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Govt to allow emergency use of covid vaccines authorized by major regulators

Under the new norms, instead of conducting a local clinical trial before seeking an emergency licensure in accordance with clinical trial regulations, the companies can conduct a bridging trial parallel to the roll-out post-authorization, the government said. (PTI)Premium
Under the new norms, instead of conducting a local clinical trial before seeking an emergency licensure in accordance with clinical trial regulations, the companies can conduct a bridging trial parallel to the roll-out post-authorization, the government said. (PTI)

  • The move comes at a time when India is facing a vaccine shortage in meeting domestic demand even as the new wave of covid-19 takes daily new additions to record levels.

NEW DELHI : In a move that could potentially pave the way for Pfizer and Johnson & Johnson’s covid-19 vaccines in India, the Centre on Tuesday said it would allow the granting of emergency licensure for vaccines that have received authorization in the US, UK, Europe, Japan or from the World Health Organization (WHO).

The move comes at a time when India is facing a vaccine shortage as both Serum Institute of India and Bharat Biotech International struggle to scale up capacity of Covishield and Covaxin, respectively, to meet domestic demand even as the new wave of covid-19 takes daily new additions to record levels.

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On Monday, India added more than 160,000 new cases, taking its total active cases to 1.25 million. This is in sharp contrast with the situation in January when case addition was under 20,000 a day on a regular basis.

Under the new norms, instead of conducting a local clinical trial before seeking an emergency licensure in accordance with clinical trial regulations, the companies can conduct a bridging trial parallel to the roll-out post-authorization, the government said.

“Further, 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 programme within the country," the Union health ministry said in a statement.

The move could allow the entry of Pfizer, Moderna and Johnson & Johnson’s vaccines into India without the need for them conducting a bridging study before.

Pfizer’s and Moderna’s vaccines have emergency use authorization from the US Food and Drug Administration (FDA), European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Agency (MHRA), Japan’s Pharmaceuticals and Medical Devices Agency, and WHO.

J&J’s single shot vaccine has an authorization from all the regulators mentioned above, except Japan’s PMDA.

To be sure, Johnson & Johnson had said that it planned to conduct a bridging study for its single-shot vaccine and was in discussion with the government about it.

It may also benefit Pfizer, which in February had withdrawn its application for emergency use in India 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.

Both vaccines, along with the mRNA vaccine from Moderna, have proved to be the workhorses of US government’s covid-19 immunization drive due to their high efficacy, as in the case of Pfizer and Moderna jabs, and practical use, in the case of Johnson & Johnson’s one-shot vaccine.

While Pfizer and Moderna’s two-shot vaccines have an efficacy of 95% and 94% respectively, a single shot of Johnson & Johnson’s vaccine has an efficacy of 66%.

Pfizer and Johnson & Johnson were not immediately available to comment on whether they would apply for restricted emergency use under the new norms.

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