J&J seeks approval to conduct local trial of its COVID-19 vaccine in India

Last week, India said it would fast-track emergency approvals for foreign-made COVID-19 vaccines

  
A vial of the Johnson & Johnson's coronavirus disease (COVID-19) vaccine is seen at Northwell Health's South Shore University Hospital in Bay Shore, New York, U.S., March 3, 2021.

A vial of the Johnson & Johnson's coronavirus disease (COVID-19) vaccine is seen at Northwell Health's South Shore University Hospital in Bay Shore, New York, U.S., March 3, 2021.

REUTERS/Shannon Stapleton

BENGALURU - 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 U.S. 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.

(Reporting by Anuron Kumar Mitra in Bengaluru; Editing by Saumyadeb Chakrabarty) ((AnuronKumar.Mitra@thomsonreuters.com; +91 99863 58469;))

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