Johnson & Johnson seeks to conduct COVID-19 vaccine trial in Indian adolescents

INDIA – US pharma giant Johnson & Johnson has submitted an application to India’s Central Drugs Standard Control Organization (CDSCO) seeking permission to conduct clinical trials of its single shot Janssen vaccine against Covid-19 on adolescents aged 12-17 years.

Conducting vaccine clinical trials among adolescents is imperative to achieve herd immunity against the Coronavirus, J&J said in an emailed statement.

J&J’s one-shot vaccine has been found to have efficacy of 85.4% against severe disease and 93.1% against hospitalization.

The U.S. pharma giant had received emergency use approval for its single-dose vaccine in India earlier this month, making it the fifth authorized vaccine in the country.

Indian health authorities have so far approved the use of vaccines developed by AstraZeneca, Bharat Biotech, Russia’s Gamaleya Institute and Moderna.

Despite the approval of Moderna’s vaccine in June, not a single dose has yet arrived due to wrangling over legal protection sought by the company.

While J&J has a supply agreement with Indian vaccine maker Biological E Ltd to bring its shot to the country, the company had said that it was too early to give a delivery timeline.

It has to be noted that in India, COVID-19 vaccination drive for all adults above 18 years of age is going on but vaccination for those below 18 years have not yet started.

The request for Johnson and Johnson’s study of its single-shot vaccine for those between 12 and 17 years of age can be important development for the COVID-19 vaccination scenario in India.

Meanwhile, the MHRA approved the Moderna vaccine for admission on 12-17-year-old children in the UK. The regulator cited that the vaccine is safe and effective in this age group.

In July, among the three COVID-19 vaccines authorized for use in the United States, only the Pfizer-BioNTech BNT162b2 mRNA COVID-19 vaccine had been authorized for adolescents aged 12–17 years, making it the first Covid vaccine to be used on children.

Since then, pother vaccine manufacturers have sought authorization for the same age group, with most receiving nods in various countries.

Speaking of the COVID-19 situation in India, as per the data from the Union Ministry of Health and Family Welfare, India reported 36,571 new cases in the last 24 hours. 57.22 crore vaccine doses have been administered under the nationwide vaccination drive.

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