Novavax, hoping to bump up its lagging European launch, asks EMA to authorize its COVID shot in teenagers

Novavax is looking for a swift green light in Europe to market its protein-based COVID vaccine Nuvaxovid in teenagers as take-up stalls in adults.

The European Commission, which finalizes all drug approvals and authorizations in Europe, gave its stamp for Nuvaxovid in adults aged 18 and older in December last year. Winning an approval in teens would open up a key target market for the company.

The idea is that Nuvaxovid, which was developed using older vaccine technology seen in flu shots, would be seen as an alternative to the newer mRNA technology used in Pfizer and Moderna’s jabs. And Novavax hoped the so-called vaccine hesitant would thus be more likely to sign up for their first vaccines. In Europe, two other non-mRNA vaccines—from AstraZeneca and Johnson & Johnson—have been hampered by safety concerns.

But Nuvaxovid has struggled to make much headway on the continent, with figures out from the Koch Institute this month showing pretty dismal numbers from some of Europe’s biggest and most populous countries.

But besides the vaccine hesitant, Novavax sees kids as another target market. And now, it’s sent off a new application to the European Medicines Agency hoping for a quick authorization in those aged 12 to 17 years old, hoping to boost its launch with a significant proportion of the population in Europe.

There are concerns that, notably with AZ’s vaccine and the two mRNA vaccines, younger people are at a higher risk of certain side effects, namely blood clots (with AZ) and myocarditis (with Pfizer and Moderna’s shots, notably in boys). Novavax is positioning itself as a new option that it says is both safe and effective.

It has data out from last year—when the delta variant was ascendant and before omicron kicked in—that its shot delivered an 80% efficacy overall. How well that translates with omicron, we don’t yet know.

In the pediatric expansion of its trial, known as PREVENT-19, Novavax said serious and severe adverse events “were low in number and balanced between vaccine and placebo groups, and not considered related to the vaccine.”

"We are continuing to see spikes in COVID-19 across Europe and recognize the need to improve vaccination rates, particularly in the pediatric population," Novavax CEO Stanley Erck said in a release. "We look forward to a decision from the European Medicines Agency and firmly believe in the benefit of diversified vaccine options."

Novavax is also still awaiting an authorization in the U.S. from the FDA.