Each year, influenza vaccine uptake is significantly affected by access. Patients may not have the time for an additional healthcare visit, and offices are challenged to staff busy vaccine clinics in addition to delivering routine care. Some help may be on the way with a new type of product. On the heels of having readily available at-home test kits for viruses like COVID-19 and, more recently, influenza, the first at-home vaccine has now been licensed.
FluMist, AstraZeneca’s live attenuated influenza vaccine (LAIV) received FDA approval for self- and caregiver-administration in the fall of 2024. It is anticipated to be available for use during the 2025-2026 influenza season. A home version of the LAIV vaccine could increase accessibility by eliminating the need for scheduling and traveling to a visit at a clinic or pharmacy, while offering the same FDA-approved, ACIP-recommended vaccine.
Self-administration of a vaccine introduces three new components, including home support through an online pharmacy service, patient-friendly packaging and instructions, and a return shipment program. Let’s take a closer look.
Determining eligibility and insurance coverage
The FluMist vaccine will be ordered through an online pharmacy service, ASPN. ASPN will ensure eligibility, manage dispensing and delivery, and provide counseling and support offered by pharmacists. ASPN pharmacists will comply with state-specific rules and regulations to determine eligibility and address documentation requirements.
Order initiation
An adult family member will initiate the order. This person will be able to request doses for additional household members. Patients won’t need to obtain a prescription themselves because, in states where it’s permitted, ASPN pharmacists will handle prescribing the vaccine. A shipping fee of $5-$10 will be charged.
Review of eligibility
The person ordering the vaccine will answer a series of eligibility screening questions aligned with ACIP-approved use of LAIV, including contraindications and precautions. Based on these answers, the system will identify which household members are eligible to receive FluMist at home.
- If someone is not eligible (e.g., someone outside the age recommendations for FluMist), the request for that person will be denied.
- In some cases, requests will need additional scrutiny to determine eligibility. In these cases, the person will be informed that the prescription is under review based on some responses.
- Some children who are eligible for healthcare-administered LAIV may not be eligible for caregiver-administered LAIV (e.g., if the state restricts the lower age for pharmacist prescribing or if the child’s vaccine coverage is through the Vaccines for Children (VFC) program). In this case, the caregiver would receive a recommendation to have the child vaccinated through a healthcare provider.
Insurance
The system will check for insurance coverage. During 2025-2026, FluMist for self-administration will be available for people with private health insurance without a need for copay. During the first year (2025-2026), no out-of-pocket option will be available. Through the VFC program, FluMist may be administered in clinical sites but not via the home administration program. However, AstraZeneca will work with the VFC program to consider how this option could be incorporated into VFC in the future.
Vaccine receipt and administration
Shipments
Package tracking information will be provided via text and email alerts. Shipments will arrive in two days or less in user-friendly packaging. Each shipment will include: a list of package contents, vaccine dose or doses for eligible household members, cold packs to maintain cold chain, a temperature monitor to confirm that the package stayed at appropriate temperatures during shipping, storage instructions (i.e., using a home refrigerator), the LAIV vaccine information statement (VIS), administration instructions, and information about how to return used vaccine delivery devices since they are considered medical waste.
Administration
Administration instructions will be offered via video or printed instructions.
- Video: A QR code included with the materials will take patients to a website with “how-to” videos.
- Printed: AstraZeneca conducted FDA-required human factors usability studies that led to the development and approval of illustration-enhanced, written instructions for use. The results showed that 100% (30/30) of intended users were able to successfully read and understand the instructions, and 100% were able to successfully self-administer or administer to a child.
Communication and support
ASPN will communicate with patients via text reminders to confirm administration of the doses. These texts will also include information about how to reach the ASPN pharmacists for questions.
After administration: Documentation and disposal
Documentation
ASPN pharmacists will report vaccine doses using the same process as retail pharmacies use, including adding to the state immunization information system (IIS) based on the address where FluMist was shipped. If the physician’s name is provided, ASPN will also report the dose to the patient’s medical home. Patients will also be able to download their vaccine record. It is unclear at this time whether employers that require annual influenza vaccination (e.g., hospitals) will accept documentation of self-administered LAIV as sufficient evidence of vaccination.
Disposal via a return shipment program
Patients will be provided with a prepaid mail-back envelope and instructions, so they can dispose of the used sprayers, which are considered medical waste. The filled envelope can be sent from any United States Postal Service pickup site (e.g., mailbox, post office). It will be delivered to a medical waste company at no cost to the patient.
Summary
The availability of FluMist for self- and caregiver-administration will expand accessibility to seasonal influenza vaccine, starting with the 2025-2026 influenza season. The new process will be supported by an online pharmacy system that includes screening, administration support and documentation. During the first year, out-of-pocket payment and VFC options will not be available, and materials will only be available in English. AstraZeneca plans to expand language options, explore VFC availability, and evaluate real-world effectiveness through a phase IV study.
Resources
For more information on Flumist, check these resources:
- Screening Checklist for Contraindications to Live Attenuated Intranasal Influenza Vaccination
- Ask the Experts: Influenza: Live Attenuated Influenza Vaccine (LAIV) Issues
For more information on the new at-home process, check these resources:
- ACIP Presentation: FluMist Self/Caregiver Administration
- FDA Approves Nasal Spray Influenza Vaccine for Self- or Caregiver-Administration
Contributed by: Sharon G. Humiston, MD, MPH, FAAP
Each year, influenza vaccine uptake is significantly affected by access. Patients may not have the time for an additional healthcare visit, and offices are challenged to staff busy vaccine clinics in addition to delivering routine care. Some help may be on the way with a new type of product. On the heels of having readily available at-home test kits for viruses like COVID-19 and, more recently, influenza, the first at-home vaccine has now been licensed.
