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COVID-19 vaccine | Expert panel to take up Pfizer, SII's emergency use authorisation applications soon

Pfizer was the first to apply for the EUA in India on December 5. However, it sought more time from the Subject Expert Committee (SEC) as its experts were busy and could not present their case on December 9.

December 22, 2020 / 05:58 PM IST
Pfizer's COVID-19 vaccine is awaiting nod of central agencies for emergency use in India.

Pfizer's COVID-19 vaccine is awaiting nod of central agencies for emergency use in India.

 
 
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The Central Drugs Standard Control Organization's expert panel will meet soon to take up the applications of Pfizer and Serum Institute of India (SII) for the emergency use authorisation (EUA) for their COVID-19 Vaccine candidates, sources told CNBC-TV18 on December 22.

Notably, Pfizer was the first to apply for the EUA in India on December 5. However, it sought more time from the Subject Expert Committee (SEC) as its experts were busy and could not present their case on December 9.

India reviewing Pfizer’s emergency use application, detailed plans in place for vaccination programme: Health Minister Harsh Vardhan

Now, the US pharma giant has written to the drug controller seeking a fresh date to present their case for the EUA.

The SII, on the other hand, had sought permission from the SEC to conduct phase III trials of COVOVAX in India as it has already conducted phase I and II trials of the vaccine candidate in the US.

However, the expert panel told SII to conduct phase two human clinical trials of COVOVAX in India before moving on to the third stage.

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