The FDA has authorized the use of FluMist, a nasal spray vaccine, for self-administration at home. This new approval provides a convenient alternative to the traditional flu shot especially for individuals who have needle aversion or find it challenging to visit healthcare settings for immunization.
The nasal spray vaccine, which was first developed by AstraZeneca two decades ago and will still require a prescription but can now be ordered online and delivered directly to homes.
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The FDA has given the green light to AstraZeneca’s FluMist nasal spray for at-home use, making it the first-ever influenza vaccine approved for self-administration outside a healthcare setting.
FluMist is a nasally administered influenza vaccine that contains a live but weakened form of the flu virus. It was first approved by the FDA in 2003 for in-office administration and has been used by healthcare providers for two decades.
Originally approved for individuals aged 5 to 49, FluMist has since been authorized for use in children as young as 2 years old.
FluMist provides a needle-free alternative for those who are averse to traditional flu shots making flu immunization less intimidating for individuals with needle phobia.
The at-home option helps overcome challenges like scheduling appointments, taking time off work or making special trips to clinics, all of which have been noted as common barriers to receiving timely flu vaccinations.
Dr. Abraar Karan, an infectious disease specialist from Stanford has addressed that these logistical barriers often prevent people from getting vaccinated. The convenience of at-home administration is expected to increase the uptake of flu vaccines before the flu season escalates.
FluMist at-home vaccines will be made available through a new online platform called FluMist Home, which is expected to launch next year. To receive the nasal spray vaccine, individuals will need to complete a questionnaire on the FluMist Home website, which will then be reviewed by a licensed pharmacist.
Once approved, the FluMist nasal spray will be shipped directly to the patient’s home, a hassle-free way to get vaccinated.
The nasal spray vaccine is suitable for people between the ages of 2 and 49. However, caregivers or parents are advised to administer the vaccine to children between 2 and 17 years old, according to FDA recommendations.
For adults, the vaccine can be self-administered with minimal instruction. It is important to note that individuals with certain medical conditions may not be eligible for FluMist.
Those with compromised immune systems or severe allergies to ingredients in the vaccine should consult with their healthcare provider before use.
The Centers for Disease Control and Prevention reports that FluMist has shown similar efficacy to the traditional flu shot in most cases.
One exception was during the 2009 flu season, when the spray underperformed in children compared to the shot. However, AstraZeneca has since modified the formulation to enhance its effectiveness.
Studies conducted outside of the United States have shown that FluMist now performs on par with the injectable flu vaccine, according to the CDC.
The out-of-pocket cost for FluMist is expected to range between $35 and $45 per dose. The price may vary depending on insurance coverage and it is anticipated that many insurance plans will cover some or all of the cost.
Nasal spray format provides a more comfortable experience compared to the injectable flu shot, which can cause mild soreness or achiness. This is appealing for parents with young children, as administering a nasal spray can be less distressing than a needle.
Additionally, the at-home administration allows for flexibility in timing, making it easier for individuals to fit vaccination into their busy schedules without having to take time off from work or school.
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Seasonal flu continues to be a global health concern with the World Health Organization estimating that there are around 1 billion cases annually leading to between 290,000 and 650,000 respiratory-related deaths.
In the U.S. alone, flu-related hospitalizations have ranged from 100,000 to 700,000 each year between 2010 and 2023 with annual deaths varying from 4,900 to 51,000 during the same period, according to data from the CDC.
Flu remains a major public health issue in the US According to the Centers for Disease Control and Prevention (CDC), between 2010 and 2023, flu caused up to 41 million illnesses annually.
It resulted in 100,000 to 710,000 hospitalizations and between 12,000 and 51,000 deaths each year. Annual flu vaccination remains the best defense against these outcomes and the approval of self-administered FluMist could help improve vaccination rates.
FluMist will not be immediately available for home use during the 2024 flu season. AstraZeneca has indicated that it will take some time to coordinate with third-party online pharmacies to ensure a smooth rollout.
The company plans to make FluMist available for home use by the 2025 flu season. This delay allows time to ensure proper distribution and a positive customer experience.
FluMist is typically covered by most insurance plans including Medicaid, Medicare and private insurance, when administered in healthcare settings. It is not yet clear if the home-administered version will be covered under the same insurance terms.
The current out-of-pocket cost for FluMist is between $35 and $45 per dose. Consumers will need to check with their insurers to confirm whether the at-home version is covered or if they will need to pay out-of-pocket.
By reducing the need for clinic or pharmacy visits, this change could help increase vaccination rates, especially for those with limited mobility, busy schedules or those who live in rural areas with less access to healthcare facilities.
AstraZeneca is working on the logistics of making FluMist widely available for home use by the next flu season. The potential success of FluMist could lead to increased acceptance of nasal vaccines and self-administered treatments in the future.
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