facility, it would have been recorded in the VRE form\u003c/em\u003e\u0026rdquo; (Health care worker, Central Region).\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eKII with a health care worker in the South Region indicated that not all the staff are familiar with the reporting system, inadequate coordination among health care workers to record VREs, and suboptimal referral practices to appropriate personnel for recording and investigation.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;When the challenge is on the vaccine, then reports go to the district office but when there are AEFIs caused by the vaccine administrator like abscess, they are dealt with at the facility and later we meet the concerned personnel and inform them on proper administration of vaccines\u0026rdquo;\u003c/em\u003e (Health worker, South Region).\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eHealth Workers from Central and South Regions reported instances that Health Workers provided treatment for AEFIs without recording these AEFIs on the reporting forms. Furthermore, the respondents expressed a need to train VHCs on the VREs. However, there were respondents from each of the Regions who indicated that there no challenges with VRE coordination and reporting.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;We are trying to have health talks but also Continuous Professional Development meetings where we can discuss issues on pharmacovigilance so that every clinician and nurse should know what to do where and where to report in case, they meet such a case. Especially on the issue of reporting we don't have a clear system so sometimes you feel like for you to start the reporting system, you waste time but if it is a proper reporting system it's easier to do\u0026rdquo;\u003c/em\u003e (Health care worker, South Region).\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eAlthough the process for VRE reporting is meant to go from District to Zone and National level, actual reporting often bypasses Zonal offices and respondents reported circumstances where Zonal staff received notification of VREs in their Zone following the receipt of a National-level investigation and response.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;Don\u0026rsquo;t even bother because we don\u0026rsquo;t have database so we need to ask from the national office. I can\u0026rsquo;t say I will extract from DHIS 2 because it only gives numbers and not all details on type of VREs but I know there is need to have a database that one can easily access information from of course with rights,\u0026rdquo;\u003c/em\u003e (Health care worker, North Region).\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec13\" class=\"Section2\"\u003e\u003ch2\u003e3.3 Opportunities to Strengthen VRE Investigations\u003c/h2\u003e\u003cp\u003eFollowing the identification of a VRE, health workers are responsible for referring the case to the HSAs, who document the VRE on official reporting forms and either investigating the VRE or referring the case to the relevant health worker for assessment. Some health workers reported that they did not know the steps required to complete the VRE investigation process. One respondent explained that although EPI coordinators participate in VRE investigation teams, the infrequency of investigations leads to a lack of experience and subsequent uncertainty on how to undertake an investigation.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;I know that the guidelines are there talk on how we should organize ourselves, prepare for the investigations, things that would need to be investigated, seek help, report to the administration, etc. These are some of the things I can remember. Maybe because we haven\u0026rsquo;t had a serious VRE case requiring an investigation so I think my team members cannot know all these steps as well. It can be a very tough issue if we can have an VRE case requiring investigation today\u003c/em\u003e\u0026rdquo; (Health Worker, North Region\u003cem\u003e).\u003c/em\u003e\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eRespondents in the North, Central and South Regions noted that the responsibility for distinguishing serious and minor VREs was not consistently assigned. One health worker in Central Region noted that HSAs were responsible for distinguishing, while another in Central Region indicated that the health worker was responsible for this determination, and a third respondent could not determine the role responsible for this decision.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;We don\u0026rsquo;t have that team which distinguishes the VREs because when VRE comes usually it\u0026rsquo;s the clinician who is the first contact, sometimes the clinician asks the EPI focal or SHSA to discuss about the VRE and if it\u0026rsquo;s serious it\u0026rsquo;s referred to higher level and minor ones are observed at the health facility\u003c/em\u003e\u0026rdquo; (Health care worker, South Region).\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eHealth Workers in each Region noted that that serious AEFIs had been detected in their health facility, with symptoms ranging from paralysis to seizures, abscess and convulsions. However, some respondents noted that there had not been any serious AEFIs reported for the past six months or have never registered any serious AEFI case. Health Workers in the Central Region added that when there is a serious AEFI and the facility cannot handle it, the patients are referred to the medical short stay at the Regional hospital, for advanced diagnostics. The investigations are done at District level and the findings are documented and sent to National EPI office. One Health Worker described the investigation process from District level:\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u0026ldquo;\u003cem\u003eWhen the case was reported to the [District Health Officer], we followed up that case\u0026hellip;. We wanted to understand what happened to the child, what vaccine did the child receive, batch number of the vaccine, what time was the child vaccinated, after vaccination what happened up until the parents reported to the hospital. The investigations were conducted in 2 days, the first day they went to investigate at the health centre then the second day they went to the health center then thereafter to the village\u003c/em\u003e\u0026rdquo; (Health care worker, South Region).