Pfizer Suffers Black Eye As Drug Regulators Bar 2.8 Billion People From Company’s C-19 Shot!

Pfizer supported the attempt to secure emergency use authorization in India for the C-19 vaccine.

India’s Central Drugs Standard Control Organization stated that its experts didn’t support the shot because the investigation still happens because of the side effects that have been reported in other states.

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Indian officials asked Pfizer to conduct a safety and efficacy study in India, Reuters reported.

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

The shots by Pfizer and Moderna have been connected to an increased risk of myocarditis. China didn’t approve of this shot there. It means that the potential market of China’s 1./45 billion people and in India 1.4 billion people is beyond Pfizer’s reach.

Chinas National Medical Products Admin has approved the Pfizer medicament called Paxlovid for adults with mild to moderate C-19 and a high risk of severe illness.

“The data collected has been endorsed by various regulatory agencies (including the most evolved), and they have given EUA [based on] … that data,” Pfizer told Reuters in a statement.

“Given our exclusive priority to government supply, we look forward to a confirmation from the government on necessary supplies, [on the] basis [of] which we will take the regulatory process forward, as we have done across the world,” it said.

India’s Central Drugs Standard Control Organization stated that Pfizer officials weren’t at the meetings after the company’s app was submitted in December.

Pfizer stated: “The company representatives have been unable to participate in previous meetings due to extremely short notices of a few hours or less and time-zone limitations,”

“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,”

Source

Western Journal Reuters The Print

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