Johnson & Johnson seeks nod to conduct Covid vaccine trials on 12-17-year-olds in India

Pharmaceutical major Johnson & Johnson has sought approval from the Central Drugs Standard Control Organisation to carry out a clinical trial of its Covid-19 vaccine on 12-17 year olds.

“On August 17, we submitted an application to the CDSCO to conduct a study of the Johnson & Johnson Covid-19 vaccine in India in adolescents aged 12–17 years. We are committed to facilitating global equitable access to our Covid-19 vaccine and recognise the unmet needs of children,” a company spokesperson said 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.”

Read | Do I need a booster if I got the Johnson & Johnson vaccine?

Since children are considered the lowest risk in a Covid-19 epidemic, they are not vaccinated in most of the countries. The experts, however, are of the opinion that it is a matter of time for vaccination to start at least for children in the 12-18 years age group.

Last month Zydus Cadila submitted its safety and tolerability data on kids to the CDSCO and said it would take about a month to analyse and submit the efficacy data on kids. The indigenous DNA vaccine ZyCoV-D has been found to be 66.6% effective in adults.

"Since it may take another 8-10 weeks for the Central Drug Standard Control Organisation to review the Zydus Cadila vaccination data, the Drugs Controller General of India may take a decision on giving vaccines to 12-18 year olds sometimes between October and December,” NK Arora, one of the Centre’s top advisors on Covid-19 vaccination policy told DH last month.

Arora said 10-12% of the Indian population would fall into the 12-18 years category, which means there would be 13-14 crore adolescents requiring the vaccine. They would be in addition to the 94.47 crore target population identified by the government.

Indian vaccine manufacturer Bharat Biotech is also carrying out a trial of its Covaxin on 2-18 year olds.

Arora and CMC Vellore professor Gagandeep Kang said reopening of schools should not be linked to Covid-19 vaccination. Rather it's important that every staff in a school is vaccinated so that a ring of vaccinated people surrounds the children. But when inoculation happens, those with comorbidities should get the shots first.