Pfizer in talks with Centre for expedited approval of its COVID-19 vaccine

Pfizer, the US pharmaceutical giant is in discussion with the Indian government about an expedited approval pathway to make the Pfizer/BioNTech COVID-19 vaccine available for use in the country, Albert Bourla, company’s CEO said on Monday, reported PTI.

In April, the pharma giant offered a not-for-profit price for its vaccine for the government immunisation programme in India. Pfizer has assured its commitment to continue engagement in helping to make vaccine available in the country.

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In a statement, the pharma company said, “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.”

Bourla said that Pfizer is discussing with India’s government about an expedited approval pathway to make our vaccine available for use in India, sharing his mail sent to Pfizer India employees through a LinkedIn post. 

Pfizer had earlier said that, during the pandemic phase, it will supply the Pfizer-BioNTech COVID-19 mRNA vaccine only through government contracts.

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“Pfizer remains committed to continuing our engagement with the government towards making the Pfizer/BioNTech vaccine available for use in the government’s immunisation programme in the country,” the company replied to PTI in an email. 

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 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).