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.
“On August 5, 2021, Johnson & Johnson Pvt. Ltd applied for Emergency Use Authorisation (EUA) of its single-dose covid-19 vaccine to the Government of India,” read the statement.
Johnson & Johnson claimed that its single-shot vaccine, in clinical trials, proved to be 85 per cent effective in preventing severe disease. The vaccine also showed protection against Covid-19 related hospitalisation and death, it said.
“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 hospitalisation and death, beginning 28 days after vaccination,” Johnson & Johnson said.
Johnson & Johnson further said Biological E will be an important part of its global supply chain network.
“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.
“We look forward to concluding our discussions with the government of India to accelerate availability of our COVID-19 vaccine to help end the pandemic,” the statement said.
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.
India recorded 44,643 new coronavirus infections taking the total tally of COVID-19 cases to 3,18,56,757, while the active cases registered an increase for the third consecutive day, according to the Union Health Ministry data updated on Friday. The number of deaths climbed to 4,26,754 with 464 fresh fatalities.
