First Self-Administered Flu Vaccine Approved by US FDA

The first influenza vaccine that does not require administration by a health care professional has been approved by the US FDA. FluMist (influenza vaccine live, intranasal; AstraZeneca) received the stamp of approval today for self- or caregiver-administration, according to an FDA news release.

“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,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in the news release.

The intranasal vaccine is already approved for the prevention of influenza caused by subtypes A and B in individuals aged 2 to 49 years. Individuals can still receive the vaccine from a health care professional in a health care setting, including the pharmacy, or administer it themselves or via a caregiver aged 18 years and older. Those who choose self- or caregiver administration will receive the vaccine from a third-party online pharmacy, along with instructions for use and storage, administration, and disposal.

The FDA's decision comes after a supplemental biologic license application (sBLA) was submitted by AstraZeneca in October 2023. The sBLA was supported by a usability study confirming the vaccine's feasibility.

With this new indication, FluMist can be a "powerful tool" in increasing vaccination rates in the US, Ravi Jhaveri, MD, division head, Infectious Disease, Northwestern University School of Medicine, told Patient Care Online in a recent interview. In the video below, Jhaveri discusses the usability study, FluMist's potential to help boost immunization efforts, the impact on primary care practices, and more.

Reference: FDA Approves Nasal Spray Influenza Vaccine for Self- or Caregiver-Administration. News release. Food and Drug Administration. September 20, 2024. Accessed September 20, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-nasal-spray-influenza-vaccine-self-or-caregiver-administration