J&J seeks nod to start Covid vaccine trials on 12-17 age group in India

Studies show the US company's vaccine has 66 percent efficacy against preventing moderate to severe Covid-19.

USA’s Johnson & Johnson (J&J) has sought the Indian drug regulator’s permission to test its Covid-19 vaccine on the 12 to 17 age group, joining a clutch of other firms seeking to inoculate children against a disease that has killed 433,589 people in the country.

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.

“Johnson & Johnson is committed to facilitating global equitable access to its COVID-19 vaccine and recognize the unmet needs of children,” the company spokesperson said.

 “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.

Before this, the company had sought emergency use authorization (EUA) in India for its single-shot vaccine. Hyderabad-based Biological E is Johnson & Johnson’s Indian vaccine-manufacturing partner.

Zydus Cadila has submitted vaccine data for children abover 12 years. Serum Institute of India is going to conduct trials on children for the Novavax vaccine candidate.
 

Union Health Minister Mansukh Mandaviya said Thursday that Covid-19 vaccines for children will be available ‘very soon’. Bharat Biotech is conducting trials on children as young as two for Covaxin vaccine.

A shield for children

Vaccine	Stage of development
Pfizer-BioNTech (US)	Administered to ages 12-plus; trials on for children aged 5 to 11; not available in India yet
Moderna (US)	Administered to ages 12-plus; trials on for children aged 5 to 11; not available in India yet
Zydus Cadila (India)	Trials done on 12-plus; Will start trials on 5-plus
Bharat Biotech (India)	Trials done on 12-plus; trials on for 2-plus
Sinovac (China)	Approved for ages 3-17; not available in India
Sinopharm (China)	Approved for ages 3-17; not available in India
Sputnik V (Russia)	Nasal vaccine trials on children ongoing in Russia. Expected to be over by Sept-Oct, 2021
Covovax (Novavax candidate) US	Trials to start on children 2 years and above in India

Source: Media reports, company statements