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

April 20, 202110:42 AM UTCUpdated ago

Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed Johnson & Johnson logo in this illustration taken October 31, 2020. REUTERS/Dado Ruvic/Illustration

BENGALURU, April 20 (Reuters) - Johnson & Johnson (JNJ.N) 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. read more

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. read more

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

Reporting by Anuron Kumar Mitra in Bengaluru