The U.S. Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee (VRBPAC) convened on Wednesday to consider whether Novavax's updated XBB-lineage protein-subunit COVID-19 vaccine meets the regulatory threshold for approval ahead of the 2026–27 respiratory virus season. The meeting, held at FDA's White Oak campus in Silver Spring, Maryland, drew attendance from public health officials, patient advocates, and representatives from competing mRNA vaccine manufacturers.

Novavax presented efficacy and immunogenicity data from its Phase 3 bridging study, which enrolled approximately 4,200 adults across sites in the United States and Mexico. The company reported that its updated formulation generated non-inferior neutralising antibody responses compared to the prior authorised version, and demonstrated a tolerability profile consistent with earlier iterations of its recombinant nanoparticle vaccine. FDA reviewers noted that the protein-subunit platform continues to serve as an alternative for individuals who have documented hesitancy toward mRNA-based products.

The committee's deliberations focused on two key questions: whether the immunogenicity bridge was sufficient to infer protection against circulating JN.1 and KP.2 descendants still prevalent in surveillance data, and whether the benefit-risk calculation favoured broad authorisation or a more targeted indication for immunocompromised adults and those over 65. Several committee members raised questions about waning immunity timelines and the optimal co-administration schedule alongside updated influenza vaccines.

Public health advocates from the Infectious Diseases Society of America and the National Foundation for Infectious Diseases testified in favour of maintaining a diverse vaccine portfolio, arguing that Novavax's protein-based option had measurably increased uptake among vaccine-hesitant populations in prior seasons. Novavax shares rose approximately 8 percent in pre-market trading ahead of the vote, reflecting investor optimism following a broadly positive FDA briefing document released two days earlier.

A favourable VRBPAC recommendation would pave the way for FDA to issue full approval or an updated Emergency Use Authorisation within weeks, allowing Novavax to begin shipping doses to pharmacy chains and federal vaccination programmes in time for an August pre-season push. A final FDA decision is expected by late May 2026, with the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices subsequently meeting to issue formal recommendation language for clinicians.