Pfizer Withdraws COVID-19 Vaccine Application in India

Various media sources reported on February 5, 2021, the SEC committee at India's Central Drugs Standard Control Organization rejected Pfizer Ltd's proposal seeking emergency licensure for its COVID-19 mRNA vaccine known as Comirnaty.

“The review committee noted the firm had not proposed any plan to generate safety and immunogenicity data in the Indian population," according to the minutes of an SEC meeting showed, adding that the committee did not recommend granting permission for the vaccine’s emergency use “at this stage.

“Pfizer remains committed to working with the Government of India and providing equitable access to our Covid-19 vaccine,” the spokesperson added that “in the meantime, we are in the process of compiling responses to queries raised by the regulator on the data provided."