Novavax Set to Deliver Protein-based Monovalent XBB COVID Vaccine as per FDA VRBPAC Recommendation in Fall

16 June 2023 | Friday | News

Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant, participated in today's U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee's (VRBPAC) meeting, which resulted in a unanimous vote recommending updating the current COVID vaccine composition to a monovalent XBB-lineage.
Image Source : Public Domain

Image Source : Public Domain

  • Novavax has developed a protein-based monovalent XBB.1.5 COVID vaccine candidate and is manufacturing at commercial scale with the intent to be in market during the fall vaccination campaign
  • Novavax shared data demonstrating that its XBB.1.5 COVID vaccine candidate induces functional immune responses to XBB subvariants including XBB.1.5, XBB.1.16 and XBB.2.3
  • If authorized, Novavax's protein-based vaccine candidate would be the only non-mRNA XBB.1.5 vaccine available in the U.S.
  • Novavax intends to supply vaccine globally, consistent with FDA, WHO and EMA recommendations

"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 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 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 potentially be applicable for forward-drift variants.

Novavax will seek updated FDA labeling for its XBB COVID vaccine candidate with the goal of it being available and accessible on par with other COVID vaccines.

Authorized Use of the Novavax COVID-19 Vaccine, Adjuvanted in the U.S.
The Novavax COVID-19 Vaccine, Adjuvanted vaccine has not been approved or licensed by the U.S. FDA, but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) as a primary series in individuals 12 years of age and older. The Novavax COVID-19 Vaccine, Adjuvanted vaccine is also authorized to provide a first booster dose at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

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