Post-authorisation effectiveness and safety study: a multicenter observational study of the effectiveness and safety of the inactivated SARS-CoV-2 vaccine.

Purpose: The coronavirus disease 2019 (COVID-19) pandemic led to the rapid development of vaccines to control the spread of infection. The inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Sinopharm BIBP vaccine was introduced in the United Arab Emirates (UAE) and registered by the Ministry of Health and Prevention before the final data of the phase III clinical trial was released. Hence, a post-authorization effectiveness and safety study was required to evaluate the effectiveness and safety profile of the vaccine. Materials and Methods: An observational Phase IV study was conducted in Sheikh Khalifa Medical City, UAE, for 18 months. The effectiveness of the BIBP vaccine was evaluated in individuals who received at least the first 2 doses and those who received the full vaccine course (with booster dose) based on immunogenicity assessment of anti-SARS-CoV-2 antibodies and protection against COVID-19. Results: About 96% of the participants showed positive results for the neutralizing antibody and anti-S antibody against the SARS-CoV-2, 14 days after the second dose of the vaccine. The participants showed similar positive results after the booster vaccine, and the antibodies remained at that level at the one-year follow-up. Only 16 participants who received at least one dose of the vaccine experienced COVID-19. Safety outcomes showed that all serious adverse events reported were unrelated to the vaccine. No death was reported in this study period. Conclusion: The inactivated BIBP Sinopharm vaccine proved safe and effective in protecting against COVID-19.