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New Delhi: A committee of experts is likely to meet this week to consider Pfizer Inc’s application seeking emergency use authorisation for its Covid vaccine in India, which the US drug maker said would only be supplied through government contracts during the pandemic phase.
“The matter has been referred to the Subject Expert Committee (SEC), the panel that advises the Drug Controller General of India on new drugs and vaccine approvals,” a senior government official told ET.
Pfizer was the first company to seek emergency use authorisation for its Covid-19 vaccine in India, soon after it secured a similar approval in the UK.
Late Sunday evening, Serum Institute of India applied for emergency use authorisation for its Covishield vaccine.
While Pfizer hasn’t undertaken trials in the country, the SEC will examine if it needs to undergo bridging studies on Indian population. Keeping in view the emergency situation, the company stands a chance to get an approval without undertaking trials, another official said.
“The matter has been referred to the Subject Expert Committee (SEC), the panel that advises the Drug Controller General of India on new drugs and vaccine approvals,” a senior government official told ET.
Pfizer was the first company to seek emergency use authorisation for its Covid-19 vaccine in India, soon after it secured a similar approval in the UK.
Late Sunday evening, Serum Institute of India applied for emergency use authorisation for its Covishield vaccine.
While Pfizer hasn’t undertaken trials in the country, the SEC will examine if it needs to undergo bridging studies on Indian population. Keeping in view the emergency situation, the company stands a chance to get an approval without undertaking trials, another official said.
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