United States: The US Food and Drug Administration (FDA) granted approval last Friday for the inaugural flu vaccine that can be self-administered, bypassing the need for a healthcare provider’s intervention. However, this innovative option will not be accessible in time for this year’s respiratory virus season.
FluMist, a nasal spray produced by AstraZeneca, has been a staple in the US since its introduction in 2003, safeguarding individuals from influenza. Currently distributed in pharmacies and healthcare environments, FluMist caters to people aged 2 to 49 who hold a valid prescription.
With this recent FDA endorsement, a new avenue opens for eligible individuals. Adults can self-administer the vaccine, and caregivers can aid children in doing so, broadening access and convenience, according to the reports.
AstraZeneca envisions launching the vaccine through a third-party online pharmacy. Upon reviewing an eligibility assessment, the pharmacy will issue prescriptions and deliver the vaccine. The pharmaceutical giant anticipates this self-administration model to debut at the onset of next year’s respiratory virus season.
Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, stated, “Today’s sanctioning of the first flu vaccine for self- or caregiver administration introduces a novel option, potentially offering greater convenience, flexibility, and accessibility for individuals and families in acquiring safe and effective seasonal flu immunizations.”
He further emphasized, “Annual vaccination remains the most effective defense against influenza, which afflicts a substantial portion of the US population annually, sometimes leading to severe complications such as hospitalization or even death. This approval demonstrates the FDA’s ongoing commitment to advancing public health.”
According to estimates from the US Centers for Disease Control and Prevention (CDC), the 2023-24 flu season resulted in at least 35 million infections, 400,000 hospitalizations, and 25,000 deaths. The CDC advocates for flu vaccinations for everyone aged six months and older, although vaccination rates have dwindled in recent years. Last season, only about half of the eligible population received the annual shot.
FluMist, notable for being the only needle-free flu vaccine available in the US, employs a live but weakened version of the influenza virus to confer protection. In contrast, injectable flu vaccines rely on either inactivated viruses or proteins to prime the immune system. AstraZeneca asserts that FluMist performs on par with its injectable counterparts, as per reports.
When the FDA initiated discussions about a self-administered flu vaccine last year, many physicians welcomed the concept of enhancing accessibility. However, they remained cautious about its impact on overall vaccination rates.
Dr. Ashish Jha, dean of the Brown University School of Public Health and former White House COVID-19 response coordinator, expressed optimism that a self-administered option could significantly enhance accessibility, particularly if available directly on pharmacy shelves rather than through intermediaries.
He pointed out that a notable segment of the population, estimated at 10-15%, harbors a deep aversion to needles, often refraining from vaccinations as a result. Offering a needle-free alternative might encourage this group to get vaccinated.
“I believe the overall effect will be moderate,” Dr Jha remarked, reflecting on the potential influence. Nonetheless, he expressed hope that the move would stimulate increased awareness through enhanced marketing by AstraZeneca or foster additional research into other intranasal vaccines that offer similar ease of access. “It’s a step in the right direction,” he concluded.