Coronavirus Disease Vaccination in Patients with Pulmonary Hypertension: A National Prospective Cohort Study

Background: Coronavirus disease (COVID-19) has potential risks for both clinical worsening and mortality among patients with pulmonary hypertension (PH). However, data regarding the protective role of vaccination in this population are still lacking. This study aimed to assess the safety of approved vaccination for patients with PH.Methods: In this national prospective cohort study, 706 patients diagnosed with PH (World Health Organization [WHO] groups 1 and 4) were enrolled from October 2021 to March 2022. The primary outcome was the composite of PH-related major adverse events. We used an inverse probability weighting (IPW) approach to control for possible confounding factors in the baseline patient characteristics.Findings: In total, 706 patients with PH participated in this study (mean age, 40·3 years; mean duration after diagnosis of PH, 8·2 years). All patients underwent standardised treatment for PH in accordance with guidelines. Among them, 278 patients did not receive vaccination, whereas 428 patients completed the vaccination series. None of the participants were infected with COVID-19 during our study. Overall, 398 patients received inactivated vaccines (CoronaVac), whereas 30 received protein subunit vaccines (ZF2001). After adjusting for baseline covariates using the IPW approach, the odds of having any adverse events due to PH in the vaccinated group did not increase (6·3% versus 8·5%, odds ratio=0·72, p=0·3). Approximately half of the vaccinated patients reported at least one post-vaccination side effect, most of which were mild, including pain at the injection site (37·1%), fever (2·6%), and fatigue (6·1%).Interpretation: COVID-19 vaccination did not augment the PH-related major adverse events for patients with WHO groups 1 and 4 PH, although there were some tolerable side effects. A large-scale randomised controlled trial is warranted to confirm this finding. The final approval of the COVID-19 vaccination for patients with PH as a public health strategy is promising.Funding: The study was supported by the National Key Research and Development Program of China (2022YFC2703902), the Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences (2020-I2M-C&T-B-003, 2021-I2M-1-018) and National High Level Hospital Clinical Research Funding (2022-PUMCH-B-099).Declaration of Interests: None of the authors have any conflict of interest to declare.Ethics Approval: This study was reviewed and approved by the institutional review board of PekingUnion Medical College Hospital, and all patients provided informed consent.