An expert panel advising the drug regulator on covid-19 vaccines on Wednesday said it needs more time to analyse clinical trial data submitted by Serum Institue of India and Bharat Biotech International in support of their applications for emergency licences. The panel met on a day the UK regulator gave emergency authorization to AstraZeneca’s vaccine. Serum Institute is seeking emergency use licence for a version of the British drugmaker’s vaccine.The subject expert committee, set up by Drugs Controller General of India (DCGI) V.G. Somani to vet vaccine proposals, will next meet on Friday and may also take up the proposal from Pfizer, the government said. Pfizer has sought an emergency licence for import of the vaccine into India, as well as a waiver on clinical trials in India.
Typically, the DCGI clears a proposal for approval or emergency licence only when it is recommended by the SEC.The deferment is particularly significant for SII’s vaccine candidate Covishield. SII’s proposal was taken up after the UK Medicines and Healthcare products Regulatory Agency gave emergency authorization to the vaccine jointly developed by AstraZeneca and Oxford University for immunizing people who are 18 years or older. The authorization is for two full doses administered with an interval of between four and 12 weeks, AstraZeneca said.
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