Novavax COVID vaccine OK’d in Europe after months of delays

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London: Novavax Inc.’s 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 on Monday (Tuesday AEDT), and a European Commission decision authorising the vaccine is expected imminently.

A vial of the Phase 3 Novavax coronavirus vaccine.Credit:AP

The move follows a decision last week by the World Health Organisation 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.

In Australia, Novavax is currently under evaluation by the Therapeutic Goods Administration.

The lag in the development of the shot has left Novavax at a disadvantage compared to rivals such as Pfizer and Moderna.

Results from two main clinical trials found the Novavax shot was effective at preventing COVID-19 and involved more than 45,000 people in total.

The first study in Mexico and the US found a 90.4 per cent 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 British showed efficacy was similar at 89.7 per cent.

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 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.

Bloomberg

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