J&J applies for EUA of its single-dose COVID-19 vaccine in India

New Delhi: Johnson & Johnson, the 134-year-old American pharma conglomerate, has now applied to the Central Drug Standard Control Organisation of India seeking emergency use approval of its single-shot vaccine. Earlier, the company had applied for a trial but as the Centre has now done away with the provision of trial for reputed and recognised vaccines, the Centre asked the vaccine maker to directly apply for approval. J&J then withdrew its earlier application and, in a statement issued on Friday, the company informed that on August 5, the company submitted its emergency use approval application.

"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.