Novavax secures full EU approval for COVID-19 vaccine Nuvaxovid

In the first of a double dose of wins for US biotech Novavax, the company has been granted full marketing authorisation (MA) by the European Commission in the EU for Nuvaxovid (NVX-CoV2373) a vaccine for preventing coronavirus disease in people aged 12 years and older.

The decision was based on positive recommendations from the Committee for Medicinal Products for Human Use of the European Medicines Agency, which concluded that results from the randomised, placebo-controlled, observer-blinded PREVENT-19 Phase 3 trial demonstrated Nuvaxovid's safety and efficacy as a primary series in individuals aged 12 and older, and as a booster dose in adults.

This milestone marks Novavax's first full marketing authorisation in the region, replacing the conditional MA granted for the same indications in 2021. The vaccine is now fully authorised for use as a primary series in individuals aged 12 and older and as a booster dose in adults aged 18 and older for the prevention of COVID-19.

John C Jacobs, president and chief executive officer of Novavax, expressed the significance of the decision, stating, "This marketing authorisation establishes the foundation for all future regulatory approvals for updated versions of our COVID vaccine, a necessity to ensure we can quickly get our vaccine to individuals in the EU. In addition to the EU, we are preparing to file for full approval in the US as well as other markets and are committed to ensuring protein-based options are available worldwide. Vaccine choice remains an integral part of public health measures."

Novavax's COVID vaccine is – at the time of writing – authorised for use in more than 40 markets around the world. However, the US is not one of them. While calls to follow the EU's authorisation are growing, Nuvaxovid has not been approved or licensed by the US Food and Drug Administration, although it has received Emergency Use Authorisation (EUA) to prevent COVID-19 as a primary series in individuals aged 12 and older. 

Shortly after the EU authorisation announcement, Novavax was given further cause for celebration, as the University of Oxford released results of the Com-COV3 study, which investigated the immune response and side effect profile of 'mixed' two-dose COVID-19 vaccine schedules in adolescents aged 12 to 16 years. The study found that a mixed schedule using a full dose of Pfizer-BioNTech followed by a full dose of Novavax resulted in fewer breakthrough infections and generated higher antibody and T-cell responses compared to the standard two full-dose Pfizer-BioNTech schedule. 

The Com-COV3 study's findings highlight the potential of the Novavax COVID-19 vaccine as a second dose in generating a robust immune response in young people. The study involved a participant-masked, randomised, and multi-site immunogenicity trial with 148 participants aged 12 to 16. All mixed and non-mixed vaccine schedules used in the study demonstrated favourable side effect profiles, with the fractional Pfizer-BioNTech group reporting fewer and milder side effects.