Pfizer withdraws emergency use bid of its COVID-19 vaccine in India!
NEW DELHI, India (PNN) - February 5, 2021 - Pfizer, Inc. has withdrawn an application for emergency-use authorization of its COVID-19 vaccine (it is NOT a vaccine; it is a medical device designed to turn your cells into incubation chambers for pathogens) in India that it has developed with Germany’s BioNTech.
The Fascist Police States of Amerika company, which was the first drug maker to apply for emergency use authorization of its COVID-19 vaccine in India, had a meeting with the country’s drugs regulator on Wednesday and the decision was made after that, the company said.
“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,” it said in a statement. “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.”
Pfizer had sought authorization for its vaccine in India late last year, but the government in January approved two much cheaper shots - one from Oxford University-AstraZeneca, and another developed at home by Bharat Biotech with the Indian Council of Medical Research.
Both companies applied for approval of their vaccines after Pfizer.
India’s Central Drugs Standard Control Organization declined to accept Pfizer’s request for approval without a small local trial on the vaccine’s safety and immunogenicity for Indians.
Indian health officials say they generally ask for so-called bridging trials to determine if a vaccine is safe and generates an immune response in its citizens whose genetic makeup can be different from people in Western nations.
There are, however, provisions under India’s New Drugs and Clinical Trial Rules, 2019, to waive such trials in certain conditions.
