MUMBAI: US firm Johnson & Johnson (J&J) has sought Emergency Use Authorisation (EUA) for its single-dose Covid-19 vaccine in India. Once approved, it will be the fourth vaccine to get EUA after Serum Institute’s Covishield, Bharat Biotech’s Covaxin and Dr Reddy’s Sputnik V.
Earlier this week, the company had said it was finalising its plans, soon after withdrawing its application for conducting local studies.
Without elaborating on vaccine manufacturing plans, J&J said its collaboration with Hyderabad-based Biological E will be an important part of its global supply chain network. The company had tied up with Biological E last year.
“This is a key 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 Limited,” a J&J spokesperson said.
The EUA submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, which demonstrated that the single-shot vaccine was 85% effective in preventing severe disease across all regions studied, and showed protection against Covid-19 related hospitalisation and death, after 28 days of vaccination, a company statement said.
J&J had withdrawn its application to the country’s drug regulator as there is no requirement of local bridging trials, after the policy-tweak of fast-tracking foreign-produced Covid-19 vaccines. Though the revised policy to facilitate the entry of imported vaccines was announced in April, there has not been progress in the launch of any foreign-made vaccines, so far.
Talks with foreign companies – Pfizer, Moderna and Johnson & Johnson – have been on for months but there is no decision by the government yet on granting the manufacturers indemnity from lawsuits.