New Delhi: The Central government has asked Covid vaccine companies, including Pfizer, to seek permission for emergency use only after conducting a local study. Reuters quoted a senior official saying that the Centre’s recommendation would only be considered for approval if a related local study was conducted.
Vinod K. Paul, head of India’s Vaccine Strategy Panel, said it had been decided in advance that a bridging trial would be held if any vaccine was to be distributed in the country. The Bridging Trial is a supplemental study aimed at gathering information on the effectiveness, safety, and dosage of a vaccine. Currently, the covishield of the Serum Institute and the Cavaxin of Bharat Biotech are licensed by the Central Government for immediate use.
Distribution of Covid vaccine starts in the country on January 16. The Serum Institute, the makers of the Covishield vaccine, conducted a month-long local study before applying for an emergency permit. The Serum Institute studied more than 1,500 people. Subsequently, on January 3, the Central Government issued an emergency permit to Covishield.