FDA approves first self-administered flu vaccine

The Food and Drug Administration (FDA) announced Friday it has approved the first flu vaccine that can be self-administered, with this version being a nasal spray as opposed to an injection.

The vaccine FluMist, manufactured by MedImmune, which was acquired by AstraZeneca in 2007, was first approved by the FDA in 2003 for individuals between five and 49 years of age. Its approval has since been expanded to include children as young as two years old.

With the FDA’s announcement Friday, FluMist is officially the first flu vaccine that can be administered without a healthcare provider’s involvement. The spray contains a weakened form of flu virus strains and still requires a prescription. It can be administered by “the vaccine recipient or a caregiver who is 18 years of age or older.”

“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,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

According the FDA, AstraZeneca plans to make FluMist available through a third-party online pharmacy.

“Those who choose this option will complete a screening and eligibility assessment when they order FluMist,” the agency stated. “The third-party pharmacy determines eligibility based on the completed screening and, if it is determined that the intended vaccine recipient is eligible, the pharmacy writes the prescription and ships the vaccine to the address provided by the individual who placed the order.”

Iskra Reic, executive vice president of vaccines and immune therapies at AstraZeneca, said in a statement, “The approval of FluMist for self-administration is an important step forward in making vaccines more accessible to fight the high annual burden of influenza.”

Nationally, flu vaccination rates in the U.S. have been dropping since the COVID-19 pandemic with rates dropping below 50 percent in the 2022-2023 flu season.