Pfizer withdraws emergency use bid of its COVID vaccine in India | Coronavirus pandemic News | Al Jazeera – (Too cheap to run a local test?)

India’s Central Drugs Standard Control Organization had declined to accept Pfizer’s request for approval without a small local trial on the vaccine’s safety and immunogenicity for Indians, Reuters has reported.

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 whose genetic makeup can be different from people in Western nations.

There are, however, provisions under India’s New Drugs and Clinical Trial Rules, 2019, to waive such trials in certain conditions.

Pfizer earlier told Reuters its application was supported by data from a global study that showed an overall efficacy rate of 95 percent with no vaccine-related, serious safety concerns.

Source: Pfizer withdraws emergency use bid of its COVID vaccine in India | Coronavirus pandemic News | Al Jazeera

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