US pharma giant Pfizer has withdrawn its application in India seeking emergency use authorization for its BNT162b2 Covid-19 vaccine.
The decision to withdraw the coronavirus vaccine comes following a meeting with the Indian drug regulator which sought more information on it for its approval.
Pfizer submitted an application seeking approval for the vaccine from the Indian drug regulator in December 2020.
It has been reported across Indian media outlets that the regulator was not keen on approving the BNT162b2 Covid-19 vaccine owing to certain side effects that have been reported in other countries.
Furthermore, it has been reported that Pfizer did not propose any plan to provide safety and efficacy of the Covid-19 vaccine among the Indian population.
However, the US pharma giant reportedly said that it will continue to engage with the Indian drug regulator and resubmit an application for the vaccine’s approval once additional data is available in the future.
The BNT162b2 Covid-19 vaccine has been jointly developed with German biotech company BioNTech. It has been approved across countries such as the US, the UK, Bahrain, Canada, and Switzerland.