Johnson & Johnson seeks regulator nod for trail of COVID-19 vaccine on 12-17 age group in India

Johnson & Johnson has sought approval of the Central Drugs Standard Control Organisation (CDSCO) to conduct a study of its vaccine against the COVID-19 disease in India among adolescents aged 12-17 years.

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New Delhi: The American pharmaceutical company, Johnson & Johnson (J&J) in a statement on Friday (August 20, 2021) said that it had submitted its application to the Central Drugs Standard Control Organisation (CDSCO) on Tuesday. In the application, Johnson & Johnson has sought approval of the organisation to conduct a study of its vaccine against the COVID-19 disease in India among adolescents aged 12-17 years.

While emphasising the fact that it is "imperative" to ensure all sections of the population, including children, are vaccinated against the coronavirus as quickly as possible to stop the virus.

Johnson & Johnson has submitted an application to the Central Drugs Standard Control Organisation (CDSCO) to conduct a study of its COVID-19 vaccine in India in adolescents aged 12-17 years.

— ANI (@ANI) August 20, 2021

"The EUA submission is based on topline efficacy and safety data from the Phase 3 clinical trial ENSEMBLE, which demonstrated our single-shot vaccine was 85 per cent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination," the statement read. 

"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 statement added.

The pharmaceutical company in its application also said that this approval, which the company is seeking, will be an important step forward in accelerating the availability of its Covid-19 vaccine to help end the pandemic.

Meanwhile, the single-shot vaccine of J&J has already been approved for the Emergency Use Authorisation (EUA) through the fast-track approval route by the Drug Controller General of India.

Earlier, Union Health Minister Mansukh Mandaviya had tweeted about the Emergency Use Authorisation being given to Johnson & Johnson.

Mandaviya had tweeted, "India expands its vaccine basket! Johnson and Johnson`s single-dose COVID-19 vaccine is given approval for Emergency Use in India. Now India has 5 EUA vaccines. This will further boost our nation`s collective fight against COVID19."

The five vaccines which have been granted emergency use authorization approval in India include Serum Institute`s Covishield, Bharat Biotech`s Covaxin, Russia`s Sputnik V, Moderna and now Johnson & Johnson (J&J).

(With Agency inputs)