J&J seeks nod for vax trial on adolescents
To achieve herd immunity, studies have to be done on children, pharma major says
Johnson & Johnson (J&J) has sought permission from the Indian drug regulator to conduct trials of its Covid-19 vaccine on adolescents aged 12 to 17 years.the firm said on Friday that it had submitted an application to the CDSCO on August 17 in this regard.
US-based pharmaceutical major Johnson & Johnson (J&J) has sought permission from the Indian drug regulator to conduct trials of its Covid-19 vaccine on adolescents aged 12 to 17 years.
The company said on Friday that it had submitted an application to the Central Drugs Standard Control Organisation (CDSCO) on August 17 in this regard. “Johnson & Johnson is committed to facilitating global equitable access to its Covid-19 vaccine and recognise the unmet needs of children,” the company spokesperson said.
The company said that to achieve herd immunity, vaccine trials have to be done on children. “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,” the spokesperson said.
J&J already has the emergency use authorisation (EUA) for its single-shot vaccine in India. It also has an Indian manufacturing partner – Hyderabadbased Biological E.
Studies have shown that the J&J vaccine has 66 percent efficacy against moderate to severe Covid-19 disease, and about 85 per cent efficacy in severe cases.
On Thursday, Union Health Minister Mansukh Mandaviya said that Covid-19 vaccines for children would be available “very soon”.
Bharat Biotech is conducting trials on children as young as 2 years for Covaxin. The Zydus Cadila’s three-dose Covid-19 vaccine has received the emergency use authorisation from the Drugs Controller General of India for use in adolescents 12 years old and above. Meanwhile, Serum Institute of India is going to conduct trials on children for the Novavax vaccine candidate.
The urgency for a children's vaccine is fuelled by multiple factors: protecting the children, reducing transmission and also as a critical precondition for re-opening schools.
Bharat Biotech has already conducted trials on children 12 years and above, and is now doing trials on smaller children, aged two and older. Trials have started at the AIIMS, New Delhi, besides a few other centres. Biotech is also betting on its intra-nasal vaccine, BBV154, as a paediatric candidate. The company has noted on its website that this vaccine will be needle-free, non-invasive, easy to administer (even without trained health care workers), and ideally suited for children. Trials are on for this candidate, too.