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Johnson & Johnson To Soon Start Clinical Bridging Trials Of Its Single-Dose Covid-19 Vaccine In India: Report
J&J
Johnson & Johnson (J&J) is likely to begin the clinical trials of its single-dose Covid-19 vaccine in India soon as it has sought Indian drug regualator's approval for the same.
The US pharma major has written to the Central Drugs Standard Control Organization (CDSCO), saying that it will soon apply for permission to carry out clinical bridging trials in India for its Covid-19 vaccine candidate.
In a bridging trial, the companies are asked by regulators to enroll around 1,000 participants to determine the safety and immunogenicity of a vaccine. It does not test the efficacy of a vaccine as that is already proven through another clinical trial, reports Indian Express.
If the vaccine is approved in India, it will provide a big boost to the ongoing Covid-19 vaccination drive in the country.
J&J’s bridging trial will be similar to that being conducted by Dr Reddy’s for Russian Sputnik V vaccine and the one by the Serum Institute of India for the Astrazeneca-Oxford vaccine.
The US pharma firm has collaborated with India's Biological E to further augment its vaccine’s manufacturing capabilities.
J&J's Covid vaccine is the only single-shot jab approved by the US drug regulator. The approval was based on data from the Phase 3 ensemble study that showed that J&J’s vaccine is 85 per cent effective in preventing severe disease across every region that was studied,
The vaccin e is also 66-72 per cent effective in preventing moderate to severe Covid cases and also protects from Covid-related hospitalization and death, beginning 28 days from the vaccination.
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