J&J seeks emergency use nod for COVID-19 vaccine in India

INDIA – Global healthcare major Johnson & Johnson has applied for emergency use approval of its coronavirus vaccine in India, moving a step closer to supplying the first single-dose COVID-19 shot to the country.

Earlier on Monday, the company had said that it remained committed to bringing its single-dose COVID-19 vaccine to India and looks forward to ongoing discussions with the Indian government.

The shot will be brought to India through a supply agreement with homegrown vaccine maker Biological E Ltd, J&J said in an emailed statement.

Biological E will be an important part of our global supply chain network, helping to supply our Johnson & Johnson COVID-19 vaccine through the extensive collaborations and partnerships we have with governments, health authorities and organizations such as Gavi and the COVAX Facility,” the statement said.

The company’s application comes at a time when legal wrangles have held up U.S. vaccine donations to India, which has not met requests for granting foreign manufacturers indemnity from lawsuits.

The company’s application comes at a time when legal wrangles have held up U.S. vaccine donations to India, which has not met requests for granting foreign manufacturers indemnity from lawsuits.

India’s drugs regulator gave emergency use authorization to the Moderna vaccine in June, as the United States readied donations for India. Pfizer and J&J were yet to seek authorization.

Health authorities in the country have also approved the use of vaccines developed by AstraZeneca (AZN.L), Bharat Biotech and Russia’s Gamaleya Institute.

J&J said it was in talks with the Indian government to accelerate the availability of its vaccine, without giving further details.

The government and Moderna are still trying to sort out issues over imports of the vaccine and indemnity, a top executive at Indian drug maker and Moderna’s local distribution partner Cipla reported.

Only about 495.3 million people from a population of more than 1.3 billion had received at least one dose of the vaccine as of Friday, according to the Indian health ministry data.

Johnson & Johnson is yet to request full approval for its shot with the U.S. Food and Drug Administration.

India recorded 44,643 new coronavirus infections taking the total tally of COVID-19 cases to 3,18,56,757, while the active cases registered an increase for the third consecutive day, according to the Union Health Ministry data updated on Friday. The death toll climbed to 4,26,754 with 464 fresh fatalities.

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