Source – Novavax
Novavax received full Marketing Authorization (MA) from the European Commission for its COVID-19 vaccine, Nuvaxovid (NVX-CoV2373). This approval comes after a positive recommendation from the Committee for Medicinal Products for Human Use of the European Medicines Agency. The vaccine is now fully authorized for use as the primary vaccination series in individuals aged 12 and older, as well as a booster dose for adults aged 18 and older, to prevent COVID-19. Initially, Nuvaxovid had received conditional MA for these indications. The Phase III PREVENT-19 trial demonstrated the vaccine’s safety and efficacy as a primary series in adults, its immunogenicity and safety as a booster dose in adults, and its efficacy and safety as a primary series in individuals aged 12 and older.
“This Marketing Authorization 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 U.S. 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.”
– John C. Jacobs, President and Chief Executive Officer, Novavax
Novavax’s COVID-19 vaccine has been authorized for use in over 40 markets worldwide.
Novavax expects to generate revenue of approximately $1.4 billion to $1.6 billion from its COVID-19 vaccine throughout 2023.