Johnson Johnson Covid Vaccine: Johnson and Johnson seeks nod to study Covid-19 vaccine among kids in India | World News – World News
“On August 17, we submitted an application to the Central Drugs Standard Control Organisation (CDSCO) to conduct a study of the Johnson and Johnson Covid-19 vaccine in India in adolescents, 12–17 years, the company said on Friday.
The company had earlier on August 7 received emergency use authorization from the drug regulator for its single-dose Covid-19 vaccine in the country for 18 years and above, making it the fifth vaccine to get the green light.
“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 statement adds.
J&J has a supply agreement with Hyderabad-based Bio E to bring its jabs to the country.
The company did not provide details on timelines, logistics and deliveries 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”, it had said.
The nod was based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, which demonstrated our single-shot vaccine was 85 per cent effective in preventing severe disease across all regions studied, and showed protection against Covid-19 related hospitalization and death, beginning 28 days after vaccination, the company said.