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

ABSTRACT:

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

SUBMITTER: Alkaabi N 

PROVIDER: S-EPMC12599421 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature