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

Pfizer has not conducted any bridge trial on Indian population for its mRNA vaccine

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Pfizer | Coronavirus Vaccine | India

Sohini Das 

Pfizer vaccine
The vaccine requires refrigeration at minus 70 degree Celsius. The company had drawn up elaborate cold chain plans for the same

on Friday said that it has withdrawn it's application for emergency use authorisation for the Covid-19 vaccine in

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. 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.

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.

While it has withdrawn the application, the firm said it remains committed to making the vaccine available for use here.

"Pfizer remains committed to making its vaccine available for use by the government in and to pursuing the requisite pathway for emergency use authorisation that enables the availability of this vaccine for any future deployment," it said.

The vaccine requires refrigeration at minus 70 degree Celsius. The company had drawn up elaborate cold chain plans for the same.

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First Published: Fri, February 05 2021. 12:51 IST
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