AZ seeks FDA okay for first self-administered flu vaccine

The FDA has started a review of an extension to the labelling for AstraZeneca’s influenza vaccine FluMist Quadrivalent which would allow it to be administered by patients themselves or a caregiver.

If approved, FluMist could become the first self-administered flu vaccine in the US, opening up a new avenue for the annual immunisation push to protect people against seasonal flu strains.

At the moment, the nasal spray is indicated for the prevention of flu in children and adults aged between two and 49 years, but still needs to be administered by a healthcare practitioner.

It has been on the market in the US since 2003 and made around $175 million in sales in the 2022-23 influenza season, but mostly in Europe, with the US accounting for around 12% of total sales, according to GlobalData estimates.

The live attenuated vaccine – known as Fluenz Tetra in some markets, including the UK – is often used for vaccinating children who are vulnerable to complications of flu infections due to underlying health conditions, and the new version could help AZ expand the use of FluMist in the market.

The application for the self-administered shot was backed by a usability study that confirmed that individuals over 18 years of age could self-administer or administer FluMist to eligible patients when given instructions for use without any additional guidance.

According to AZ, the FDA is due to deliver a decision on the application in the first quarter of next year, so it could become an option for the 2024-25 flu season.

“A self-administered option for FluMist Quadrivalent would leverage the unique attributes of the product, providing a convenient new choice for individuals and families who want to protect their loved ones against flu,” said Ravi Jhaveri, head of infectious diseases at Northwestern University School of Medicine in the US.

“Vaccination rates for children and adults under 50 years of age declined in the 2022-2023 flu season, highlighting a need for more accessible solutions,” he added.

“The ability for individuals and parents to choose where to administer an injection-free flu vaccine could help increase access and, subsequently, vaccination rates, and greatly benefit those most impacted by this serious and contagious respiratory illness.”

AZ’s head of vaccines and immune therapies, Iskra Reics, said the goal is to make FluMist an option for people to order directly into their homes from an online pharmacy system, suggesting that could “revolutionise flu vaccination.”

The US Centers for Disease Control and Prevention (CDC) recommends seasonal flu vaccines for people aged six months and older every year, but take-up is typically less than half do so.

On average, about 8% of the US population gets sick from flu each season, with thousands of deaths estimated, although, mortality data is tricky to collate, as flu is not a reportable disease in most US states.