J&J's single-dose Covid vaccine gets approval for emergency use in India

Now India has 5 EUA vaccines. This will further boost our nation's collective fight against Covid, says Union Health Minister Mansukh Mandaviya

Johnson and Johnson’s single-dose Covid vaccine has been given approval for emergency use in India, announced Union Health Minister Mansukh Mandaviya on Twitter on Saturday.

"Now India has 5 EUA vaccines. This will further boost our nation's collective fight against #COVID19," tweeted Mandaviya.

The US pharma major had sought approval for its single shot vaccine from the Indian regulator earlier this week. 

"We are pleased to announce that on August 7, 2021, the Government of India issued Emergency Use Authorization (EUA) for the Johnson & Johnson Covid-19 single-dose vaccine in India, to prevent Covid in individuals 18 years of age and older," said Johnson & Johnson India spokesperson.

In April the company had indicated that it was in discussions with the Indian government about starting a bridging clinical study for the vaccine.

India has now done away with the provision of trial for Covid-19 vaccines that are approved by foreign regulators like the USFDA or UK-MHRA, and thus the vaccine maker was asked to apply directly for approval.

The J&J spokesperson had earlier said the vaccine would come to India through its collaboration with Indian drug firm Biological E in Hyderabad, which will produce it. 

“Biological E will be an important part of our global supply chain network, helping to supply our vaccine through the extensive collaborations and partnerships we have with governments, health authorities and organisations such as Gavi and the Covax Facility,” the spokesperson said. 

Earlier, Mahima Datla, MD and CEO of Biological E, had told Business Standard that J&J was looking to produce 500-600 million doses at its plant but did not specify whether this is a per annum figure or the total doses specified in the contract.

While exact details have not been revealed, the J&J vaccine is likely to be made in India under the Quad Vaccine Partnership, an alliance between India, the US, Japan and Australia.  

Biological E has not revealed its manufacturing or stock-piling plans, nor whether production will be scaled up from the initial quantity.

J&J has said earlier its vaccine can remain stable at 2-8 degree Celsius for up to three months and the company will ship the vaccine using the same cold chain technologies it uses today to transport treatments for cancer, immunological disorders and other medicines.

The vaccine Ad26.COV2.S developed by J&J’s arm Janssen got an emergency use authorisation from the US Food and Drug Regulator (USFDA) in February this year based on data from the phase 3 Ensemble study. J&J conducted clinical trials on 43,783 participants across countries including the US.

The USFDA noted that “the vaccine was approximately 77 per cent effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85 per cent effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination.”

The European Medical Agency (EMA) authorised the vaccine in March.

The United States Centers for Disease Control and Prevention, the national public health agency of the US, has said that the vaccine had high efficacy at preventing hospitalisation and death in people who did get sick. The CDC has also noted that the Janssen vaccine was 66.3 per cent effective in clinical trials at preventing laboratory confirmed Covid-19 illness in people who had no evidence of prior infection 2 weeks after receiving the vaccine.

“Early evidence suggests that the J&J/Janssen vaccine might provide protection against asymptomatic infection, which is when a person is infected by the virus that causes COVID-19 but does not get sick,” the CDC has noted.