Johnson & Johnson Seeks Approval To Conduct Covid-19 Vaccine Trial On Children In India

by Bhaswati Guha Majumder - Aug 21, 2021 09:07 AM
Johnson & Johnson Seeks Approval To Conduct Covid-19 Vaccine Trial On Children In IndiaJ&J
Snapshot
  • India has already granted Emergency Use Authorisation (EUA) to the jab —also known as Janssen Covid-19 vaccine, developed by Johnson & Johnson- owned Janssen Biotech Inc.— in August.

American pharmaceutical company Johnson & Johnson has applied to the Indian drug regulator for authorisation to conduct trials of its Covid-19 vaccine on teenagers aged between 12 and 17 years.

The company announced on 20 August that it had submitted an application to the Central Drugs Standard Control Organisation (CDSCO) in this regard on 17 August.

A spokesperson of the company said: "Johnson & Johnson is committed to facilitating global equitable access to its Covid-19 vaccine and recognising the unmet needs of children.”

Johnson & Johnson believes that vaccine trials on children are required to develop herd immunity. According to the spokesperson, it is vital that Covid-19 vaccine clinical studies continue in this demographic to attain herd immunity in the long run and “we remain deeply committed to the critical work needed to make our Covid-19 vaccine equitably accessible for all age groups”.

The need for a vaccine that can be given to children is fuelled by a number of issues, including the need to safeguard them from the novel virus, reduce transmission and as a necessary prerequisite for reopening schools.

India has already granted Emergency Use Authorisation (EUA) to the jab —also known as Janssen Covid-19 vaccine, developed by Johnson & Johnson- owned Janssen Biotech Inc.— in August.

It also has a manufacturing partner in India — Biological E — which is based in Hyderabad. The Food and Drug Administration in the United States has issued a EUA for this single-shot vaccine on 27 February.

According to studies, this particular jab is 66 per cent effective against mild to severe Covid-19 disease and 85 per cent effective in severe cases.

In the case of Covid-19 vaccines for children, on 19 August, without taking any specific names, the Union Health Minister, Mansukh Mandaviya, stated that it will be available "very soon".

The next day, on 20 August, the Indian drug regulators approved Zydus Cadila's three-dose for emergency use.

The three-dose vaccine, developed by Gujarat’s Ahmedabad-based pharmaceutical company, is a DNA vaccine and received approval for emergency use in adults and children aged 12 or over.

The company applied for the authorisation for the vaccines called ZyCoV-D on 1 July based on an efficacy rate of 66.6 per cent, found in a late-stage trial involving over 28,000 participants around the country.

This is the world's first plasmid DNA vaccine against the novel coronavirus caused disease.

However, apart from Zydus Cadila, India’s Covaxin maker Bharat Biotech is currently conducting trials on children aged 2 and older.

The Hyderabad-based company has already carried out trials involving kids who are 12-years-old and above. Bharat Biotech’s trials have started at the All India Institute of Medical Science (AIIMS), New Delhi, and a few other centres in the country.

The company is also working on an intra-nasal vaccine — BBV154 — which is currently considered as a vaccine candidate for children.

Since it will be a needle-free vaccine, it is believed that this Covid-19 vaccine candidate would not only be easy to administer but also one of the best options to vaccinate youngsters.

Meanwhile, as per reports, the Serum Institute of India — which has been making the Indian version of Oxford-AstraZeneca jab, Covishield — has decided to test the Novavax vaccine candidate on youngsters.

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