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J&J’s one-shot COVID-19 vaccine submitted to the EU

Published on 17/02/21 at 12:22pm
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Johnson & Johnson has applied to the EMA for marketing authorisation of their one-shot COVID-19 vaccine in Europe.

The submission is based on the company’s Phase III ENSEMBLE trial, which proved the jab to be 85% effective at preventing serious symptoms of the virus, and showed total protection against COVID-19-related hospitalisation and death 28 days after vaccination.

Once conditional marketing authorisation is granted, the company must continue to fulfil further obligations within certain timelines, including the supply of more data.

Johnson & Johnson announced it had begun a rolling submission with the EMA for its investigational vaccine in December, allowing data to be reviewed as it became available. The company has started rolling submissions in several other countries, as well as with WHO.

Dr Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson, said: “Throughout Europe, there remains an urgent need for additional COVID-19 vaccines, and today’s submission is a significant step forward in ensuring the European Union has another option to help reduce the impact the pandemic has had in Europe and around the world.

“We stand ready to begin distributing our vaccine within the European Union in the second quarter of 2021.”

The Johnson & Johnson vaccine varies from the other shots currently available due to the fact it can be administered in only one dose. It can also be stored at temperatures of 2-8° C and is cheaper than most other vaccines too, at roughly £7 ($9.70) a dose.

The vaccine makes use of the company’s AdVac platform, which was also used to develop and manufacture Johnson & Johnson’s Ebola shot, as well as to make its investigational Zika, RSV, and HIV vaccines.

Jack Goddard

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