As Bharat Biotech’s Covaxin is now in use among children in the 15-17 age group, the company plans to conduct vaccine safety surveillance to check the possible side effects.
Post-marketing surveillance, also known as post-licensure surveillance, is important for continued monitoring of the safety of the vaccine.
The subject expert committee of the Drug Controller General of India (DCGI) is examining Bharat Biotech’s proposal for post-marketing surveillance and is expected to give its recommendations soon.
After monitoring select subjects in clinical trial, a post-market surveillance is the first real-world study for safety assessment of vaccines.
Bharat Biotech will also monitor all Adverse Events Following Immunization (AEFI) and reasons that may lead to AEFIs, for example, incorrect vaccine administration practices.
A robust post-market surveillance of vaccines is essential to policy decisions for further use of the vaccine in the country.
India started inoculating children on January 3, 2022. Over 1.6 crore youngsters in the 15-17 age group are already fully vaccinated in the country and over 70% have received their first dose.
For now, the National Technical Advisory Group on Immunization has only allowed one Covid-19 vaccine, Covaxin, to be administered to this age group.
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