\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec14\" class=\"Section2\"\u003e\u003ch2\u003e3.4. Causality Assessment on the reported serious AEFIs\u003c/h2\u003e\u003cp\u003eRespondents from seven Districts reported that their Districts had not established District-level causality assessment committees; thus, causality assessment could not occur at the district level. District-level respondents from all three Regions further explained that they are only responsible for investigations and that causality assessments are conducted at National level by the Ministry of Health, WHO, pharmacovigilance and other key stakeholders.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;Of course, I can say, at the district we don\u0026rsquo;t do the causality assessment and we do not have that team, in fact ours we do just the investigations\u0026rdquo;\u003c/em\u003e (Health Worker, South Region).\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec15\" class=\"Section2\"\u003e\u003ch2\u003e3.5 Responding to VREs\u003c/h2\u003e\u003cp\u003eRespondents at all levels of the health system emphasized the importance of sharing the results of an investigation and causality assessment with community members to build and sustain trust between the community and the health system. Following an investigation or upon receiving the results of a causality assessment, the DHO is responsible for calling the facility in-charge or EPI focal person, who then shares the findings with the case, the caregivers of the case, and surrounding community. While most respondents did not report experience with responding to non-AEFI VRE investigations, one respondent from the North Region reported that investigation findings from two non-AEFI VREs had been addressed by the District-level Health Education team. Respondents from Health Facilities noted infrequent dissemination of investigations and causality assessments from either the National level or the Districts. One FGD participant in Central Region attributed these inconsistencies to the lack of formal processes for responding to VREs:\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;I remember there was one woman whose child had an AEFI where the injection site got hardened and darkened, she went to the HSA in the community who referred the client to the Clinician here and after the Clinician examined the child he said the injection site has recovered therefore no medication was required so she was sent home. The HSA later followed the client to her home and provided some health talk to those surrounding\u0026rdquo;\u003c/em\u003e (Health Worker in Central Region)\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eFor serious AEFIs, respondents noted that the investigations are supposed to start within 24 hours if reported directly to the facility and 72 hours if identified in the community. However, respondents in Central Region noted that investigations typically did not begin until two weeks after the identification of a serious AEFI. Investigation delays were attributed to lack of clinical staff availability, inadequate supplies of stationary and AEFI reporting forms, lack of allowances, and no dedicated fuel for transport of the AEFI reporting forms. Respondents suggested that timeliness of investigations could be improved with faster identification and reporting of VREs to the District and National level.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;When a serious VRE is investigated, it goes from a facility level, to district and then national level. It is at the national level where it is delayed because the national level comes and conducts its own investigation\u0026rdquo;\u003c/em\u003e (Health Worker, South Region).\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eKey informants noted that investigation findings were meant to be transmitted to the community, but this feedback did not often reach the community.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;The challenge is that feedback [from the CAC] is not there in most cases unless if it\u0026rsquo;s a special case, for example when COVID-19 vaccine was just initiated there was feedback in most cases that were being reported and the reason could be because there were a lot of rumors (Non AEFIs) so it was one way of clearing the rumor and also the VREs were new to health workers. For routine immunization, feedback was not frequently done\u0026rdquo;\u003c/em\u003e (Health care worker, South Region).\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec16\" class=\"Section2\"\u003e\u003ch2\u003e3.5 Considerations for non-AEFI VREs: Community and social listening\u003c/h2\u003e\u003cp\u003eRespondents in all three Regions highlighted the absence of guidance documents and assessments on community and social listening at the District and Health Facility-level. However, respondents in both the North and South Regions asserted that community assessment and microplanning activities were ongoing, led by HSAs. In addition, one respondent from South Region noted that HSAs also routinely receive social reports from community members and during Health Facility interactions.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u0026ldquo;\u003cem\u003eEach and every HSA is supposed to conduct assessment activities in their areas. We give our micro plans to the [Senior HAS] SHSA who compiles them and make a plan for the facility. On reports, every HSA writes a report when they find a VRE case and give it to the SHSA\u003c/em\u003e\u0026rdquo; (Health Worker, North Region).\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eCommunity listening sessions varied by District, with some noting that these sessions are regularly conducted during bi-monthly outreach sessions or by mobile phones and others reporting no activities in the previous six months.