Safe For 12+, 'Highly Effective' Against New Variants: Why Pfizer Is Seeking Fast-Track Nod
As India continues to ramp up indigenous production of anti-coronavirus jabs, vaccine giant Pfizer recently offered their COVID-19 vaccine to India.
Now, Pfizer has told Indian authorities that its jab has shown "high effectiveness" against the SARS-CoV-2 variant prevalent in India and on people of Indian ethnicity or nationality, while it is suitable for everyone aged 12 years or above and can be stored for a month at 2-8 degrees, sources said.
2-8 degrees storage a gamechanger
The 2-8 degrees storage is a gamechanger as previously the vaccine was said to only be storable at a much lower temperature that's colder than most standard refrigerators and cold storage can provide.
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 the 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 ĄŽbusiness as usual' and we must not respond to it with processes as usual too," news agency PTI quoted sources as saying.
Pfizer, govt to jointly work on 3 key issues
PTI sources further said that Pfizer and the government have agreed to jointly work on three key issues -- procurement through a central government pathway, indemnity and liability and the regulatory requirement for post-approval bridging studies -- to accelerate approval for the company's COVID-19 vaccine in India.
"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," Pfizer told the government during the meeting.?
Pfizer has said India should "rely on the 44 authorizations, including WHO approval, facilitate a 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.
"High vaccine effectiveness" against variants?
"Recent data points confirm the high effectiveness of BNT612b2 2-dose regimen against SARS-CoV-2 variants, and among individuals of Indian ethnicity," Pfizer has said.Providing data, it said UK's Public Health England (PHE) has 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.
