An expert body of India’s top drug regulator has recommended that Pfizer’s Covid-19 vaccine be banned in the country’s emergency, prompting the US drug giant to withdraw its application. Indian Express looks at Pfizer’s body problems and response:
What is this Covid-19 policy?
Pfizer developed this vaccine, ‘BNT162b’, in partnership with German biotech firm BioNTech. The vaccine uses mRNA technology, which uses RNA molecules of messengers that tell cells what proteins do. MRNA, in this case, has a code that tells cells to reproduce spike protein – a component of SARS-CoV-2 that allows it to enter cells and spread Covid-19 infection in the body.
Once implanted in the body, cells will use mRNA instructions, form copies of spike protein, a return that is expected to stimulate immune cells to make antibodies against them.
Unlike other people with vaccines, mRNA drugs are genetically advanced – they do not need the virus to be planted and doubled, just a code of the most important part of the immune system to target. Another advantage is that they can be made in large quantities in large circles called bioreactors.
Pfizer received an emergency use permit (EUA) from the UK during talks with the Central Drugs Standard Control Organization (CDSCO) in early December to obtain a similar permit.
What is a professional body concern?
The CDSCO Subject Committee of the Experts considering Pfizer’s proposal did not recommend that Drug Controller General of India (DCGI) approve the application immediately.
“After a thorough consideration, the committee has not yet recommended the granting of an emergency use permit in the country yet,” the minutes of the SEC meeting of 3 February said.
This was due to concerns about certain critical events (SAEs) and that additional security information had not been made since the local survey in the country.
“The committee noted that cases of disability, anaphylaxis and other SAE’s were reported during postal marketing and the causes of vaccine cases are being investigated. In addition, the company has not yet proposed any plan to generate safety and immunogenicity data for the Indian population, ”he said.
What was Pfizer’s response?
Pfizer has decided to withdraw its application until it can add the additional details required by the Indian regulator.
“Based on the negotiations and our understanding of the additional details that may be required by the regulator, the company has decided to withdraw its application at this time,” said a Pfizer spokesman.
Does this mean that the Pfizer vaccine will not be available in India?
At this stage, the vaccine will no longer be used in India. However, the company says it will “keep in touch” with India’s regulatory authorities and submit its application for more information “as it will be available soon.”
“Pfizer remains committed to making its vaccine available for use by the Government of India and to adhere to the necessary procedures for the authorization of emergency use that allows for the availability of this vaccine in any future delivery,” said a company spokesman.