The European Commission on Monday approved a Covid-19 vaccine made by Novavax, making it the fifth vaccine available in the 27 nations of the EU.
“At a time when the Omicron variant is spreading rapidly, and where we need to step up vaccination and booster administration, I am particularly pleased with the current approval of the Novavax vaccine,” said Ursula von der Leyen, President of the European Commission. said in a statement.
But it is not yet clear how well the vaccine, known as Nuvaxovid, will work against the infectious new Omicron variant. And there may not be much demand for the new vaccine in Europe, which is already in line with vaccines from Pfizer-BioNTech and other sources.
Novavax, based in Maryland, last year won $ 1.7 billion in support from the US government to develop a vaccine made from proteins from the coronavirus. Despite the lavish support, Novavax lagged behind vaccine developers Pfizer-BioNTech and Moderna, struggling with its clinical trials and production.
In the end, however, Novavax showed that their vaccine could offer strong protection. In a final report published last week in The New England Journal of Medicine, the company’s 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 used for decades and generally have a strong track record of safety and mild side effects. Nuvaxovid side effects are usually mild or moderate and disappear within a few days.
Novavax merged with the Serum Institute of India as a production partner, and in recent weeks the new vaccine has had a number of regulatory successes. Indonesia and the Philippines approved the vaccine last month.
Last week, the World Health Organization gave Nuvaxovid a list of emergency uses, a stamp of approval that accelerates the adoption of vaccines in countries that cannot carry out major assessments on their own.
Novavax has already placed a number of purchase orders. The company also plans to deliver 1.1 billion doses to Covax, a consortium that seeks to distribute vaccines to countries around the world. In a earnings interview on November 4, Novavax officials said they expected to produce over two billion doses by 2022.
In August, the European Commission agreed to buy up to 200 million doses of the vaccine. The Commission approved Nuvaxovid following a recommendation issued on Monday by the European Medicines Agency.
In a statement, Novavax said they expected the first doses to arrive in Europe in January.
But Europe has been using other vaccines for almost a year, and the European Commission has unlocked a plentiful supply, with an agreement of up to 2.4 billion doses from Pfizer-BioNTech alone.
On Monday, Pfizer-BioNTech announced that an agreement had been reached with the European Commission to purchase over 200 million doses in 2022. These will be in addition to the 450 million doses already set to be delivered in 2022.
Coronavirus pandemic: important things to know
Novavax introduces its vaccine at a moment when the pandemic is undergoing a global shift. The Omicron variant, which can evade some of the immunity given by existing vaccines, is rapidly increasing to dominance in large parts of Europe and elsewhere.
The company is investigating how well Omicron can avoid antibodies produced by two doses of Nuvaxovid, but has not yet published the results of the experiment.
In a small clinical study in South Africa, Novavax found that another variant, called Beta, drastically reduced the effect of the vaccine to less than 50 percent. This effect may have been unusually low because some of the volunteers in the study had HIV and thus had weakened immune systems. Novavax estimated that the effect of the vaccine against Beta was 60 percent in people without HIV
In studies of other vaccines, researchers have found that Omicron is generally better at avoiding vaccines than Beta. This increases the possibility that Nuvaxovid will be even less effective in preventing Omicron infections than those caused by Beta.
“We can not speculate on Omicron until we see the data,” said Alison Chartan, a spokeswoman for Novavax.
Nuvaxovid may be more useful as a source of booster shots. This month, British researchers reported that when people switched from other vaccines to Nuvaxovid for their boosters, the vaccine could increase the level of antibodies against the coronavirus. If the levels are high enough, they can provide strong protection against Omicron.
This month, Novavax announced that they are developing an Omicron-specific version of the vaccine and said it would test the new vaccine over the next few weeks. Novavax has said it expects to submit an application to the US Food and Drug Administration by the end of December.