Weeks, after it got Emergency Use Authorisation (EUA) for its single-shot COVID-19 vaccine in India, Johnson & Johnson (J&J), has now submitted an application to study its vaccine on adolescents in the country.
The US pharmaceutical company has submitted an application to the Central Drugs Standard Control Organisation (CDSCO) to conduct a study of its COVID-19 vaccine in India in adolescents aged 12-17 years, ANI reported on August 20.
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J&J’s Janssen COVID-19 vaccine was given EUA in India on August 7. This was announced by Health Minister Mansukh Mandaviya, who tweeted: "India expands its vaccine basket! Johnson and Johnson’s single-dose COVID-19 vaccine is given approval for Emergency Use in India. Now India has 5 EUA vaccines.”
It had applied for EUA for its jab on August 6 and was granted the approval the same day by the Drugs Controller General of India (DCGI), PTI reported citing a senior official.
Notably, J&J had earlier also sought approval to conduct a phase-3 clinical trial of its vaccine on approximately 600 participants in two age groups — those aged 18 and below 60 years and those aged 60 years and above — to evaluate the safety, reactogenicity, and immunogenicity of the jab in healthy Indian adults. However, on July 29, the firm withdrew its proposal.
There are now five vaccines that have been granted EUA — J&J's single-shot Janssen, Serum Institute's Covishield, Bharat Biotech's Covaxin, Russia's Sputnik V, and Moderna.
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