FDA reviewing application for 1st flu vaccine that could be self-administered at home

If approved, it would be the first flu vaccine cleared for self-administration

ByMeg Tirrell, CNN
Tuesday, October 24, 2023

The US Food and Drug Administration is reviewing an application for the nasal spray flu vaccine FluMist to be able to be self-administered at home, drugmaker AstraZeneca said Tuesday.

The vaccine, the only nasal spray option against flu, has been on the market in the United States since 2003. AstraZeneca has asked the FDA to allow adults ages 18 to 49 to be able to give themselves the vaccine, or to give it to children as young as age 2, citing a "usability study" showing people can do it properly without a health care provider present. If approved, it would be the first flu vaccine cleared for self-administration.

Patients would still need to go through an online pharmacy system to order the vaccine, which would then be shipped to their home in temperature-controlled packaging, AstraZeneca's Dr. Lisa Glasser told CNN.

The hope is that a self-administered flu vaccine option could increase uptake; while the US Centers for Disease Control and Prevention recommends everyone age 6 months and older get a seasonal flu vaccine every year, fewer than half of Americans get vaccinated.

"One of the things we've learned from the pandemic is that actually people can do things for themselves, they can take maybe more responsibility for their own health care in their own hands than perhaps we realized or even thought possible," Glasser, AstraZeneca's head of US medical affairs, vaccines and immune therapies, said in an interview.

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During the COVID-19 pandemic, she noted, "We put nasal swab tests in people's hands and they used them successfully."

The FDA is expected to make a decision about whether to clear FluMist for self-administration in the first three months of next year, AstraZeneca said. If the FDA OKs the change, AstraZeneca said FluMist would be available for self-administration in the 2024-2025 flu season. It would still be available through traditional channels as well, administered at the doctor's office or pharmacy, Glasser said.

Physicians welcomed the news a flu vaccine could become more accessible, but didn't expect a potential approval for self-administration would change vaccination rates significantly.

"If this would increase compliance, that would be fantastic," Dr. Aaron Glatt, chief of infectious diseases and hospital epidemiologist at Mount Sinai South Nassau, told CNN.

Documentation would be crucial, though, said Glatt, also a spokesperson for the Infectious Diseases Society of America - so that patients don't accidentally get the vaccine more than once, or say they received it without actually having had it.

Glasser said AstraZeneca will provide a way to make documentation "practical and helpful for not only for the patient, or the person, but also for their health care professionals," though she said it was too early to provide details.

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The online ordering system will also provide a way to ensure the vaccine isn't used by people who shouldn't take it, Glasser said. The CDC notes FluMist is not indicated for anyone with a weakened immune system 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 different technology - either killed viruses or proteins to train the immune system to fight off the virus. AstraZeneca says FluMist has shown to be as effective as other flu vaccines.

Dr. Ashish Jha, dean of the Brown School of Public Health and the former White House COVID-19 response coordinator, said a self-administered flu vaccine option could be even more accessible if it were available to buy on pharmacy shelves, rather than through a gatekeeper.

But he noted as many as 10 to 15% of people may be needle-phobic and hesitant to get vaccines, so increasing ways to access a needle-free version could boost uptake.

If the FDA clears the change, he said, "I think the impact is going to be modest." But he said he hoped it to would lead to increased awareness, potentially through more marketing from AstraZeneca, or more research into additional intranasal vaccines that are easier to get. "I see this as a relatively positive step."