MedPath

FDA Approves First At-Home Flu Vaccine, FluMist, Expanding Access and Convenience

• The FDA has approved FluMist, the first influenza vaccine for at-home use, expanding access beyond traditional healthcare settings. • Adults up to age 49 can self-administer FluMist, while caregivers can administer it to individuals aged 2-17, all with a prescription. • Starting next fall (2025-2026 flu season), adults 18+ can order FluMist online after an eligibility assessment and pharmacist approval. • FluMist, a nasal spray vaccine using weakened live influenza virus, has been available since 2003 but previously required administration by medical professionals.

The U.S. Food and Drug Administration (FDA) approved FluMist on September 20, 2024, marking the first influenza (flu) vaccine authorized for at-home use. This approval aims to increase accessibility and convenience for individuals seeking protection against the flu.

FluMist: A Needle-Free Option

FluMist is administered as a nasal spray and utilizes a weakened form of live influenza virus strains A and B to stimulate a lasting immune response. Initially approved in 2003 for individuals aged 5 to 49, its use was later extended to children aged 2 to 5 in 2007. Previously, administration was restricted to medical providers in clinical settings.

Expanding Access Through At-Home Administration

Under the new FDA approval, adults up to 49 years of age can self-administer FluMist. Caregivers can administer the vaccine to individuals between 2 and 17 years old. A prescription remains necessary for at-home use. Starting with the 2025-2026 flu season, individuals 18 years and older can order FluMist through a third-party online pharmacy via FluMist's website. This process involves completing an eligibility assessment, followed by pharmacist approval before the vaccine is shipped.

Impact and Availability

The FDA anticipates that this new option will enhance convenience and flexibility, leading to increased access to flu vaccination. FluMist is expected to be available for at-home use during the 2025-2026 flu season.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

FDA Approves Novel Therapies for Pediatric Conditions: Eosinophilic Esophagitis, Anaphylaxis, and Atopic Dermatitis

Dupilumab (Dupixent) gains FDA approval as the first treatment specifically for children aged 1-11 with eosinophilic esophagitis, addressing a critical unmet need for this age group.
Epinephrine nasal spray (Neffy) is approved as the first nasal spray for anaphylaxis treatment in adults and children over 66 lbs, offering a needle-free alternative for emergency use.

Novavax Resumes Clinical Trials for COVID-19 and Flu Combination Vaccine After FDA Clearance

The FDA has lifted a clinical hold on Novavax, allowing the company to resume trials for its COVID-19 and influenza combination vaccine (CIC) and standalone influenza vaccines.
The Phase III trial will assess the CIC vaccine's efficacy in adults aged 65 and older, comparing its immune response to standard vaccines.

Novavax Launches Phase 3 Trial for COVID-19-Influenza Combination and Stand-Alone Influenza Vaccines

Novavax has initiated a Phase 3 trial for its COVID-19-Influenza Combination (CIC) vaccine and stand-alone influenza vaccine, evaluating immunogenicity and safety.
The trial compares the CIC and stand-alone influenza vaccines to Novavax's updated COVID-19 vaccine and a licensed seasonal influenza vaccine in adults aged 65 and older.

FDA Approves First At-Home Flu Vaccine, FluMist, Expanding Access for 2025-26 Season

The FDA has approved FluMist, the first influenza vaccine for at-home use, administered as a nasal spray, for individuals aged 2-49 years.
This approval expands access to flu vaccination by allowing self-administration for adults up to 49 and caregiver administration for those aged 2-17 with a prescription.

FDA Authorizes First Over-the-Counter Combination Flu and COVID-19 Test

The FDA has granted marketing authorization to the Healgen Rapid Check COVID-19/Flu A&B Antigen Test, the first over-the-counter combination test for flu and COVID-19.
This test is authorized for self-use by individuals 14 years and older with respiratory symptoms and for children aged 2-13 when administered by an adult.

Insignis Therapeutics Receives Positive FDA Feedback for Needle-Free Anaphylaxis Treatment, IN-001

Insignis Therapeutics received positive feedback from the FDA on its IN-001 clinical program, a needle-free epinephrine sublingual spray for anaphylaxis treatment.
Phase I study results showed IN-001 achieved comparable epinephrine pharmacokinetic profiles to injections, supporting its potential as a needle-free alternative.

FDA Authorizes First Over-the-Counter Combination Flu and COVID-19 Test

The FDA has granted De Novo marketing authorization to Healgen Scientific for its Rapid Check COVID-19/Flu A&B Antigen Test, the first OTC combination test.
The test utilizes a nasal swab to detect proteins from SARS-CoV-2, influenza A, and influenza B, providing results in approximately 15 minutes.

Vaccine Updates: FDA Approves Self-Administered FluMist, Updated Novavax COVID-19 Vaccine

The FDA has approved FluMist, a nasal spray flu vaccine, for self- or caregiver-administration, making it the first flu vaccine with this capability, indicated for individuals aged 2 to 49 years.
Novavax's updated COVID-19 vaccine has received FDA emergency use authorization for individuals aged 12 years and older, set to be available in pharmacies and grocers across the United States.

FDA Approves First Self-Administered Flu Vaccine, FluMist, for At-Home Use

The FDA has approved FluMist, a nasal spray flu vaccine, for self-administration, marking the first flu vaccine that can be administered at home.
FluMist is approved for individuals aged 2 to 49 and will be available through an online pharmacy with a prescription, starting next flu season.

ARS Pharma's Neffy Aims to Expand Pediatric Access for Type 1 Allergic Reactions

ARS Pharmaceuticals seeks FDA approval for Neffy 1 mg to treat type 1 allergic reactions, including anaphylaxis, in children weighing 33-66 lbs..
Neffy 1 mg offers a needle-free epinephrine delivery option, potentially reducing fear and accidental needle sticks in young patients.

Reference News

[1]
FDA Approves The First Flu Vaccine For At Home Use, Providing A Needle Free Option ... - Mondaq
mondaq.com · Nov 13, 2024

FDA approved the first at-home flu vaccine, FluMist, on September 20, 2024, offering a needle-free nasal spray option fo...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy