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Pfizer Withdraws Request for Emergency Use of its Covid-19 Vaccine in India | India News

NEW DELHI: Pfizer Inc withdrew an emergency use authorization request for its Covid-19 vaccine in India that it had developed with Germany’s BioNTech, the company told Reuters on Friday.
The American company, which was the first pharmaceutical company to apply for authorization for the emergency use of its Covid-19 vaccine in India, had a meeting with the country’s drug regulator on Wednesday and the decision was made after that, the company said. .
“Based on the deliberations of the meeting and our understanding of the additional information that the regulator may need, the company has decided to withdraw its request at this time,” it said in a statement to Reuters.
“Pfizer will continue to collaborate with the authority and will resubmit its request for approval with additional information as it becomes available in the near future.”
Pfizer had applied for authorization for its vaccine in India late last year, but the government approved two much cheaper injections in January: one from the University of Oxford / AstraZeneca and another developed in-house by Bharat Biotech with the Indian Council for Medical Research. . Both companies had applied for approval of their vaccines after Pfizer.
India’s Central Medicines Standards Control Organization refused to accept Pfizer’s application for approval without a small local trial on the vaccine’s safety and immunogenicity for Indians, Reuters reported.
Indian health officials say they generally request so-called bridging trials to determine whether a vaccine is safe and elicits an immune response in its citizens whose genetic makeup may be different from people in Western nations. However, there are provisions under the India New Drugs and Clinical Trials Rules 2019 to waive such trials under certain conditions.
Pfizer previously told Reuters that its app was backed by data from a global study that showed an overall 95% efficacy rate without serious vaccine-related safety concerns.

Times of India