Johnson & Johnson withdraws application for accelerated approval of COVID-19 vaccine in India

Johnson & Johnson has withdrawn its proposal to seek accelerated approval of its COVID-19 vaccine in India, Reuters reported the Drugs Controller General of India (DCGI) as saying.

The DCGI did not provide any further details.

The US company had in April submitted its application to the DCGI seeking approval to conduct a bridging clinical study of single-dose Janssen COVID-19 vaccine candidate in India to comply with local regulations.

However, India later removed the requirement for a bridging study of COVID-19 vaccines that have been approved abroad by the WHO, the US, the EMA etc.

J&J had then stated: "As per DCGI's recent announcement, (there is) now no requirement of conducting bridging clinical studies of COVID vaccines in India. We're in discussions with GoI & exploring how best to accelerate our ability to deliver our single-dose vaccine to India."

When J&J had applied to the DCGI in April, the vaccine's trials in the US were paused amid reports of rare blood clots being triggered by the jab.

The J&J's withdrawal has come amidst ongoing talks over the indemnity issues. The government has said that a team was in constant touch with vaccine makers.

"This team is in continuous dialogue with Pfizer, Moderna and Johnson & Johnson to discuss and address various issues including the issue of indemnity," Bharati Pravin Pawar, the Minister of State for Health, had said.

Johnson & Johnson is yet to apply for full approval for its vaccine in the United States.