A panel of experts on Wednesday held back emergency authorisation to COVID vaccine candidates of Serum Institute and Bharat Biotech demanding more data on safety and efficacy.
The ‘India Today’ reported that the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) may wait for the United Kingdom (UK) to first grant emergency authorization to Serum’s vaccine.
The applications of Pfizer, Serum Institute of India and Bharat Biotech were discussed at the CDSCO meeting on Wednesday.
The Union Health ministry said the CDSCO is not the authorisation body, but provides vital recommendations, which are then considered for approval by the Drugs Controller General of India (DCGI).
The process of authorisation is a long drawn one and may take one or two weeks, the Serum Institute said on the development.
Meanwhile, the Centre clarified that the two requests for emergency use have not been turned down. “The media report about the rejection of Serum Institute and Bharat Biotech’s emergency use authorisation of vaccine is fake,” the Union Ministry of Health and Family Welfare said in a tweet.
Covishield is a vaccine manufactured in India by Serum and developed by Oxford University and Astrazeneca in the UK. Bharat Biotech is developing an indigenous Covid-19 vaccine named Covaxin.