Johnson & Johnson seeks emergency approval for its single-dose Covid-19 vaccine in India

Johnson & Johnson on Friday said it has applied for emergency use approval of its single-dose coronavirus vaccine in India.

J&J has tied up with domestic vaccine maker Biological E Ltd to produce the vaccines for the Indian market as well as globally.

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

Also read: J&J says committed to bringing its Covid vaccine to India

When approved, the J&J vaccine would be the fifth vaccine that would be availability for use in India.

India's drug regulator has approved homegrown Covaxin, Serum Institute's Covishield, Russia-made Sputnik V and Moderna's vaccine for use in the country.

“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 J&J statement said.

The EUA submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, which demonstrated that company's single-shot vaccine was 85% effective in preventing severe disease across all regions studied, and showed protection against Covid-19 related hospitalisation and death, beginning 28 days after vaccination, it added.