Sources from the Directorate General for Drugs and Inspection of India (DCGI) told India Today that Johnson & Johnson has withdrawn its proposal to seek approval of its only Covid19 vaccine in India. Johnson & Johnson has not indicated the reasons for its withdrawal.
The US-based company applied for approval in April to conduct bridging clinical studies of its vaccine candidate Janssen Covid19 in India. It was previously reported
that thousands of doses of Johnson & Johnson’s vaccine could reach India in July.
Johnson & Johnson’s viral vector vaccine Covid19 was authorized by the US FDA for emergency use in February 2021. However, a few weeks after the approval, the vaccine was associated with a rare but severe blood clotting disorder.
Last month, the European drug regulatory agency added a rare neurodegenerative disease Guillain-Barré syndrome as a possible rare side effect of Johnson & Johnson’s Covid19 vaccine after reviewing 108 reported cases worldwide.
According to data from the World Health Organization (WHO), Johnson & Johnson vaccine is 66.3% effective against mild to moderate Covid19, and 76.3% effective against severe to critical infections. In addition, it provides 100% protection for Covid19 hospitalization 28 days after vaccination.
Johnson & Johnson said its single-shot vaccine shows confidence for Delta variants and other emerging strains.
To date, Covishield, Covaxin, Sputnik V and Moderna of AstraZeneca in India have approved an Emergency Use Authorization (EUA) for four vaccines.
