Johnson & Johnson Seeks Regulator Nod for Vaccination Trials in 12-17-Year-Olds in India

A health worker prepares a vial of the Johnson & Johnson Coronavirus vaccine at a Pop-up Covid-19 vaccination site set up in a baseball stadium parking lot. (Bruce Cotler/ZUMA Wire/dpa/IANS photo)

NEW DELHI – The American-based pharma major Johnson & Johnson has applied to the Central Drugs Standard Control Organization for permission to conduct a vaccine trial of the Covid-19 single shot Janssen vaccine in India on children in the 12-17 age group.

J&J said in a statement that it had submitted its application Aug. 17, and 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.

The single-shot vaccine of J&J is the second Covid-19 vaccine which has already been approved for the Emergency Use Authorization through the fast-track approval route by the Drug Controller General of India.

In the statement, Johnson & Johnson India also said this was an important step forward in accelerating the availability of its Covid-19 vaccine to help end the pandemic.

Earlier, Union Health Minister Mansukh Mandaviya had tweeted about the Emergency Use Authorization 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.