Johnson & Johnson seeks permission to conduct COVID vaccine trials on adolescents in India
The J&J single-shot vaccine has shown 85% efficacy in protection against coronavirus in phase 3 clinical trials.
New Delhi: Global healthcare major Johnson & Johnson has sought permission from the Central Drugs Standard Control Organisation (CDSCO) in India to conduct clinical trials of its single shot Janssen vaccine against Covid-19 on adolescents aged 12-17 years.
The J&J single-shot vaccine has shown 85% efficacy in protection against coronavirus in phase 3 clinical trials.
"Johnson & Johnson is committed to facilitating global equitable access to its Covid-19 vaccine and recognize the unmet needs of children. On August 17, 2021, we submitted an application to the Central Drugs Standard Control Organisation (CDSCO) to conduct a study of the Johnson & Johnson Covid-19 vaccine in India in adolescents aged 12 – 17 years," Johnson & Johnson India spokesperson was quoted as saying on Mirror Now.
"To ultimately achieve herd immunity, it is imperative that Covid-19 vaccine clinical trials continue to move forward in this population, and we remain deeply committed to the critical work needed to make our Covid-19 vaccine equitably accessible for all age groups,” the spokesperson added.
The single shot vaccine developed by Johnson and Johnson was granted Emergency Use Authorisation (EUA) in India by the Drug Controller General of India (DCGI) in August.
"The US-based pharmaceutical company had applied for Emergency Use Authorisation for its jab on Friday and was granted the approval the same day by the Drugs Controller General of India (DCGI)," a senior health ministry official had said.
Johnson & Johnson's vaccine is a single-dose jab, whereas the three vaccines cleared by India so far are of double doses.
India has so far approved four vaccines - AstraZeneca's Covishield, Bharati Biotech's Covaxin, Russian Gamaleya Institute's Sputnik V and Moderna's vaccine.
India recorded a marginal increase in daily Covid-19 cases on Friday with 36,571 new infections in the last 24 hours, taking the tally to 3,23,58,829, according to the Union Health Ministry data. The death toll rose to 4,33,589 with 540 fatalities reported in the last 24 hours, while the case fatality rate stands at 1.34%.
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