Why did Pfizer withdraw its application for emergency-use in India?

Last updated on February 16th, 2021 at 07:06 am

On Friday, Pfizer pulled out its application for emergency use approval of its Coronavirus vaccine in India, as they failed to meet India’s drug regulator’s request for a local safety and immunogenicity study.

According to the Indian health officials, they usually ask for bridging trials to find out vaccines immune response in its citizens. Therefore, provisions under India’s rules to waive such tests in some situations.

The Central Drugs Standard Control Organisation(CDSCO) stated that its experts didn’t approve the vaccine due to its side effects were still being investigated abroad.

India started its vaccine drive on Jan 16, vaccinating a large portion of 1,000,000 individuals with Serum Institute of India’s (SII) Covisheild vaccine and Bharat Biotech’s Covaxin vaccine.

Pfizer has chosen to pull out its application until it can produce the extra data needed by the Indian controller. 

“In view of the consultations at the meeting and our comprehension of additional data that the controller may require, the organization has chosen to pull out its application right now,” expressed a Pfizer representative. 

As of now, the Pfizer vaccine won’t be utilized in India. However,  the pharma giant Pfizer company says it will “keep on engaging with the Indian drug regulatory authority and resubmit its proposal with extra data as it appears soon”.

Pfizer Inc has manufactured the vaccine ‘BNT162b’, in a joint effort with German firm BioNTech. The vaccine comprises mRNA technology, which utilizes messenger RNA molecules that mention to cells what proteins to fabricate. The mRNA, for this situation, is coded to advise the cells to reproduce the spike protein–the piece of the SARS-CoV-2 infection that permits it to infiltrate the cells and infect the body. 

Once infused into the body, the cells will utilize the mRNA’s, making duplicates of the spike protein, which is consequently expected to incite the immune cells to make antibodies to battle it. 

“Pfizer is committed to making the vaccine accessible for use by the Government in India and to seeking after the imperative pathway for emergency use approval that helps in availability of this jab for any future deployment,” said the Pfizer company’s representative.