Johnson and Johnson have submitted to India's drug regulator seeking to perform clinical trials of its Coronavirus vaccine for individuals under the age group of 12 to 17 in india. The application was proposed to the Central Drugs Standard Control Organisation (CDSCO) on Tuesday, August 17. The application seeks to conduct trials of J&J’s single-dose Covid-19 vaccine.
Confirming the application the firm said that it is dedicated to facilitating globally fair access to its vaccine for Covid and also identifies the unmet requirements of children.
"On 17 August 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,” 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," it added.
The Drug Controller General of India permitted emergency US authorization to J&J's Covid vaccine on August 7 for adults.
Johnson and Johnson is the 5th vaccine for Coronavirus and the second foreign-made dose to receive emergency use approval in the country.
Moderna Covid vaccine is the first to receive such authorisation.
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If approved, J&J will become the third vaccine in India to be tested on children. Meanwhile, two vaccine candidates being tested amongst kids are:- Bharat Biotech’s Covaxin and Zydus Cadila’s ZyCov-D.
Around 525 volunteers have been selected for the Covaxin trial, while the ZyCov-D phase II/III clinical studies trial includes 1,000 participants in the 12-18 age group.
India consists of 145.4 million people in the age group of 12 to 18.
Earlier, this year Johnson & Johnson associated with India based pharma company in Hyderabad - Biological E to perform clinical trials and also manufacture its Covid vaccine in India.
The vaccine for Coronavirus is produced by the Janssen Pharmaceutical Companies of J&J.
The US pharma firm through Biological E in May had applied for permission to conduct clinical trials of its vaccine in India.
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After experts warned that a third wave could hit India soon and the peak will be seen by October, many painted that kids will be potential targets during the third wave. Meanwhile, several states started arranging essential medical equipment for children, increasing the number of beds, stocking up medical oxygen.
Last month, AIIMS director Dr Randeep Guleria said that Covid vaccines for children possibly be available by September, adding that it could be the biggest advantage in breaking the chain of virus transmission.