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Influenza vaccine vial and syringe.

Pediatric practices urged to pre-book flu vaccines for 2025-’26 season following AAP recommendations, FDA strain selection

March 14, 2025

The AAP is urging annual influenza vaccination for all children ages 6 months and older this fall as the Food and Drug Administration (FDA) made its vaccine strain recommendations.

AAP recommendations for the 2025-’26 season are the same as this season’s. Any licensed influenza vaccine appropriate by age and health status can be used for vaccination in children and adolescents. The AAP does not have a preference for any influenza vaccine product for children and adolescents with no contraindications to influenza vaccination and for whom more than one licensed, age-appropriate product is available.

“Influenza vaccine is the best way to protect children against severe and life-threatening influenza illness,” said Kristina A. Bryant, M.D., FAAP, a member of the AAP Committee on Infectious Diseases.

The AAP will publish its influenza policy statement in Pediatrics later this year but released recommendations now so pediatricians can pre-book vaccines.

The AAP’s recommendations come as the FDA made its recommendations Thursday to vaccine manufacturers for the virus strains to be used in flu vaccines for the 2025-’26 season. FDA recommendations are similar to last year’s strain selection. 

The FDA recommends that the trivalent formulation of egg-based influenza vaccines contain an A/Victoria/4897/2022 (H1N1)pdm09-like virus; an A/Croatia/10136RV/2023 (H3N2)-like virus; and a B/Austria/1359417/2021 (B/Victoria lineage)-like virus.

The trivalent formulation of cell- or recombinant-based influenza vaccines is recommended to contain an A/Wisconsin/67/2022 (H1N1)pdm09-like virus; an A/District of Columbia/27/2023 (H3N2)-like virus; and a B/Austria/1359417/2021 (B/Victoria lineage)-like virus.

The FDA recommendations are the same as those made by the World Health Organization, which recommends that trivalent vaccines be used in the 2025-'26 northern hemisphere season. 

The FDA canceled its Vaccines and Related Biological Products Advisory Committee meeting scheduled for March 13, where advisers planned to publicly discuss data and provide a recommendation to the FDA on strains for vaccines. In its place, scientific and public health experts from the FDA, Centers for Disease Control and Prevention (CDC) and Department of Defense met privately to discuss U.S. and global surveillance data related to the epidemiology and antigenic characteristics of flu viruses currently circulating.

At-home vaccine option

A new option expected to be available for the 2025-’26 season is AstraZeneca’s FluMist, which does not need to be administered by a health care provider and can be taken at home. The FDA approved use of the FluMist nasal spray for home administration last year for people ages 2-49 years. Adults can administer FluMist to themselves, while a caregiver would need to administer FluMist to children ages 2-17 years.

FluMist at Home will not be available to children who receive vaccines through the Vaccines for Children program and is not recommended for patients who need documentation of flu vaccination.

FluMist has comprised 5% of total flu vaccination administered annually in recent years. As a result, the overall impact of FluMist at Home on in-office flu vaccination rates is anticipated to be negligible.

Flu activity remains high

The recommendations come as the 2024-’25 influenza season remains one of the worst in nearly a decade. The CDC estimates that there have been at least 41 million illnesses, 540,000 hospitalizations and 23,000 deaths from influenza so far this season. The 2024-’25 season is classified as a “high severity season” overall for all age groups and is the first such season since 2017-’18.

Twenty more pediatric flu deaths were reported to the CDC for the week ending March 8, bringing the total for the 2024-’25 season to 134. Sixteen of the 20 deaths were associated with influenza A viruses and four with influenza B. Some of the deaths may have occurred as early as the week ending Dec. 28, 2024.

“Coming off one of the most severe influenza seasons in several years, it is important for all children 6 months and older to get vaccinated against flu,” said Dr. Bryant, healthcare epidemiologist at Norton Children’s Hospital in Louisville, Ky.

Despite four straight weeks of declines, the percentage of all outpatient visits for respiratory illness was higher for the week ending March 8 than it was for the same week in the last four flu seasons. Lab-confirmed flu hospitalizations also were higher for the week ending March 8 than they were for the same week in the last three flu seasons.

The CDC expects several more weeks of flu activity and recommends everyone 6 months and older get a flu shot, which begins to protect against disease about two weeks after administration.

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