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Covid: Trial and test waiver for foreign vaccines

Requirements of post-approval to be relaxed by bridging clinical testing of every batch of jabs already approved by authorities in the US, UK, Europe, Japan, and WHO
In an order issued on Tuesday, the CDSCO said the waiver decision had been taken “in the light of the huge vaccination requirements in India … and the need for increased availability of imported vaccines to meet the national needs”.
In an order issued on Tuesday, the CDSCO said the waiver decision had been taken “in the light of the huge vaccination requirements in India … and the need for increased availability of imported vaccines to meet the national needs”.
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G.S. Mudur   |   New Delhi   |   Published 03.06.21, 03:07 AM

India has waived clinical trials and batch-by-batch testing on foreign Covid-19 vaccines approved by select foreign regulatory authorities, easing the possible entry of vaccines from Pfizer, Moderna, Johnson & Johnson and a vaccine from China into the country.

The Central Drugs Standard Control Organisation (CDSCO) has said it would waive the requirements of post-approval bridging clinical trials and testing of every batch of Covid-19 vaccines already approved by authorities in the US, UK, Europe, Japan and the World Health Organisation.

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In an order issued on Tuesday, the CDSCO said the waiver decision had been taken “in the light of the huge vaccination requirements in India … and the need for increased availability of imported vaccines to meet the national needs”.

The order amends an April 15 decision by the CDSCO to grant restricted emergency use approval to foreign vaccines approved by select regulatory authorities but on the condition that the companies would post-approval conduct bridging clinical trials within 30 days. The CDSCO had also said that the first 100 recipients of such imported vaccines would be assessed for safety for seven days before such vaccines are rolled out into the vaccination campaign.

The CDSCO’s June 1 order retains the condition that require safety observations on the first 100 recipients but has exempted such imported vaccines from bridging clinical trials and from the need to test every batch at India’s Central Drugs Laboratory.

Health officials have asserted that the Indian government has been in talks with Pfizer, Moderna, and Johnson & Johnson, but the companies are unable to immediately supply their vaccines to India because they are supplying to other countries that had signed advance purchase pacts.

Pfizer has indicated that it can supply 50 million doses to India in 2021 but will deal only with the central government. The company has also asked for indemnification from the Centre just as it had sought from the governments of over 100 other countries, including the US.

The CDSCO waiver would in principle allow China’s Sinovac vaccine to enter the country as the vaccine received emergency use listing approval from the World Health Organisation on Tuesday.

Public health experts have welcomed the waiver but some said it is belated. “This decision should have been taken over six months ago when it was clear that India would need imported vaccines,” said a public health specialist who requested anonymity. “We’re learning late, learning the hard way.”

Pfizer had earlier this year sought emergency use approval for its Covid-19 vaccine in the country and had offered to provide logistical support for the vaccine’s transportation that requires temperatures lower than those demanded by Covishield and Covaxin — the current vaccines used in India.

But a CDSCO expert panel had denied the approval in February amid what many health experts, including at least two members of India’s Covid-19 national task force, believe was high emphasis on domestically-produced vaccines.

One top government medical researcher in early January had described Covishield — the AstraZeneca vaccine produced in India by the Serum Institute — as “make in India” and Covaxin, the homegrown vaccine from Bharat Biotech as “made in India” vaccines.



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