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Novavax Covid vaccine wins European approval after months of delays


Novavaxs vaccine was cleared by European regulators and is set to become the first Covid-19 shot of its kind in the region, giving countries another tool as they race to protect their populations in the face of the omicron variant.

The protein-based shot, known as Nuvaxovid, was recommended by the European Medicines Agency, according to a statement Monday, and a European Commission decision authorizing the vaccine is expected imminently.

The move follows a decision last week by the World Health Organization granting the vaccine emergency-use status. It's a boost for Novavax, 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 development of the shot compared to rivals such as Pfizer and Moderna hit its stock hard in recent months.

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 U.S. found a 90.4% reduction in the number of symptomatic Covid-19 cases from seven days after the second dose, compared with people given a placebo. The second study in the U.K. showed efficacy was similar at 89.7%.

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

The Maryland-based company's vaccine mimics the coronavirus's spike protein, sparking an immune response that prepares the body for a real infection. The vaccine 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.

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 authorization 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 immunization," Stanley Erck, Novavax's CEO, wrote in the statement.

Published : December 21, 2021

By : Bloomberg