THE HAGUE – The European Union’s executive branch on Monday authorized a fifth COVID-19 vaccine for use in the 27-nation bloc, giving the green light to the two-dose vaccine made by U.S. biotech company Novavax.
The European Commission confirmed a recommendation from the bloc's drug regulator to grant conditional marketing authorization for the vaccine for people ages 18 and over. The decision comes as many European nations are battling surges in infections and amid concerns about the spread of the new omicron variant.
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Novavax says it's testing how its shots will hold up against omicron, and like other manufacturers has begun formulating an updated version to better match that variant in case in case it’s eventually needed.
“At a time where the omicron variant is rapidly spreading, and where we need to step up vaccination and the administration of boosters, I am particularly pleased with today’s authorization of the Novavax vaccine," European Commission President Ursula von der Leyen said.
Much about omicron remains unknown, including whether it causes more or less severe illness. Scientists say omicron spreads even easier than other coronavirus strains, including delta, and it is expected to become dominant in some countries by early next year. Early studies suggest the vaccinated will need a booster shot for the best chance at preventing an omicron infection. But even without the extra dose, vaccination still should offer strong protection against severe illness and death.
The Novavax shot joins those from Pfizer-BioNTech, Moderna, Johnson & Johnson and AstraZeneca as the authorized vaccines in the EU. The bloc has ordered up to 100 million Novavax doses with an option for 100 million more.
The European Commission said the first doses were expected to arrive in early 2022. EU member states have ordered around 27 million doses for the first quarter of next year.
Last week, the World Health Organization gave emergency approval to the Novavax vaccine, paving the way for its inclusion in the U.N.-backed program to get such vaccines to poorer countries around the world.
The European Medicines Agency, the EU's drug regulator, 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 the company 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.”
Last summer, Novavax reported that 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.
The Novavax 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 statement, 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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