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Saturday, March 06, 2021

Explained: Why has Pfizer’s vaccine application for India been turned down for now?

The Subject Expert Committee under CDSCO that looked into Pfizer's proposal and presentation did not recommend that the Drug Controller General of India (DCGI) approve the application at present.

Written by Prabha Raghavan , Edited by Explained Desk | New Delhi |
Updated: February 6, 2021 11:06:39 am
Pfizer covid 19 vaccine, Pfizer covid vaccine india, Pfizer coronavirus vaccine india, BNT162b, india coronavirus vaccine, cdsco, mrna technology, coronavirus vaccine news, indian express explainedPfizer had received emergency use authorisation (EUA) from the UK by the time it had approached the Central Drugs Standard Control Organisation (CDSCO) in early December for a similar approval. (Source: Reuters)

An expert body under India’s apex drug regulator has recommended against granting approval to Pfizer’s Covid-19 vaccine under emergency circumstances in the country, prompting the American drug giant to withdraw its request. The Indian Express looks at what concerns have been raised by the body and Pfizer’s response:

What is this Covid-19 vaccine?

Pfizer developed this vaccine, ‘BNT162b’, in collaboration with German biotech firm BioNTech. The vaccine uses mRNA technology, which makes use of the messenger RNA molecules that tell cells what proteins to build. The mRNA, in this case, is coded to tell the cells to recreate the spike protein–the part of the SARS-CoV-2 virus that allows it to penetrate the cells and spread the Covid-19 infection in the body.

Once injected into the body, the cells will use the mRNA’s instructions, creating copies of the spike protein, which is in return expected to prompt the immune cells to create antibodies to fight it.

Unlike several other vaccine candidates, mRNA vaccines are synthetically developed–they don’t need the virus to be cultivated and replicated, just the code for the most crucial part that the body’s immune system is to target. Another advantage is that they can be manufactured at a large scale in large vats called bioreactors.

Pfizer had received emergency use authorisation (EUA) from the UK by the time it had approached the Central Drugs Standard Control Organisation (CDSCO) in early December for a similar approval.

What are the expert body’s concerns?

The Subject Expert Committee under CDSCO that looked into Pfizer’s proposal and presentation did not recommend that the Drug Controller General of India (DCGI) approve the application at present.

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“After detailed deliberation, the committee has not recommended for grant of permission for emergency use in the country at this stage,” stated minutes of the SEC’s meeting dated February 3.

This was due to concerns over certain Serious Adverse Events (SAEs) and the fact that additional safety information had not been generated from local trials in the country.

“The committee noted that incidents of palsy, anaphylaxis and other SAE’s have been reported during post marketing and the causality of the events with the vaccine is being investigated. Further, the firm has not proposed any plan to generate safety and immunogenicity data in Indian population,” stated the minutes.

What was Pfizer’s response?

Pfizer has decided to withdraw its application until it can generate the additional information required by the Indian regulator.

“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,” stated a Pfizer spokesperson.

Does this mean Pfizer’s vaccine will not be available in India?

At this stage, the vaccine will not be used in India. However, the company says it will “continue to engage” with the Indian regulatory 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,” said the company’s spokesperson.

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