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Pfizer Unable to Secure COVID Vaccine Authorization in India, China Due to Side Effect Concerns

Pfizer

Pfizer

Multinational pharmaceutical and biotechnology corporation Pfizer had previously requested that health officials accept approvals from regulatory agencies based outside of India, a request that was denied by India’s Central Drugs Standard Control Organization (CDSCO), the nations regulatory body for cosmetics, pharmaceuticals and medical devices. File photo: Ron Adar, Shutter Stock, licensed.

NEW YORK, NY – American multinational pharmaceutical and biotechnology corporation Pfizer has ceased its efforts into securing emergency-use authorization for their COVID-19 vaccine in India due to the lack of support from health regulators in the South Asian country, who are still conducting probes into the drug’s known side effects.

Currently, that puts the 1.4 billion people that reside in India beyond Pfizer’s grasp, most likely denying the drug company a major payday.

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Pfizer had previously requested that health officials accept approvals from regulatory agencies based outside of India, a request that was denied by India’s Central Drugs Standard Control Organization (CDSCO), the nations regulatory body for cosmetics, pharmaceuticals and medical devices.

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REPORT: [Reuters] – Pfizer Inc has WITHDRAWN an application for emergency-use authorization of its COVID-19 vaccine in India, after FAILING TO MEET DRUG REGULATORS DEMAND for a local safety and immunogenicity study…

— Chuck Callesto (@ChuckCallesto) February 16, 2022

India’s drug regulators have effectively declined Pfizer’s COVID vaccine emergency use approval, citing an ongoing investigation into side effects reported in other countries.

As a result, the vaccine won’t be available in the country.

This is a great win for medical integrity. pic.twitter.com/pmOovMTOwi

— Dr. Simone Gold (@drsimonegold) February 22, 2022

CDSCO expressed concern over some of the health-related issues associated with Pfizer’s vaccine – such as an inflammation of the heart muscle known as myocarditis, among others – and insisted that the pharmaceutical giant conduct additional safety and efficacy studies in India before they would consider granting an emergency authorization for its use, according to India’s ThePrint.

“The firm presented its proposal for emergency use authorization of Covid-19 mRNA Vaccine BNT162b before the committee,” ThePrint reported. “The committee noted that incidents of palsy, anaphylaxis and other SAEs (serious adverse events) have been reported during post-marketing and the causality of the events with the vaccine is being investigated.”

Despite their denial of Pfizer’s vaccine, Indian health officials have granted their approval of a new Russian-made COVID-19 vaccine called Sputnik Light.

China is another country that has not given their approval for emergency-use authorization to Pfizer, denying the company the opportunity to distribute their COVID-19 vaccine to the country’s 1.45 billion inhabitants. China’s National Medical Products Administration has conditionally approved the use of Pfizer’s Paxlovid however, which is a drug used to treat adults with COVID-19.



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