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J&J’s one-dose COVID-19 vaccine granted EU authorisation

Company aiming to begin vaccine delivery to EU in the second half of April

Johnson & Johnson’s (J&J) single-dose COVID-19 vaccine has scored a conditional marketing authorisation (CMA) from the European Commission, the company announced yesterday. 

J&J submitted its vaccine for a CMA in the EU in February, basing the submission on top-line efficacy and safety data from the phase 3 ENSEMBLE trial.

The ENSEMBLE study was conducted in eight countries across three continents, with 44% of participants enrolled in the US, 41% in Central and South America and 15% in South Africa.

Across all participants from the different geographies, the vaccine was 66% effective overall in preventing moderate-to-severe COVID-19, 28 days after vaccination.

The data also demonstrated that the vaccine was 85% effective in preventing severe disease across all regions and showed protection against COVID-19-related hospitalisation and death, beginning 28 days after vaccination.

The CMA was issued on the same day that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the J&J vaccine to prevent COVID-19 in adults aged 18 years and older.

“For more than a year, we have been working around the clock – leveraging the scientific minds, scale and resources of our global organisation to bring forward a COVID-19 vaccine,” said Alex Gorsky, chairman and chief executive officer at J&J.

“We are thrilled with [the] conditional marketing authorisation by the European Commission, which enables our single-dose vaccine to reach many more communities in need, as we continue to do everything we can to help bring an end to this pandemic,” he added.

J&J said in a statement that it is aiming to begin delivery of its COVID-19 vaccine to the EU in the second half of April, and to supply 200 million doses to the EU in 2021.

Earlier this week, Reuters reported that J&J is facing supply issues in the EU for delivery of its COVID-19 vaccine.

An EU official told Reuters that J&J had informed the European Union that it is currently experiencing supply issues that could impact its delivery commitments to the EU in the second quarter of the year.

J&J is reportedly having issues with the supply of vaccine ingredients and equipment, putting its delivery goal of supplying 55 million doses to the EU by the end of June 2021 ‘under stress’.

Article by
Lucy Parsons

12th March 2021

From: Regulatory



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