J&J's single-dose Covid-19 vaccine gets approval for emergency use in India

India approved US major Johnson & Johnson’s (J&J) single dose Covid-19 vaccine for emergency use on Saturday. The country now has five approved Covid vaccines. 

J&J did not divulge details of when the vaccine will be available in India and what kind of initial volumes can be expected. 

Health Minister Mansukh Mandaviya said in a tweet: “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 be the fifth Covid-19 vaccine to get approval after Covishield, Covaxin, Sputnik V and Moderna in India. 

J&J spokesperson confirmed the same. “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,” the spokesperson said.

"This decision was based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, which demonstrated our single-shot vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination," the company added. 

On Friday the company had said it had applied for EUA to the Government of India and was granted the approval the same day by the Drugs Controller General of India (DCGI). 

“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,” J&J has said. 

Mahima Datla, MD and CEO of Biological E, had told Business Standard earlier that J&J was looking to produce 500 mn doses from its facility. 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, US, Japan and Australia. Biological E has not revealed plans on J&J vaccine manufacturing, stock-piling and whether it would be scaled up from the initial 500 mn-600 mn doses. 

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.