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Adverse Reactions To Pfizer Vaccine Weaken Case For India Trial Waiver

 
• By Vibha Ravi

Indian regulator is likely to ask Pfizer/BioNTech to conduct clinical trials before granting an accelerated approval, but recruitment could prove challenging for the COVID-19 vaccine as anaphylactic reactions in the US and UK sparks worry.

Pfizer BioNTech Covid-19 logos with vaccine concept
Pfizer/BioNTech Might Have To Conduct Clinical Trials For BNT-162b2 In India • Source: Shutterstock

The Indian regulator, Drugs Controller General of India (DCGI), is very likely to ask Pfizer Limited, India. to conduct local clinical trials of the Pfizer Inc./BioNTech SE mRNA vaccine before considering an Emergency Use Authorization (EUA), referred to as accelerated approval process in India.

The company was first off blocks in seeking such approval, but at a meeting of the regulator’s Subject Expect Committee (SEC) on 9

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