Breaking: FDA Approves FluMist as First-Ever Self-, Caregiver-Administered Flu Vaccine
The vaccine will be made available via third-party online pharmacies.
Nasal spray flu vaccine FluMist has been approved by the FDA for self- or caregiver-administration, according to an agency news release.1 It is approved for the prevention of the flu caused by influenza virus subtypes A and B and is indicated for use in individuals aged 2 to 49 years.
It is the first and only flu vaccine that does not need to be administered by a health care provider.
FluMist contains a weakened form of live strains of the influenza virus. The vaccine was first approved by the FDA in 2003 for use in individuals aged 5 to 49 years; in 2007, approval was expanded to include children between 2 and 5 years of age.
FluMist is the first and only flu vaccine available for self- or caregiver-administration. | image credit: vetrana - stock.adobe.com
“Today’s approval of the first influenza vaccine for self- or caregiver-administration provides a new option for receiving a safe and effective seasonal influenza vaccine potentially with greater convenience, flexibility, and accessibility for individuals and families,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “Getting vaccinated each year is the best way to prevent influenza, which causes illness in a substantial proportion of the US population every year and may result in serious complications, including hospitalization and death.”
READ MORE: The 2024-2025 Flu Season: What to Expect
Although the vaccine can be administered by oneself or a caregiver, a prescription is still required to receive FluMist. Vaccine recipients or caregivers must be 18 years of age or older.
FluMist will be available through a third-party online pharmacy. Interested individuals must complete a screening assessment during their order, and the pharmacy will determine eligibility based on screening results. If the vaccine recipient is eligible, the pharmacy will write the prescription and ship the vaccine to the individual who made the request. In addition to the vaccine, those requesters will receive the prescribing information, information for patients and their caregivers, and instructions for use.
This approval comes just as flu season in the Northern Hemisphere is set to begin: Typically, the season begins in October and can run through April or May. The flu can cause mild to severe illness that presents across a range of symptoms, including body aches, fever, cough, sore throat, tiredness, and stuffy or runny nose. Although many cases are mild, the flu can be life-threatening and lead to serious complications causing hospitalization or death.
According to CDC data, between 2010 and 2023, the flu has caused between 9.3 million and 41 million illnesses, 100,000 and 710,000 hospitalizations, and 4900 and 51,000 deaths annually.
In addition to FluMist, manufactured by AstraZeneca, a total of 8 other flu vaccines are also available, manufactured by GSK, Sanofi, and CSL Seqirus.2 All vaccines for the 2024-2025 flu season are trivalent. Egg-based vaccines will contain an A/Victoria/4897/2022 (H1N1)pdm09-like virus; an A/Thailand/8/2022 (H3N2)-like virus; and a B/Austria/1359417/2021 (B/Victoria lineage)-like virus. Cell- or recombinant-based flu vaccines will contain an A/Wisconsin/67/2022 (H1N1)pdm09-like virus; an A/Massachusetts/18/2022 (H3N2)-like virus; and a B/Austria/1359417/2021 (B/Victoria lineage)-like virus.3
READ MORE: Immunization Resource Center
References
FDA approves nasal spray influenza vaccine for self- or caregiver administration. News release. FDA. September 20, 2024. Accessed September 20, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-nasal-spray-influenza-vaccine-self-or-caregiver-administration
Influenza vaccine products for the 2024-2025 influenza season. Immunize.org. Accessed September 20, 2024. https://www.cdc.gov/flu/season/faq-flu-season-2024-2025.htm
Information for the 2024-2025 flu season. CDC. Reviewed September 11, 2024. Accessed September 20, 2024. https://www.cdc.gov/flu/season/faq-flu-season-2024-2025.htm
