Pfizer chairman and CEO Albert Bourla on Monday said the company was in discussions with the Indian government to expedite the approval of the Pfizer-BioNTech vaccine for use in India. He said the application had been submitted months ago.
“Pfizer is aware that access to vaccines is critical to ending this pandemic. Unfortunately, our vaccine is not registered in India,” Bourla said.
Bourla also announced Pfizer was rushing shipments of its medicines valued at more than $70 million which have been identified by the Indian government as part of its Covid treatment protocol and includes steroid medication to reduce inflammation, anti-coagulants to prevent blood clotting and antibiotics to treat secondary bacterial infections.
Pfizer had in April offered a ‘not-for-profit’ price for its vaccine for the Indian government’s immunisation programme.
The Indian government has permitted the emergency use approval of the imported vaccines in India which have been granted emergency approval for restricted use by regulators in the US, the EU, the UK, Japan and WHO.
Expressing concern about the critical Covid-19 situation in India with the highest rates of infection and hospitalisation and the need the treat those who are suffering in hospitals, Bourla said the medicines were being rushed from Pfizer’s distribution centres in the US, Europe and Asia over the next 90 days.
The Pfizer chairman further said they would be working with the government and NGO partners to take these medicines, that are being donated, to public hospitals across the country free of charge.
The Pfizer-BioNTech Covid-19 vaccine has been authorised for emergency use by the USFDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 for use in individuals 16 years of age and older. The Pfizer BioNTech Covid-19 vaccine is a messenger RNA vaccine that has both synthetic and enzymatically produced components from naturally occurring substances such as proteins. The vaccine does not contain any live virus.
According to Pfizer, the vaccine effectiveness was at least 97% against symptomatic Covid-19 cases, hospitalisations, severe and critical hospitalisations, and deaths. Vaccine effectiveness was 94% in case of asymptomatic SARS-CoV-2 infections.