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regular-article-logo Monday, 06 May 2024

Covid: India’s drug regulatory authority approves Johnson & Johnson’s single-dose vaccine

J&J indicated on Saturday it is too early to specify timelines or doses for the country

Our Special Correspondent New Delhi Published 08.08.21, 12:37 AM
The J&J vaccine will be domestically produced by the Hyderabad-based vaccine maker Biological E under a pact signed last year with J&J.

The J&J vaccine will be domestically produced by the Hyderabad-based vaccine maker Biological E under a pact signed last year with J&J. Shutterstock

India’s drug regulatory authority on Saturday approved Johnson & Johnson’s single-dose Covid-19 vaccine, raising the count in the country’s basket to five, but the quantum of doses to be available for India remains unspecified.

The Central Drugs Standard Control Organisation has issued emergency use authorisation (EUA) for the J&J vaccine that qualified for rapid approval under new rules crafted earlier this year for vaccines already approved by regulatory authorities in Europe, the UK and the US.

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The J&J vaccine will be domestically produced by the Hyderabad-based vaccine maker Biological E under a pact signed last year with J&J.

However, J&J indicated on Saturday it is too early to specify timelines or doses for India.

“While we look forward to meeting our delivery commitments, it is premature for us to speculate on the timing of our vaccine deliveries,” a J&J India spokesperson told The Telegraph.

The J&J product is the fifth Covid-19 vaccine to receive EUA in India, after approvals to AstraZeneca-Serum Institute’s Covishield and Bharat Biotech’s Covaxin in January, Russia’s Sputnik-V in April, and Moderna’s vaccine in June.

But India’s vaccination campaign is currently relying almost entirely on Covishield and Covaxin with limited stocks of Sputnik V. Covishield made up around 442 million, Covaxin around 62 million, and Sputnik V less than 600,000 among the 505 million doses administered until Saturday morning.

Health experts tracking Covid-19 vaccine supplies worldwide had predicted earlier this year that India was unlikely to receive large volumes of doses from foreign vaccine manufacturers during much of 2021 because it had not invested in advance purchases as many other countries had done last year.

The health ministry has said it expects India to have access to 1,350 million doses of Covid-19 vaccines between August and December this year with which it will be able to vaccinate all adults -- an estimated 943 million people by year-end.

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