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Pfizer Withdraws Application for Emergency Use of Its COVID-19 Shots in India

Pfizer Withdraws Application for Emergency Use of Its COVID-19 Shots in India

A worker passes a line of freezers holding Pfizer’s COVID-19 vaccine candidate in Puurs, Belgium. Photo: Pfizer/Handout via Reuters.

New Delhi: Pfizer Inc. has withdrawn an application for emergency-use approval of its COVID-19 vaccine candidate in India that it has developed with Germany’s BioNTech, the company told Reuters on Friday.

The US company, which was the first drugmaker to apply for emergency use approval of its COVID-19 vaccine candidate in the country, had a meeting with India’s drugs regulator on Wednesday and the decision was made after that, the company said. The regulator is the Central Drug Standards Control Organisation.

“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,” it said in a statement to Reuters, adding it will in the future look to resubmit its application with the additional information that the regulator requires.

Pfizer had earlier said it will pursue its request for India to approve its COVID-19 vaccine candidate if the government commits to buying shots first.

And even before that, a senior government official had said that any vaccine maker, including Pfizer, must conduct an additional local study to be considered for the country’s immunisation programme,

Serum Institute of India, the local manufacturer of the vaccine candidate developed by AstraZeneca and the University of Oxford, is currently conducting a seven-month-long study with 1,600 participants before it can seek a license to sell doses in the open market.

Local media have reported that Pfizer had sought to import and distribute its vaccine candidate in India without doing local trials. In early December, it was the first company to seek emergency-use approval in the world’s second-most populous country but has not attended subsequent meetings called by India‘s Central Drugs Standard Control Organisation, according to minutes of the deliberations.

“As of now, the pre-condition for any vaccine to be implemented in India is that you have to do a bridging trial,” Vinod K. Paul, who heads a government panel on vaccine strategy, said in an interview.

The government has already distributed 16.5 million doses of the two approved vaccine candidates to states, with a plan to deliver 600 million jabs to the most vulnerable people in the next six to eight months. Serum Institute has stockpiled 50 million doses of the AstraZeneca vaccine candidate and says it will raise its monthly output to much more than that now the approval has come.

Indian health officials say they generally ask for so-called bridging trials to determine if a vaccine candidate is safe and generates an immune response in its citizens whose genetic makeup can be different from people in western nations. There are, however, provisions under India‘s New Drugs and Clinical Trial Rules 2019, to waive such trials in certain conditions.

(Reuters – reporting by Krishna N. Das; editing by Euan Rocha)

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