The Food and Drug Administration (FDA) approved the first influenza vaccine that individuals can self-administer at home without a health care provider.
FluMist, manufactured by AstraZeneca, is sprayed into the nose.
“FluMist contains a weakened form of live influenza virus strains and is sprayed in the nose. A prescription is still required to receive FluMist. There are now two approved options for receiving FluMist,” the FDA wrote.
“The vaccine may be administered by a health care provider in a health care setting (including a pharmacy) or it may be administered by the vaccine recipient or a caregiver who is 18 years of age or older,” it added.
BREAKING – The FDA approved at-home use of a nasal spray for flu vaccinations, allowing for the first time a self-administered alternative to flu shots – NYT
— Insider Paper (@TheInsiderPaper) September 20, 2024
“FluMist is approved for the prevention of influenza disease caused by influenza virus subtypes A and B in individuals 2 through 49 years of age,” the agency wrote.
“It was initially approved by the FDA in 2003 for use in individuals 5 through 49 years of age, and in 2007, the FDA approved the use of FluMist to include children 2 through 5 years of age,” it added.
The FDA approved FluMist
administration at home, making it the first influenza vaccine that does not need to be administered by a healthcare provider, the agency announced on Friday.The nasal spray, which contains weakened forms of live virus strains, requires a prescription…
— Informed NJ Nurses (@InformedNJNurse) September 20, 2024
“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, M.D., Ph.D., 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 U.S. population every year and may result in serious complications, including hospitalization and death. This approval adds another option for vaccination against influenza disease and demonstrates the FDA’s commitment to advancing public health,” he added.
STAT News reports:
Supplies for home administration will be ordered through an online portal, FluMist Home. Individuals will need to fill in an online questionnaire, which will be reviewed by a pharmacist to determine if they are eligible for self-administration; those approved will have their vaccine delivered to them.
“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,” Iskra Reic, AstraZeneca’s executive vice president for vaccines and immune therapies, said in a statement.
Side effects reported after receipt of FluMist include fever over 100 degrees Fahrenheit in children from ages 2 through 6, runny nose and nasal congestion in individuals ages 2 through 49, and a sore throat in adults 18 through 49 years of age.
Individuals can self-administer FluMist or give it to their children at home starting in fall 2025.
One X user noted the the FluMist vaccine sheds, saying it’s the “quickest way to make the rest of your family sick as well.”
REGARDLESS of what they may say, the FluMist DOES in fact “shed.”
This is the quickest way to make the rest of your family sick as well.
And the people around you.
Do not do this.
https://t.co/kIXFDuY31J
— Carole Mac (@HerbsandDirt) September 21, 2024
The FDA insert for FluMist references “shedding studies.”
“The highest proportion of subjects in each group shed one or more vaccine strains on Days 2-3
post vaccination. After Day 11 among individuals 2 through 49 years of age (n = 443), virus titers did not
exceed 1.5 log10 TCID50/mL,” the insert reads.
From the FDA:
For those interested in self- or caregiver-administration, the vaccine manufacturer plans to make the vaccine available through a third-party online pharmacy. Those who choose this option will complete a screening and eligibility assessment when they order FluMist. The third-party pharmacy determines eligibility based on the completed screening and, if it is determined that the intended vaccine recipient is eligible, the pharmacy writes the prescription and ships the vaccine to the address provided by the individual who placed the order. The vaccine can then be administered to the prescribed household member(s) at their convenience. A caregiver should administer FluMist to individuals 2 through 17 years of age, as individuals in this age group should not self-administer the vaccine.
A study was conducted with vaccine recipients and caregivers to evaluate whether the instructions for use were appropriately designed so that recipients and caregivers could safely and effectively use the vaccine.
Vaccine recipients and caregivers who administer FluMist will be sent the vaccine, the Prescribing Information, Information for Patients and their Caregivers and Instructions for Use. The Instructions for Use provides detailed instructions for storage, administration and disposal of FluMist.
Read the full insert HERE.
WATCH:
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