Pfizer seeks expedited nod for COVID-19 vaccine in India, donates drugs worth more than Rs 510 Cr
“Unfortunately, our vaccine is not registered in India, even though our application was submitted months ago. We are currently discussing an accelerated approval path with the Indian government to make our Pfizer BioNTech vaccine available for use in the country,” said Bourla.
Pfizer is in solidarity with all those currently affected by COVID-19 in India and around the world and will continue to do everything possible to provide help, he added.
“As we work to meet public health needs and to partner with the Government of India in finding a way for our vaccine, please know that you and your loved ones are the first in our thoughts and prayers” said Bourla.
In early April, Pfizer announced that it was offering a not-for-profit price for its vaccine to the government vaccination program in India.
“Pfizer remains committed to our commitment to the government to make the Pfizer and BioNTech vaccine available for the government’s vaccination program in the country,” the company said in an email response to PTI in April.
The Indian government last month issued emergency approval for the vaccines imported into India, which are approved by the United States Public Health Agency (USFDA), the European Medicines Agency (EMA), the United Kingdom’s Medicines and Health Products Regulator ( EMA)) have been approved. UK MHRA), Pharmaceuticals and Medical Device Agency (PMDA) Japan or those listed in the WHO (Emergency Use Listing).