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NEW DELHI, Feb. 5 (Reuters) – Pfizer Inc has withdrawn an application for emergency use permission of its COVID-19 vaccine in India that it developed with Germany’s BioNTech, the company told Reuters on Friday.
The US company, which was the first drug manufacturer in India to apply for an emergency use permit for its COVID-19 vaccine, met with the country’s regulator on Wednesday, and the decision was made afterward, the company said.
“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.
“Pfizer will continue to liaise with the authority and resubmit its approval request with additional information as it becomes available in the near future.”
Pfizer had requested approval for its vaccine in India late last year, but the government approved two much cheaper injections in January: one from Oxford University / AstraZeneca and another developed in-house by Bharat Biotech with the Indian Council of Medical Research. Both companies had applied for approval for their vaccines after Pfizer.
India’s Central Drugs Standard Control Organization had declined to accept Pfizer’s request for approval without a small local trial into the vaccine’s safety and immunogenicity for Indians, Reuters reports.
Indian health officials say they generally ask for so-called bridging tests to determine whether a vaccine is safe and generates an immune response in citizens whose genetic makeup may be different than in people in Western countries. However, there are provisions in India’s New Drugs and Clinical Trial Rules, 2019, to dispense with such studies under certain conditions.
Pfizer previously told Reuters that its application was supported by data from a global study showing 95% overall efficacy with no vaccine-related serious safety concerns. (Reported by Krishna N. Das; adapted by Euan Rocha and Raju Gopalakrishnan)