Could a self-administered flu vaccine be on its way?

In 2003, FDA approved AstraZeneca's FluMist, an intranasal flu vaccine, for individuals ages two to 49 years of age. It is the only intranasal vaccine licensed for human use in the United States.

On Tuesday, AstraZeneca announced it submitted a supplemental biologics license application to FDA that would allow the vaccine to be self-administered by individuals ages 18 to 49. It would also allow adults ages 18 and older to administer the vaccine to eligible children.

The company based its application on a "usability study" that found people can administer the vaccine effectively without a healthcare provider present when given instructions for use.

"We really feel confident that people will be able to do it," said Lisa Glasser, head of AstraZeneca's U.S. medical affairs for vaccines and immune therapies. She also noted that people would still be able to receive the vaccine at a doctor's office or pharmacy. "It is meant to enhance the ability to access influenza vaccination. That's the goal."

"One of the things we've learned from the pandemic is that actually people can do things for themselves, they can take maybe more responsibility for their own health care in their own hands than perhaps we realized or even thought possible," Glasser added. "[W]e put nasal swab tests in people's hands and they used them successfully."

After consulting with a medical professional, people would be able to order the vaccine and have it delivered to their homes under appropriate temperature controls. The vaccine would come in a pre-filled, needleless syringe and include instructions on safe administration. 

FDA is currently reviewing the application and is expected to make a decision during the first quarter of 2024. If approved, the vaccine would be available next autumn, in time for the 2024-2025 flu season.

Commentary

Although a self-administered vaccine could improve access, many health experts say it's unlikely the new option would increase vaccination rates significantly.

"I think the impact is going to be modest," said Ashish Jha, dean of the Brown School of Public Health and the former White House COVID-19 response coordinator.

Andrew Pavia, chief of the division of pediatric infectious diseases at the University of Utah and director of hospital epidemiology at Primary Children's Medical Center, said the idea of a self-administered flu vaccine was interesting, but noted that there could be issues with this approach.

"First is handling and maintenance since it needs to be refrigerated," Pavia said. "The second is making sure that it gets up the child's nose adequately. Both are probably manageable."

Separately, Aaron Glatt, chief of infectious diseases and hospital epidemiologist at Mount Sinai South Nassau and a spokesperson for the Infectious Diseases Society of America, said documentation would be crucial to ensure patients don't get a vaccine more than once or report that they received the vaccine without actually getting it. Data on how well the vaccine performs will also need to be tracked.

AstraZeneca plans to provide a way to make documentation "practical and helpful for not only for the patient, or the person, but also for their health care professionals," Glasser said. However, she added that it's too early to provide concrete details.

Jha said he saw the self-administered vaccine "as a relatively positive step" and hoped it would lead to increased awareness for flu vaccination or more research into additional intranasal vaccines. (Branswell, STAT, 10/24; Tirrell, CNN, 10/24; Reuters, 10/24)

Going into the fall, the United States may see a new surge of respiratory viruses, including COVID-19, respiratory syncytial virus (RSV), and influenza. To protect against illness, federal health officials are encouraging people to get vaccinated once new shots against these three viruses are available.