The US pharma major Johnson and Johnson’s single-dose Covid-19 vaccine has been granted approval for emergency use in India, Union Health Minister Mansukh Mandaviya announced on Twitter.
Mandaviya on Saturday tweeted, “Now India has 5 EUA vaccines. This will further boost our nation’s collective fight against #COVID19.”
Earlier this week, Johnson & Johnson had sought approval from the Indian drug regulator for its single shot Covid-19 vaccine.
The company had revealed that it was in discussions with the India about starting a bridging clinical study for it’s single shot vaccine in the month of April.
The Indian government cancelled the provision for Covid-19 vaccines trials that have been approved by foreign regulators. Therefore the US vaccine maker was asked to directly apply for it’s approval.
Earlier, the company had said that its vaccine shot con continue to remain stable at 2-8 degree Celsius for nearly three months and J&J will export the vaccine using the same cold storage technologies it uses to ship treatments for cancer, and several other medicines.
Based on data from the phase 3 Ensemble study in February this year, the US Food and Drug Regulator (USFDA) authorised the emergency use of Ad26.COV2.S vaccine developed by J&J’s arm Janssen. The company has carried out clinical trials on 43,783 participants across several countries including the US.
“The vaccine is about 77 percent effective in preventing severe/critical Covid-19 appearing at least 14 days after vaccination and 85 percent effective in preventing severe/critical Covid-19 appearing at least 28 days after vaccination.”
The vaccine has high efficacy at preventing hospitalisation and fatality in people who get sick to the coronavirus, the US Centers for Disease Control and Prevention, the national public health agency of the US, has said.