Johnson and Johnson's single-dose COVID vaccine gets Centre's nod for emergency use in India

Johnson and Johnson's single-dose vaccine for COVID has got approval for Emergency Use in India, said Union Health Minister Mansukh Mandaviya on Saturday. The US vaccine maker had applied for Emergency Use Authorisation of its jab in India on Thursday.

Mandaviya in a tweet said, "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."

It is the third foreign-made vaccine to get Emergency Use Authorisation in India after the US's Moderna and Russia's Sputnik V. 

J&J, in a statement, said, "The Government of India issued Emergency Use Authorization (EUA) for the Johnson & Johnson COVID-19 single-dose vaccine in India... This decision was based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial."

J&J had asked for authorisation after data from its Phase 3 trials said its single-dose COVID shot is 85.4% effective in preventing severe disease across all regions studied. It also showed protection of 93.1% against COVID-19 related hospitalisation and death, 28 days from vaccination.

The vaccine got approval from the US FDA in February this year. 

While Moderna has got approval in India, the pharma company is stuck with a legal indemnity issue.