Multiple pharmaceutical companies have spearheaded vaccine development, including Pfizer-BioNTech, Moderna and Oxford/AstraZeneca, with each claiming strong efficacy following clinical trials.
Some countries have granted their chosen vaccines emergency use authorizations (EUA), giving the green light for distribution to start for those most at risk of the disease and frontline workers. For now, vaccine demand continues to exceed supply.
The Claim
Conspiracy theory website Infowars claimed on February 14, 2021, that India had banned the Pfizer-BioNTech vaccine due to safety concerns. On Thursday morning, there was a rise in Google web searches around the claim, such as “India banned Pfizer vaccine” and “Pfizer vaccine banned in India.” Twitter users also repeated the claim on that platform in the days after it was made.
An article and video on Infowars.com ran under the headline of “U.S. Troops Refusing COVID Injections + India Bans Pfizer Jab.” A summary under the article headline said: “The COVID hoax is unraveling as major governments cancel inoculation programs as illnesses and death trigger massive backlash.”
In the segment, host Alex Jones claimed five governments had banned COVID vaccines. To back up his claim about an India ban, Jones cited a report published on the website of Mint, an Indian financial daily newspaper published by Delhi-based media group HT Media.
He said: “India…just said we are not taking it and giving you emergency use authorization to give this to people without studying it.”
The Facts
On February 3, 2021, India’s Subject Expert Committee (SEC), a panel that advises the nation’s Central Drugs Standard Control Organisation (CDSCO), a national regulatory body focused on pharmaceuticals and devices, ruled that the Pfizer-BioNTech vaccine should not be recommended for an EUA in the country “at this stage.”
It confirmed that prior to the decision, Pfizer-BioNTech presented a proposal for EUA of its COVID vaccine BNT162b before the expert health committee.
Rejecting the proposal, the SEC ruled: “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.”
On February 5, Reuters reported Pfizer Inc. withdrew its application for emergency use authorization of its COVID vaccine in India after the meeting with the regulator.
The CDSCO wanted a small local scheme known as a bridging trial, which would help determine if the dose produces an immune response in its own citizens.
A Pfizer Inc. spokesperson told Reuters at the time: “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.
They added: “Pfizer will continue to engage with the authority and re-submit its approval request with additional information as it becomes available in the near future.”
For now, two vaccines are approved in India. One is the Oxford-AstraZeneca vaccine—which is being distributed under the local name of Covishield—and another is called Covaxin, developed by Bharat Biotech, a drugmaker based in Hyderabad, India.
The World Health Organization advises that the Pfizer-BioNTech vaccine should not be taken by people with a history of severe allergic reactions to vaccines, people who are pregnant (due to insufficient data) and anyone under the age of 16.
The Centers for Disease Control and Prevention (CDC) has published the list of known side effects and echoed advice that residents with a history of severe allergic reactions should not yet be administered with a dose of the Pfizer-BioNTech COVID vaccine.
The Ruling
Mostly False.
India has not banned the Pfizer vaccine. However, it has turned down its request for an emergency use authorization “at this stage.” Pfizer has said it will re-submit its approval request with additional information when it becomes available in the “near future.”
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