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Pfizer Drops India Vaccine Application After Regulator Seeks Local Trial

February 21st, 2021

Via: Reuters:

Pfizer Inc said on Friday it had withdrawn an application for emergency-use authorisation of its COVID-19 vaccine in India, after failing to meet the drug regulator’s demand for a local safety and immunogenicity study.

…

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.

Related: Newsweek ‘Fact Check’ Claims India Vaccine Ban “Mostly False” While Admitting De Facto Ban

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