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No recommendation for emergency approval in India yet, SEC seeks more data from Bharat Biotech, SII

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New Delhi, Dec 30: The Subject Expert Committee (SEC) in Central Drugs Standard Control Organisation (CDSCO) that met on Wednesday did 'not consider' the emergency approval of COVID-19 vaccines from Pfizer, Serum Institute of India (SII) and Bharat Biotech Pvt Limited.

No recommendation for emergency approval in India yet, SEC seeks more data from Bharat Biotech, SII

According to the report, the SEC said that the vaccine will not be given authorisation "yet" as more data is needed.

"Further time was requested on behalf of Pfizer. The additional data and information presented by SII and Bharat Biotech Pvt Ltd. was perused and analysed by SEC. The analysis of the additional data and information is going on. SEC will convene again on January 1," the expert panel said in a statement

The development comes hours after the UK gave its go-ahead to the Oxford University-AstraZeneca COVID-19 vaccine. The approval by Medicines and Healthcare products Regulatory Agency (MHRA) means the vaccine is both safe and effective.

The UK's National Health Service (NHS) was already lining up thousands of medics and volunteers to be ready to deliver jabs up and down the country.

The vaccine, which also has a tie-up with the Serum Institute of India, was being evaluated by the MHRA after the final cut of data was submitted by the government last Monday.

Britain has ordered 100 million doses of the jab, with 40 million expected to be available by the end of March.

AstraZeneca chief Pascal Soriot has stressed that researchers have found the "winning formula" using two doses of the vaccine, ahead of the final results being published.

He has raised hopes that the jabs are more effective than first thought and should be effective against a new variant of the coronavirus that is now causing havoc in most parts of the UK.

However, the SEC will meet again on January 1 to discuss over granting approval to a Covid-19 vaccine for emergency use in India.

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