Global health body updates Bharat Biotech’s decision date covaxin At its latest as of October 2021 i will Guidance document for COVID-19 vaccines on 29 September. Prior to this latest update, the status on the WHO website for the vaccine was shown as “Yet to be confirmed”.
While the status of the Covaxin assessment appears on the WHO website as Congoing, the Strategic Advisory Group of Experts on Immunization of the WHO Strategic Advisory Group (SAGE) is on 5 October to discuss and consider the EUL’s recommendation for Covaxin. will hold a meeting.
According to the draft agenda of the SAGE meeting uploaded on the WHO website, Bharat Biotech will submit an expert group on risk management plans as well as safety and efficacy data of the vaccine’s Phase-1, 2 and 3 clinical trial results. will make a presentation. and other implementation considerations.
Updates during the meeting on Covaxin clinical trial data from SAGE Phase 1, 2, 3 and post marketing studies on safety, immunogenicity, efficacy and effectiveness, as well as an outline of ongoing and planned studies on its safety and effectiveness, as well as updates on global will discuss. Regional and country level plans for vaccine safety monitoring.
After the group assesses the evidence, SAGE member Hannah Nohyneck will present a draft recommendation for the vaccine. “Based on the evidence presented, the expert panel will present its draft recommendations on the use of Bharat Biotech’s vaccine in priority populations,” the SAGE agenda said.
SAGE, which is the WHO’s principal advisory group for Vaccines and Immunization, advises WHO on overall global policies and strategies, including its relationship to vaccines and technology, research and development, delivery of vaccinations and other health interventions.
Covaxin’s EUL has been reviewed by the WHO since 6 July, when rolling data began to be submitted. Many of those who have banned it are waiting for WHO approval as it will make international travel easier.