Next flu season, people may be able to skip the pharmacy line and get the annual influenza vaccine in the comfort of their home.
If the FDA signs off on an AstraZeneca proposal, adults between 18 and 49 years old will be able to self-administer the company’s FluMist Quadrivalent intranasal vaccine or give it to children ages 2 and older. And on a broader level, the change could open the door for other do-it-yourself vaccines in the future, said Natasha Boliter, a senior analyst for Citeline.
“Everyone's quite health conscious after COVID and slightly more willing to take vaccines,” she said. “So, this is coming at a good time to get a new option to the market.”
Making the case for home use
AstraZeneca supported its recent Supplemental Biologics License Application (sBLA) submission with data from a usability study showing adults had no trouble following instructions to administer the needle-free nasal vaccine correctly.
“They’re bolstered by the fact that during COVID everyone managed to do at home nasal swab tests to test themselves,” Boliter said. “And you could argue that that was probably a more complicated process than just administering the vaccine intranasally.”
If approved — the expected PDUFA date will be in early 2024 — people could order the vaccine through an online pharmacy system and have it shipped to their home in temperature-regulated packaging. AstraZeneca is betting that the added convenience will improve vaccine compliance — while the global market for influenza vaccines may increase to $14.35 billion by 2030, uptake dipped in the 2022-2023 season.
“I think [AstraZeneca] is hoping to increase revenues by capturing people who wouldn't normally get a flu vaccine in that adult age bracket."
Senior analyst, Citeline
“The ability for individuals and parents to choose where to administer an injection-free flu vaccine could help increase access and, subsequently, vaccination rates, and greatly benefit those most impacted by this serious and contagious respiratory illness,” said Dr. Ravi Jhaveri, division head of Infectious Disease at the Northwestern University School of Medicine in a written AstraZeneca release.
While the focus over the past few years has shifted to COVID-19, influenza still takes a heavy toll, and many in the industry have sounded the alarm over low flu vaccination rates.
“On average, about 8% of the U.S. population gets sick from flu each season, with a range of between 3% and 11%, depending on the season. Children 5 to 17 years of age represent 39% of acute respiratory infection medical visits, even though they only make up about 22% of the U.S. population,” according to AstraZeneca.
A new revenue stream?
Now the question is: If the at-home vaccine is approved, will people use it?
The live-attenuated vaccine has an advantage because it’s been on the market for more than two decades and is already familiar to patients. It’s also one of only a handful of approved nasal vaccines around the globe.
While there aren’t many other intranasal vaccines, there is increased interest in developing new options, particularly for COVID-19. However, because the vaccine contains a weakened form of the live flu virus, not everyone can take it, including people with compromised immune systems, children under 2, adults over age 50, or those with certain risk factors.
“Historically, (FluMist) is mainly used in the pediatric population,” said Boliter, because live attenuated vaccines have unique benefits in this group, as well as the appeal of the jab-free option. While it’s most often used to vaccinate children, an at-home option could be a novel way for companies to continue offering adult flu clinics in the work-from-home era, she said.
“I think [AstraZeneca] is hoping to increase revenues by capturing people who wouldn't normally get a flu vaccine in that adult age bracket,” Boliter said.
Studies have found people are receptive to the idea of self-administered vaccines, she said.
“I think overall it’s quite positive and I think it has a good chance of getting self-administration approval,” Boliter said.
That said, while an at-home option will be a good addition to the existing vaccine landscape, it probably won’t be revolutionary, Boliter noted
“Giving the self-administration route could improve uptake somewhat, but I don’t think it’s going to massively change coverage rates and revenue,” she said. “I think it is just a good alternative.”