Govt Examining Pfizer's Request for Indemnity, Will Take Decision on Merit: VK Paul

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The government is examining Pfizer's request for indemnity and will take a decision in the larger interest of people and on merit, NITI Aayog Member (Health) V K Paul said on Thursday. At a press conference, Paul said, "Yes we are engaged with Pfizer and they have indicated the availability of a certain amount of vaccine in the coming months, possibly starting in July." "We are looking at what their expectations are from the government and they are looking at what our expectations are from them. That's the process in which this will move. Because they will have to come to India and apply for licensure in India, that's one path and there are imperatives of cold chain and supply.

"They have requested indemnity to all the nations, including the country of origin. We are examining this request and will take a decision in the larger interest of people and on merit. This is under discussion and there is no decision as of now," Paul said. Seeking a fast-track approval for its COVID-19 vaccine, US major 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, besides it is suitable for everyone aged 12 years or above and can be stored for a month at 2-8 degrees, sources said on Wednesday.

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). 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 Government of India to have 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 "Pfizer's COVID-19 vaccine as expeditiously as possible to India".

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. "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.

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