No trial needed for its single dose Janssen COVID vaccine in India: Johnson & Johnson

The United States drug giant Johnson & Johnson will not be conducting local trials in India for its single-dose Janssen COVID-19 vaccine, a spokesperson said on Tuesday. The company informed that this decision was taken after the Drugs Controller General of India (DCGI)'s recent announcement that the trials are no longer required.

Johnson & Johnson won't conduct COVID-19 vaccine trials in India

"As per the recent announcement by the Drugs Controller General of India (DCGI), there is no longer a requirement to conduct bridging clinical studies of COVID-19 vaccines in India," Johnson & Johnson, India spokesperson told ANI.

The DCGI recently announced that COVID-19 vaccines, which were approved for restricted use by drug regulators in the United States, United Kingdom, Europe, and Japan, or which were in the list of WHO'S emergency use listing would not have to go for bridging trials in India. The company also said that it is in discussions with the government of India.

"We are in ongoing discussions with the Government of India and are exploring how best to accelerate our ability to deliver the Johnson & Johnson single dose COVID-19 vaccine to the people of India," DCGI said.

Johnson & Johnson To Toss 60 MN Doses Of COVID-19 Vaccine

Recently, the US Food and Drug Administration has reportedly told Johnson & Johnson to discard about 60 million doses of its COVID-19 vaccine that were produced at a troubled Baltimore plant. According to NBC News, the FDA ordered the vaccines to be tossed after determining they were “not suitable for use”. However, two people familiar with the decision told the media outlet that the FDA is planning to allow Johnson & Johnson to distribute 10 million doses that were manufactured at the same facility. 

The doses in question were produced at the Emergency BioSolutions plant in Baltimore. As per reports, the facility threw away ingredients for 15 million does in late April because of contamination with materials from the AstraZeneca vaccine, which was also manufactured at the same plant. At that time the FDA’s subsequent inspection of the Baltimore facility revealed that it had serious problems with unsanitary conditions and had failed to properly train workers.  

(With ANI Inputs)

(Image Credits: AP/PTI)