Amid the sultry summer months, a few signs of fall become apparent, such as the appearance of school supplies on stores shelves after the Fourth of July. Another is doses of flu vaccine on the move, and three of the companies that supply doses for the US market announced this week that shipments have begun.
Meanwhile, the 2024-25 season is still in the rearview mirror, a period that marked the first high-severity season since 2017-18. Hospitalizations for flu were the highest since the 2010-11 season, according to the US Centers for Disease Control and Prevention (CDC).
On a sobering note, the past flu season came with the highest number of pediatric flu deaths in any nonpandemic year since the condition became reportable since 2004. All pediatric age-groups were affected, and 42% of patients had no known underlying health conditions. In its weekly flu update today, the CDC reported 4 more pediatric deaths, which occurred from March to June, lifting the season's total to 260.
GSK, CSL Seqirus, Sanofi begin shipments
GSK yesterday announced that it had begun shipping doses of its trivalent vaccine to healthcare providers and pharmacies to prepare for the 2025-26 flu season, following licensing and lot release from the Food and Drug Administration (FDA). It said Flulaval and Fluarix will be available as 0.5-milliliter single-dose prefilled syringes for people ages 6 months and older.
Also, CSL Seqirus yesterday said it began shipping doses of its flu vaccine products, Flucelvax (a cell-based vaccine for people ages 6 months and older), Fluad (an adjuvanted vaccine for people ages 65 and older), and Afluria (an egg-based vaccine for people ages 6 months and older).
Stefano Merlo, PharmD, vice president of operations for CSL Seqirus' North American division, said, "Given the high severity of last flu season, the timely delivery of flu vaccines is more important than ever, allowing healthcare providers to prepare for and begin vaccinations ahead of the season and continue throughout."
Meanwhile, Sanofi yesterday started shipping doses of its products to health systems, pharmacies, hospitals, physician practices, nursing homes, and other facilities, Thomas Grenier, MSc, MBA, head of Sanofi's North American vaccine unit, said in a LinkedIn post. He said the severe flu season was one of the worst in decades, even affecting his own family twice. "It may only be July, but helping prevent those serious consequences is constantly on our minds at Sanofi," he added.
Changes in this year's lineup
There are a few changes to the flu vaccine offerings for the upcoming season, based on recent FDA approvals. One is the added availability of FluMist for self- or caregiver administration. Still offered through healthcare providers, the expanded availability for the only needle-free option was approved by the FDA in September 2024 and recommended by the CDC's vaccine advisory committee in April.
MedImmune has said it plans to offer FluMist through a third-party pharmacy. Those seeking the self or caregiver option will complete a screening and eligibility assessment when ordering the vaccine. If eligibility is established, the pharmacy writes the prescription and ships the vaccine to the person who placed the order. It is approved for self-use in adults and for caregiver administration by adults to children ages 2 to 17 years old.
Also, in March the FDA approved an expanded age indication for Flublok, allowing its use in children as young as 9 years old. The CDC's advisory committee recommended the vaccine in June.