Pfizer has reportedly sought fast-track approval for its coronavirus vaccine. The pharma giant has told the Centre that its COVID-19 vaccine is “highly effective” against the COVID-19 strain prevalent in India.
Presenting data to support its claim, Pfizer told authorities that its vaccine has demonstrated “high effectiveness” against the COVID-19 variant prevalent in India and on the people of Indian ethnicity or nationality.
The company added that its vaccine is also suitable for everyone aged 12 years or above and can be preserved for a month at 2-8 degrees. Earlier this week, Pfizer told the Centre it was prepared to offer 5 crore dosages of its vaccine to India between July and October this year.
However, the company has sought certain relaxations comprising indemnification.
“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,” a source quoted Pfizer as having communicated to the Indian government, the PTI reported.
Another source privy to the discussions said that following recent meetings between the Indian government and Pfizer’s Chairman and CEO Albert Bourla, they have agreed to jointly work on three key issues to accelerate approval for the company’s COVID-19 vaccine in India, namely procurement through a central government pathway; indemnity and liability; and the regulatory requirement for post-approval bridging studies.
While India has administered over 20 crore doses so far since the launch of its vaccination drive in mid-January, it is still a long way to reach the vaccination for the entire population, more so in the backdrop of many states having flagged shortage of vaccines and the gap between supply and requirement widening amid the deadly second wave.
India is currently using mainly two ‘made-in India’ jabs Covishield manufactured by the Serum Institute and Covaxin of Bharat Biotech and Russian-made Sputnik V at a smaller scale to inoculate its population, all of which are approved only for those aged 18 years and above.
In its latest communication to the government, Pfizer has also thanked the Centre for having agreed to its request for procurement through a central government pathway and to discuss “the Indemnity and Liability protection”.
“The timely alignment and execution of the draft Heads of Terms will enable Pfizer to reserve the allocation of doses and pave the pathway for executing the Distribution and Supply Agreement,” the company told the government while seeking fast-tracking the regulatory pathway to help it supply “Pfizer’s COVID-19 vaccine as expeditiously as possible to India”.
Pfizer has said India should “rely on the 44 authorisations, including WHO approval, facilitate an EUA (Emergency Use Authorisation)/Restricted Use pathway for the Pfizer vaccine in India, and not seek a local PSA (Post Approval Commitment) study.”
The company is, however, open to considering safety surveillance of the first 100 subjects after understanding the process to be followed.
It has also stated that the Pfizer vaccine has undergone significant development over the last six months which includes improvement in storage conditions at 208 degrees for over one month (31 days) at the site of vaccination.
“Recent data points confirm the high effectiveness of BNT612b2 2-dose regimen against SARS-CoV-2 variants, and among individuals of Indian ethnicity,” Pfizer said.
Providing data, it said the UK’s Public Health England (PHE) reported high vaccine effectiveness (87.9 per cent) against the B.1.617.2 variant, most reported in India, in an observational study (concluded on May 22, 2021).
It further said 26 per cent of study participants overall were of “Indian or British Indian” ethnicity, and also included Bangladeshi (1.4 per cent), Pakistani (5.9 per cent), and any other Asian background (5.7 per cent), indicating that the observed vaccine effectiveness applies to these groups as well.
Also, the data from Qatar’s nationwide immunization program demonstrated high vaccine effectiveness – 89 per cent against B.1.1.7 variant (first detected in the UK) and 75 per cent against B.1.351 variant (first detected in South Africa).
It said 24 per cent of study participants were of Indian nationality (more than 6,000), and others included Nepalese (6-12 per cent), Bangladeshi (4-11 per cent), Sri Lankan (3-4 per cent), Pakistani (4-6 per cent), indicating that the observed vaccine effectiveness applies to these groups as well.
