Patients and caregivers may be one step closer to having the ability to give themselves or someone else a flu vaccine without having to go to a pharmacy or clinic.
The Food and Drug Administration will review AstraZeneca’s supplemental Biologics License Application (sBLA) for its self-administered nasal flu vaccine, FluMist Quadrivalent, the British pharma giant announced Tuesday.
If approved, FluMist Quadrivalent would be the first flu vaccine available to be self-administered by eligible patients or caregivers and add an additional option to be vaccinated against influenza,” AstraZeneca noted in a press release.
FluMist Quadrivalent has been available as a nasal flu vaccine since the FDA originally approved it in 2003 and nearly 200 million doses have been administered globally, according to AstraZeneca.
Since the peak of the COVID-19 vaccination rollout in 2021, however, vaccination rates for both COVID-19 and flu have dropped significantly.
In particular, there has been a 15% decrease in vaccination among pregnant people, as well as a 5% drop among children, according to data from the Centers for Disease Control and Prevention.
Even as several big pharma players develop new combination mRNA vaccines — like Moderna’s dual flu and COVID-19 vaccine mRNA-1083 – the biotech space is also seeking to find new ways of administering them in the hopes of increasing uptake.
The FDA has set a Prescription Drug User Fee Act date for the self-administered version of FluMist sometime in the first quarter of 2024. AstraZeneca said that with an approval, it would be available in the U.S. for next year’s flu season.
“For more than 20 years, FluMist Quadrivalent has served as a critical public health tool as the only intranasal flu vaccine providing protection to communities around the world,” Iskra Reic, EVP of vaccines and immune therapies at AstraZeneca, said in a statement. “FluMist now has the potential to be the first and only self-administered flu vaccine, which could revolutionize flu vaccination. Our ambition is for FluMist to be ordered directly to people’s homes, providing an innovative, more accessible option for individuals, families and communities.”
AstraZeneca is slated to release its latest quarterly earnings report on November 9.