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;These outreach clinics are done once or twice a month. As a facility, we do not have community listening tools but rather we get information through personal mobile phones as other community members have our phone numbers and they contact us anytime\u0026rdquo; (\u003c/em\u003eHealth Worker, South Region\u003cem\u003e)\u003c/em\u003e\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eHealth Facilities staff reported community listening conduits, including community meetings with local leaders, Facebook pages, Community Health Action groups (CHAG), Health Advisory Committee (HAC), Area Development Committee (ADC), Village Health Committees (VHCs), Village Development Committees (VDC), suggestion boxes, Health promoters, an ombudsman office at the facility and encouraging community to report anything to the nearest Health Facility or the HSAs in their catchment area. Supplemental resources during the COVID-19 pandemic supported community listening through a phone hotline, community listening sessions, or radio call-in shows.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;Sometimes we have panel discussions on community radios, we have three community radios \u0026hellip; so sometimes we utilize these to have panel discussions where the community are given time to ask questions through phone calls and we respond to them immediately or we just give the message via the radio and I give my number so that in case someone has a question should call directly to me and be explained to individually\u0026rdquo;\u003c/em\u003e (Health Worker, South Region).\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eMost respondents stated that their Health Facilities do not produce or have access to social listening reports. Three respondents, one from Central Region and two from South Region, noted that their District developed social listening reports. Each described a process of sharing social listening reports at District level with the HPO, DHO, and HMIS focal points, then disseminated either the social listening report or a strategy to address the VREs identified to HACs. Most respondents indicated that informal social listening channels existed to address rumors through community engagement with local leaders, religious leaders and influential leaders, HAC, VDC, health education services like health talks, and community interface meetings.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;We utilize the opportunity when there are local leader\u0026rsquo;s meetings. [He] invites HSAs to his meetings and at some point\u0026hellip; said that he wants his chiefs to be exemplary by getting vaccinated in their vaccination sites. Apart from this we established a committee known as Champions committee composed of chiefs, youths, women who got vaccinated of COVID-19 vaccine specifically all the 2 doses or booster. So, their main role is to sensitize the community on COVID-19 vaccine and dispelling all the rumors surrounding the vaccine\u0026rdquo;\u003c/em\u003e (Health Worker, Central Region).\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec17\" class=\"Section2\"\u003e\u003ch2\u003e3.7 Coordination mechanism\u003c/h2\u003e\u003cp\u003eA well-functioning VRE response system requires strong coordination between both community members and the health system as well as within health system structures. In particular, health Facility and District-level coordination between surveillance and communication focal points requires strengthening for effective VRE response. Respondents noted several opportunities for strengthening coordination between the surveillance and communication structures. The respondent in the Central Region noted that training on VREs had only included HSAs and recommended expanding training offerings on VRE to the relevant communications and health promotions focal points. Some respondents highlighted the availability and use of an overarching crisis and risk management plan as a crucial element of their successful coordination across stakeholders, while others cited the absence of this plan in their district as a barrier to proactive coordination. Some respondents noted that their district team developed risk communication plans on an as-needed basis to tailor planning for the specific issue arising. These plans are implemented through local key stakeholders such as local leaders and can included dedicated resources for community engagement. In addition, these plans include components to equip volunteers:\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;We do capacity building to either volunteers or healthcare workers such as HSAs. Sometimes we even go beyond HSAs to other cadres like clinicians and nurses depending on what issue we are handling\u0026rdquo; (\u003c/em\u003eHealth Worker, Central Region).\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec18\" class=\"Section2\"\u003e\u003ch2\u003e3.8 Media Engagement\u003c/h2\u003e\u003cp\u003eVRE responses can also involve media engagement, either through the Health Education Unit at national level or the Health Education Promotion and District Information officer at District level. The Health Education Unit has a guideline that outlines what to expect and how to communicate whenever something new has happened. It also guides on the channels of communication and engagement that can be employed. All the Health Education and Health Promotion officers interviewed stated that they monitor the media and develop communications messages to rapidly respond to potential VREs. Media engagement also occurs through community radio Q\u0026amp;A programs or media visits to Health Facilities or District offices. The Health Education Unit in the Ministry of Health conducts community mobilization, sensitization and produces promotional materials.\u003c/p\u003e\u003cp\u003eRespondents identified a variety of funding sources to support VRE response. In South Region, a respondent noted COVID-19 VRE plan implementation was supported with funding from international organizations, while another respondent from Central Region noted funding from Kamuzu University of Health Sciences. Others stated that their plans were either unfunded or that no funded source had been identified.