American company Johnson & Johnson has applied to the Indian regulator seeking an emergency use authorisation on its single-dose vaccine.
The company said this just days after it clarified, it had withdrawn an earlier application to start bridging trials in the country, after India revised its rules and sought to fast-track approvals on vaccines that already have regulatory approvals in other countries. J&J’s announcement that it has approached the Central Drug Standard Control Organisation (CDSCO) for an EUA comes within hours of another American company, Novavax saying that it had (along with India-partner Serum Institute) applied for EUAs in India and two other countries.
J&J meanwhile, said in a statement,“On 5th August 2021 Johnson & Johnson Pvt. Ltd applied for Emergency Use Authorization (EUA) of its single-dose Covid-19 vaccine to the Government of India. 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 EUA submission is based on safety and efficacy data from the Phase 3 ENSEMBLE clinical trial, which demonstrated J&J’s single-shot vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against Covid-19 related hospitalisation and death, beginning 28 days after vaccination, the spokesperson said.
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