Pfizer was the first pharma company who had applied for emergency use authorization of its COVID-19 vaccine in India.
Pfizer Inc has withdrawn an application for emergency-use authorization of its COVID-19 vaccine in India that it has developed with Germany’s BioNTech, the company told Reuters on Friday. The U.S. based pharma company, which was the first drugmaker to apply for emergency use authorization of its COVID-19 vaccine in India, had a meeting with the country’s drugs regulator on Wednesday and the decision was made after that, the company said.
“Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time,” it said in a statement to Reuters. It added that the company will stay connected with the authority and will again submit the approval request along with additional information as soon as it becomes available in the near future.
According to government sources, while Pfizer had sought clinical trial waiver for its vaccine, the Subject Expert Committee (SEC) did not consider its proposal and insisted on a bridging study that it opined should be conducted on Indian population, The Economic Times reported. “It's proven that the vaccine is safe. However, the intention of the experts is to see how this vaccine is immunogenicity and that’s why they wanted a bridging study on Indian population,” a source further said.
However, Pfizer was the first to apply for the approval of the vaccine, the government approved two other vaccines in January that are cheaper than Pfizer vaccine - Covishield, Serum Institute of India's locally produced Oxford-AstraZeneca vaccine and Covaxin, developed locally by Bharat Biotech with the Indian Council of Medical Research. India started a mass vaccination drive on January 16.
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