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Pfizer withdraws approval application in India

Pfizer world headquarters in New York City, USA. Pfizer is one of two COVID vaccine candidate manufacturers to request emergency use authorisation in India. Image credit: Jim.henderson, Public domain, via Wikimedia Commons
Pfizer world headquarters in New York City, USA. Image credit: Jim.henderson, Public domain, via Wikimedia Commons

Drugmaker Pfizer has rescinded its emergency use authorisation application for its vaccine candidate against COVID-19. However, it intends to resubmit. 

The pharmaceutical giant sought emergency use authorisation for its vaccine in India last year but “has decided to withdraw its application at this time” according to a company spokesperson. Pfizer’s vaccine showed promising results in phase-III trials, where data indicated a high level of efficacy.

Pfizer developed the vaccine in conjunction with BioNTech. It became the first company to seek emergency use authorisation in India for a COVID-19 vaccine from the Drug Controller General of India. However, it withdrew its application following a meeting with regulators earlier this week. As reported by The Hindu, “on Wednesday, an expert committee of the DCGI declined to approve the vaccine on the grounds that there were reports of “palsy, anaphylaxis and other Severe Adverse Events” after the vaccine’s approvals in some other countries and that it still wasn’t clear if this was connected to vaccination. 

“Moreover, Pfizer India hadn’t spelt out a plan to generate safety and immunogenicity data in the Indian population, the committee noted.” 

The Central Drug Standard Control Organisation (CDSCO) has declined Pfizer’s request for approval in the absence of a bridging trial, designed to establish a vaccine’s safety and immunogenicity for the Indian population.

“Pfizer will continue to engage with the authority and resubmit its approval request with additional information as it becomes available in the near future,” the company said. A spokesperson said “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.”

Two vaccines are approved for use in India – domestically-manufactured Covaxin, by Bharat Biotech with the Indian Council of Medical Research, and the vaccine produced by AstraZeneca and the University of Oxford. India’s vaccination campaign against COVID-19 is underway, with more than four million doses administered to date. 

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