J&J in talks with Centre for trial of single-shot Covid-19 vaccine

US major Johnson and Johnson (J&J) has initiated talks with the Centre to start clinical trials of its single-shot Covid-19 vaccine in India.
 
This comes at a time when the country is grappling with adequate vaccine supplies to meet its national Covid-19 vaccination programme.
 
A J&J India spokesperson said: “At J&J, we remain fully focused on bringing a safe and effective Covid-19 vaccine to people around the world, if authorised for use by local health authorities. We are in discussions with the Government of India with the objective of starting clinical study of our Janssen Covid-19 vaccine candidate in India, subject to local regulatory nod.”
 
So far, any approval to start clinical trials (bridging studies) has not been granted to the firm, confirmed a source close to the development.
 
In India, J&J has a manufacturing partner in Hyderabad-based Biological E. Mahima Datla, managing director and chief executive of Biological E, had earlier said J&J was looking to produce 500 million doses from its facility.
 
J&J has said 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.

 
Russia’s Sputnik V is another contender to get approval from the Indian drug regulator. Sputnik V has completed bridging trials and is now awaiting nod for emergency use authorisation here. It has lined up more than 250 million doses for India and Indian manufacturing sites would be producing over 850 million doses here for both domestic consumption and exports.
 
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) nod in February, based on the data from the phase 3 Ensemble study.
 
It demonstrated that the vaccine was 85 per cent effective in preventing severe disease. It also showed protection against Covid-19 related hospitalisation and death, beginning 28 days after vaccination, J&J had said.  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), too, authorised the vaccine in March.
 
The US drug major has said it is committed to making its Covid-19 vaccine available on a not-for-profit basis for emergency use.
 
J&J has begun shipping its vaccine and expects to deliver 100 million single-shot vaccines to the US during the first half of 2021.
 
The United States Centers for Disease Control and Prevention, the national public health agency of the US, has said 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 two 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.