Why physicians are skeptical of first at-home flu vaccine approval

The first influenza vaccination that does not need to be administered by a healthcare provider has just been approved by the FDA.^[] On September 20, 2024, FluMist was approved for at-home use, but it won’t be available for self-administration until Fall 2025. 

“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, director of the FDA’s Center for Biologics Evaluation and Research, in a news release.^[]

What physicians are saying

Dean Blumberg, MD, Chief of Pediatric Infectious Disease at UC Davis, remains skeptical of the vaccine's impact. “If we look at influenza vaccination in the US, the rates have really been steady at around 50% of the entire population getting influenza vaccine,” he tells MDLinx. “This is despite massive educational efforts to encourage people to get vaccinated.”

But there is still reason to be cautiously optimistic. William Schaffner, MD, an expert in infectious diseases at Vanderbilt University, discusses FluMist’s potential benefits.

"The first [benefit] is that people who are averse to needle sticks can get their flu vaccine at home through the nasal spray route,” Dr. Schaffner tells MDLinx. “And we certainly hope that some people who don't want to go to the doctor's office [will] take advantage of this.” He also notes the convenience factor: “They can get their flu vaccine at their own time, in their own homes, if they like.”

How it works

FluMist was first approved by the FDA in 2003 as a vaccination administered by a healthcare professional, for individuals 5–49 years of age.^[] It’s recent at-home approval helps prevent against influenza subtypes A and B in people 2–49 years of age; it is sprayed into the nose and contains a weak form of live influenza. Patients and caregivers can order the at-home vaccine via an online pharmacy, but must first complete a screening and eligibility assessment.

If the application is for a person aged 17 and under, the vaccination must be administered by a caregiver.

Comparing efficacy

Interim estimates from the CDC suggest the 2023/2024 influenza vaccination, in pediatric populations, was 59%–67% effective in outpatient settings and 52%–61% effective against influenza-associated hospitalization.^[] Among adults, vaccine effectiveness was 33%–49% in outpatient settings and 41%–44% effective against influenza-associated hospitalizations.^[]

“Theoretically, nasal vaccine should provide better protection, because not only are you getting a systemic immune response, meaning antibodies in the bloodstream, but you're also getting localized immunity, mucosal immunity, and secretory IgA,” he tells MDLinx. “That should protect better, but it turns out that in reality, the FluMist vaccine works about the same as the inactivated, injected vaccine, so there doesn't seem to be an advantage there.”

“The other difference is that it (FluMist) is a live vaccine, and so theoretically, it could multiply more than you would want it to in hosts who have compromised immune systems. And so that's why there is a limited portion of the population that the vaccine is approved for,” he says.