A doctor holds an ampoule of the coronavirus vaccine from BioNTech and Pfizer between his fingers in the pharmacy of the University Hospital of Tübingen (UKT).
Sebastian Gollnow photo alliance Getty Images
Pfizer has withdrawn an application for an emergency use permit of its Covid-19 vaccine in India developed by BioNTech in Germany, the company told Reuters on Friday.
The U.S. company, the first drug dealer to apply for an emergency use permit on the 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 discussions at the meeting and our understanding of any additional information that the regulator may have, the company has decided to withdraw their application at this time,” he said. the report to Reuters.
“Pfizer will continue to liaise with the authority and will submit its license application with additional information as soon as it becomes available. “
Pfizer had been approved for its vaccine in India at the end of last year, but in January the government agreed to two much cheaper shots – one from Oxford University / AstraZeneca and another on developed at home by Bharat Biotech by the Medical Research Council of India. Both companies had applied to approve their vaccines after Pfizer.
Central India’s General Drug Control Agency had refused to accept Pfizer’s application for approval without a small local test of safety and immunogenicity for Indians, Reuters has reported.
Indian health officials say they are usually calling for so-called bridge tests to determine if a vaccine is safe and generates a protective response in its citizens that may be causing inter-genetics. different from people in Western countries. There are provisions, however, under the New India Drug and Clinical Trials Regulations, 2019, to allow such trials in certain circumstances.
Pfizer earlier told Reuters that its claim was backed by data from a global study that showed an overall effectiveness rate of 95% with no major concerns about vaccine-related safety.