FDA Approves FluMist, First At-Home Flu Vaccine

The U.S. Food and Drug Administration (FDA) has introduced a new era in flu prevention by approving FluMist nasal spray as the first influenza vaccine that can be self-administered at home. This milestone, announced on Friday, September 20, 2024, is expected to significantly enhance the convenience, flexibility, and accessibility of flu vaccinations for individuals and families across the nation.

Dr. Peter Marks, the director of the FDA's Center for Biologics Evaluation and Research, emphasized the potential benefits of this new vaccination method. He described FluMist as a safe and effective seasonal influenza vaccine that offers greater convenience compared to traditional methods of vaccination, which typically involve a visit to a doctor's office or a local pharmacy.

FluMist is not a new player in the influenza vaccine market. MedImmune's FluMist was first approved in 2003 for individuals aged 5 to 49 to prevent the flu, with its approval later extended to children aged 2 to 5 in 2007. The vaccine is a nasal spray containing a weakened form of the live influenza virus. Until now, it has always been administered by a healthcare provider.

The new approval means that individuals aged 18 and older can now self-administer FluMist or administer it to a child in their care, provided they have a prescription. The FDA noted that the vaccine manufacturer plans to distribute FluMist through a third-party online pharmacy. Those opting for this method will need to complete a screening and eligibility assessment when ordering the vaccine.

The FDA's decision was based on a study that assessed whether the instructions for use were adequately designed to ensure that recipients and caregivers could safely and effectively administer the vaccine. Those prescribed FluMist will receive comprehensive instructions on how to administer, store, and dispose of the product.

Influenza continues to pose a significant health risk in the United States. The U.S. Centers for Disease Control and Prevention (CDC) reports that between 2010 and 2023, the flu has caused up to 41 million illnesses, led to between 100,000 and 710,000 hospitalizations, and resulted in up to 51,000 deaths. This new method of administration could help mitigate these numbers by making the vaccine more accessible.

As with any vaccine, there are potential side effects associated with FluMist. The FDA has identified several possible reactions, including fever over 100°F in children aged 2 through 6, runny nose and nasal congestion in individuals aged 2 through 49, and a sore throat in adults aged 18 through 49.

This new at-home vaccination option represents a significant step forward in public health, offering an alternative to traditional flu shots that could improve vaccination rates and ultimately reduce the impact of the influenza virus on the population.