UK's Medicines and Healthcare products Regulatory Agency tells ThePrint vaccine review includes poring over pages of lab data. If cleared, it will likely boost chances of the vaccine's approval in India.
The trials for the vaccine in India are being carried out by Serum Institute of India (SII) and the company has applied for its emergency authorisation use.
The company has been asked to submit the safety data of M1 adjuvant — the patented technology of Novavax made to enhance the immune response — along with published literature.
Speaking at the Global Technology Summit 2020 organised by Carnegie India, Poonawalla said the government can intervene and protect vaccine manufacturers from 'frivolous claims'.
The applications of Bharat Biotech and Serum Institute of India are under consideration, while that of the Indian arm of Pfizer has not yet been taken up.
3 firms have applied for emergency use approval, but no clarity yet on if people will get to choose a vaccine, or what the state’s role in procurement will be.
The recommendations on granting of authorisation will be made on three parameters — safety, quality and efficacy. The Drug Controller General of India will take the final decision.
According to the ICMR, Serum Institute of India has already manufactured 40 million doses of the vaccine under the at-risk manufacturing and stockpiling license obtained from DCGI.
ICMR chief Dr Balram Bhargava says the idea is to reach a ‘critical mass’, which refers to a point when there are enough people who have been vaccinated to break transmission chain.
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