FDA Approves First Self-Administered Flu Vaccine in Spray Form

The Food and Drug Administration (FDA) announced on Friday a significant advancement in influenza vaccination by broadening the approval of the FluMist nasal spray to become the first “self-administered” influenza vaccine. However, this change means that the vaccine will not be available for home shipment until at least the next flu season.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, expressed enthusiasm about the approval, stating that this new option offers a safe and effective way for individuals to receive their seasonal influenza vaccine with increased convenience, flexibility, and accessibility.

FluMist, manufactured by AstraZeneca, initially received approval in 2003 for administration by healthcare providers, similar to other flu vaccines. With the new approval, adults can now obtain the FluMist vaccine for use at home, allowing them to administer it themselves or to their children.

Despite the FDA’s approval, patients will still be required to secure a prescription from a healthcare provider to use the vaccine. AstraZeneca has detailed plans to sell FluMist directly to consumers via an online pharmacy, where adults can complete a screening questionnaire to obtain a prescription before ordering shipments for home use.

It’s important to note that FluMist is not recommended for everyone. The vaccine contains a live but weakened version of the influenza virus, which presents limitations for certain populations. Pregnant individuals or those who are severely immunocompromised should avoid this vaccine.

In recent years, FluMist has seen decreased usage among pharmacies and healthcare providers. This decline followed a recommendation from the Centers for Disease Control and Prevention (CDC) in 2016, which advised against its use due to “poor or relatively lower effectiveness” compared to other flu vaccines.

AstraZeneca took steps to address this issue, redesigning the vaccine’s antigens, which led to the CDC lifting its recommendation against FluMist in 2018. Since then, however, the CDC has noted that there hasn’t been sufficient data for new official effectiveness estimates to compare FluMist with other flu vaccines, primarily due to its limited use across the United States.

AstraZeneca has pointed to data from Europe indicating that FluMist demonstrates “comparable” effectiveness when stacked against more commonly used vaccines in that region.

The company initially aimed for FDA approval in time for this flu season, submitting data the previous year demonstrating that adults were capable of accurately following instructions to self-administer the vaccine spray. However, AstraZeneca did not provide comments explaining the delayed timing of the FDA’s approval.

A spokesperson for AstraZeneca commented, “We’re working diligently to bring this ‘first-of-its-kind’ innovative and convenient self-administered flu vaccine to consumers and look forward to launching FluMist Home as soon as next flu season.” The company emphasized that it needed additional time to collaborate with its partners to guarantee a seamless customer experience for FluMist’s rollout for home use.