Discussions on with Indian govt for expedited approval of COVID-19 vaccine: Pfizer

Global pharma major Pfizer is discussing with the Indian government an expedited approval pathway to make Pfizer-BioNTech vaccine available for use in the country, the company's Chairman and CEO Albert Bourla said on Monday.

Earlier in April, Pfizer said that it had offered a not-for-profit price for its vaccine for the government immunisation programme in India and it remains committed to continuing engagement with the government to make the vaccine available 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 said in a mail sent to Pfizer India employees that he has shared on his LinkedIn post.

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Pfizer has earlier said that, during the pandemic phase, it will supply the Pfizer-BioNTech COVID-19 mRNA vaccine only through government 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 company had said in April in email response to PTI.

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

In another development, the global pharma major is sending its medicines worth $70 million (over Rs 510 crore), from its distribution centres in the US, Europe and Asia, that have been identified as part of India's COVID-19 treatment protocol, the company's Chairman and CEO Albert Bourla said on Monday.

"We are deeply concerned by the critical COVID-19 situation in India, and our hearts go out to you, your loved ones and all the people of India," he said in a mail sent to Pfizer India employees that he has shared on his linked.in post.

"We are committed to being a partner in India's fight against this disease and are quickly working to mobilize the largest humanitarian relief effort in our company's history," Bourla said.

Right now, Pfizer colleagues at distribution centres in the US, Europe and Asia are hard at work rushing shipments of Pfizer medicines that the Government of India has identified as part of its COVID-19 treatment protocol, he added.