Pharmaceutical company AstraZeneca said the Food and Drug Administration has accepted an application to consider allowing FluMist Quadrivalent to become the first flu vaccine available to be self-administered by patients.
If granted final approval by the FDA, the vaccine could allow patients ages 18-49 an opportunity to administer a flu vaccine on their own without a doctor or pharmacist. It would also allow caregivers of those ages 2-49 the ability to administer the vaccine.
Unlike traditional flu vaccines, FluMist uses a needle-free nasal spray.
"A self-administered option for FluMist Quadrivalent would leverage the unique attributes of the product, providing a convenient new choice for individuals and families who want to protect their loved ones against flu," Dr. Ravi Jhaveri, a Northwestern University professor of pediatrics, said in an AstraZeneca press release. "Vaccination rates for children and adults under 50 years of age declined in the 2022-2023 flu season, highlighting a need for more accessible solutions. The ability for individuals and parents to choose where to administer an injection-free flu vaccine could help increase access and, subsequently, vaccination rates, and greatly benefit those most impacted by this serious and contagious respiratory illness."
AstraZeneca said it hopes to get the green light in time for the 2024-25 flu season.
The FDA first approved use of the nasal flu vaccine in 2003 for those ages 5-49. In 2007, the FDA expanded its approval for those ages 2-5. It is currently only allowed to be administered in health care settings.
The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices noted that studies from 2013-16 noted a lower effectiveness rate of FluMist Quadrivalent compared to injectable flu vaccines. The committee voted in 2016 that the vaccine should not have been used for the 2016-17 flu season.
The FDA, however, said that the benefits of FluMist Quadrivalent outweighed any potential risks.
According to the CDC, 57.4% of children ages 6 months through 17 years got a flu shot in the 2022-23 season. It was the lowest flu vaccination rate among children since 2012-13.
About 62.5% of pediatric flu vaccines in 2022-23 were administered at doctor's offices, while 16.9% were administered at pharmacies and 11.5% at clinics and health centers, the CDC said. The percentage of children getting vaccinated at pharmacies has more than doubled in the last five years.
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