J&J seek approval for vaccine trial of 12-17 age group in India


The US pharma giant Johnson & Johnson (J&J) has sought approval from India’s drugs regulator to conduct clinical trials of its Covid-19 vaccine for the people in the 12-17 age group in the country.

The company submitted an application to the Central Drugs Standard Control Organization (CDSCO) on Tuesday, August 17, to conduct the trials of J&J’s single-dose Covid-19 vaccine.

Since the government later modified its regulatory provisions for grant of emergency use authorization to foreign-made Covid-19 vaccines, J&J put forth a fresh application for grant of emergency use authorization on August 5. J&J withdrew its earlier application to conduct the bridging studies.

On August 7, the Drugs Controller General of India granted J&J’s Covid vaccine emergency use authorization for adults. It is the fifth vaccine and the second foreign-made after Moderna’s to receive such authorization.

If permitted, J&J’s would be the third Covid-19 vaccine to be tested for use in children in India.

J&J has confirmed the development. “Johnson & Johnson is committed to facilitating global equitable access to its Covid-19 vaccine and recognizes the unmet needs of children. On 17 August 2021, we submitted an application to the Central Drugs Standard Control Organization (CDSCO) to conduct a study of the Johnson & Johnson Covid-19 vaccine in India in adolescents aged 12-17 years,” said J&J India spokesperson in a statement.

“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.”

J&J entered a partnership with India’s Hyderabad-based Biological E earlier this year to conduct a clinical trial and produce its Covid-19 vaccine in India. The vaccine is developed by the Janssen Pharmaceutical Companies of J&J.

Through Biological E, the American company in May applied for permission from the national drugs controller to conduct bridging clinical trials locally in India for its Covid-19 vaccine.

Apart from the J&J and Moderna vaccines, the other three Covid-19 vaccines approved for emergency use in India are Bharat Biotech’s Covaxin, Serum Institute of India’s Covishield, and the Russian-made Sputnik V.