FDA Approves First At-Home Flu Vaccine, But Availability Delayed Until Next Season

On Friday, the U.S. Food and Drug Administration (FDA) approved the first flu vaccine that can be administered at home, eliminating the need for a healthcare professional to administer it. However, this new optionwon’t be available in time for the current flu season.

FluMist, a nasal spray manufactured by AstraZeneca, has been protecting Americans from influenza since its introduction in 2003. Traditionally, FluMist is available in pharmacies and healthcare settings for individuals between the ages of 2 and 49, provided they have a prescription.

With the FDA’s latest decision, a second option has been added for those eligible to receive FluMist: it can now be administered at home. Adults can self-administer the vaccine, and caregivers can assist children in receiving it.

AstraZeneca plans to make this at-home vaccine available through a third-party online pharmacy. The pharmacy will prescribe and ship the vaccine after reviewing a screening and eligibility assessment. The company expects this option to be ready in time for the start of next year’s flu season.

In a statement, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, praised the development, stating, “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.”

He continued by emphasizing the importance of vaccination, saying, “Getting vaccinated each year is the best way to prevent influenza, which causes illness in a substantial proportion of the U.S. population every year and may result in serious complications, including hospitalization and death. This approval adds another option for vaccination against influenza disease and demonstrates the FDA’s commitment to advancing public health.”

Influenza remains a significant public health concern in the U.S. During the 2023-24 flu season, the virus caused an estimated 35 million illnesses, 400,000 hospitalizations, and 25,000 deaths, according to the U.S. Centers for Disease Control and Prevention (CDC). To combat these numbers, the CDC recommends that everyone aged 6 months and older receive a flu vaccine annually. However, flu vaccination rates have been dropping in recent years. During the last flu season, only about half of eligible adults and children received their annual flu shot.

FluMist offers the only needle-free flu vaccination option in the U.S. Unlike injectable flu vaccines, which use killed viruses or proteins to help the immune system develop defenses against the flu, FluMist uses a live, weakened version of the virus to provide protection. AstraZeneca reports that FluMist is as effective as traditional flu vaccines.

When the FDA first announced last year that it was considering the possibility of approving a self-administered flu vaccine, several physicians welcomed the potential for making vaccines more accessible, although some expressed doubts about whether it would significantly increase vaccination rates.

Dr. Ashish Jha, dean of the Brown University School of Public Health and former White House Covid-19 response coordinator, shared his thoughts at the time. He remarked that while a self-administered flu vaccine would be more accessible, especially if it could eventually be bought directly off pharmacy shelves, rather than through an online pharmacy that acts as a gatekeeper, he wasn’t convinced that it would make a significant impact on vaccination numbers.

Jha acknowledged, however, that the needle-free aspect of FluMist could help overcome vaccine hesitancy among those who have a fear of needles. “As many as 10% to 15% of people may be needle-phobic and hesitant to get vaccines, so increasing ways to access a needle-free version could boost uptake,” he said.

He tempered his expectations, predicting that the impact of a self-administered vaccine option would likely be modest. “I think the impact is going to be modest,” Jha said. However, he added that he hoped this development would increase awareness of flu vaccines, possibly through greater marketing efforts by AstraZeneca or more research into other intranasal vaccines that are easier to obtain.

“I see this as a relatively positive step,” Jha commented, noting that while the change might not revolutionize flu vaccination rates, it could still be a step in the right direction toward making vaccines more accessible and convenient.

Despite this FDA approval being a milestone, the timing of its availability will limit its impact on the current respiratory virus season. With plans to launch the at-home vaccine in time for next year’s flu season, the potential for its influence on vaccination rates remains to be seen. For now, those seeking flu protection will need to rely on existing methods, such as visiting a healthcare provider or pharmacy.

As flu season continues to pose a threat, health authorities urge everyone to get vaccinated and protect themselves from the potentially severe complications of the flu. The CDC, in particular, stresses the importance of vaccination not just for individual health but also for the protection of communities, especially the most vulnerable, such as young children, the elderly, and those with weakened immune systems.

FluMist’s needle-free technology offers an alternative for those uncomfortable with traditional injections, and with the added convenience of at-home administration, it is hoped that more people will choose to vaccinate themselves and their families. However, until the new self-administered option becomes widely available, the public must continue relying on the flu vaccines currently available in pharmacies and healthcare settings.

In the meantime, experts will watch closely to see whether this new option can help reverse the decline in flu vaccination rates in the U.S., where millions still fall ill from the flu each year despite the widespread availability of vaccines. For now, the push to increase awareness and accessibility continues, as public health officials emphasize that annual flu vaccination remains the best defense against a virus that continues to affect a significant portion of the population each season.