J&J seeks approval to conduct vaccine trial in India

Reuters | Tuesday, 20 April 2021

Johnson & Johnson is seeking to conduct a local clinical trial in India for its single-dose COVID-19 vaccine, which was paused in the United States last week on reports of rare blood clots.

The company said on Tuesday it had submitted an application to India's drug regulator - the Drugs Controller General of India - requesting approval for the "bridging" safety and immunogenicity study for its vaccine.

The global rollout of the single-dose vaccine, which is seen as a vital weapon in the fight against the COVID-19 pandemic, received a jolt when US federal health agencies last Tuesday recommended pausing its use.

J&J's India application, which the company said was to comply with local regulations, comes as the country grapples with a second wave in COVID-19 cases that has severely strained its health system and caused shortages of oxygen and medicines.

Last week, India said it would fast-track emergency approvals for foreign-made COVID-19 vaccines, a move that would exempt companies from carrying out "bridging" trials for their vaccines.

Johnson & Johnson did not immediately give more details about the process.