Johnson & Johnson has applied to India’s Central Drug Standard Control Organization for emergency use permission of their single-shot vaccination. The company had previously submitted for a study, but because the Centre no longer provides trials for reputable and recognised vaccines, the vaccine developer was invited to apply for permission directly. J&J then withdrew its previous application and, according to a statement released on Friday, submitted an emergency use approval application on August 5.
“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. Limited. 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 company said in a statement.
If J&J’s vaccine gets approval in India, it will be the second foreign-made vaccine to be approved in the country, after Moderna.
J&J’s vaccine developed by Janssen Pharmaceutical Companies of Johnson & Johnson comprises one shot and is found to have 85.4 per cent efficacy against severe disease and 93.1 per cent against hospitalisation.
The US FDA authorised Johnson & Johnson’s single-dose Covid-19 vaccine for emergency use in February 202. Now, the single-shot vaccine is approved in several countries.
What has apparently stalled Moderna to export vaccines to India is the issue of legal indemnity as both Moderna and Pfizer had sought this legal cover in India. According to the latest developments, Pfizer has not allowed for emergency use approval and Moderna has got the approval but is stuck with the indemnity issue. If J&J’s application is cleared, it will be the first among these three major pharma companies in the US to send vaccines to India. Legal indemnity might not be an issue as Biological E is the local partner of J&J.
“The EUA submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, which demonstrated our single-shot vaccine was 85 per cent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination,” J&J said.