The U.S. Food and Drug Administration (FDA) has made a groundbreaking decision by approving the first influenza vaccine that can be self-administered, marking a significant step towards increasing accessibility to flu prevention. This vaccine, known as FluMist, is a nasal spray manufactured by AstraZeneca and has been available in the United States since 2003, requiring a prescription for use by individuals aged 2 to 49 in pharmacies and healthcare settings. However, it will not be available for self-administration in time for the current respiratory virus season.
With Friday’s approval, FluMist now offers a new option for those eligible to receive the vaccine, allowing adults to self-administer it or for caregivers to assist children in receiving it. AstraZeneca plans to distribute the vaccine through a third-party online pharmacy, which will prescribe and ship the vaccine after conducting a screening and eligibility assessment. The company anticipates that this self-administration option will be ready for the next respiratory virus season.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, emphasized the importance of this approval, stating, “Today’s approval of the first influenza vaccine for self- or caregiver-administration provides a new option for receiving a safe and effective seasonal influenza vaccine potentially with greater convenience, flexibility, and accessibility for individuals and families.” He reiterated that annual vaccination is the best defense against influenza, which affects millions of people in the U.S. each year, leading to severe complications, hospitalizations, and even fatalities.
According to estimates from the U.S. Centers for Disease Control and Prevention (CDC), the flu caused approximately 35 million illnesses, 400,000 hospitalizations, and 25,000 deaths during the 2023-24 season. The CDC recommends that everyone aged six months and older get vaccinated annually, but vaccination rates have declined in recent years, with only about half of adults and children receiving their flu shots last season.
FluMist is currently the only needle-free vaccination option available in the U.S. It utilizes a live, weakened version of the influenza virus for immunity, whereas traditional injectable vaccines use killed viruses or proteins. AstraZeneca claims that FluMist is just as effective as other flu vaccines on the market.
The FDA’s recent move towards self-administration follows previous discussions among healthcare professionals regarding the potential benefits of increased accessibility for vaccination. Experts have expressed cautious optimism about the impact of self-administered vaccines on overall vaccination rates. Dr. Ashish Jha, dean of the Brown University School of Public Health, noted that while this change may not drastically increase uptake, it could raise awareness and lead to more research into additional easy-to-access intranasal vaccines.
As the respiratory virus season approaches, the approval of FluMist for self-administration represents a positive step towards enhancing public health measures and improving access to flu vaccinations across the United States.
