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Pfizer Withdraws COVID-19 Jab Application in India After Regulator Demands Local Trial


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Pfizer has withdrawn its application for emergency use authorization (EUA) of its COVID-19 injection in India, the world’s second-most populated country. 

Indian drug regulators demanded the pharmaceutical giant partake in a local safety and immunogenicity study.

Pfizer would rather miss out on billions of guaranteed profits selling their mRNA gene therapy in the highly-populated market than let an independent trial study the injections. 

That raises eyebrows about the data Pfizer and the FDA are desperate to hide from outside eyes in the United States and other countries Pfizer has contracts. 

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Reuters noted:

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Unlike other companies conducting small studies in India for foreign-developed vaccines, Pfizer had sought an exception citing approvals it had received elsewhere based on trials done in countries such as the United States and Germany.

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. There are, however, provisions under India’s rules to waive such trials in certain conditions.

The U.S. company, which was the first drugmaker to seek emergency approval in India for its vaccine developed with Germany’s BioNTech, made the withdrawal decision after a meeting with India’s Central Drugs Standard Control Organisation (CDSCO) on Wednesday.

The drug regulator said on its website its experts did not recommend the vaccine because of side effects reported abroad were still being investigated. It also said Pfizer had not proposed any plan to generate safety and immunogenicity data in India.

“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,” Pfizer 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’s refusal to conduct an independent trial says all you need to know about the corruption amongst the pharmaceutical company and American drug regulators.


 

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