Safety of Cov2-Bio COVID-19 Vaccine in Healthy Populations Aged 18 years and Above in Indonesia

Background: According to WHO Target Product Profile for COVID-19 Vaccines, vaccine development should be indicated for active immunization in all populations, including the elderly, in conjunction with other control measures to curtail or end an outbreak. In this study, we evaluated the safety of SARS-CoV-2 protein subunit recombinant vaccine (CoV2-Bio) in healthy population aged 18 years and above in Indonesia. Methods This study is an observer-blinded, randomized, and controlled prospective phase 1 intervention study about the safety of CoV2-Bio COVID-19 vaccine. We evaluated the safety in two age groups: adult (18–59 years old) and elderly (above 60 years old). There were 54 healthy participants in total, of which 30 were adults and 24 were elderly. Each group was then randomized to receive either three doses of CoV2-Bio COVID-19 or two doses of Sinovac and one placebo. The vaccines in both groups were administered approximately 28 days apart. Subjects were followed up to approximately 3 months. We analyzed the data using IBM SPSS 25. Results A total of 54 healthy participants divided into adult (n = 30) and elderly (n = 24) groups were enrolled. There was no significant difference of any local or systemic adverse event in terms of incidence rate or intensity in control group and vaccine group. No serious adverse events were deemed related to vaccine administration. Conclusion CoV2-Bio COVID-19 vaccine is safe in healthy populations aged 18 years old and above. Trial registration: This study has been registered in ClinicalTrials.gov ID: NCT05067894 on October 5, 2021.