The Indian Government has not approved the Pfizer ‘vaccine’, even for emergency use, expressing concerns that Clinical Data would not be produced by Pfizer to support the application in India and about recorded side-effects in other countries.
With over 11 million cases of Covid-19 recorded and more than 157,000 deaths, one would think that approval for the Pfizer vaccine in India would be a formality. But no.
Pfizer submitted an application to the Indian drug regulator in December 2020, aiming to import the vaccine for sale and distribution in India.
On February 3, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) met with Pfizer to review their application proposal.
“The committee noted that incidents of palsy, anaphylaxis, and other SAEs like vascular dementia have been reported during post-marketing and the causality of the events with the vaccine is being investigated”.
Pfizer also wanted a waiver of clinical trials on the Indian continent; the SEC didn’t like that either, stating, “Further, the firm has not proposed any plan to generate safety and immunogenicity data in the Indian population”.
The net result from the SEC was “After detailed deliberation, the committee has not recommended for grant of permission for emergency use in the country at this stage”.
Pfizer spun this rather differently claiming that they had withdrawn their application for emergency use of their vaccine in India adding, “Pfizer remains committed to making its vaccine available for use by the government in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,” the spokesperson said. But missing out on 1.38 billion people can’t be that good for business.
The Indian Government wants clear and transparent clinical data run by people it trusts in its own country and needs reassuring on side-effects. Rather like we all do, really.