Novavax COVID-19 vaccine was granted emergency use authorization by the Food and Drug Administration (FDA) for adolescents between the ages of 12 and 17, the Maryland-based biotech company announced.
Experts hope that the protein-based vaccine, doses of which are administered three weeks apart, will be more acceptable to unvaccinated people who have refused jabs made with mRNA vaccine technology used by Pfizer and Moderna or are allergic to some of their components.
Novavax president and CEO Stanley Erck said in a statement that his company hopes to increase vaccination rates in light of the ongoing COVID-19 surges and faced with the start of fall and the back-to-school season.
He hopes that given the parents and caregivers are familiar with protein-based vaccines used in other disease areas, the Novavax vaccine may have a special role in adolescent vaccination.
Back in 2020, Novavax, which is trying to position its shot as an alternative first-line defense for unvaccinated people who’ve refused mRNA shots a booster for the vaccinated, won $1.6 billion in federal backing as part of Operation Warp Speed.
FDA granted the two-dose vaccine emergency authorization for use in adults 18 and older in July followed by the Centers for Disease Control and Prevention’s (CDC) endorsement later the same month.
President Biden, whose administration has already purchased 3.2 million doses of the Novavax vaccine, praised the decision of the CDC and the FDA, calling it a step in the right direction battle against Covid.
However, there’s still the lingering concern over myocarditis that occurs as a side effect within 20 days of vaccination.
At the beginning of the month, the European Medicines Agency (EMA) recommended that the Novavax vaccine must carry a warning of two inflammatory conditions of the heart and also identified severe allergic reactions, i.e. anaphylaxis, as potential side effects of the vaccine sold as Nuvaxovid in Europe.
It later agreed with the biotech company to update the vaccine label accordingly.