FluMist gets FDA approval for self-administration

USA—FluMist, a needle-free nasal spray from AstraZeneca, has been licensed in the United States as the first self-administered influenza vaccine.

The US Food and Drug Administration (FDA) recently approved individuals up to the age of 49 to administer the vaccine themselves, while parents or carers can administer it to children aged 2 to 17.

The decision was made after a detailed submission that included results from a usability study demonstrating that people aged 18 and up could successfully self-administer the vaccine or administer it to others in the eligible age range.

FluMist, a live attenuated influenza vaccine (LAIV), was licensed for use by healthcare providers in 2003, just like standard flu vaccinations.

With this new permission, adults can now buy the vaccine for themselves or give it to their children at home, which is a huge step towards increasing immunisation accessibility.

Influenza, also known as the flu, remains a global health concern, with up to one billion illnesses reported each year.

Around 3 to 5 million people suffer with severe symptoms, which can lead to hospitalisations, complications, or even death.

The flu also considerably impacts education and the workforce, with 47% of school days missed and about 1 to 2 workdays lost each year due to the illness.

Despite the serious consequences of influenza, vaccination rates have been on the decline in the US. Since the 2020-2021 flu season, adult vaccination rates have decreased by 3.3%.

One common reason cited for skipping the vaccine is the failure to attend regular well-care visits, with research suggesting that offering at-home vaccination options could help boost vaccination rates.

Commenting on the approval, Dr. Ravi Jhaveri, Division Head of Infectious Diseases at Northwestern University’s School of Medicine, emphasized the importance of this development.

He highlighted that families and caregivers can now protect themselves from the flu using a convenient, needle-free vaccine at home.

According to Dr. Jhaveri, influenza continues to burden individuals, communities, and healthcare systems every year, making it crucial to introduce more accessible vaccination tools to reduce health disparities.

Iskra Reic, Executive Vice President of Vaccines and Immune Therapies at AstraZeneca, echoed this sentiment, stating that the self-administration approval marks a key advancement in making vaccines more accessible.

Reic pointed out that for over 20 years, FluMist has been the only nasal spray flu vaccine licensed in the US.

With the new self-administration option, it becomes the first flu vaccine to allow individuals, families, and communities to access influenza protection without needing to visit traditional healthcare settings.

AstraZeneca plans to launch FluMist Home, a service where eligible individuals 18 years and older can order the vaccine online.

After completing a questionnaire that a pharmacist reviews, the vaccine will be shipped directly to their homes, further simplifying access to flu protection. 

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