Johnson & Johnson seeks nod for trial of single-dose vaccine on adolescents in India
Highlights
- The vaccine has shown 85% efficacy in Phase 3 human clinical trials.
- It was granted Emergency Use Authorisation through the fast-track approval route by the Drug Controller General of India.
"Johnson & Johnson is committed to facilitating global equitable access to its COVID-19 vaccine and recognize the unmet needs of children. 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," Johnson & Johnson India spokesperson told Mirror Now.
"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 spokesperson added.
J&J's one-shot vaccine has been found to have efficacy of 85.4% against severe disease and 93.1% against hospitalisation.
The single shot vaccine of J&J is the second COVID-19 vaccine which has been granted Emergency Use Authorisation (EUA) through the fast-track approval route by the Drug Controller General of India.
Moderna was the first foreign-made vaccine to be approved in the country for use, but the launch got stuck over indemnity issues.
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