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The government on Tuesday revised regulations for foreign vaccines that have received emergency use authorization (EUA) from top regulators, including the World Health Organization. Mint looks at what it means for India’s vaccination drive.

What has the Indian government done?

Under the clinical trial rules, a foreign company has to conduct a bridging study before it seeks an authorization that determines if the vaccine is equally safe and effective among the Indian population as it is in the country where extensive human trials have been conducted. However, there are certain clauses, which, in case of an emergency, allow the regulator to authorize a foreign vaccine if it has been approved by another national regulator. The Indian government has basically invoked this provision of the clinical trial rules to allow foreign companies to export their vaccines.

What are the likely implications?

Foreign companies can now seek an authorization from the DCGI V.G. Somani for their vaccines without conducting a bridging study before submitting their applications, if they have received an authorization from the USFDA, UK Medicines and Healthcare products Regulatory Agency, European Medicines Agency, Japan’s Pharmaceuticals and Medical Devices Agency or WHO. However, they will have to conduct a bridging study in India parallel to the rollout after getting authorization. Also, the first 100 beneficiaries of such vaccines shall be assessed for seven days for safety outcomes before it is rolled out further.

In the pipeline
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In the pipeline

Which companies stand to benefit from govt’s move?

Pfizer’s and Moderna’s mRNA vaccines and J&J’s single-shot jab can immediately apply for an emergency import licence, as they have authorisations from at least two of the five regulators. Serum Institute of India could also benefit from the revised rules if Novavax secures an EUA from the USFDA, as it is contract manufacturing the vaccine under its brand Covovax.

Are there any concerns?

A bridging study helps determine whether a vaccine is equally safe and effective in the local population. While theoretically, safety and immune response of the jabs may differ in populations, experts don’t foresee a significant change as bridging studies for covid-19 jabs are usually conducted in 1,600 participants, which may not be a large sample size to find out population-specific safety issues. Also, in terms of immune response, while there may be some variation, it may not be significant enough to lower the efficacy.

What is the way forward?

While the move will help hasten the approval process, it may not be enough to immediately improve vaccine supply. Say, if J&J gets an emergency authorization, it may be unlikely that supply to India will be immediately ramped up, especially because J&J has prior commitments to the US and European Union. Even Biological E, with which J&J has a manufa-cturing pact, has not yet started making the vaccines. At least for April, as cases peak and some areas seem to face vaccine shortage, the situation may continue.

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