Our Vaccine Highly Effective On Covid-19 Variant Prevalent I
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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, while it is suitable for everyone aged 12 years or above and can be stored for a month at 2-8 degrees, sources said on May 26.

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).

A source 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.

"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 a fast-tracking 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.

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. "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. Also, the data from Qatar's nationwide immunization program demonstrated high vaccine effectiveness -– 89 per cent against B.1.1.7 variant (first detected in the UK) and 75 per cent against B.1.351 variant (first detected in South Africa).

Pfizer has urged the Government of India to rely upon WHO's testing pathways of reliance on testing certificates from country of origin instead of mandating local testing and batch release stating that it will also help fast track vaccine introduction and prevent vaccine wastage.

Source:
https://health.economictimes.indiatimes.com/news/pharma/our-vaccine-highly-effective-on-covid-19-variant-prevalent-in-india-suitable-for-12-years-and-above-pfizer-to-govt/82992895
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