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Novavax wins approval of EU regulator after months of delays

Novavax wins approval of EU regulator after months of delays

2 min. 20.12.2021 From our online archive
European Medicines Agency authorises shot for use, in a major boost for manufacturer after setbacks in rollout
The European Medicines Agency authorised the use of the Novavax vaccine on Monday
The European Medicines Agency authorised the use of the Novavax vaccine on Monday
Photo credit: AFP

Novavax’s Covid-19 vaccine has been cleared by European regulators and is set to become the first protein-based shot against the disease in Europe.  

The shot, known as Nuvaxovid, was recommended by the European Medicines Agency, according to a statement on Monday. A European Commission decision authorising the vaccine is expected imminently.

That follows a decision last week by the World Health Organization granting emergency-use status to the vaccine.

It’s a boost for Novavax’s shot, which has suffered months of delays after manufacturing problems despite securing some of the largest funding from the Trump administration in the early stages of the pandemic. 

The lag in the commercial development of a shot compared to rivals such as Pfizer and Moderna, hit its stock hard since hitting highs in February. Novavax rose as much as 8.8% to $236.50 (€209.40) in early New York trading on Monday.

The Maryland-based company’s vaccine mimics the coronavirus’s spike protein, sparking an immune response that prepares the body for a real infection. It requires two doses three weeks apart and can be stored at refrigerator temperatures, making it easier to transport than some messenger RNA shots.

The vaccine also shows strong potential in mix-and-match booster campaigns, relying on an approach that has been used for many years in vaccines against hepatitis, meningitis and other diseases, according to the vaccine alliance, Gavi.  

Results from two main clinical trials found the shot was effective at preventing Covid and involved more than 45,000 people in total. The first study in Mexico and the US found a 90.4% reduction in the number of symptomatic Covid-19 cases from 7 days after the second dose, compared with people given a placebo. The second study in the UK showed vaccine efficacy was similar at 89.7%.

There’s limited data on the effectiveness of Nuvaxovid against omicron, according to the European regulator. 

It also broadens Europe’s arsenal as the virus continues to spread. Novavax and the European Commission announced a supply agreement for as many as 200 million doses of the vaccine in August.

“An authorisation from the commission would deliver the first protein-based vaccine to the EU during a critical time when we believe having choice among vaccines will lead to increased immunisation,” Stanley Erck, Novavax’s chief executive officer, wrote in the statement.

©2021 Bloomberg L.P.

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