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COVID-19 vaccine may get approval in early January

COVID-19 vaccine may get approval in early January

New Delhi: It seems the country would get its vaccine against the Covid-19 in the first week of the New Year as the Subject Expert Committee in the Central Drugs Standard Control Organisation (CDSCO), which met on Wednesday to consider the Emergency Use Authorisation (EUA) request of Pfizer, Serum Institute of India (SII) and Bharat Biotech, has convened its next meeting on Friday – January 1, 2021 to take a "final call" on vaccine approval.

According to Union Health Ministry, the additional data and information presented by SII and Bharat Biotech was perused and analysed by the SEC, while Pfizer sought further time for the presentation of other required data.

"The analysis of the additional data and information is going on. The SEC will convene again on January 1, 2021," ministry said.

As per sources, the SEC has sought updated factsheet and prescribing information from SII and more data from Bharat Biotech. The SEC would recommend for the approval of the vaccine and the final call in this regard would be taken by the Health Ministry in coordination with CDSCO, the sources said. Notably, the development has come on the day the Oxford-AstraZeneca vaccine was granted approval in the United Kingdom. The SII is manufacturing Oxford-AstraZeneca in India. The SII had earlier said that it was hoping for the emergency use approval by the end of this month or January in India.

Claiming that SII is ready to distribute the vaccine soon after the approval, SII officials said that the government has not yet placed a purchase order for the Covishield vaccine.

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