European Commission authorizes fifth vaccine against COVID-19

Brussels, Belgium | Xinhua | The European Commission on Monday granted conditional marketing authorization for Nuvaxovid, the fifth COVID-19 vaccine authorized in the European Union (EU).

The authorization of the vaccine, developed by Novavax, followed a scientific recommendation based on an assessment of the safety, effectiveness and quality of the vaccine by the European Medicines Agency (EMA). It was endorsed by the EU member states, the Commission said.

A conditional marketing authorization is given on the basis of less complete data than is normally required, and may be considered if the benefit of a medicine’s immediate availability clearly outweighs the risk linked to the fact that not all the data are yet available.

EMA’s recommendation, issued on Sunday, said that results from two clinical trials had shown that Nuvaxovid was effective at preventing COVID-19 in people aged over 18. One study conducted in Mexico and the United States found a 90.4 percent reduction in the number of symptomatic cases, while a second study in the United Kingdom showed an efficacy of 89.7 percent.

European Commission President Ursula von der Leyen said the authorization has come at a time when the Omicron variant is rapidly spreading across the EU, and vaccination needs to be stepped up.

“I am particularly pleased with today’s authorization of the Novavax vaccine,” von der Leyen said. “This is the fifth safe and effective vaccine of our vaccine portfolio, offering welcome additional protection to the European citizen against the pandemic.”

The authorization of Nuvaxovid should provide “strong encouragement” for those who have not yet received a vaccine or booster dose to do so, she added.

Stella Kyriakides, European Commissioner for Health and Food Safety, said this is the first protein-based vaccine that shows promising results against COVID-19.

“Vaccination and boosting to increase protection against COVID-19 is today more important than ever if we are to stem the wave of infections and counter the emergence and spread of new variants,” Kyriakides said.

The Commission signed the contract with Novavax on Aug. 4. 2021. With the conditional market authorization, starting from early 2022 Novavax will be able to deliver up to 100 million vaccines to the EU.

The EU has previously authorized the marketing of COVID-19 vaccines developed by BioNTech/Pfizer, Moderna, AstraZeneca and Janssen.

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Xinhua