AstraZeneca
Image of AstraZeneca FluMist.
CNN
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The U.S. Food and Drug Administration is reviewing its application for FluMist, a nasal spray vaccine that can be self-administered at home, pharmaceutical company AstraZeneca said Tuesday.
This vaccine, the only nasal spray option for influenza, has been on sale in the United States since 2003. AstraZeneca has asked the FDA to allow adults ages 18 to 49 to vaccinate themselves or to vaccinate their children. It cites “usability studies” that have shown that people as young as two years old can do it properly without the presence of a health care provider. If approved, it would be the first influenza vaccine approved for self-administration.
AstraZeneca’s Dr. Lisa Glasser told CNN that patients will still need to use an online pharmacy system to order the vaccine, which will be delivered to their homes in temperature-controlled packaging.
It is hoped that the option of self-administered influenza vaccines will increase vaccination rates. The Centers for Disease Control and Prevention recommends that everyone 6 months of age and older get the seasonal influenza vaccine annually, but less than half of Americans are vaccinated.
“One of the things we’ve learned from the pandemic is that people are actually capable of doing things on their own, and perhaps more than we ever imagined or thought possible. It means they can probably take more responsibility for their health care into their own hands.” Glasser, AstraZeneca’s head of U.S. medicine, vaccines and immunotherapy, said in an interview.
During the COVID-19 pandemic, “we offered people the nasal swab test and people took advantage of it,” she said.
AstraZeneca said the FDA will decide whether to allow self-administration of Flumist in the first three months of next year. AstraZeneca said FluMist would be available for self-administration during the 2024-2025 influenza season if the FDA approves the changes. It will still be available through traditional channels and will be administered at doctor’s offices and pharmacies, Glasser said.
Doctors welcomed news that influenza vaccines could become more available, but did not expect the possibility of self-administration approval to make a big difference in vaccination rates.
“If this increases compliance, that’s great,” Dr. Aaron Glatt, chief of infectious diseases and hospital epidemiologist at Mount Sinai South Nassau Hospital, told CNN.
But Glatt, who is also a spokesperson for the Infectious Diseases Society of America, said documentation is needed to ensure patients don’t accidentally receive multiple doses of the vaccine or claim they received the vaccine when they actually didn’t. said it will be important.
Glasser said AstraZeneca offers ways to make the document “practical and useful not only for patients and individuals, but also for health care professionals,” but said it was too early to provide details. .
Glasser said the online ordering system would also provide a way to keep the vaccine from being used by people who shouldn’t get it. The CDC says Flumist is not indicated for people who are immunocompromised and is only indicated for people between the ages of 2 and 49.
FluMist uses a live, attenuated version of the influenza virus to provide protection against influenza, while the injectable version uses a different technology, killed viruses or proteins, to train the immune system to fight the virus. To do. AstraZeneca says Flumist has been shown to be as effective as other influenza vaccines.
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Dr. Ashish Jha, dean of the Brown School of Public Health and former White House COVID-19 response coordinator, believes that more self-administered influenza vaccine options will be available once they are available on pharmacy shelves. He said it could be easier. Gatekeeper.
But he noted that as many as 10% to 15% of people may be hesitant to get vaccinated due to fear of needles, so providing more ways to access needle-free versions could increase uptake rates. .
If the FDA approves the change, “the impact would be modest,” he said.But he said he hoped Further marketing of AstraZeneca and research into additional, more readily available intranasal vaccines could lead to increased awareness. “I think of this as be It’s a relatively positive step.”
