The country’s drug regulator declined to accept the request without first conducting a local trial on the safety and immunogenicity of the vaccine in Indian nationals.
US pharmaceutical company Pfizer has withdrawn its request for emergency permission to use its covid-19 vaccine in India, developed in collaboration with German company BioNTech, the company told Reuters on Friday.
The company made the decision after holding a meeting with the country’s drug regulator on Wednesday. “Based on the deliberations at the meeting and our understanding of the additional information that the regulator may require, the company has decided at this time to withdraw its request,” the company said.
Pfizer will continue to communicate with the authority as well will resubmit your approval request with additional information as it will become available in the near future, ”he added.
The drug company had applied for a license for its vaccine late last year, but the Indian government approved two cheaper vaccines in January, one from AstraZeneca and another developed by Bharat Biotech in conjunction with the Indian Council for Medical Research.
According to Reutres, India’s Central Medicines Control Organization declined to accept Pfizer’s application for approval without first conducting a small local investigation into the safety and immunogenicity of the vaccine in Indian nationals.
Indian health authorities generally need further testing to determine whether a vaccine is safe and elicits an immune response in its citizens, whose genetic makeup may differ from that of people in Western countries.
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