FluMist, AstraZeneca’s live attenuated influenza vaccine (LAIV) received FDA approval for self- and caregiver-administration in the fall of 2024. It is anticipated to be available for use during the 2025-2026 influenza season. A home version of the LAIV vaccine could increase accessibility by eliminating the need for scheduling and traveling to a visit at a clinic or pharmacy, while offering the same FDA-approved, ACIP-recommended vaccine.
Self-administration of a vaccine introduces three new components, including home support through an online pharmacy service, patient-friendly packaging and instructions, and a return shipment program. Let’s take a closer look.
Determining eligibility and insurance coverage
The FluMist vaccine will be ordered through an online pharmacy service, ASPN. ASPN will ensure eligibility, manage dispensing and delivery, and provide counseling and support offered by pharmacists. ASPN pharmacists will comply with state-specific rules and regulations to determine eligibility and address documentation requirements.
Order initiation
An adult family member will initiate the order. This person will be able to request doses for additional household members. Patients won’t need to obtain a prescription themselves because, in states where it’s permitted, ASPN pharmacists will handle prescribing the vaccine. A shipping fee of $5-$10 will be charged.
Review of eligibility
The person ordering the vaccine will answer a series of eligibility screening questions aligned with ACIP-approved use of LAIV, including contraindications and precautions. Based on these answers, the system will identify which household members are eligible to receive FluMist at home.
- If someone is not eligible (e.g., someone outside the age recommendations for FluMist), the request for that person will be denied.
- In some cases, requests will need additional scrutiny to determine eligibility. In these cases, the person will be informed that the prescription is under review based on some responses.
- Some children who are eligible for healthcare-administered LAIV may not be eligible for caregiver-administered LAIV (e.g., if the state restricts the lower age for pharmacist prescribing or if the child’s vaccine coverage is through the Vaccines for Children (VFC) program). In this case, the caregiver would receive a recommendation to have the child vaccinated through a healthcare provider.
Insurance
The system will check for insurance coverage. During 2025-2026, FluMist for self-administration will be available for people with private health insurance without a need for copay. During the first year (2025-2026), no out-of-pocket option will be available. Through the VFC program, FluMist may be administered in clinical sites but not via the home administration program. However, AstraZeneca will work with the VFC program to consider how this option could be incorporated into VFC in the future.
Vaccine receipt and administration
Shipments
Package tracking information will be provided via text and email alerts. Shipments will arrive in two days or less in user-friendly packaging. Each shipment will include: a list of package contents, vaccine dose or doses for eligible household members, cold packs to maintain cold chain, a temperature monitor to confirm that the package stayed at appropriate temperatures during shipping, storage instructions (i.e., using a home refrigerator), the LAIV vaccine information statement (VIS), administration instructions, and information about how to return used vaccine delivery devices since they are considered medical waste.
Administration
Administration instructions will be offered via video or printed instructions.
- Video: A QR code included with the materials will take patients to a website with “how-to” videos.
- Printed: AstraZeneca conducted FDA-required human factors usability studies that led to the development and approval of illustration-enhanced, written instructions for use. The results showed that 100% (30/30) of intended users were able to successfully read and understand the instructions, and 100% were able to successfully self-administer or administer to a child.
Communication and support
ASPN will communicate with patients via text reminders to confirm administration of the doses. These texts will also include information about how to reach the ASPN pharmacists for questions.
After administration: Documentation and disposal
Documentation
ASPN pharmacists will report vaccine doses using the same process as retail pharmacies use, including adding to the state immunization information system (IIS) based on the address where FluMist was shipped. If the physician’s name is provided, ASPN will also report the dose to the patient’s medical home. Patients will also be able to download their vaccine record. It is unclear at this time whether employers that require annual influenza vaccination (e.g., hospitals) will accept documentation of self-administered LAIV as sufficient evidence of vaccination.
Disposal via a return shipment program
Patients will be provided with a prepaid mail-back envelope and instructions, so they can dispose of the used sprayers, which are considered medical waste. The filled envelope can be sent from any United States Postal Service pickup site (e.g., mailbox, post office). It will be delivered to a medical waste company at no cost to the patient.
Summary
The availability of FluMist for self- and caregiver-administration will expand accessibility to seasonal influenza vaccine, starting with the 2025-2026 influenza season. The new process will be supported by an online pharmacy system that includes screening, administration support and documentation. During the first year, out-of-pocket payment and VFC options will not be available, and materials will only be available in English. AstraZeneca plans to expand language options, explore VFC availability, and evaluate real-world effectiveness through a phase IV study.
Resources
For more information on Flumist, check these resources:
- Screening Checklist for Contraindications to Live Attenuated Intranasal Influenza Vaccination
- Ask the Experts: Influenza: Live Attenuated Influenza Vaccine (LAIV) Issues
For more information on the new at-home process, check these resources:
- ACIP Presentation: FluMist Self/Caregiver Administration
- FDA Approves Nasal Spray Influenza Vaccine for Self- or Caregiver-Administration
Contributed by: Sharon G. Humiston, MD, MPH, FAAP