Pfizer cites Indian origin of UK test subjects, all-clear for children, to seek faster approval

“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 has said.

It has said that 26 per cent of participants overall in the recent observational study by Public Health England (PHE) in the United Kingdom were of “Indian or British Indian” 26% in UK study that showed high effectiveness were of Indian ethnicity, Pfizer tells govt ethnicity. This study, which was concluded on May 22, reported a high vaccine effectiveness of 87.9 per cent against the B.1.617.2 variant, which is most reported in India.

The 26 per cent Indian or British Indian study participants included Bangladeshis (1.4 per cent), Pakistanis (5.9 per cent) and those from any other Asian background (5.7 per cent), indicating that the observed vaccine effectiveness applies to these groups as well.

Also, data from Qatar’s nationwide immunisation programme had demonstrated high vaccine effectiveness of 89 per cent against B.1.1.7 (first detected in the UK), and 75 per cent against B.1.351 (first detected in South Africa), Pfizer said.

It said 24 per cent of participants in this study were of Indian nationality (more than 6,000), Nepalese (6-12 per cent), Bangladeshi (4-11 per cent), Sri Lankan (3-4 per cent), and Pakistani (4-6 per cent) — again indicating that the observed vaccine effectiveness applies to these groups as well.

Pfizer, which is ready to offer 5 crore doses to India between July and October this year and has sought certain relaxations including indemnification, has held a series of interactions with Indian government authorities recently, including one this week, during which it shared the most recent data points regarding efficacy trials and approvals for its vaccine in various countries and by the World Health Organisation (WHO).

“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.

Another source privy to the discussions said that following recent meetings between the Indian government and Pfizer’s Chairman and CEO Albert Bourla, the two sides have agreed to jointly work on three key issues to accelerate approval for the company’s Covid-19 vaccine in India, viz., procurement through a central government pathway, indemnity and liability, and the regulatory requirement for post-approval bridging studies.

India is currently using Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin, besides small amounts of the Russian-made Sputnik V vaccines, to inoculate its citizens.

In its latest communication to the government, Pfizer has thanked the Government of India 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 of the regulatory pathway to help it supply “as expeditiously as possible to India”.