(Add details)
NEW DELHI, Feb 5 (Reuters) – Pfizer Inc. has withdrawn an application for emergency use of its COVID-19 vaccine in India, which it developed with BioNTech in Germany, the company told Reuters on Friday .
The American company, which was the first drug manufacturer to apply for 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 afterwards, he said. company.
“Based on the deliberations at 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 interact with the authority and resubmit its request for approval with additional information as it becomes available in the near future.”
Pfizer applied for permission to vaccinate in India late last year, but the government approved two much cheaper photos in January – one at Oxford University / AstraZeneca and another developed at home by Bharat Biotech in conjunction with the Indian Medical Research Council. Both companies have applied for their vaccines after Pfizer.
India’s central drug control organization has refused to accept Pfizer’s application without a small local study on vaccine safety and immunogenicity for Indians, Reuters reported.
Indian health officials say they generally call for so-called linkage studies to determine if a vaccine is safe and generate an immune response in its citizens, whose genetic structure may be different from people in Western nations. However, there are provisions under the new 2019 Rules on Medicines and Clinical Trials in India to waive such studies under certain conditions.
Pfizer previously told Reuters that its application was backed by data from a global study that showed an overall effectiveness rate of 95%, with no safety concerns related to the vaccine. (Reporting by Krishna N. Das; Editing by Euan Rocha and Raju Gopalakrishnan)