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American healthcare company Johnson & Johnson has sought approval in India to study its single dose vaccine in adolescents.
“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 company spokersperson told BusinessLine , on the submission made on August 17 to address the unmet needs of children.
The development comes within 10 days of being among the early movers to get an “emergency use authorisation” in India for the use of its vaccine in adults. “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 company said.
J&J has an existing tie-up with Hyderabad’s Biological E for local manufacture of its vaccine. But future details on manufacture, import and distribution are unclear.
Vaccines for children are a key concern as schools attempt to reopen. Other vaccine-makers including Bharat Biotech, Zydus Cadila and Serum Institute of India (on the Novavax vaccine) are in the fray to bring out child or adolescent vaccines, as the case may be.
The adult J&J vaccine received emergency approvals in India based on efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, the company had then said.
Findings of the study
The study had demonstrated that J&J’s single-shot vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against Covid-19 related hospitalisation and death, beginning 28 days after vaccination.
Globally, the company has updated information on its Covid-19 vaccine to include information on rare neurological cases and concerns involving “very rare” instances of unusual blood clots. No details are, however, available from the company or CDSCO on how this is being addressed in India.
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