Pfizer seeks expedited nod for its COVID-19 vaccine in India

A vial of the Pfizer-BioNTech coronavirus disease (COVID-19) vaccine. File   | Photo Credit: Reuters

Pfizer is in discussions with the government for an expedited approval pathway to make Pfizer-BioNTech vaccine available, its chief Albert Bourla said on Monday, while stating that the firm is donating medicines worth $70 million (over ₹510 crore) for treatment of COVID-19 patients.

“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 posted on

Pfizer is committed to being a partner in India’s fight against this disease and is quickly working to mobilise the largest humanitarian relief effort in the company’s history, he said.

“Right now, Pfizer colleagues at distribution centres in the U.S., Europe and Asia are hard at work rushing shipments of Pfizer medicines that the Government of India has identified as part of its COVID treatment protocol,” Mr. Bourla said.

Pfizer is donating these medicines to help make sure that every COVID-19 patient in every public hospital can have access to its medicines they need free of charge, he said.

“These medicines, valued at more than $70 million, will be made available immediately, and we will work closely with the government and our NGO partners to get them to where they are needed most,” Mr. Bourla said.

This effort, in combination with the Pfizer Foundation funding that supports humanitarian organisations providing essential and life-saving equipment to India, such as ventilators, oxygen concentrators and consumables, is our most comprehensive humanitarian relief response ever, he said.

He also said the company is aware that access to vaccines is critical to ending this pandemic.

“Unfortunately, our vaccine is not registered in India though our application was submitted months ago. We are discussing with the Indian government an expedited approval pathway to make our Pfizer-BioNTech vaccine available for use in the country.

“As we work to meet the public health need and to be a partner with the Government of India to establish a path forward for our vaccine, please know you and your loved ones are foremost in our thoughts and prayers.”

Pfizer said last month it had offered a not-for-profit price for its vaccine for the government immunisation programme in India.

“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 which have been granted emergency approval for restricted use by U.S. 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).

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Printable version | Jun 17, 2021 1:49:39 AM |

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