Novavax has announced that an updated version of its COVID-19 vaccine has received Emergency Use Authorisation (EMA) from the US Food and Drug Administration (FDA) for use in individuals aged 12 years and older.
The Novavax COVID-19 vaccine, Adjuvanted has been updated to include the spike protein from the SARS-CoV-2 omicron variant lineage XBB.1.5.
The authorisation was based on non-clinical data showing that the monovalent vaccine induced functional immune responses against the XBB.1.5, XBB.1.16 and XBB.2.3 variants.
Additionally, the vaccine was shown to induce neutralising antibody responses to the emerging subvariants BA.2.86, EG.5.1, FL.1.5.1 and XBB.1.16.6, along with robust CD4+ polyfunctional cellular responses against EG.5.1 and XBB.1.16.6.
The FDA has determined that the vaccine met statutory criteria for issuance of an EUA and that the known and potential benefits outweigh the vaccine’s known and potential risks.
“[The] authorisation provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support EUA,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
Individuals aged 12 years and older who were previously vaccinated with COVID-19 vaccines, as well as those who have not recently received an updated mRNA COVID-19 vaccine, will be eligible to receive a single dose.
Unvaccinated individuals will be eligible to receive two doses of the vaccine.
In the coming days, batches of the vaccine will be released by the Center for Biologics Evaluation and Research nationwide, in thousands of locations, for active immunisation against COVID-19.
John Jacobs, president and chief executive officer of Novavax, said: “Novavax’s authorisation today means people will now have the choice of a protein-based non-mRNA option to help protect themselves against COVID-19.
“In the coming days, individuals in the US can go to pharmacies, physicians’s offices, clinics and various government entities to receive an updated Novavax vaccine.”
In July this year, Novavax’s COVID-19 vaccine was granted full marketing authorisation in the EU for use as a primary series in individuals aged 12 and older for COVID-19 prevention, as well as a booster dose in adults aged 18 and older.