WHO recommendation COVID-19 Vaccine Beijing Institute of Biological Products Co., Ltd.(BIBP) /Sinopharm
The COVID-19 Vaccine BIBP, also known as Inactivated COVID-19 (VERO CELL) vaccine is produced in Vero Cells and inactivated with ß-propiolactone. The SARS-CoV-2 antigen is purified and adsorbed with Aluminum Hydroxide. The product can be stored at 2-8°C for 24 months and holds a VVM7. The applicant, the Beijing Institute of Biological Products Co., Ltd. (BIBP) (China) had submitted a dossier to support the Emergency Use Listing (EUL).
The vaccine has been authorized by the Chinese National Regulatory Authority (NRA) – the National Medicinal Product Administration (NMPA) - as well as other regulatory authorities.
The assessment included the review of the quality, non-clinical, clinical - including Risk Management Plan (RMP) - and inspection of the manufacturing facilities.
The application included interim analyses of a phase1/2 and a bridging study conducted in China, and a phase 3 study conducted in the United Arab Emirates and other Arab countries. Vaccine efficacy against laboratory-confirmed symptomatic COVID-19 was estimated to be 78% in adults 18-59 years of age. Lack of data prevented estimating the efficacy of the vaccine in individuals 60 years of age and older and with comorbidities. The vaccine was shown to be immunogenic and no safety concerns have been identified in clinical studies.