J&J in talks with Modi govt to start clinical trials for its single-shot Covid vaccine in India

New Delhi: US pharma giant Johnson & Johnson has said it is in talks with the Modi Johnson has said it is in talks with the Modi government to start clinical trials for its single-shot Covid-19 vaccine in India. The company has informed the Central Drugs Standard Control Organisation (CDSCO), the Indian drug regulator, about its plan to start “bridging clinical trials” soon.

The move will help India ramp up the vaccination drive amid the rising number of Covid cases in the country. “We are in discussions with the Government of India with the objective of starting a bridging clinical study of our Janssen COVID-19 vaccine candidate in India, subject to local regulatory approvals,” J&J’s spokesperson told ThePrint via an email. “At Johnson & Johnson, we remain fully focused on bringing a safe and effective COVID-19 vaccine to people around the world, if authorized for use by local health authorities,” the spokesperson said. A bridging trial is a supplementary trial performed in a new region or country to get more clinical data on efficacy, safety, and dose regimen. It can be done on over approximately 1,000 participants. Johnson & Johnson Covid vaccine can be shipped and stored at standard refrigeration temperatures. A senior official at CDSCO also confirmed that the company has reached out to the regulator and will submit the protocol of the trial before the expert panel, in the coming weeks. government to start clinical trials for its single-shot Covid-19 vaccine in India. The company has informed the Central Drugs Standard Control Organisation (CDSCO), the Indian drug regulator, about its plan to start “bridging clinical trials” soon. Produced by Science Communication and Dissemination Directorate, (SCDD), CSIR, Anusandhan Bhawan, New Delhi 2.The move will help India ramp up the vaccination drive amid the rising number of Covid cases in the country. “We are in discussions with the Government of India with the objective of starting a bridging clinical study of our Janssen COVID-19 vaccine candidate in India, subject to local regulatory approvals,” J&J’s spokesperson told The Print via an email.

“At Johnson & Johnson, we remain fully focused on bringing a safe and effective COVID-19 vaccine to people around the world, if authorized for use by local health authorities,” the spokesperson said. A bridging trial is a supplementary trial performed in a new region or country to get more clinical data on efficacy, safety, and dose regimen. It can be done on over approximately 1,000 participants. Johnson & Johnson Covid vaccine can be shipped and stored at standard refrigeration temperatures. A senior official at CDSCO also confirmed that the company has reached out to the regulator and will submit the protocol of the trial before the expert panel, in the coming weeks.

https://www.csir.res.in/news-bulletin

https://www.csir.res.in/sites/default/files/06%20To%2010%20April%20%202021.pdf

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