Protein-based Monovalent XBB-lineage COVID-19 Vaccine Coming Soon

Novavax, Inc. today announced it participated in the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee's (VRBPAC) meeting.

This VRBPAC meeting resulted in a unanimous vote recommending updating the current COVID vaccine composition to a monovalent XBB-lineage.

"Novavax expects to be ready for the commercial delivery of a protein-based monovalent XBB COVID vaccine this fall in line with today's VRBPAC recommendation," said John C. Jacobs, President, and Chief Executive Officer, Novavax, in a press release on June 15, 2023.

"In partnership with regulators and public health authorities, Novavax has been developing and manufacturing this vaccine candidate, and now that we are nearing harmonization on guidance from the FDA, the World Health Organization, and European Medicines Agency, we believe we are in a better position to offer an alternative vaccine choice for individuals worldwide."

Novavax presented data at the VRBPAC meeting that supports the recommendation to vaccinate this fall (2023) with a monovalent XBB strain.

Novavax data showed that its XBB.1.5 COVID vaccine candidate induced functional immune responses for XBB.1.5, XBB.1.16, and XBB.2.3 variants, indicating a broad response that could be applicable for forward-drift variants.

The journal Vaccine published study results on June 2, 2023 that found correlates of protection imply a fourth (5 µg SARS-CoV-2 recombinant spike protein + 50 µg Matrix-M™ adjuvant) post-boost efficacy of ≥ 82% for Omicron variants and did not increase local/systemic reactogenicity in those aged 18–84 years.

Novavax COVID-19 vaccine brands include Nuvaxovid, CovoVax, NVX-CoV2373, and TAK-019, and are available in about 40 markets globally.