Pfizer withdraws emergency use application for COVID-19 vaccine in India

Pfizer has withdrawn the emergency use authorisation application for its coronavirus vaccine in India. It was the first pharmaceutical company to seek EUA from Drugs Controller General of India (DCGI) after its vaccine was approved in the UK and Bahrain.

"In pursuance of the Emergency Use Authorisation of its COVID-19 vaccine, Pfizer participated in the Subject Expert Committee meeting of the Drug Regulatory Authority of India on February 3. Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time," said the company in a statement on Friday.

The pharma major said that it will continue to engage with the authority and submits its approval request again with more information in the near future. It said that it remains committed to make its coronavirus vaccine available for use by the Indian government. It said it will pursue the required process to gain emergency use approval by the government.

In its December application, Pfizer had sought permission to sell and distribute its coronavirus vaccine in India, besides waiver of clinical trials on Indian population as per the New Drugs and Clinical Trials Rules, 2019 provisions.

India has already started the vaccination programme with healthcare and frontline workers. Bharat Biotech Covaxin and Serum Institute's Covishield are currently being used for immunisation. While Pfizer has been approved for emergency use in several countries, it was awaiting its approval in India.

However, things were not going as smoothly for Pfizer as it would have wanted. In Norway, 29 elderly people with serious underlying health conditions died after receiving the shot. The country had inoculated 42,000 individuals and focussed on those at higher risk of contracting coronavirus.

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