EXCLUSIVE-Pfizer withdraws order for emergency use of its COVID-19 vaccine in India | Article / [AMP] | Reuters

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By Krishna N. Das

NEW DELHI February 5 (Reuters) – Pfizer Inc. withdrew an application for emergency use authorization for its COVID-19 vaccine in India, developed with BioNTech in Germany, the company told Reuters on Friday.

The American company, which was the first pharmaceutical company to request 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. company.

“Based on the deliberations of the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its order at this point,” the company said in a statement to Reuters.

“Pfizer will continue to engage with the authority and resubmit your approval request with additional information as it becomes available in the near future.”

Pfizer had sought authorization for its vaccine in India last year, but the government in January approved two much cheaper vaccines – one from Oxford University / AstraZeneca and one developed at home by Bharat Biotech with the Indian Medical Research Council. Both companies requested approval for their vaccines after Pfizer.

The Central Medicines Control Organization of India 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 often ask for so-called transition tests to determine whether a vaccine is safe and generates an immune response in its citizens, whose genetic makeup may differ from that of people in Western nations. There are, however, provisions under the New Drug Rules and Clinical Trials of India, 2019, to dispense with such trials under certain conditions.