Pfizer has told Indian authorities that its vaccine has shown high effectiveness against the SARS-CoV-2 variant prevalent in India and on people of Indian ethnicity or nationality. It said the jab is suitable for everyone aged 12 years or above and can be stored for a month at 2-8 degrees.
The pharmaceutical major is ready to offer five crore doses to India between July and October this year and has sought certain relaxations including indemnification. As such, it has held a series of interactions with the Indian government authorities, including one this week, wherein it shared the most recent data points regarding efficacy trials and approvals for its vaccine in various countries and by the WHO.
A source told PTI that Pfizer and the Indian government 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.
India is currently using two made-in-India jabs, Covishield manufactured by Serum Institte 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.
“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 while seeking fast-tracking the regulatory pathway to help it supply Pfizer’s COVID-19 vaccine as expeditiously as possible to India. It said India should rely on the 44 authorizations, including WHO approval, facilitate a EUA (Emergency Use Authorization)/Restricted Use pathway for the Pfizer vaccine in India and not seek a local Post Approval Commitment study.
Moreover, over the past six months, Pfizer vaccine has undergone significant development 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.
It also pointed out that 26% of study participants overall were of “Indian or British Indian” ethnicity, and also included Bangladeshi (1.4%), Pakistani (5.9%) and any other Asian background (5.7%), indicating that the observed vaccine effectiveness applies to these groups as well.