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J&J applies for EU authorisation for one-dose COVID-19 vaccine

Submission is based on top-line efficacy and safety data from the phase 3 ENSEMBLE trial

Johnson & Johnson (J&J) is seeking a conditional marketing authorisation from the European Medicines Agency (EMA) for its one-dose COVID-19 vaccine candidate.

In a statement, J&J said that the EMA submission is based on top-line efficacy and safety data from the recently published 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.

In South Africa, J&J said that 95% of the COVID-19 cases observed in the study were caused by the newly discovered B.1.351 virus variant.

Although the vaccine is less effective against the B.1.351 variant that was first discovered in South Africa, J&J said that the jab was 85% effective in preventing severe disease across all regions studied.

Importantly, the one-dose jab could be rolled out with more ease and efficiency compared to other two-dose regimens.

The vaccine is also estimated to remain stable for two years at -20°C and for at least three months at +2 to 8°C (standard refrigerator temperatures).

“Throughout Europe, there remains an urgent need for additional COVID-19 vaccines, and [this] 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,” said Paul Stoffels, vice chairman of the executive committee and chief scientific officer at J&J.

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

The European Commission (EC) has an advanced purchase agreement with J&J for 200 million doses of its one-dose vaccine, which also includes an option to secure up to 200 million additional doses after the initial supply.

J&J also reached an agreement with the US government in August 2020 to supply 100 million doses of its COVID-19 vaccine

The US government also has the option to purchase an additional 200 million doses under a subsequent agreement.

The UK government has secured 30 million doses of J&J’s vaccine, which will be supplied on a not-for-profit basis during the emergency pandemic.

So far, J&J has filed its vaccine candidate, seeking an emergency use authorisation, with the US Food and Drug Administration (FDA).

Further rolling reviews of the jab have also been initiated in several countries across the globe, as well as with the World Health Organization (WHO).

Article by
Lucy Parsons

17th February 2021

From: Regulatory



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