June 28, 2022

sii: No robust trial data, government rejects SII and Bio E’s proposals on booster jabs | India News – Times of India

MUMBAI: An expert panel of the health ministry has turned down separate proposals from Serum Institute of India (SII) and Biological E on booster jabs, citing a lack of robust trial data.
The subject expert committee (SEC), which advises the drug regulator on vaccines and new drugs, also did not clear Biological E’s other application seeking emergency approval of its Covid vaccine, Corbevax. It has sought more data on safety and other parameters, which could delay the vaccine’s launch.
India is yet to take a call on booster shots in the wake of the spread of the Omicron strain.
While taking up Biological E’s application on using the indigenously-developed Corbevax for booster shots, the SEC recommended that it submit a revised clinical trial protocol, noting that safety and efficacy data from the phase 3 trials is yet to be evaluated. It asked for complete safety and immunogenicity data of the vaccine, justification for the proposed age group, timing of the booster shot and the sample size.
The SEC asked SII to conduct local trials to prove Covishield’s efficacy as a booster dose before its application can be reviewed. As per official sources, the panel said the company had not presented any data from India and that its request for approval of the booster was based on immunogenicity data of only 75 subjects from a UK study.

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