Sun. Jun 13th, 2021

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Amid Pfizer Talks, Centre Reiterates Policy Change For Foreign Vaccines

Pfizer has said it is ready to offer 5 crore doses to India between July and October this year

New Delhi: The government stressed that it has scrapped local trials for “well-established” foreign vaccines to fast-track imports, soon after Pfizer said it is ready to offer five crore doses this year but sought relaxations including indemnity from liability.

  1. In a statement, the government said it is in talks with Pfizer for “earliest possible” imports of its shots and that it had also had discussions with Johnson & Johnson and Moderna. “We reiterate our request to all international vaccine makers to come and make in India – for India and for the world,” it said.

  2. The government last month announced fast-track approvals for foreign vaccines, removing the need for local safety trials before emergency approval.

  3. The insistence on local trials was said to be a key reason for stalled discussions with Pfizer. “The provision has now been further amended to waive the trial requirement altogether for the well-established vaccines manufactured in other countries,” the government said in its statement.

  4. Pfizer has reportedly told the government that its vaccine has shown “high effectiveness” against the mutant strain dominant in India and on people of Indian ethnicity or nationality. The company has also said its shots are suitable for all above 12 years and can be stored for a month at 2-8 degrees.

  5. The US-based vaccine maker has said it is ready to offer 5 crore doses to India between July and October this year, but has sought relaxations including indemnity in a series of recent interactions with the government, according to Press Trust of India.

  6. Pfizer has immunity in countries like the US where it cannot be sued for any adverse effects. India has so far not given any manufacturer indemnity against the costs of compensation for any severe side effects.

  7. “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,” Pfizer told the government, according to a source quoted by PTI.

  8. PTI quoted another source as saying that after the government’s meetings with Pfizer CEO Albert Bourla, it was agreed that both sides would jointly work on three key factors to speed up approval — procurement through a central government pathway; indemnity and liability; and doing away with post-approval bridging studies.

  9. “As soon as Pfizer indicated vaccine availability, the central government and the company have been working together for the earliest possible import of the vaccine,” said VK Paul, the head of India’s Covid task force.

  10. The government has been using Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin to vaccinate people. Russia’s Sputnik V will become the third vaccine to be used. But supplies are far short of the millions of doses needed to vaccinate most citizens.

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