New Delhi: American firm johnson And Johnson has sought approval from India’s drug regulator to conduct a clinical study of its COVID-19 vaccine among adolescents.
“On August 17, we submitted an application to Central Drugs Standard Control Organization (CDSCO) to study Johnson & Johnson COVID-19 vaccine in India in adolescents aged 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 for those 18 years and above in the country, making it the fifth vaccine to get the green light.
“To ultimately achieve herd immunity, it is imperative that COVID-19 vaccine clinical trials in this population continue to advance, and we continue to make our COVID-19 vaccine equally accessible to all age groups. Deeply committed to the critical tasks required.” Adds statement.
J&J has a supply agreement with Hyderabad based bio To bring your jobs in e country.
The company did not provide details on timelines, logistics and delivery for India.
“While we look forward to meeting our delivery commitments, it is premature for us to speculate about the timing of our vaccine delivery”, it had said.
The node was based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, which showed that our single-shot vaccine was 85 percent effective in preventing severe disease in all areas studied, and COVID-19-related hospitalization and Shows protection against death. , 28 days after vaccination, the company said.
“On August 17, we submitted an application to Central Drugs Standard Control Organization (CDSCO) to study Johnson & Johnson COVID-19 vaccine in India in adolescents aged 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 for those 18 years and above in the country, making it the fifth vaccine to get the green light.
“To ultimately achieve herd immunity, it is imperative that COVID-19 vaccine clinical trials in this population continue to advance, and we continue to make our COVID-19 vaccine equally accessible to all age groups. Deeply committed to the critical tasks required.” Adds statement.
J&J has a supply agreement with Hyderabad based bio To bring your jobs in e country.
The company did not provide details on timelines, logistics and delivery for India.
“While we look forward to meeting our delivery commitments, it is premature for us to speculate about the timing of our vaccine delivery”, it had said.
The node was based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, which showed that our single-shot vaccine was 85 percent effective in preventing severe disease in all areas studied, and COVID-19-related hospitalization and Shows protection against death. , 28 days after vaccination, the company said.
.