India approves J&J’s single-dose vaccine

NEW DELHI: India has granted Johnson & Johnson’s singledose Covid-19 vaccine emergency use authorisation, Union health minister Mansukh Mandaviya said on Saturday, making it the fifth vaccine and the second foreign-made shot to be cleared for use in the country.

The pharmaceutical company, however, said it was too early to give a delivery timeline for the vaccine. It said earlier on Friday that it applied for emergency use approval. The vaccine will be brought to India through a supply agreement with homegrown vaccine maker Biological E Ltd, J&J has 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 #COVID19,” the Union health minister tweeted on Saturday.

Apart from the J&J vaccine, the four other Covid-19 shots approved for emergency use in India are Bharat Biotech’s Covaxin, Serum Institute of India’s Covishield, the Russianmade Sputnik V, and the Moderna vaccine.

“While we look forward to meeting our delivery commitments, it is premature for us to speculate on the timing of our vaccine deliveries,” the company told Reuters.

The J&J vaccine, which has shown 66-72% efficacy in different trials, has been approved by regulators in the US, UK, Europe and the World Health Organization. The company in May applied for a permission to carry out bridging trials – smaller clinical trials that are meant to assess if the findings are similar to larger trials carried out elsewhere. But it withdrew the request last week and filed for emergency approval directly, making use of a change in policy in India that allows coronavirus vaccine makers to do so if they have received approvals by certain regulators around the world.

In a statement issued on Saturday, the American pharma major said: “We are pleased to announce that on 7th August 2021, the Government of India issued Emergency Use Authorization (EUA) for the Johnson & Johnson COVID-19 single-dose vaccine in India, to prevent COVID-19 in individuals 18 years of age and older.”

“This decision was based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial,” the company said.