The U.S. Food and Drug Administration (FDA) has approved AstraZeneca’s nasal flu vaccine, FluMist, for self-administration without the need for a healthcare provider. The FDA announced the approval on Friday, stating that FluMist is now authorized for individuals aged 2 to 49 for the prevention of influenza subtypes A and B.
FluMist, a nasal spray, has been deemed safe and effective since its initial approval in 2003 for individuals aged 5 to 49. Subsequently, in 2007, the FDA approved its use for children aged 2 to 5 as well. Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, emphasized the importance of annual influenza vaccination to prevent illness and its serious complications, which can lead to hospitalization and death.
According to the FDA, between 2010 and 2023, the flu has caused millions of illnesses, hospitalizations, and deaths annually. Despite being self-administered, FluMist still requires a prescription. Common side effects include fever, nasal congestion, runny nose, and sore throat in different age groups.
The package insert warns about the rare occurrence of Guillain-Barré Syndrome (GBS) following influenza vaccination, especially in children under 5 experiencing wheezing after receiving FluMist. GBS is a serious condition that affects the nerves and can lead to weakness, numbness, and paralysis.
Dr. Marks highlighted that the FDA’s approval of FluMist provides another vaccination option against influenza, showcasing the agency’s dedication to public health.
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