HQ Team
September 22, 2024: AstraZeneca’s Flumist, the first at-home flu vaccine, got approved by the Food and Drug Administration, enabling consumers with a prescription to order online beginning next year.
The needle-free nasal spray was approved to be self-administered by adults up to 49 years of age or administered by a parent or caregiver to individuals 2-17 years of age, according to a company statement.
It was initially approved by the FDA in 2003 for use in individuals between five and \49 years of age, and in 2007, the FDA approved the use of FluMist to include children from two years of age up to five.
“It is the first vaccine to prevent influenza, more commonly known as the flu, that does not need to be administered by a health care provider,” according to a statement from the FDA.
“Today’s 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,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.
“Getting vaccinated each year is the best way to prevent influenza, which causes illness in a substantial proportion of the US population every year and may result in serious complications, including hospitalization and death. This approval adds another option for vaccination against influenza disease,” he said.
Fall and winter
Flu is a common and contagious respiratory disease that is caused by influenza viruses that typically circulate during the fall and winter in the US. It can cause mild to severe illness with symptoms that usually appear suddenly, such as body aches, fever, coughing, sore throat, tiredness and a stuffy or runny nose.
Flu can be life-threatening and cause serious complications that can lead to hospitalization or death, particularly in high-risk groups such as the elderly, young children and people with certain chronic medical conditions.
Each flu season is different and the health impacts can be substantial and vary widely from season to season, with some flu seasons being worse than others.
According to the US Centers for Disease Control and Prevention, flu has resulted in about 9.3 million to 41 million illnesses, 100,000 to 710,000 hospitalizations and 4,900 to 51,000 deaths annually between 2010 and 2023. Numerous FDA-approved vaccines are available each flu season to prevent influenza.
FluMist contains a weakened form of live influenza virus strains and is sprayed inside the nose.
A prescription is still required to receive FluMist, according to the FDA.
Convenience of home
The vaccine may be administered by a healthcare provider in a healthcare setting (including a pharmacy) or it may be administered by the vaccine recipient or a caregiver who is 18 years of age or older.
Ravi Jhaveri, MD, Division Head, Infectious Diseases, Professor of Pediatrics (Infectious Diseases), Northwestern University School of Medicine, Chicago, US, said: “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.
“Each year, influenza poses a significant burden for people, society and health systems; additional tools to increase access to vaccinations, while also reducing disparities, are critical.”
Vaccination rates for influenza have declined in adults in the US since the 2020–21 season by 3.3%.
In a US survey, a common reason for adults not to receive a vaccination included failure to attend regular well-care visits, while having access to at-home vaccination options was shown to potentially increase influenza vaccination uptake.
About 200 million doses of FluMist have been distributed across the globe since 2023, according to MedImmune LLC, an arm of AstraZeneca which got the marketing approval.
