Pfizer’s Chief Executive Officer Albert Bourla said on Monday that the pharmaceutical company was in talks with the Indian government for an “expedited approval pathway” for use of its coronavirus vaccine in the country.
“Pfizer is aware that access to vaccines is critical to ending this pandemic,” Bourla said on LinkedIn. “Unfortunately, our vaccine is not registered in India although our application was submitted months ago.”
Russia’s Sputnik V is the third vaccine to receive emergency-use authorisation in India after the Serum Institute’s Covishield and Bharat Biotech’s Covaxin. Several states in India have run out of vaccines, exacerbating a dire second wave of infections.
Although Pfizer had not conducted local trials in India, provisions under Clinical Trial Rules, 2019, allowed it to seek approval without conducting the tests. It was permitted as the vaccine had received approval from a foreign drug regulator recognised by the Central Drugs Standard Control Organization.
Last month, the Centre had also allowed emergency use approval of the imported vaccines in India which got permission for restricted use by United States Food and Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency, among others.
Bourla said the company was “deeply concerned” by the coronavirus situation in India. “Our hearts go out to you, your loved ones and all the people of India,” he wrote. “We are committed to being a partner in India’s fight against this disease and are quickly working to mobilise the largest humanitarian relief effort in our company’s history.”
The Pfizer chief announced a donation of medicines worth more than $70 million (over Rs 510 crore) to India from its distribution centres in the United States, Europe and Asia. “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.
This comes at a time when the Joe Biden administration in the US has been under mounting pressure to help countries desperately in need of vaccines, especially given its own swift inoculation drive.
The chief executive officer said the medicines will be made available immediately. “We will work closely with the government and our NGO [non-governmental organisation] partners to get them to where they are needed most,” he added.