\u003c/p\u003e\u003c/div\u003e"},{"header":"4.0 Discussion","content":"\u003cp\u003eWe assessed Malawi\u0026rsquo;s system readiness to implement a COVID-19 VRE response plan using a mixed methods assessment in ten Districts representing all three Regions. We found that elements of the VRE response plan were being implemented, particularly pertaining to the subset of AEFI-related VREs. To strengthen the AEFI-related structures, respondents recommended expanded training for AEFI identification and reporting among HSA and Health Promotions staff at Health Facility level, including incentivizing AEFI reporting to overcome fear and reprimand. Delays in reporting, investigation and feedback to the Health Facility and community were identified as crucial challenges in the current system.\u003c/p\u003e\u003cp\u003eRespondents highlighted the unmet need to implement cohesive VRE response plan framework at District and Health Facility level, particularly with regards to community and social listening, VRE investigation feedback to community, and communication between surveillance and communication pillars. Respondents also highlighted the need to strengthen the identification and response to non-AEFI VREs. To achieve a fully functioning VRE response system, respondents recommended strengthening and standardizing the safety surveillance and infoveillance systems, including the investigation flow process feedback. To address reporting delays, there is a need to consider and use appropriate technologies for the rapid transmission for sensitive records. To achieve and sustain optimal system functioning, there is a need to invest in the sustained funding for VRE systems, particularly for community listening and community feedback mechanisms.\u003c/p\u003e\u003cp\u003eThese findings add to the literature by identifying system needs to implement a VRE response system in low- and middle- income countries. Similar concerns of reprisal were identified by Health Workers in Kenya (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e) and highlight the need for both positive incentives to report VREs and regular training and mentorship to support Health Worker competencies in identifying VREs (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). The challenges in terms of providing feedback and incomplete investigations were also reported in Zimbabwe, however, partnership between institutions involved in immunizations and the regulatory authority was reported to have improved the surveillance (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e). Phone applications have been successfully piloted to reduce delays in AEFI reporting and response in Germany (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e); technological solutions like this could be further explored in lower resource settings. System assessments in Nigeria and Kenya also identified budget constraints as a key barrier to successful implementation of these systems (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e). More research is needed to identify options to increase and sustain investment in VRE systems.\u003c/p\u003e\u003cp\u003e\u003cb\u003eStrengths and Limitations\u003c/b\u003e\u003c/p\u003e\u003cp\u003eOne key strength lies is the breadth of respondent perspectives, with over 100 health workers interviewed, representing ten Districts from the Health Facility to National level. It is the first assessment to evaluate Malawi\u0026rsquo;s readiness to implement a VRE response system, and the first VRE system readiness evaluation of which we are aware in an LMIC. However, several limitations should be considered. First, this assessment was cross-sectional and thus only represents the immediate time period following the development of Malawi\u0026rsquo;s VRE response plan, when COVID-19 funding was still available in country but before widespread dissemination of the plan itself. The ten Districts were purposively selected; however, they included respondents from ten Districts in each of Malawi\u0026rsquo;s three Regions. As a qualitative assessment, these findings are not meant to be representative of the health system overall; instead they provide in-depth thematic identification of key challenges in the VRE response system.\u003c/p\u003e"},{"header":"5.0 Conclusion","content":"\u003cp\u003eThis system readiness assessment identified the need to strengthen processes and communication within the health system and with the community. By fully implementing Malawi\u0026rsquo;s VRE response plan, Malawi\u0026rsquo;s health system can more readily identify, report, investigate and respond to VREs, safeguarding population health and bolstering confidences in vaccination.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAuthor contribution\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSave Kumwenda (SK) reviewed the protocol, data collection tools, collected data, conducted data analysis and produced the first draft and participated in revising the manuscript for final submission, Mphatso Nyamasauka (MN) collected data, conducted the qualitative data analysis and helped in writing draft manuscript, Davis Makupe (DM) participated in data collection, conducted qualitative data analysis and participated in draft manuscript writing, Sandra Machiri (SM) reviewed the protocol, helped in drafting the manuscript, Nenani Chisema (NC) participated in protocol development, data collection and drafting of the manuscript, Mavuto Thomas (MT) helped in community mobilization, data collection and participated in draft manuscript writing, \u0026nbsp;Rhoda Chado (RC) assisted community mobilization for data collection, data analysis and participated in draft manuscript writing, Alvin Phiri (AP) helped in reviewing the protocol, data collection and participated in draft manuscript writing, and Atupele Kapito (AK) led the protocol development, data analysis, data collection and draft manuscript writing.