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Serum Institute requests local trial for Novavax vaccine: CEO | India News

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NEW DELHI: The Serum Institute of India (SII), the world’s largest vaccine manufacturer, has asked local authorities to conduct a small national test of Novavax Inc.’s COVID-19 vaccine, which was found to be 89.3% effective in a test in the United Kingdom.
Serum A decision on an Indian trial of the Novavax vaccine was expected soon, Chief Executive Adar Poonawalla told Reuters on Friday, hours after the US company reported efficacy data.
“We have already submitted a request to the drug controller’s office for the bridge trial, a few days ago,” Poonawalla said. “So they should also give that approval soon.”
The Novavax UK trial, which enrolled 15,000 people aged 18 to 84, is expected to be used to apply for use in Britain, the European Union and other countries.
IBS is already producing in bulk a vaccine created by the University of Oxford and AstraZeneca, and Poonawalla told Reuters earlier this month that his company would make “more than 40-50 million doses per month” of the Novavax vaccine from April.
Health officials say they generally request so-called bridge trials to determine whether a vaccine is safe and elicits an immune response in its citizens, whose genetic makeup may be different from people in Western nations.
However, there are provisions under the rules introduced in 2019 to waive such lawsuits under certain conditions. Pfizer Inc requested an exception while seeking an emergency use authorization for its vaccine developed with German partner BioNTech SE, a request that the government rejected.
The Pfizer vaccine has not been approved in India, whose immunization campaign uses a homegrown vaccine developed by Bharat Biotech and the Indian Council for Medical Research, and the AstraZeneca / University of Oxford vaccine.

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