Pfizer withdraws emergency-use authorization application in India
US-based vaccine developer and manufacturer Pfizer Inc said today that it has withdrawn the application for emergency-use approval of its COVID-19 vaccine in India that it has developed with Germany’s BioNTech.
According to Reuters, the company said that it had discussed the formalities with the Subject Expert Committee of the Drug Regulatory Authority of India on Wednesday and made the decision after that. Pfizer was the first pharmaceutical company to apply for emergency-use approval of its COVID-19 vaccine in the country.
The company in a statement 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 added that this decision was only temporary and that Pfizer will applying for the approval of its vaccine again once it has met the Drug Regulatory Authority of India’s requirements.
According to a government insider, the SEC had decided not to consider Pfizer’s proposal for relaxation in the guidelines relating to clinical trials of untested drugs and recommended that the company first initiate a study to get an opinion from the Indian population.
Another source confirmed, “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.”