The U.S. Food and Drug Administration on Friday approved the first influenza vaccine that doesn’t require administration by health care workers, but it won’t be in time for the respiratory virus season. Related video above: Doctors warn of COVID-19, RSV, influenza as kids return to school FluMist is a nasal spray made by AstraZeneca that has been used to prevent influenza in the United States since 2003. It is currently available at pharmacies and other health care providers for people ages 2 to 49 with a prescription. Friday’s FDA approval adds a second option for people eligible for the vaccine. Adults can self-vaccinate at home, and children can get the shot with the help of a caregiver. AstraZeneca plans to allow self-vaccination through third-party online pharmacies, which will prescribe and ship the vaccine after screening and eligibility checks. The FDA expects this option to be available in time for the start of next year’s respiratory virus season. “Today’s approval of the first influenza vaccine for self- or caregiver administration provides a new option for individuals and families to receive a safe and effective seasonal influenza vaccine that is more convenient, flexible, and accessible,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “Getting vaccinated annually is the best way to prevent influenza. Influenza annually causes illness in a significant portion of the U.S. population and can lead to serious complications, including hospitalization and death,” he said. “This approval adds another vaccination option against influenza illness and demonstrates the FDA’s commitment to improving public health.” According to estimates from the U.S. Centers for Disease Control and Prevention, influenza will cause at least 35 million illnesses, 400,000 hospitalizations, and 25,000 deaths in the 2023-2024 season. The CDC recommends vaccination for everyone 6 months of age or older each season. However, uptake has declined in recent years, and last season, only about half of adults and children received their annual influenza vaccine. FluMist is the only needle-free flu vaccination option available in the United States. It uses a live, attenuated flu virus to provide protection, while the injected version uses a different technology that uses either an inactivated virus or a protein to train the immune system to fight the virus. AstraZeneca says FluMist has been shown to be as effective as other flu vaccines. When the FDA announced last year that it was looking into the possibility of a self-administered flu vaccine, doctors told CNN that while they welcomed a more accessible option, they didn’t expect self-administration to significantly change vaccination rates. Ashish Jha, dean of the Brown University School of Public Health and former White House COVID-19 response coordinator, said at the time that a self-administered flu vaccine option would be even more accessible if it were available on pharmacy shelves without going through gatekeepers. But he noted that more ways to get a needle-free vaccine could boost uptake, since as many as 10 to 15 percent of people may be hesitant to get the vaccine because of needle phobia. “I think the impact would be modest,” Jha said of the possibility. But he said he hopes that increased awareness will come from AstraZeneca’s increased marketing and more research into additional intranasal vaccines that may be more readily available. “I think this is a relatively positive step.” CNN’s Meg Tyrrell contributed to this report.
(CNN) —
The U.S. Food and Drug Administration on Friday approved the first flu vaccine that doesn’t need to be administered by health care workers, but it won’t be available in time for respiratory virus peak season.
Related video above: Doctors warn about COVID-19, RSV, flu as kids return to school
FluMist is a nasal spray made by AstraZeneca that has been used to prevent influenza in the United States since 2003. It is currently sold through pharmacies and other health care providers to people ages 2 to 49 who have a prescription.
Friday’s FDA approval adds a second option for people who are eligible to get the vaccine: Adults can vaccinate themselves or their children can get the shot at home with the help of a parent or guardian.
AstraZeneca plans to allow people to self-administer the vaccine through third-party online pharmacies that will prescribe and ship the vaccine after screening and eligibility assessments, and the company expects the option to be available by the start of the respiratory virus season next year.
“Today’s approval of the first influenza vaccine that can be self- or caregiver-administered provides individuals and families with a new option for a safe and effective seasonal influenza vaccine that is more convenient, flexible and accessible,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
“Getting vaccinated annually is the best way to prevent influenza, which annually causes illness for a significant portion of the U.S. population and can lead to serious complications, including hospitalization and death,” he said. “This approval adds a new option for vaccinating against influenza illness and demonstrates the FDA’s commitment to improving the public health.”
The US Centers for Disease Control and Prevention (CDC) estimates that influenza will cause at least 35 million infections, 400,000 hospitalizations, and 25,000 deaths in the 2023-2024 season. The CDC recommends vaccination for everyone aged 6 months or older each season. However, vaccination rates have declined in recent years, and only about half of adults and children received their annual influenza vaccination last season.
FluMist is the only needle-free flu vaccination option available in the U.S. The vaccine uses a live, weakened influenza virus to provide protection, while injectable vaccines use a different technology that uses inactivated virus or proteins to train the immune system to fight the virus. According to AstraZeneca, FluMist has been proven to be as effective as other flu vaccines.
When the FDA announced last year that it was looking into the possibility of self-vaccination of the flu vaccine, doctors told CNN that while they welcomed a more accessible option, they didn’t expect it to significantly change vaccination rates.
Dr. Ashish Jha, dean of the Brown University School of Public Health and former White House COVID-19 response coordinator, said at the time that the option of self-vaccinating the flu vaccine would become more accessible if it were available on pharmacy shelves, without going through gatekeepers.
However, they noted that as many as 10 to 15 percent of people may be hesitant to get vaccinated because of a fear of needles, so increasing access to needle-free vaccines could improve uptake.
“I think the impact will be small,” he said of the possibility. But he said he hopes this will lead to increased awareness through further marketing of AstraZeneca and/or through research into additional intranasal vaccines that may be more readily available. “I see this as a relatively positive step.”
CNN’s Meg Tyrrell contributed to this report.
