Pfizer retracts request for emergency approval of Covid-19 vaccine in India

 

Pfizer on Friday said that it has withdrawn it's application for emergency use authorization for the Covid-19 vaccine in India.

The US based drug major said that it would submit the additional information as it becomes available in the near future,

The company met the Subject Expert Committee (SEC) on February 3.

"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. Pfizer will continue to engage with the authority and resubmit its approval request with additional information as it becomes available in the near future," a company spokesperson said.

The firm had missed appearing before the SEC thrice before. It had said that short notice and time zone difference were the reasons behind it.

Pfizer has not conducted any bridge trial on Indian population for its mRNA vaccine. The Indian regulator has asked foreign vaccine makers like Astrazeneca and Russia's Sputnik V to conduct safety and immunogenicity trials on Indians. Read More