Home/ Companies / News/  J&J seeks EUA for single-shot covid-19 vaccine in India

NEW DELHI: Johnson & Johnson (J&J) on Friday said it has applied for emergency use authorization (EUA) for its single-shot covid-19 vaccine in India.

The EUA submission is based on top-line efficacy and safety data from the Phase 3 ensemble clinical trial, which showed the vaccine was 85% effective in preventing severe disease across all regions studied, and offered protection against covid-19 hospitalization and death starting 28 days after vaccination, the company said.

“On August 5, 2021, Johnson & Johnson Pvt. Ltd applied for EUA of its single-dose covid-19 vaccine to the Government of India," a spokesperson for J&J India said in a statement.

This follows the US company’s announcement on Monday that it is committed to bring its covid-19 vaccine to India and looked forward to ongoing talks with the Indian government.

The company said the EUA application is a key milestone that would pave the way for offering the vaccine to India and other countries through a partnership with Biological E Ltd. “Biological E will be an important part of our global supply chain network, helping to supply our J&J covid-19 vaccine through the extensive collaborations and partnerships we have with governments, health authorities and organizations such as Gavi and the COVAX facility," according to the statement.

“We look forward to concluding our discussions with the Government of India to accelerate availability of our covid-19 vaccine to help end the pandemic," it said.

J&J’s vaccine leverages the AdVac vaccine platform proprietary technology that was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its investigational Zika, RSV and HIV vaccines.

J&J said its single-shot vaccine showed strong promise against the delta variant and other emerging strains.

The J&J/Janssen vaccine was listed for emergency use by the World Health Organization (WHO) on 12 March 2021. The vaccine has been authorized for use in Europe, the US and other countries, with the widest experience to date in the US.

The Indian government is also in talks with pharma majors Pfizer and Moderna to import covid-19 vaccines.

More than 490 million vaccine doses have been administered across the country so far.

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Updated: 06 Aug 2021, 10:58 PM IST
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