Pfizer’s vaccine is based on genetic material or mRNA.
Global pharma major Pfizer is in talks with the Indian government to establish 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 May 3.
"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.
Last month, the pharmaceutical major had offered a not-for-profit price for its COVID-19 vaccine for the Indian government's immunisation programme. "We continue to be in discussions with the government and remain committed to make our vaccine available for deployment in India’s immunisation programme,” a Pfizer company spokesperson had told Moneycontrol.
The drug manufacturer had also said its priority would be to exclusively support governments by supplying its vaccine only to governments for their immunisation programmes.
In February, the company had withdrawn an application for emergency-use authorisation (EUA) of its COVID-19 vaccine in India, after failing to meet the drug regulator’s demand for a local safety and immunogenicity study.
But circumstances have changed now, with Pfizer becoming eligible to directly seek EUA from the Drugs Controller General of India (DCGI) to import its COVID-19 vaccine, as the government recently waived the requirement of submitting local bridge trial data upfront for vaccines approved by the USFDA, European Medicines Agency (EMA), UK MHRA, PMDA Japan or those listed with the WHO under Emergency Use Listing. All these regulatory agencies have approved the Pfizer vaccine.
In his mail, Bourla also said Pfizer would be sending medicines worth $70 million (over Rs 510 crore) to India from its distribution centres in the US, Europe and Asia. These are medications that have been identified as part of India''s COVID-19 treatment protocol.
"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 the mail, which he has shared on his linked.in post.
"We are donating these medicines to help make sure that every COVID-19 patient in every public hospital across the country can have access to the Pfizer medicines they need free of charge," Bourla 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," he added.