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.
Follow our coverage of the coronavirus crisis here
Discover the latest Business News, Sensex, and Nifty updates. Obtain Personal Finance insights, tax queries, and expert opinions on Moneycontrol or download the Moneycontrol App to stay updated!
Find the best of Al News in one place, specially curated for you every weekend.
Stay on top of the latest tech trends and biggest startup news.