Pfizer in talks with India over expedited approval for COVID-19 vaccine
Pfizer top executive announced a donation of medicines worth more than $70 million
New Delhi: Pfizer is in discussions with the Indian government seeking an "expedited approval pathway" for its COVID-19 vaccine, its CEO Albert Bourla said on LinkedIn on Monday, announcing a donation of medicines worth more than $70 million.
"Unfortunately, our vaccine is not registered in India although our application was submitted months ago," he said.
"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 also said that the company's COVID-19 oral antiviral pill, which is in early-stage trials, could be ready by the end of the year, media reported.
According to CNBC, the company, which developed the first authorised Covid-19 vaccine in the US with German drugmaker BioNTech, began an early-stage clinical trial for testing a new antiviral therapy for Covid-19 in March.
The drug is part of a class of medicines called protease inhibitors and works by inhibiting an enzyme that the virus needs to replicate in human cells. "If clinical trials go well and the Food and Drug Administration (FDA) approves it, the drug could be distributed across the US by the end of the year," Bourla told CNBC.
Protease inhibitors are used to treat other viral pathogens such as HIV and hepatitis C, the report said.
Last month, the pharmaceutical giant asked the US Food and Drug Administration (FDA) to expand the Emergency Use Authorisation (EUA) for its Covid-19 vaccine to include children ages 12 to 15.
The request to expand emergency use comes just days after Pfizer released data demonstrating its vaccine was 100 per cent effective and well-tolerated by the younger group.