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EU approves Maryland-based Novavax COVID-19 vaccine for bloc, 5th approval – CBS Baltimore

THE HAGUE, Netherlands (AP) – The executive branch of the European Union on Monday authorized a fifth COVID-19 The vaccine is used in the 27-nation bloc, giving the green light to a two-dose vaccine made by the US biotech company Novavax.

The European Commission has confirmed the recommendation from the bloc’s drug regulator to grant a conditional marketing authorization for vaccines to persons 18 years of age and older. The decision comes as many European countries are battling an increase in infections and amid concerns about the spread of the new omicron variant.

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Novavax says it’s testing how its photos will withstand omicrons, and like other manufacturers has begun building an updated version to better accommodate that variant in case it is ultimately necessary.

“At a time when the omicron variant is spreading rapidly and where we need to step up vaccination and booster use, I am particularly pleased with the Novavax vaccine licensing today,” said the Commission Chairman. European Commission Ursula von der Leyen said.

Much is still unknown about omicrons, including whether it causes more or less severe disease. Scientists say the omicron spreads even more easily than other strains of coronavirus, including in the lowlands, and it is expected to become dominant in some countries early next year. Early studies show that vaccination will require a booster shot for the best chance of preventing an omicron infection. But even without an additional dose, vaccination should still provide strong protection against serious illness and death.

The Novavax vaccine combined with vaccines from Pfizer-BioNTech, Moderna, Johnson & Johnson and AstraZeneca is an authorized vaccine in the EU. The block has ordered up to 100 million doses of Novavax with the option to add another 100 million.

The European Commission says the first doses are 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 a United Nations-supported program to make such a vaccine available to poorer countries. In the world.

The European Medicines Agency, the EU’s drug regulator, said its human medicines committee had concluded by consensus “that the vaccine data are robust and meet the EU criteria for efficacy”. efficiency, safety and quality”.

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The COVID-19 vaccine trains the body to recognize the coronavirus by detecting the mutated protein that envelops it, but the Novavax option is built very differently from the most widely used shots.

It is a protein vaccine, made using an older technology that has been used for many years to make other 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 it with an immune-boosting chemical.

Novavax President and CEO Stanley C. Erck said the company will “deliver the first protein-based vaccine to the EU at a critical time when we believe that choosing between vaccines will lead to strengthen immunity”.

Last summer, Novavax reported that a study of 30,000 people in the US and Mexico found the vaccine to be safe and 90% effective at fighting symptomatic infections from previous variants. Similar to findings from a trial of 15,000 people in the UK. A follow-up study showed that a booster dose six months after the last injection could increase antibodies against the virus enough to deal with the extremely contagious delta variant, which was the biggest threat at the time. that point.

The Novavax vaccine has long been predicted to help increase the global supply of the vaccine, as the shots only need to be refrigerated. But Novavax was delayed for months because of problems during large-scale production.

In a statement, Novavax said the Serum Institute of India manufacturer will supply initial dosages to the EU and subsequent dosages will come from other manufacturing locations in their global supply chain. .

Dr. Gregory Glenn, Novavax’s director of research and development, recently told The Associated Press that the problem is not simply producing the mutant protein itself, but rather the ability to manufacture and bottle it in quantity. big. Glenn said the company now has enough production capacity. It’s partnered with India’s giant Serum Institute, and the two companies recently received emergency authorizations for injections in Indonesia and the Philippines. In addition, Novavax has located production facilities in the Czech Republic, Korea and elsewhere.

Novavax has been approved for emergency use in Indonesia and the Philippines, has pending applications with the World Health Organization and the UK, and plans to file an application with the US Food and Drug Administration in Last year.

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https://baltimore.cbslocal.com/2021/12/20/eu-approves-maryland-based-novavax-covid-19-vaccine-for-bloc-5th-approved/ EU approves Maryland-based Novavax COVID-19 vaccine for bloc, 5th approval – CBS Baltimore

JOE HERNANDEZ

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