Discussions on with Indian authorities for expedited approval of Covid-19 vaccine: Pfizer


Global Pharma main Pfizer is discussing with the Indian authorities an expedited approval pathway to make Pfizer-BioNTech vaccine accessible to be used within the nation, the corporate’s Chairman and CEO Albert Bourla stated on Monday.

Earlier in April, Pfizer stated that it had provided a not-for-profit value for its vaccine for the federal government immunisation programme in India and it stays dedicated to persevering with engagement with the federal government to make the vaccine accessible in India.

“Pfizer is aware that access to vaccines is critical to ending this pandemic. Unfortunately, our vaccine is not registered in India although our application was submitted months ago.

We are currently discussing with the Indian government an expedited approval pathway to make our Pfizer-BioNTech vaccine available for use in the country,” Bourla stated in a mail despatched to Pfizer India workers that he has shared on his linked.in publish.

Pfizer has earlier stated that, in the course of the pandemic section, it is going to provide the Pfizer-BioNTech Covid-19 mRNA vaccine solely by way of authorities contracts.

“Pfizer remains committed to continuing our engagement with the government towards making the Pfizer and BioNTech vaccine available for use in the government’s immunisation programme in the country,” the corporate had stated in April in e-mail response to PTI.

The Indian authorities final month allowed emergency use approval of the imported vaccines in India which have been granted emergency approval for restricted use by United States Food and Drug Administration (USFDA), European Medicines Agency (EMA), UK Medicines and Healthcare merchandise Regulatory Agency (UK MHRA), Pharmaceuticals and Medical Device Agency (PMDA) Japan or that are listed in WHO (emergency use itemizing).