INDIA, February 10, 2021 (LifeSiteNews) – US-based COVID-19 vaccine maker Pfizer has withdrawn its application for emergency-use authorization of its product in India after the country’s health authorities demanded local safety testing.
India’s drug regulator last weekdeclined Pfizer’s request that its experimental COVID-19 mRNA vaccine “BioNTech” (BNT162b) be approved without a local trial of the product’s safety on the country’s population.
The country’s Central Drugs Standard Control Organisation formed a Subject Expert Committee that met on Feb. 3 to discuss Pfizer’s proposal for the emergency use authorization of its COVID-19 experimental vaccine.
“The committee noted that incidents of palsy, anaphylaxis and other SAE’s have been reported during post marketing and the causality of the events with the vaccine is being investigated,” the committee reported.
“Further, the firm [Pfizer] has not proposed any plan to generate safety and immunogenicity data in Indian population. After detailed deliberation, the committee has not recommended for grant of permission for emergency use in the country at this stage,” the committee added.
Pfizer in turn withdrew its application.