Novavax Inc. said it will ask global regulators to clear the first protein-based Covid-19 vaccine for use in teens ages 12 to 17 after a trial showed it prevented symptomatic cases.
The vaccine was 80% effective against Covid-19 in a late-stage trial involving 2,247 adolescents in which it mainly faced the delta strain, Novavax said Thursday in a statement. There were no significant safety concerns, and the drugmaker said it will file this quarter with global regulators for authorization.
Unlike messenger RNA shots that turn the body’s cells into vaccine factories, Novavax’s shot sparks an immune response by mimicking the coronavirus spike protein. It requires two doses three weeks apart and can be stored at refrigerator temperatures, making it easier to transport than some other immunizations.
European regulators have cleared a two-shot regimen for adults, and Gaithersburg, Maryland-based Novavax filed last month for U.S. authorization for use in adults.
Still, the U.S. market for Novavax’s vaccine may be limited. There are already three alternatives for adults, and the vaccine from Pfizer Inc. and BioNTech SE was cleared for adolescents in May. Since then, 57% of the country’s 12- to 17-year-olds have been fully vaccinated.
Though the Pfizer-BioNTech shot is the only one authorized for U.S. children and teens, Moderna Inc. hopes to soon secure Food and Drug Administration clearance for its shot. Moderna has faced delays as regulators study the risk of myocarditis, a rare form of heart inflammation.
The pharmaceutical developer Novavax says it has asked the European Medicines Agency to extend the authorization of its coronavirus vaccine to children aged 12 to 17 amid a surge of disease across the continent.
In a statement on Thursday, Novavax said its request is based on data from research in more than 2,200 adolescents aged 12 to 17 in the U.S., which found its vaccine to be about 80% effective against COVID-19. The study was done when the delta variant was the predominant virus in the U.S. The main side effects reported were pain at the injection site, headache and tiredness.
The EU drug regulator gave Novavax’s two-dose COVID-19 vaccine for adults the green light in December; the shot has also been cleared by Indonesia, Australia and the World Health Organization, among others. The EMA has previously OK'ed vaccines made by Pfizer-BioNTech and Moderna for use in children from age 6.
The Novavax vaccine relies on an older technology that’s been used for years to make shots for diseases like influenza and pertussis. The Maryland-based Novavax drugmaker uses genetic engineering to grow harmless copies of the coronavirus spike protein in insect cells. Scientists then extract and purify the protein and then mix in an immune-boosting chemical.
Novavax has run into repeated production problems and mainly relies on other factories to make its vaccine. It has delayed delivery of its shots to numerous countries in Europe and despite pledges to make 250 million doses available to COVAX, not a single vaccine has been shared with the U.N.-backed effort to distribute shots to poorer countries.
According to the European Centre for Disease Prevention and Control, more than half of adolescents in the EU have not yet been fully vaccinated against COVID-19. Numerous countries across the continent have recently seen a jump in coronavirus cases, due largely to the spread of the hugely infectious omicron subvariant BA.2 and the relaxation of nearly all COVID-19 protocols.
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