Vaccine Ready For 12+, Pfizer Tells Centre, Seeks Fast-Track Approval

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New Delhi:

Pfizer has told the government its Covid vaccine shows “high effectiveness” against the India-dominant variant of the virus that experts believe is behind the devastating second wave of infections and deaths in the country, sources told news agency PTI Wednesday.

Sources said the pharma giant told the government its vaccine is suitable for everyone over the age of 12 and, crucially, can be safely stored for a month between two and eight degrees Celsius.

Pfizer is in talks with the government to roll out five crore doses between July and October – if it receives significant regulatory relaxations, including indemnification. Company and government officials have held a series of meetings over the past few weeks, including one on Monday.

“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,” the company told the government, according to PTI.

Sources said Pfizer told the government it should “rely on the 44 authorisations, including WHO approval (to) facilitate emergency use authorisation… and not seek a local PSA (Post Approval Commitment) study.”

It is, however, sources said, open to considering safety surveillance of the first 100 subjects after understanding the process to be followed.

A second source told PTI that these discussions, which involved Pfizer Chairman and CEO Albert Bourla, focused on three key issues to accelerate approval for the vaccine.

These issues are: procurement through a central government pathway, indemnity and liability, and the regulatory requirement for post-approval bridging studies.

Pfizer was approached by the Delhi government which was looking to buy vaccines directly rather than rely on the centre’s new “liberalised” policy, about which questions have been raised after documents appeared to show the centre had fixed the quantities Delhi could buy.

However, the company told the Delhi government it would only deal with central governments.

WHOAnother 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.

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.

Covaxin is expected to shortly start trials for the 2-18 age group.

With input from PTI



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