India authorises J&J’s Covid-19 vaccine for emergency use

India has approved Johnson & Johnson’s (J&J) single-dose Covid-19 vaccine for emergency use, expanding the total number of anti-SARS-CoV-2 vaccines authorised in the country to five.

J&J submitted an application seeking emergency use authorization (EUA) for the vaccine to the Government of India on 5 August this year.

The company said it was too early to give a delivery timeline, Reuters reported. The vaccine doses will be made available in India through a partnership with the domestic company Biological E.

In a statement, J&J said: “This is an important milestone that paves the way to bringing our single-dose Covid-19 vaccine to the people of India, and the rest of the world, through a collaboration with Biological E.

“Biological E will be an important part of our global supply chain network, helping to supply our Johnson & Johnson Covid-19 vaccine through the extensive collaborations and partnerships we have with governments, health authorities and organisations such as Gavi and the COVAX Facility.”

The EUA submission in India is based on efficacy and safety results from the Phase III ENSEMBLE clinical trial, which showed that the vaccine had 85% efficiency in preventing severe Covid-19 in all regions analysed.

Furthermore, the single-dose vaccine was demonstrated to offer protection against Covid-19 linked hospitalisation and death, from 28 days after the inoculation.

Last month, J&J reported that its single-dose Covid-19 vaccine stimulated robust, continued neutralising antibody activity against the Delta (B.1.617.2) variant, as well as other SARS-CoV-2 viral variants.

The data was from an analysis of blood samples collected from a subset of subjects in the ENSEMBLE trial.

Apart from the J&J vaccine, Indian health authorities have authorised the use of Covid-19 vaccines developed by AstraZeneca, Bharat Biotech, Russia’s Gamaleya Institute and Moderna.

Moderna received approval for its vaccine in June but the vaccine doses have not arrived in the country so far due to legal protection sought by the company, Reuters added.