The European Commission gave the go-ahead for the fifth vaccine in the European Union, a Covid-19 vaccine made by Novavax.
Ursula von der Leyen, president of the European Commission, said in a statement that she was pleased with the authorization of the Novavax vaccine.
It is not known how well the vaccine will work against the new Omicron variant. The new vaccine may not be in demand in Europe, which is already filled with vaccines from Pfizer-BioNTech and other sources.
Novavax, based in Maryland, won over $1 billion in support from the United States government to develop a vaccine for the coronaviruses. Novavax struggled with its clinical trials and manufacturing despite the lavish support.
Novavax showed that it could offer strong protection. Nuvaxovid was found to be 100 percent effective against moderate to severe disease in a final report published last week in The New England Journal of Medicine.
The safety and mild side effects of vaccines based on proteins have been used for decades. The side effects of Nuvaxovid are usually mild or moderate.
The new vaccine had a string of regulatory successes after Novavax collaborated with the Serum Institute of India. The vaccine was authorized by Indonesia and the Philippines.
The World Health Organization granted Nuvaxovid an emergency-use listing last week, which means it can be used in countries that cannot conduct large-scale reviews of their own.
Novavax has a number of purchase orders. Covax is a consortium that seeks to distribute vaccines to countries around the world. Novavax officials said on the earnings call that they expected to produce over two billion doses in the year 2022.
The European Commission agreed to purchase up to 200 million doses of the vaccine. The European Medicines Agency recommended Nuvaxovid on Monday.
In a statement, Novavax said that it expected initial doses to arrive in Europe in January.
Europe has been using other vaccines for nearly a year, and the European Commission has locked up an abundant supply, with an agreement for up to 2.4 billion doses from Pfizer-BioNTech alone.
The European Commission and Pfizer-BioNTech reached an agreement to purchase over 200 million doses of the drug. 450 million doses will be delivered in 2022.
Novavax is introducing its vaccine at a time when there is a global shift. The Omicron variant, which can evade some of the immunity provided by existing vaccines, is rapidly rising to dominance in Europe.
The company is trying to figure out how Omicron can evade the Nuvaxovid produced by two doses.
In a small clinical trial in South Africa, Novavax found that the vaccine's efficacy was reduced to less than 50 percent. Some of the volunteers in the study had weakened immune systems, which may have made the efficacy low. The vaccine's efficacy was 60 percent in people without H.I.V., according to Novavax.
Researchers have found that Omicron is better at evading vaccines than Beta. It's possible that Nuvaxovid will be less effective at preventing Omicron infections than it is at preventing Beta infections.
Alison Chartan, the director of external communications at Novavax, said that they can't speculate on Omicron until they see the data.
Nuvaxovid may be a good source of booster shots. British researchers reported this month that when people switched from other vaccines to Nuvaxovid for their boosters, the vaccine could raise their antibody levels against the coronaviruses. If the levels are high enough, they can protect against Omicron.
Novavax said this month that it would test a new vaccine in the next few weeks and that it was developing an Omicron-specific version. Novavax expects to submit an application to the FDA by the end of the year.
