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FDA & Government News

FDA Greenlights First DIY Flu Vaccine

The FDA's approval for self-administration could change how the U.S. addresses flu cases annually.

Conexiant

The FDA approved FluMist for self- or caregiver administration, marking the first influenza vaccine that does not require administration by a health care 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.

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 of over 100°F in children aged 2 to 6 years
  • Runny nose and nasal congestion in individuals aged 2 to 49 years
  • Sore throat in adults aged 18 to 49 years

A study was conducted to evaluate the efficacy of the instructions for use, ensuring recipients and caregivers could safely and effectively use the vaccine. Notably, individuals aged 2 to 17 years should not self-administer; a caregiver should administer the vaccine for this age group.

Regulatory and Distribution Details

  1. The approval was granted to MedImmune LLC. 
  2. Recipients will receive the vaccine along with prescribing information, information for patients and their caregivers, and instructions for use.
  3. The instructions for use provide detailed guidance on storage, administration, and disposal.

"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