PHILADELPHIA, PA — GSK plc has announced the start of shipments for its trivalent seasonal influenza vaccines, FLULAVAL and FLUARIX, to healthcare providers and pharmacies across the United States. The rollout follows recent licensing and lot-release approvals from the U.S. Food and Drug Administration (FDA), positioning GSK to supply vaccines in preparation for the upcoming 2025-26 flu season.
Both vaccines will be distributed in 0.5 mL, single-dose, pre-filled syringes and are approved for use in individuals aged six months and older.
The move comes as public health officials emphasize the critical importance of vaccination in reducing the risk of influenza and its potentially severe complications. The U.S. Centers for Disease Control and Prevention (CDC) recommends annual flu shots for everyone six months and older without contraindications, ideally by the end of October.
Last year’s flu season was classified by the CDC as high severity — the first such designation since 2017-18 — with estimates indicating it was the most severe in 15 years. Between October 2024 and May 2025, the CDC reported an estimated 47 to 82 million flu illnesses, up to 1.3 million hospitalizations, and as many as 130,000 deaths attributed to the virus.
For the upcoming season, the FDA’s advisory committee recommended that egg-based vaccines include strains targeting A/Victoria/4897/2022 (H1N1)pdm09-like, A/Croatia/10136RV/2023 (H3N2)-like, and B/Austria/1359417/2021 (B/Victoria lineage)-like viruses.
With distribution already underway, GSK aims to support widespread early vaccination efforts to mitigate another potentially severe flu season and protect vulnerable populations nationwide.
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