Healthcare major Johnson & Johnson received emergency use authorisation for single dose COVID-19 vaccine, Union Health Minister Mansukh Mandaviya announced on Saturday, August 7. “India expands its vaccine basket! Johnson and Johnson’s single-dose COVID-19 vaccine is given approval for Emergency Use in India. Now India has 5 EUA vaccines. This will further boost our nation's collective fight against #COVID19,” he tweeted.
“We are pleased to announce that on 7th August 2021, the Government of India issued Emergency Use Authorization (EUA) for the Johnson & Johnson COVID-19 single-dose vaccine in India, to prevent COVID-19 in individuals 18 years of age and older," a Johnson & Johnson spokesperson said in a statement. J&J had applied for EUA on August 5.
The EUA submission, J&J had said, is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, which demonstrated that company's single-shot vaccine was 85% effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalisation and death, beginning 28 days after vaccination.
"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," an earlier statement by the company said.
Compared to other international vaccines yet to be approved in India, the J&J vaccine is easier to handle, lasting three months in the refrigerator compared to the Pfizer and Moderna, which need to be frozen. According to the World Health Organisation, Johnson & Johnson’s vaccine is a single-dose vaccine, estimated to remain stable for two years at -4°F (-20°C), and a maximum of 4.5 months at routine refrigeration temperatures of 36° to 46°F (2° to 8°C).
India saw a single-day rise of 38,628 new coronavirus cases as of the bulletin on Saturday, August 7, taking the infection tally to 3,18,95,385, while the death toll climbed to 4,27,371 with 617 fresh fatalities, according to the Union health ministry. The active cases are at 4,12,153 and the national recovery rate was recorded at 97.37%, the data updated at 8 am showed. A decrease of 2,006 cases has been recorded in the active COVID-19 caseload in a span of 24 hours.
Cumulative vaccine doses administered has so far reached 50.10 crore under the nationwide vaccination drive.
With inputs from PTI