Pfizer withdraws COVID-19 vaccine emergency use bid in India

by Celine Castronuovo - 02/05/21 8:10 AM ET

Pfizer has removed its bid for emergency approval of its coronavirus vaccine in India, citing additional information needed by the country’s drug regulator, the pharmaceutical company confirmed to The Hill.

The decision, first reported by Reuters on Friday, came after a Wednesday meeting with India’s Central Drugs Standard Control Organization.

“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,” Pfizer said in a statement shared with The Hill.

The company added that it “will continue to engage with the authority and resubmit its approval request with additional information as it becomes available in the near future.”

The statement went on to say, “Pfizer remains committed to making its vaccine available for use by the Government in India and to pursuing the requisite pathway for emergency use authorization that enables the availability of this vaccine for any future deployment.”

According to Reuters, Pfizer was the first company to apply for emergency use authorization for its coronavirus vaccine in India late last year, though the country’s drug regulatory agency has declined to approve the inoculation until a small local trial is conducted to measure the safety and efficacy of the vaccine for Indians.

India has already approved COVID-19 vaccines from two other companies that applied for emergency authorization after Pfizer — the Oxford-AstraZeneca vaccine being used around the world and a vaccine developed in India by a company called Bharat Biotech in partnership with the Indian Council of Medical Research.

India last month began a massive vaccination rollout campaign, which aims to vaccinate 300 million people in a country with a population of over 1.3 billion people.

The first round of vaccinations targeted 30 million health care and front-line workers and 270 million people who are either over the age of 50 or have an underlying medical condition that puts them at higher risk for complications from COVID-19.