J&J seeks regulator nod for vax trials in 12-17 age group in India

The American pharma J&J said in a statement that it had submitted its application on Tuesday, 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.

New Delhi: The American-based pharma major Johnson & Johnson (J&J) has applied to the Central Drugs Standard Control Organisation (CDSCO) for permission to conduct a vaccine trial of the Covid-19 single shot Janssen vaccine in India on children of 12-17 age group.

The American pharma J&J said in a statement that it had submitted its application on Tuesday, 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 Authorisation (EUA) 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, the 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).