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Business News/ Science / Health/  Johnson & Johnson single-shot vaccine 'safe and effective' against virus: USFDA
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Johnson & Johnson single-shot vaccine 'safe and effective' against virus: USFDA

The vaccine was 72% effective in a US clinical trial, the USFDA mentioned

Johnson & Johnson (REUTERS)Premium
Johnson & Johnson (REUTERS)

Johnson & Johnson’s much anticipated one-shot vaccine is 'safe and effective' against COVID-19 infection, US regulator said.

The vaccine was 72% effective in a US clinical trial, the USFDA mentioned. There were no COVID-19 related deaths in the vaccinated group, according to USFDA. The analysis supported a favorable safety profile with no specific safety concerns identified that would preclude issuance of an EUA.

"The vaccine candidate was 85% effective in preventing severe disease across all regions studied, 28 days after vaccination in all adults 18 years and older," Johnson & Johnson said earlier. The vaccine prevented 66% of moderate to severe cases of COVID-19, according to a company statement. Over 44,000 participants took part in the late stage trial of Johnson & Johnson’s coronavirus vaccine.

The J&J shot delivers genetic instructions for human cells to create a specific protein of the coronavirus, in order to train the immune system for the live virus. Moderna Inc. and Pfizer Inc. have generated stronger overall efficacy rates, but require two shots. The single-shot vaccine could go a long way toward ending the pandemic, experts said. “A one-shot vaccine is considered by the World Health Organization to be the best option in pandemic settings, enhancing access, distribution and compliance," said Paul Stoffels, M.D., vice chairman of the executive committee and chief scientific officer, Johnson & Johnson.

“These topline results with a single-shot COVID-19 vaccine candidate represent a promising moment. The potential to significantly reduce the burden of severe disease, by providing an effective and well-tolerated vaccine with just one immunization, is a critical component of the global public health response," Stoffels added.

“These results are a testament to the extraordinary efforts of everyone involved in our COVID-19 vaccine candidate clinical program, and we are extremely grateful to the clinical trial staff and trial participants for their invaluable contributions," said Mathai Mammen, M.D., Ph.D., global head, Janssen Research & Development.

The phase 3 study of 45,000 people across 80 countries potentially included cases of new strains identified in South Africa and Brazil, US pharmaceutical's chief financial officer said.

"In terms of supply we're very confident and on track to meet all of our commitments," he added. The pharma giant earlier promised 100 million doses to the US by the end of June, about 200 million doses by the end of the year to the EU with shipments starting in April, and 200 million doses to developing countries that will begin shipping in the second half of the year.

The vaccine could become the third to receive emergency use authorization in the US.

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Published: 24 Feb 2021, 07:28 PM IST
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