Novavax’s Covid Vaccine Approved in Europe

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The European Commission on Monday official A Covid-19 vaccine made by Novavax makes it the fifth vaccine available in 27 countries of the European Union.

“I am particularly pleased that the Novavax vaccine has been approved today, at a time when the Omicron variant is spreading rapidly and we need to accelerate the implementation of vaccination and boosters,” said Ursula von der Leyen, president of the European Commission. said in a statement.

However, it is not yet clear how well the vaccine, known as Nuvaxovid, will work against the infectious new variant of Omicron. And in Europe, there may not be much demand for the new vaccine, which is already flooded with vaccines from Pfizer-BioNTech and other sources.

Maryland-based Novavax received $1.7 billion last year from the US government to develop a vaccine made from coronavirus proteins. Despite ample support, Novavax lagged behind vaccine developers Pfizer-BioNTech and Moderna and struggled with clinical trials and production.

Ultimately, however, Novavax has shown that its vaccine can provide powerful protection. in a final report published In The New England Journal of Medicine last week, company researchers found that Nuvaxovid was 90 percent effective against symptomatic infection and 100 percent effective against moderate to severe disease.

Protein-based vaccines have been in use for decades and generally have a strong track record of safety and mild side effects. The side effects of Nuvaxovid are usually mild or moderate and go away within a few days.

Novavax has collaborated with the Serum Institute of India as a manufacturing partner, and in recent weeks the new vaccine has achieved a number of regulatory successes. Indonesia and the Philippines authorized the vaccine last month.

Last week, the World Health Organization gave Nuvaxovid an emergency use list; it’s a seal of approval that accelerates the adoption of vaccines in countries that are unable to conduct their own large-scale reviews.

Novavax has already placed a number of purchase orders. The company also plans to supply. 1.1 billion doses to Covax, a consortium aiming to distribute vaccines to countries around the world. In an earnings call on November 4, Novavax officials said they expect production. more than two billion doses in 2022.

In August, the European Commission agreed to purchase up to 200 million doses of vaccines. Commission authorized Nuvaxovid after a recommendation issuance by the European Medicines Agency on Monday.

Novavax said in a statement that it expects the first doses to reach Europe in January.

But Europe has been using other vaccines for about a year now, and the European Commission has locked in ample supply with a deal for up to 2.4 billion doses from Pfizer-BioNTech alone.

On Monday, Pfizer-BioNTech announced He reported that an agreement has been reached with the European Commission to purchase more than 200 million doses in 2022. These will be in addition to the 450 million doses scheduled to be delivered in 2022.

Novavax is launching its vaccine at a time when the pandemic is taking a global turn. Omicron variant, avoiding some of the immunity provided by current vaccinesrapidly dominates in most of Europe And elsewhere.

The company is investigating how well Omicron can get rid of antibodies produced by two doses of Nuvaxovid, but has yet to publish the results of the experiment.

In a small clinical trial in South Africa, Novavax developed another variant called Beta, greatly reduced the effectiveness of the vaccine less than 50 percent. This efficacy may have been unusually low as some of the volunteers in the study had HIV and therefore weakened their immune systems. Novavax estimates the vaccine’s effectiveness against Beta in people without HIV at 60 percent

In studies of other vaccines, researchers have found that Omicron’s constantly better It avoids making more vaccines than beta. This raises the possibility that Nuvaxovid will prove less effective at preventing Omicron infections than infections caused by Beta.

“We can’t speculate about Omicron without seeing the data,” said Alison Chartan, Novavax’s director of external communications.

Nuvaxovid may be more useful as a supplemental source of attraction. This month, British researchers reported He said that when people switch from other vaccines to Nuvaxovid for their boosters, the vaccine could raise antibody levels against the coronavirus. If the levels are high enough, they can provide strong protection against Omicron.

This month, Novavax announced its development A special edition for Omicron He promoted his vaccine and said he would test the new vaccine in the next few weeks. Novavax said it expects to submit an application to the United States Food and Drug Administration by the end of December.

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