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India rolls out red carpet for foreign Covid-19 vaccines

Pfizer, which withdrew its application for importing its mRNA vaccine after the subject expert committee of India’s drug regulator rejected its request for a waiver for a local trial, is likely to be the biggest beneficiary of the relaxed rules in India  (Photo: Reuters)Premium
Pfizer, which withdrew its application for importing its mRNA vaccine after the subject expert committee of India’s drug regulator rejected its request for a waiver for a local trial, is likely to be the biggest beneficiary of the relaxed rules in India (Photo: Reuters)

Move paves way for use of Pfizer and Johnson and Johnson shots amid a deluge of cases

India agreed to fast-track vaccine approvals that have already been authorized by one of four foreign drug regulators or the World Health Organization (WHO), clearing the way for the use of Pfizer and Johnson and Johnson shots amid a wrenching surge in infections and deaths.

Vaccines approved by drug regulators in the US, UK, European Union and Japan or those that have been cleared by the WHO will be eligible for use in India without having to conduct a local bridging trial, a Union health ministry statement said on Tuesday.

The move comes at a time when India is facing an acute shortage of vaccines as both Serum Institute of India and Bharat Biotech International struggle to scale up production of Covishield and Covaxin, respectively, to meet domestic demand even as India topped the daily infection counts of other countries.

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“Doing away with the bridging study is a farsighted move and would help ease the vaccine shortage. India might also need to consider an alternative to Covishield for the younger age groups in view of its link to blood clots," said Lalit Kant, a scientist and former head of epidemiology and communicable diseases at the Indian Council of Medical Research (ICMR).

On Monday, India added more than 160,000 new cases, taking its total active cases to 1.25 million. This is in sharp contrast to the situation in February when daily case addition was below 10,000 per day.

Under the new norms, instead of conducting a local clinical trial before seeking an emergency use authorization, vaccine makers can conduct a bridging trial parallel to the rollout post-authorization, the government said.

“The first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunization," the health ministry statement said.

The move could pave the way for the use of Pfizer, Moderna and J&J’s vaccines in India.

The J&J vaccine, however, faced a setback on Tuesday after US regulators paused immunizations with the shot, pending a review of rare blood clots.

Pfizer, which withdrew its application for importing its mRNA vaccine after the subject expert committee of India’s drug regulator rejected its request for a waiver for a local trial, is likely to be the biggest beneficiary of the relaxed rules in India.

Vaccines made by Pfizer, J&J and Moderna have proved to be the workhorses of the US government’s immunization drive.

While Pfizer and Moderna’s two-shot vaccines have an efficacy of 95% and 94%, respectively, a single shot of J&J’s vaccine has an efficacy of 66%. “We have noted the recent announcement with regard to the regulatory pathway for global vaccines. We remain committed to continuing our engagement with the government towards making the Pfizer and BioNTech vaccine available for use in the government’s immunization programme in the country," a spokesperson for Pfizer said in a statement.

A spokesperson for Johnson & Johnson did not immediately respond to a question on whether the company would apply for restricted emergency use under the new norms.

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