Coronavirus | Pfizer withdraws Emergency Use Authorisation application for its COVID-19 vaccine in India

DCGI expert panel had declined approval on the grounds that there were reports of “palsy, anaphylaxis and other Severe Adverse Events” after vaccine’s approvals in some other countries

February 05, 2021 12:04 pm | Updated 07:16 pm IST - New Delhi

For representational purpose only.

For representational purpose only.

Pfizer India has withdrawn its application with India’s Drug Controller General of India (DCGI) to allow its vaccine to be made available in India, a company spokesperson said on Friday.

On Wednesday, an expert committee of the DCGI declined to approve the vaccine on the grounds that there were reports of “palsy, anaphylaxis and other Severe Adverse Events” after the vaccine’s approvals in some other countries and that it still wasn’t clear if this was connected to vaccination. Moreover, Pfizer India hadn’t spelt out a plan to generate safety and immunogenicity data in the Indian population, the committee noted.

“Pfizer will continue to engage with the authority and resubmit its approval request with additional information as it becomes available in the near future. Pfizer remains committed to making its vaccine available for use by the Government in India and to pursuing the requisite pathway for emergency use authorisation that enables the availability of this vaccine for any future deployment,” a company statement said.

Novel technology

The Pfizer-BioNTech m-RNA vacccine employs a novel technology—in the form of small piece of genetic material from the coronavirus called a messenger ribonucleic acid—to make a vaccine for the coronavirus. Interim Phase-3 efficacy trials in Americans showed that those inoculated were 95% more likely to be protected than those who didn’t take the vaccine.

After being approved in the United States, the United Kingdom and the European Union, Pfizer also applied for the vaccine to be made available in India under ‘emergency use listing’ conditions. This is the clause under which Covishield and Covaxin have been approved in India. While the latter has been administered to over 4.5 million Indians, Pfizer India had been given an opportunity at least thrice, since late December, to appear before the Subject Expert Committee (SEC) of the DCGI to furnish evidence enough for an approval. However Pfizer hadn’t appeared multiple times, Health Secretary Rajesh Bhushan said early last month.

The U.S. based Centres for Disease Control and Prevention, which is monitoring adverse reactions from vaccines, said that until January 18, there were 50 cases of anaphylaxis—a treatable but severe allergic reaction that is extremely rare but can also be lethal—post administration of the Pfizer vaccine. That worked out to about 5 per million doses administered, down from its previously reported rate of 11.1 per million doses administered through Dec. 23.

Bell’s palsy is a treatable condition that causes a temporary weakness or paralysis of one side of the face. The U.S. Food and Drug Administration (FDA) released analysis in December of safety data on the Pfizer/BioNTech vaccine. The study involved 38,000 people and saw four develop Bell’s palsy, with none in the placebo group developing the condition.

Sub-zero refrigeration

A requirement of the Pfizer-BioNTech vaccine is that it needs sub-zero refrigeration leading to increased costs, particularly in India. “Now that we have two vaccines available in India and enough stocks so far and in the pipeline, the committee reckoned that reports of anaphylaxis be thoroughly understood before the Pfizer vaccine is recommended,” said a person familiar with SEC proceedings, who declined to be identified.

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