J&J submits application to CDSCO for study of Covid-19 vaccine on adolescents

It was "imperative" to ensure all sections of the population, including children, were vaccinated against the virus at the earliest

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CDSCO DCGI FDA

Last Updated on August 24, 2021 by The Health Master

Johnson & Johnson has submitted an application to the Central Drugs Standard Control Organisation (CDSCO) to conduct a study of its vaccine against the coronavirus (Covid-19) disease in India among adolescents aged 12-17 years.

In a statement released on Friday, the American pharmaceuticals company reportedly said it had submitted its application to the Indian drug regulator on Tuesday.

It further said it was “imperative” to ensure all sections of the population, including children, were vaccinated against the virus at the earliest.

“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 added.

Medicine Injection Vaccine
Picture: Pixabay

Johnson & Johnson’s single-dose vaccine was granted approval for emergency use in India on August 7 after applying for approval from CDSCO on August 5. It had made the submission based on “topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial”.

The trials had showed the single-shot vaccine was 85 per cent effective in preventing severe cases of coronavirus disease across all the regions that were studied.

The vaccine also demonstrated protection against coronavirus-related hospitalisation and death, beginning 28 days after vaccination.

Before this, the company had withdrawn its proposal seeking accelerated approval of its Covid-19 vaccine in the country, without giving additional details.

The government had earlier said inoculation of children against the virus is likely to begin very soon. On Thursday, Bharat Biotech’s managing director Krishna Ella said the trial phase of clinical studies in volunteers in the 2-18 age group has been completed and the vaccination drive may start as early September.

There are two vaccine candidates that have been tested among children in India: Bharat Biotech’s Covaxin and Zydus Cadila’s ZyCov-D. The Covaxin trial includes 525 volunteers while ZyCov-D’s trials – as part of the phase II/III clinical studies – includes 1,000 volunteers in the 12-18 age group.

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