(CNN) The US Food and Drug Administration on Friday approved the first flu vaccine that doesn’t need to be administered by health care workers, but it won’t be available in time for peak respiratory virus season.
FluMist is a nasal spray made by AstraZeneca that has been used to prevent influenza in the United States since 2003. It is currently sold through pharmacies and other health care providers to people ages 2 to 49 who have a prescription.
Friday’s FDA approval adds a second option for people who are eligible to get the vaccine: Adults can vaccinate themselves or their children can get the shot at home with the help of a parent or guardian.
AstraZeneca plans to allow people to self-administer the vaccine through third-party online pharmacies that will prescribe and ship the vaccine after screening and eligibility assessments, and the company expects the option to be available by the start of the respiratory virus season next year.
“Today’s approval of the first influenza vaccine that can be self- or caregiver-administered provides individuals and families with a new option for a safe and effective seasonal influenza vaccine that is more convenient, flexible and accessible,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
“Getting vaccinated annually is the best way to prevent influenza, which annually causes illness for a significant portion of the U.S. population and can lead to serious complications, including hospitalization and death,” he said. “This approval adds a new option for vaccinating against influenza illness and demonstrates the FDA’s commitment to improving the public health.”
The US Centers for Disease Control and Prevention (CDC) estimates that influenza will cause at least 35 million infections, 400,000 hospitalizations, and 25,000 deaths in the 2023-2024 influenza season. The CDC recommends that everyone age 6 months or older get vaccinated each season. But vaccination rates have declined in recent years, and last season only about half of adults and children got their annual flu shot.
FluMist is the only needle-free flu shot option available in the U.S. The vaccine uses a live, weakened influenza virus to provide protection, but the shot uses a different technology: an inactivated virus or a protein that trains the immune system to fight the virus. According to AstraZeneca, FluMist has been proven to be as effective as other flu vaccines.
When the FDA announced last year that it was looking into the possibility of self-vaccination of the flu vaccine, doctors told CNN that while they welcomed a more accessible option, they didn’t expect it to significantly change vaccination rates.
Dr. Ashish Jha, dean of the Brown University School of Public Health and a former White House coronavirus response coordinator, said at the time that the option of self-vaccinating the flu vaccine would become more accessible if it were available on pharmacy shelves without gatekeepers.
However, they noted that as many as 10 to 15 percent of people may be hesitant to get vaccinated because of a fear of needles, so increasing access to needle-free vaccines could improve uptake.
“I think the impact will be small,” he said of the possibility. But he said he hopes it will lead to increased awareness through further marketing of AstraZeneca and through studies of additional intranasal vaccines that may be more accessible. “I see this as a relatively positive step.”
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