British pharmaceutical company AstraZeneca applied on Tuesday for permission from the U.S. Food and Drug Administration to market a self-administered, needle-free nasal spray vaccine for annual flu protection.
Executive Vice President for Vaccines and Immune Therapies Iskra Reic said in a press statement that the product FluMist has been a “critical public health tool” for more than 20 years and is approved for patients ages 2 to 49.
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“FluMist now has the potential to be the first and only self-administered flu vaccine, which could revolutionize flu vaccination,” Reic said. “Our ambition is for FluMist to be ordered directly to people’s homes, providing an innovative, more accessible option for individuals, families, and communities.”
FluMist is the only nasal spray vaccine on the market and has a comparable efficacy rate to traditional injection vaccines for those under the age of 50, who are less at risk of experiencing serious illness due to influenza. Over 200 million doses of FluMist have been sold worldwide since it was first approved in the United States in 2003.
Influenza vaccination rates have been on the decline since the COVID-19 pandemic, with flu vaccine coverage in adults over 18 decreasing by 2.5 percentage points. Flu vaccination for children between 6 months and 17 years has plateaued.
“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,” said Ravi Jhaveri, Pediatric Infectious Diseases division head at the Children’s Hospital of Chicago.
According to AstraZeneca, if approved, the product could be administered by anyone over the age of 18 to patients within the appropriate age range.
“The ability for individuals and parents to choose where to administer an injection-free flu vaccine could help increase access and, subsequently, vaccination rates,” Jhaveri said.
The FDA is slated to make its decision about the product within the first quarter of 2024.
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The Centers for Disease Control and Prevention estimates that between 9 million and 41 million people become sick with influenza annually. In the worst years, the CDC estimates there are over 710,000 hospitalizations and 52,000 deaths.
On average, the flu costs $10.4 billion in direct costs for hospitalizations and outpatient visits for adults.
