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NEW DELHI, February 5 (Reuters) – Pfizer Inc. has withdrawn an emergency permit application for its COVID-19 vaccine in India, which it developed with German BioNTech, the company told Reuters on Friday.
The U.S. company, which was the first drugmaker to apply for emergency use of its COVID-19 vaccine in India, held a meeting with the country’s drug regulator on Wednesday and the decision was made afterwards, the company said. .
“Based on the deliberations during the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time,” he told Reuters in a statement.
“Pfizer will continue to contact the authorities and resubmit its request for approval with additional information as it will be available in the near future.”
Pfizer requested permission for its vaccine in India late last year, but the government approved two much cheaper shots in January – one from the University of Oxford / AstraZeneca and another developed at home by Bharat Biotech with the Indian Medical Council Research. Both companies applied for approval of their vaccines after Pfizer.
India’s Central Drugs Standard Control Organization has refused to accept Pfizer’s request for approval without a small local test on the safety and immunogenicity of the vaccine for Indians, Reuters reported.
Indian health officials say they generally ask for so-called bridging trials to determine if a vaccine is safe and elicits an immune response from its citizens whose genetic makeup may differ from people in Western countries. However, there are provisions under India’s New Drugs and Clinical Trial Rules, 2019, to waive such trials in certain conditions.
Pfizer earlier told Reuters the application was backed up by data from a global study that showed an overall efficacy rate of 95%, with no serious problems with the vaccine. (Reporting by Krishna N. Das; Editing by Euan Rocha and Raju Gopalakrishnan)