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. This follows the recent licensure and lot-release approval from the US Food and Drug Administration (FDA). Both vaccines are supplied in 0.5 mL single-dose, pre-filled syringes and are approved for individuals aged six months and older.
The US Centers for Disease Control and Prevention (CDC) emphasizes that annual flu vaccination is the most effective way to reduce the risk of influenza and its serious complications. While the CDC advises receiving the vaccine by the end of October, vaccination efforts can continue as long as flu remains a public health concern.1 Annual vaccination is recommended for everyone aged six months and older without contraindications.1,2
During the 2024–25 flu season—classified by the CDC as the most severe since 2017–18—there were an estimated 47 to 82 million flu illnesses, 610,000 to 1.3 million hospitalizations, and 27,000 to 130,000 deaths related to influenza.3,4,5 Preliminary data suggests it was the worst US flu season in the past 15 years.
For the upcoming 2025–26 flu season, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) has recommended the inclusion of the following strains in egg-based influenza vaccines for the Northern Hemisphere:
A/Victoria/4897/2022 (H1N1)pdm09-like virus
A/Croatia/10136RV/2023 (H3N2)-like virus
B/Austria/1359417/2021 (B/Victoria lineage)-like virus6