1st At-Home Flu Vaccine Approved
FluMist nasal spray nixes the needle. Now approved for self-dosing, it could be packaged and ready for the next year’s flu season, AstraZeneca says.
At a Glance
- FluMist has been used for more than 20 years but home delivery and self-dosing should take the pinch out of prevention.
- Cartons will include instructions for using the prefilled syringe (PFS) prep the dose, and use the sprayer.
- FluMist will be shipped to homes in a cold pack and should not be used after 12 hours at room temperature.
FluMist has been used in the United States for more than 20 years, but this is the first time the nasal spray flu vaccine has been approved for delivery and administration at home. Its late-September approval by the US Food and Drug Administration (FDA) allows a vaccine recipient or caregiver 18 or older to self-administer the vaccine — an option that should make getting an annual flu shot less of a chore.
This, the only at-home flue vaccine, is “coming as soon as next year,” according to AstraZeneca, whose MedImmune subsidiary plans to make it available through a third-party online pharmacy. Those interested in self-administration will complete a screening and eligibility assessment when ordering FluMist. If the pharmacy determines that the person is eligible, it will write the prescription and ship the vaccine to the address provided.
IFU instrumental for self-administration.
FluMist recipients will receive one dose at 0.2 milliliters through the FluMist Home program. Each dose is a suspension supplied in a single-dose, prefilled intranasal sprayer with a dividing clip. In addition to the vaccine, recipients will receive prescribing information, information for patients and their caregivers, and instructions for use (IFU). The IFU provide detailed instructions for storage, administration, and disposal of FluMist.
According to an AstraZeneca spokesperson, human factors/usability studies evaluated if individuals 18 through 49 years of age could appropriately administer FluMist when given IFU. Results showed that 100% of intended users administered a full dose.
Detailed instructions will show how to use the prefilled syringe (shown) from the carton, and prep and use the sprayer.
The detailed IFU include labeled diagrams that show the user how to remove the prefilled syringe (PFS) from the carton, prep it for use, and activate the sprayer. The dose divider clip aids compliance and ensures that a full dose is delivered into the first nostril. The clip is then removed to deliver the remaining dose into the second nostril.
In addition to IFU, administration videos will be readily available for those who prefer media instruction. Families will receive detailed instructions on administration in the packaging as well as direct access to videos on how to self-administer or administer to a child.
Below: The general news media have provided a bit of early consumer education:
Cold chain storage and transport.
Glass PFS systems approved for cold storage of FluMist have a 20-week shelf life at -25º Celsius. The same PFS systems used for FluMist were the subject of a BD study of glass syringe integrity in deep cold storage, which was conducted in response to deep cold storage requirements for mRNA COVID-19 vaccines. Study results indicated that glass barrel PFS systems are suitable for products that require storage temperatures of -20ºC and -40ºC — well below FluMist’s recommended storage temperature of 2ºC to 8ºC.
AstraZeneca shares that FluMist will be shipped to individuals’ homes in a cold pack that lasts up to 12 hours from time of delivery. Once received, it should be refrigerated as soon as possible. FluMist should not be used if stored at room temperature for more than 12 hours.
Used sprayers should not be disposed of in the household trash. Instead, they should be returned via the return shipment program, following the steps outlined in the shipping directions.
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