THE HAGUE, Netherlands -- The European Union’s drugs regulator gave the green light Monday to a fifth COVID-19 vaccine for use in the 27-nation bloc, granting conditional marketing authorization to the two-dose vaccine made by U.S. biotech company Novavax.
The European Medicines Agency decision to recommend granting conditional marketing authorization for the vaccine for people aged 18 and over, which must be confirmed by the EU’s executive commission, comes as many European nations are battling surges in infections and amid concerns about the spread of the new omicron variant.
Novavax says it currently is testing how its shots will hold up against the omicron variant, and like other manufacturers has begun formulating an updated version to better match that variant in case in case it’s eventually needed.
The Novavax shot joins those from Pfizer-BioNTech, Moderna, Johnson & Johnson and AstraZeneca in the EU’s vaccine armory. The EU has ordered up to 100 million doses of the Novavax vaccine with an option for 100 million more.
The EMA said that it's human medicines committee concluded by consensus “that the data on the vaccine were robust and met the EU criteria for efficacy, safety and quality.”
COVID-19 vaccines train the body to recognize the coronavirus by spotting the spike protein that coats it, but the Novavax option is made very differently than the most widely used shots.
It is a protein vaccine, made with an older technology that’s been used for years to produce other kinds of vaccines. The Maryland-based Novavax uses genetic engineering to grow harmless copies of the coronavirus spike protein in insect cells. Scientists extract and purify the protein and then mix in an immune-boosting chemical.
Novavax President and CEO Stanley C. Erck said if the European Commission confirms the EMA decision the company would “deliver the first protein-based vaccine to the E.U. during a critical time when we believe having choice among vaccines will lead to increased immunization.”
Last summer, Novavax reported a study of 30,000 people in the U.S. and Mexico found the vaccine was safe and 90% effective against symptomatic infection from earlier variants, similar to findings from a trial of 15,000 people in Britain. A follow-up study found a booster dose six months after the last shot could rev up virus-fighting antibodies enough to tackle the extra-contagious delta variant, which at the time was the biggest threat.
It was not immediately clear how much supply Novavax will be able to ship, and when. Its vaccine was long anticipated to help increase global vaccine supplies, as the shots require only refrigerated storage. But Novavax was delayed for months because of problems lining up large-scale manufacturing.
In a staetment, Novavax said the Serum Institute of India manufacturer will supply the initial doses for the EU and later doses will come from other manufacturing sites in its global supply chain.
Dr. Gregory Glenn, Novavax’s research and development chief, recently told The Associated Press the problem wasn’t producing the spike protein itself, which is straightforward, but capacity to make and bottle large quantities. Glenn said the company now has enough manufacturing capability. It partnered with the huge Serum Institute of India, and two companies recently received emergency authorization of the shots in Indonesia and the Philippines. In addition, Novavax has lined up production facilities in the Czech Republic, South Korea and elsewhere.
Novavax has been given emergency use authorization in Indonesia and the Philippines, has applications pending with the World Health Organization and Britain, and plans to file with the U.S. Food and Drug Administration by year’s end.
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