The FDA approved FluMist for self- or caregiver-administration, marking the first influenza vaccine that does not require administration by a healthcare provider. The approval applies to individuals aged 2 through 49 years for the prevention of influenza disease caused by influenza virus subtypes A and B.
FluMist, a live attenuated influenza vaccine delivered intranasally, has been in use since its initial FDA approval in 2003 for ages 5 through 49, with subsequent approval in 2007 extending its use to children aged 2 through 5 years. The current approval maintains the same age range but introduces a novel self-administration option.
Key Points:
- FluMist is the first self-administered influenza vaccine approved by the FDA
- The approval covers individuals aged 2 through 49 years
- The vaccine can be self-administered or provided by a caregiver aged 18 or older
- A prescription is still required to obtain FluMist
- The vaccine will be available through a third-party online pharmacy
Efficacy and Safety: FluMist contains weakened live influenza virus strains and has demonstrated safety and efficacy over many years of use. The most commonly reported side effects include:
- Fever >100°F in children aged 2-6 years
- Runny nose and nasal congestion in individuals aged 2-49 years
- Sore throat in adults aged 18-49 years
Administration Process: For self- or caregiver-administration, the vaccine manufacturer will distribute FluMist through a third-party online pharmacy. The process involves:
- Completion of a screening and eligibility assessment by the orderer
- Prescription issuance by the third-party pharmacy based on eligibility
- Shipment of the vaccine to the provided address
- Self-administration or administration by a caregiver at the recipient's convenience
Notably, individuals aged 2-17 years should not self-administer; a caregiver should administer the vaccine for this age group.
Study on Instructions for Use: A study was conducted to evaluate the efficacy of the instructions for use, ensuring recipients and caregivers could safely and effectively use the vaccine. Details of this study's methodology and results were not provided in the FDA announcement.
Epidemiological Context: According to the CDC, influenza has resulted in:
- 9.3 million to 41 million illnesses annually
- 100,000 to 710,000 hospitalizations annually
- 4,900 to 51,000 deaths annually These figures represent data from 2010 to 2023
Regulatory and Distribution Details:
- The approval was granted to MedImmune LLC
- Recipients will receive the vaccine along with Prescribing Information, Information for Patients and their Caregivers, and Instructions for Use
- The Instructions for Use provide detailed guidance on storage, administration, and disposal of FluMist
"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," remarked Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research.
Reference:
U.S. Food and Drug Administration. FDA Approves Nasal Spray Influenza Vaccine for Self- or Caregiver-Administration. PR Newswire. https://www.prnewswire.com/news-releases/fda-approves-nasal-spray-influenza-vaccine-for-self--or-caregiver-administration-302254354.html