Tuesday, April 16, 2024

FDA Reviews Self-Administered Influenza Vaccine: A Potential Game-Changer

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The US Food and Drug Administration (FDA) has initiated a review of proposed labeling changes for AstraZeneca’s influenza vaccine FluMist Quadrivalent, a move that could make it the first self-administered flu vaccine in the United States. This development could revolutionize the annual flu immunization process.

Currently, FluMist is indicated for flu prevention in individuals aged two to 49 years but must be administered by a healthcare professional. However, if the FDA approves this extension, patients or caregivers could administer the nasal spray themselves.

FluMist has been on the US market since 2003 and generated approximately $175 million in sales during the 2022-23 influenza season, with most sales occurring in Europe. The US accounted for just 12% of total sales, as estimated by GlobalData.

The live attenuated vaccine, known as Fluenz Tetra in some markets, is commonly used to vaccinate children vulnerable to flu complications due to underlying health conditions. The new self-administered version could significantly expand FluMist’s usage.

The application for the self-administered option was supported by a usability study demonstrating that individuals over 18 years old could use FluMist without additional guidance.

The FDA is expected to decide on the application in the first quarter of the next year, potentially making it available for the 2024-25 flu season.

Dr. Ravi Jhaveri, head of infectious diseases at Northwestern University School of Medicine, emphasized the need for more accessible vaccination solutions, especially for children and adults under 50, as vaccination rates declined in the previous flu season. A self-administered option could increase access and vaccination rates.

AstraZeneca aims to offer FluMist as an option for direct home delivery through online pharmacy systems, potentially transforming flu vaccination.

The US Center for Disease Control and Prevention (CDC) recommends seasonal flu vaccines for everyone aged six months and older each year. However, the uptake remains below 50%. On average, around 8% of the US population falls ill due to the flu each season, with a significant number of estimated deaths, although accurate mortality data can be challenging to collect as flu is not a reportable disease in most US states.

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