US-based healthcare major Johnson & Johnson has sought approval to conduct COVID-19 vaccine trials in adolescents between the ages of 12 to 17 years in India. The company had recently received emergency use authorisation from the Government of India for its single dose COVID-19 vaccine. “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,” a spokesperson from Johnson & Johnson India said in a statement.
On Thursday, August 19, Union Health Minister Mansukh Mandaviya said that COVID-19 vaccines for children could be launched very soon. Director of the National Institute of Virology Priya Abraham has said that phase 2 / 3 clinical trials for those between 2 and 18 years of age are underway, and the Covaxin vaccine for children may become available by September, or just after September. Other than Covaxin, she said that trials are also on for Zydus Cadila, which could also be made available for children.
The Government of India issued emergency use authorisation for Johnson & Johnson’s single-dose vaccine earlier on August 7. The pharma giant has said that topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial showed that J&J’s single-dose vaccine was 85% effective in preventing severe disease across all regions that were studied. It showed protection against COVID-19 related hospitalisation and death starting 28 days after vaccination, J&J said.
As the severe second wave of COVID-19 started to subside in many parts of India, states had announced measures to enhance pediatric health care, anticipating children to be among the vulnerable sections during a third wave. Schools and colleges have also started to reopen in parts of the country, with the drop in COVID-19 infections. “To ultimately achieve herd immunity, it is imperative that COVID-19 vaccine clinical trials continue to move forward in this population (adolescents) and we remain deeply committed to the critical work needed to make our COVID-19 vaccine equitably accessible for all age groups,” the J&J spokesperson said.
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