EU approves 5th COVID-19 vaccine, by Novavax

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 those age 18 and over. The decision comes as many European nations are battling surges in coronavirus infections and amid concerns about the spread of the Omicron variant.

Novavax says it’s testing how its vaccine will hold up against Omicron and, like other manufacturers, has begun formulating an updated version to better match that variant.

“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 than other coronavirus variants. Scientists say Omicron spreads more easily than other strains, including Delta. 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 should offer strong protection against severe illness and death.

The Novavax shot joins those from Pfizer-BioNTech, Moderna, Johnson & Johnson and AstraZeneca as authorized COVID-19 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 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 a program backed by the United Nations to get vaccines to poorer countries around the world.

The EU’s drug regulator, European Medicines Agency, said it had concluded “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 differently than the most widely used shots. It is a protein vaccine, made with older technology that has been used for years to produce other kinds of vaccines. Maryland-based Novavax uses genetic engineering to grow harmless copies of the coronavirus spike protein in insect cells; scientists extract and purify the protein, then mix in an immune-boosting chemical.

Stanley C. Erck, Novavax’s president and chief executive, 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 to be safe and 90% effective against symptomatic infection from earlier coronavirus variants — similar to findings from a trial of 15,000 people in Britain. A follow-up study found that 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 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 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 that producing the spike protein is straightforward, but the ability to make and bottle large quantities had been problematic. Glenn said the company now has enough manufacturing capability.

In addition to the partnership with the Serum Institute of India, Novavax has emergency authorization for manufacturers in Indonesia and the Philippines and has lined up production facilities in the Czech Republic, South Korea and elsewhere.

Novavax has applications pending with the World Health Organization and Britain and plans to file with the U.S. Food and Drug Administration by the end of the year.