US pharma giant Johnson & Johnson has sought approval from Indian drug regulators to conduct a trial of its COVID-19 vaccine in the 12 to 17-year-old age group, the company said on Friday.
Conducting vaccine clinical trials among adolescents is imperative to achieve herd immunity against the coronavirus, J&J said in an emailed statement.
The U.S. pharma giant had received emergency use approval for its single-dose vaccine in India earlier this month, making it the fifth authorised vaccine in the country.
While J&J has an agreement with Indian vaccine maker Biological E Ltd to make its doses in the country, the company had said that it was too early to disclose a schedule for the delivery.
Also read: Zydus Cadila vaccine for kids aged 12 to 18 years coming soon
The company said on Friday that it has submitted an application to the Central Drugs Standard Control Organisation (CDSCO) on August 17 to conduct a study.
Studies have shown the J&J vaccine has 66 percent efficacy against preventing moderate to severe Covid-19, and about 85 percent efficacy against severe cases.
“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 J&J spokesperson said.
Indian pharma major Zydus Cadila has also submitted vaccine data for children above 12 years.
Serum Institute of India is also going to conduct trials on children for the Novavax vaccine candidate.
Union Health Minister Mansukh Mandaviya said on Thursday that Covid-19 vaccines for children will be available ‘very soon’. Bharat Biotech is conducting trials on two-year-old children for the homegrown Covaxin vaccine.