(HealthDay News) — On Friday, the US Food and Drug Administration approved the FluMist nasal vaccine for self-administration at home.
It is a “new option for receiving a safe and effective seasonal influenza vaccine potentially with greater convenience, flexibility and accessibility for individuals and families,” Peter Marks, MD, director of the FDA Center for Biologics Evaluation and Research, said in an agency news release.
It has been a long time coming, however: MedImmune FluMist was first approved in 2003 for people ages 5 to 49 years to prevent flu, and then approval was extended to children ages 2 to 5 years in 2007. It is a nasal spritz that contains a weakened form of the live influenza virus. However, until now, it was always administered by a healthcare provider.
A prescription will still be needed to get FluMist, the FDA said, and only individuals aged 18 years and older are authorized to administer it to themselves or a child in their care.
“For those interested in self or caregiver administration, the vaccine manufacturer plans to make the vaccine available through a third-party online pharmacy,” the FDA said. “Those who choose this option will complete a screening and eligibility assessment when they order FluMist.”
Friday’s approval was based on a study “conducted with vaccine recipients and caregivers to evaluate whether the instructions for use were appropriately designed so that recipients and caregivers could safely and effectively use the vaccine,” the FDA noted. Anyone who is prescribed FluMist will receive the vaccine as well as detailed instructions on how to administer, store, and dispose of the product.
This approval of FluMist was granted to MedImmune.