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors wish to thank all participants for sharing their rich experiences with Vaccine-Related Event response in all levels of the health system. We also wish to thank the data collectors, particularly Dr. Robert Thindwa, Nyokase Phiri Msiska, Chrissy Soda, Brian Kapito, Daisy Mtonga, Mavuto Yesaya and Thoko Makuwira for their efforts to recruit and interview participants. We extend thanks to the US-CDC team for technical and financial support including Jane Gidudu, Nuadum Muriel Konne, Sandra Kiplagat, and Kimberly E. Bonner.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis assessment was funded by the Centers for Disease Control and Prevention.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eClinical trial number:\u003c/strong\u003e Not Applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll authors declare no conflicts of interested pertinent to this manuscript; all have provided their conflict-of-interest disclosures.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConfirmation about methods: \u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll authors confirm that all methods were carried out in accordance with relevant guidelines and regulations.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData Availability\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData in form of transcripts, recordings and excel file is available upon request to the corresponding author.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthical approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBefore data was collected the study was cleared by the National Health Research Ethics committee (Protocol #23/02/3178). All subjects provided an informed written consent before participating in the study.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent to publish\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll authors signed their consents to publish this manuscript and all subjects provided an informed written consent to participate in the study which included information that the data provided might be published after analysis.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eVaccine safety events. managing the communications response : a guide for ministry of health EPI managers and health promotion units. Copenhagen: World Health Organisation, Regional Office for Europe; 2013.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eNnaji CA, Owoyemi AJ, Amaechi UA, Wiyeh AB, Ndwandwe DE, Wiysonge CS. Taking stock of global immunisation coverage progress: the gains, the losses and the journey ahead. 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User preferences for a mobile application to report adverse events following vaccination. Pharmazie. 2020;75(1):27\u0026ndash;31.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eOmoleke SA, Getachew B, Isyaku A, Aliyu AB, Mustapha AM, Dansanda SM, et al. Understanding and experience of adverse event following immunization (AEFI) and its consequences among healthcare providers in Kebbi State, Nigeria: a qualitative study. BMC Health Serv Res. 2022;22(1):741.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Vaccine related events (VREs), vaccination, community engagement, feedback, training, adverse effect following immunization and Malawi, VRE response plan, vaccine safety preparedness","lastPublishedDoi":"10.21203/rs.3.rs-7041748/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7041748/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eThe Malawi Ministry of Health and partners developed a comprehensive COVID-19 VRE response plan in 2022. We explored MoH readiness to implement the plan by assessing the availability of VRE-related documents describing overall process of identifying, reporting, investigating, and coordinating a VRE response; and assessing the strengths, weaknesses and recommendations for improvements in the current system. We conducted a cross-sectional mixed methods assessment among MoH staff involved in VRE response at national, district, and health facilities levels using a survey and a semi-structured interview guide in ten districts in Malawi during April\u0026mdash;May, 2023. Availability of ten VRE-related documents was assessed and visually confirmed. We assessed the count of each of the survey findings by district and zone. Ten key themes pertaining to VRE identification, reporting, investigation and response were explored in 109 Key Informant Interviews (KIIs) and six Focus Group Discussions (FGDs). Of the 109 KIIs, 91% of those interviewed worked at District or Health Facility levels. We conducted 6 FGDs at the Health Facility level. We analyzed 74 survey responses. More than 60% of respondents reported having access to VRE-related documentation, but less than 10% reported access to non-AEFI VRE related guidance. KII and FGD respondents identified existing processes for AEFI-related VREs, but noted the lack of training, coordination and budgetary support for non-AEFI VRE activities. Optimal deployment of Malawi\u0026rsquo;s COVID-19 VRE response plan will require expanded training opportunities, sustained funding and improved coordination across all levels of the health system and between surveillance and communications functions.\u003c/p\u003e","manuscriptTitle":"Country readiness in responding to COVID-19 Vaccine-Related Events (VREs) in Malawi: a mixed methods readiness assessment April—May, 2023","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-08-21 09:50:10","doi":"10.21203/rs.3.rs-7041748/v1","editorialEvents":[{"type":"communityComments","content":2}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"9e0c96d4-ce3d-4a39-9ff6-84dcbbc9b516","owner":[],"postedDate":"August 21st, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-10-29T08:38:47+00:00","versionOfRecord":[],"versionCreatedAt":"2025-08-21 09:50:10","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7041748","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7041748","identity":"rs-7041748","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}