The country’s drug regulator refused to accept the request without first conducting a local trial on the vaccine’s safety and immunogenicity in Indian nationals.
The American pharmaceutical company Pfizer has withdrawn its request for authorization of emergency use in India of its vaccine against covid-19, developed with the German company BioNTech, according to commented the company told Reuters on Friday.
The company made the decision after holding a meeting on Wednesday with the country’s drug regulator. “Based on the deliberations at the meeting and our understanding of the additional information the regulator may need, the company has decided to withdraw its request at this time,” the company said.
“Pfizer will continue to interact with the authority and will resubmit your approval request with additional information as it becomes available in the near future, “he added.
The drugmaker had applied for authorization 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 refused to accept Pfizer’s application for approval without first conducting a small local trial on the safety and immunogenicity of the vaccine in Indian nationals.
Indian health authorities generally require further testing to determine if a vaccine is safe and elicits an immune response in its citizens, whose genetic makeup may be different from that of people in Western nations.
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