FDA approves FluMist for self- or caregiver-administration

FDA approves FluMist for self- or caregiver-administration | Image Credit: © Calin - © Calin - stock.adobe.com.

Influenza Vaccine Live (FluMist; AstraZeneca) is now FDA approved for the prevention of influenza disease caused by subtypes A and B for self- or caregiver-administration among individuals aged 2 to 49 years, according to an announcement from the federal agency.

Initially approved for use in 2003 for individuals aged 5 to 49 years, the FDA approved use of the nasal vaccine in children as young as 2 years of age in 2007.

FluMist, which still requires a prescription, contains a weakened form of live influenza virus strains that are sprayed in the nose. With the updated indication, the vaccine may be administered by a health care provider in a health care setting (including a pharmacy) or it may be administered by the vaccine recipient or a caregiver who is 18 years of age or older, the FDA stated.

Tina Tan, MD, FAAP, FIDSA, FPIDS, Professor of pediatrics, Feinberg School of Medicine, Northwestern University; pediatric infectious diseases attending, Ann & Robert H. Lurie Children's Hospital of Chicago, told Contemporary Pediatrics this expanded indication should help boost vaccination rates, though there are limitations.

"This intranasal live attenuated vaccine has been around for years as an option for influenza vaccination but utilization of the vaccine has been less than expected," Tan said. "It can only be given to healthy individuals 2 to 49 years of age with no underlying conditions, including asthma. Making it available for in home use should increase the use of this vaccine and influenza vaccine, however, it will be important that the selling of this vaccine be monitored as you do not want the wrong individuals receiving the vaccine."

Tan added caution and attention to instruction for FluMist for self- or caregiver-administration should be taken, and that when available, the vaccine should help those weary of needles.

"There will need to be clear instructions as to what should be done if the person does not receive the entire dose given that this is a nasal spray, but there is some volume to it, so parts of the dose could drip out of the nose," Tan said. "In home vaccine is not available this influenza season but is expected to be available next influenza season. It's definitely an option for needlephobic individuals."

"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,” said Peter Marks, MD, PhD, in a press release from the FDA.

Marks is the director of the FDA's Center for Biologics and Evaluation and Research. "This approval adds another option for vaccination against influenza disease and demonstrates the FDA’s commitment to advancing public health.”

The common and contagious respiratory disease typically circulates during the fall and winter seasons in the United States. Per the Centers for Disease Control and Prevention (CDC), influenza has resulted in about 9.3 million to 41 million illnesses, 100,000 to 710,000 hospitalizations and 4,900 to 51,000 deaths annually between 2010 and 2023.

Several vaccines approved by the FDA are available during the traditional influenza season, including those recommended by the CDC and the Advisory Committee on Immunization Practices (ACIP).

Fever over 100°F in children 2 through 6 years of age, runny nose and nasal congestion in individuals 2 through 49 years of age, and a sore throat in adults 18 through 49 years of age are the most commonly reported side effects of FluMist, according to the FDA.

The agency noted that those interested in self- or caregiver-administration can expect the vaccine to be available via a third-party online pharmacy, and those who choose this option will complete a screening and eligibility assessment when they order FluMist.

Caregivers should administer FluMist to individuals aged 2 to 17 years, "as individuals in this age group should not self-administer the vaccine," the FDA stated.

Reference:

FDA Approves Nasal Spray Influenza Vaccine for Self- or Caregiver-Administration. FDA. Press release. 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?utm_medium=email&utm_source=govdelivery