Novavax Protein-based Monovalent XBB COVID-19 Vaccine Ready for Fall Immunization Campaign

Novavax has developed and begun to manufacture a protein-based monovalent XBB.1.5 COVID-19 vaccine with the intent for it to be available during the fall immunization campaign, the company announced in a press release last week.

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Novavax announced the development after participating in the FDA Vaccines and Related Biological Products Advisory Committee’s (VRBPAC) meeting, which resulted in a unanimous vote to upgrade the current composition of the COVID-19 vaccine to monovalent XBB-lineage, the release reads.

“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 of Novavax, in the release.

At the VRBPAC meeting, Novavax presented data showing that its XBB.1.5 COVID-19 vaccine candidate resulted in functional immune responses for XBB.1.5, XBB.1.16, and XBB.2.3 variants, according to the press release.

These data supported their recommendation that a fall vaccination campaign should use a monovalent XBB strain; the campaign would result in a broad response that could be applicable for forward-drift variants in the future, the company said.

Novavax intends to update the FDA labeling for its XBB COVID-19 vaccine candidate, with their main goal being availability and accessibility that is on par for other COVID-19 vaccines, the press release stated.

If authorized, their protein-based vaccine candidate would be the only non-mRNA XBB.1.5 vaccine that is available in the United States, they wrote in the release.

“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,” Jacobs said.

Reference

Novavax. Novavax Prepared to Deliver Protein-based Monovalent XBB COVID Vaccine Consistent with FDA VRBPAC Recommendation for the Fall. News release. June 15, 2023. Accessed on June 21, 2023. Available at https://ir.novavax.com/2023-06-15-Novavax-Prepared-to-Deliver-Protein-based-Monovalent-XBB-COVID-Vaccine-Consistent-with-FDA-VRBPAC-Recommendation-for-the-Fall.