Pfizer withdraws application for Emergency Use Authorisation of Covid vaccine in India

Tribune News Service

New Delhi, February 5

Pfizer on Friday withdrew its application seeking grant of Emergency Use Authorisation (EUA) of its Covid vaccine in India after the regulators sought additional data.

Pfizer was the first to apply for EUA in India but has been repeatedly asked to update its data as the company never applied for any bridging studies here.

Under the Indian clinical trial rules, any company with a new drug or vaccine should apply for bridging studies in India to produce domestic safety data involving Indians.

Russia had very early on tied up with Dr Reddy’s Lab in Hyderabad to conduct bridging studies in India for Sputnik V vaccine.

Pfizer is learnt to have said it would meet the requirements listed by India’s Central Drugs Standards Control Organisation and consider re-submitting the application.

The UK was the first to license Pfizer vaccine.