The vaccine, the only nasal spray against influenza, has been on the market in the United States since 2003. AstraZeneca has asked the FDA to allow adults ages 18 to 49 to give the vaccine to themselves or to children as young as 2 years old, citing a “usability study” that shows people can get it can do correctly even without the presence of a healthcare provider. If approved, it would be the first flu vaccine approved for self-administration.
Patients would still have to go through an online pharmacy system to order the vaccine, which would then be sent to their home in temperature-controlled packaging, Dr. AstraZeneca’s Lisa Glasser told CNN.
There is hope that a self-administered flu vaccination option could increase uptake; While the U.S. Centers for Disease Control and Prevention recommends everyone 6 months and older get vaccinated against the seasonal flu every year, fewer than half of Americans get vaccinated.
“One of the things we’ve learned from the pandemic is that people can actually do things for themselves, they can perhaps take more responsibility for their own health care than we might have thought or even thought possible,” AstraZeneca’s Glasser, the head of the U.S. Department of Medical Affairs, Vaccines and Immunotherapies, said in an interview.
During the COVID-19 pandemic, she noted, “We put nasal swab tests in people’s hands and they have used them successfully.”
AstraZeneca said the FDA is expected to make a decision on whether to approve FluMist for self-administration in the first three months of next year. If the FDA approves the change, FluMist will be available for self-administration during the 2024-2025 flu season, according to AstraZeneca. It would still be available through traditional channels, such as a doctor’s office or pharmacy, Glasser said.
Doctors welcomed news that a flu vaccine could become more accessible, but did not expect a possible approval for self-administration to make a significant difference to vaccination rates.
“If this increased compliance, that would be fantastic,” said Dr. Aaron Glatt, chief of infectious diseases and hospital epidemiologist at Mount Sinai South Nassau, told CNN.
But documentation is crucial, said Glatt, also a spokesman for the Infectious Diseases Society of America – so that patients don’t accidentally get the vaccine more than once or say they got it without actually receiving it.
Glasser said AstraZeneca will provide a way to make documentation “practical and helpful not only for the patient or person, but also for their healthcare professional,” although she said it was too early to provide details.
The online ordering system will also provide a way to ensure the vaccine is not used by people who should not take it, Glasser said. The CDC notes that FluMist is not suitable for people with weakened immune systems and only for people ages 2 to 49.
FluMist uses a live, weakened version of the influenza virus to provide protection against the flu, while injectable versions use a different technology – either killed viruses or proteins to train the immune system to fight off the virus. According to AstraZeneca, FluMist has been shown to be as effective as other flu vaccines.
Dr. Ashish Jha, dean of the Brown School of Public Health and former White House COVID-19 response coordinator, said a self-administered flu vaccine option could be even more accessible if it were available on pharmacy shelves rather than over the counter at a gatekeeper.
However, he noted that up to 10% to 15% of people may have needle phobia and be hesitant to get vaccinated, so more options for access to a needle-free version could increase acceptance.
If the FDA approves the change, he said, “I think the impact will be modest.” But he hoped it would lead to greater awareness, perhaps through more marketing from AstraZeneca or more research into additional intranasal vaccines that are more lightweight are to be obtained. “I see this as a relatively positive step.”