Covid: Pfizer seeks faster approval, tells India its vaccine ‘highly effective’ on dominant variant
Pfizer was the first company to seek emergency use authorisation for its vaccine in India late last year, but it withdrew application later.
American pharmaceutical company Pfizer has told the Indian government that its Covid vaccine has shown “high effectiveness” against the virus variant that is dominant in India and on people of Indian ethnicity or nationality, The Indian Express reported on Thursday.
The company has sought fast-track approval for its vaccine. It is in talks with the Centre to roll out five crore doses between July and October this year, while asking for significant regulatory relaxations, according to PTI.
“The current situation in India, and across the world, is not ‘business as usual’ and we must not respond to it with processes as usual too,” Pfizer reportedly said.
It has told the government that the vaccine was suitable for everyone aged 12 years or older, and more importantly, can be safely stored for a month at 2 to 8 degrees Celsius.
“Recent data points confirm the high effectiveness of BNT612b2 [as the Pfizer-BioNTech vaccine is technically known] 2-dose regimen against SARS-CoV-2 variants, and among individuals of Indian ethnicity,” Pfizer said.
Citing data, the company said the Public Health England in the United Kingdom has reported high vaccine effectiveness of 87.9% against the B.1.617.2 variant, which is most dominant in India. It added that 26% of study participants overall were of “Indian or British Indian” ethnicity. The study also included Bangladeshis (1.4%), Pakistanis (5.9%) and those from other Asian background (5.7%), indicating that the observed vaccine effectiveness applied to these groups too.
Data from Qatar’s nationwide immunisation programme, Pfizer added, shows high vaccine effectiveness – 89% against B.1.1.7 variant first detected in the UK and 75% against B.1.351 variant which was first found in South Africa.
Pfizer was the first company to seek emergency use authorisation for its vaccine in India late last year. But it withdrew its application in February after the drugs regulator asked for a local safety study for the vaccine.
As coronavirus cases surged during the second wave of the pandemic, the government said last month it would fast-track approval for some foreign shots, with companies now required to do a local trial within 30 days of approval, not before.
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.