FDA approves self-administered flu vaccine

If you hate getting a flu shot, this will be welcome news to your arm: You'll be able to get an at-home flu vaccine starting next year.

The Food and Drug Administration has approved the first flu vaccine that can be self-administered. The new version is a nasal spray as opposed to an injection.

FluMist is officially the first flu vaccine that can be administered without a healthcare provider's involvement, though it still requires a prescription. It can be administered by the vaccine recipient or by a caregiver to individuals between the ages of 2 and 49.

"For the first time, families and caregivers will be able to protect themselves against influenza with a needle-free, self-administered vaccine, from the convenience of their own home," Dr. Ravi Jhaveri, professor of pediatrics at Northwestern University, said in a statement.

The FluMist vaccine was first approved by the FDA in 2003 for individuals between five and 49 years of age. Its approval has since been expanded to include children as young as 2 years-old.

FluMist is the first vaccine to prevent the flu that does not need to be administered by a health care provider. It contains a weakened form of live influenza virus strains and is sprayed in the nose.

Drugmaker AstraZeneca plans to make the vaccine available through a third-party online pharmacy, which will deliver FluMist directly to their homes. Eligible patients will complete a screening questionnaire that is reviewed by a pharmacist, who can approve the prescription for shipment. FluMist will also be available traditionally in offices and pharmacies for administration by healthcare professionals.

"The approval of FluMist for self-administration is an important step forward in making vaccines more accessible to fight the high annual burden of influenza," said Iskra Reic, executive vice president of vaccines and immune therapies at AstraZeneca.

Seasonal influenza causes up to 1 billion infections each year and can result in severe outcomes for about 3-5 million patients including hospitalizations, complications and death, according to the World Health Organization.

During the 2022-2023 season, an estimated 31 million people were infected with the flu virus and 14 million visited a healthcare provider for influenza, with 360,000 hospitalizations and 21,000 deaths, according to data from the Centers for Disease Control.

Getting a flu vaccine has been shown to reduce flu illnesses, doctor's visits, and missed school and work days, and reduce the risk of flu-related hospitalization and death. Despite this, vaccination rates for influenza have declined in adults in the US since the 2020–21 season by 3.3%, per the CDC.

"Approval of the first influenza vaccine for self- or caregiver-administration provides a new option for receiving a safe and effective seasonal influenza vaccine potentially with greater convenience, flexibility and accessibility for individuals and families," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement. "Getting vaccinated each year is the best way to prevent influenza, which causes illness in a substantial proportion of the U.S. population every year and may result in serious complications, including hospitalization and death."

While AstraZeneca did not provide a timeline for release, reports indicate FluMist will be available by prescription next year.

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