Caregiver-administered influenza vaccine’s Biologics License Application accepted by FDA

Caregiver-administered influenza vaccine’s Biologics License Application accepted by FDA | Image Credit: © Axel Kock - © Axel Kock - stock.adobe.com.

The FDA has accepted a supplemental Biologics License Application (sBLA) for the approval of self- or caregiver-administered option for Influenza Vaccine Live, Intranasal (FluMist Quadrivalent; AstraZeneca), according to a press release from AstraZeneca.¹

If the sBLA is approved, Influenza Vaccine Live, Intranasal would be the first flu vaccine available for self-administration by eligible parents or caregivers, adding another tool to fight against influenza.¹

Influenza Vaccine Live, Intranasal is FDA approved for active immunization to prevent influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine, according to the FDA.² The currently approved nasal spray vaccine is administered by a health care professional with 1 spray in each nostril.³

A usability study for self- or caregiver-administered Influenza Vaccine Live, Intranasal supported the sBLA. The study demonstrated that individuals older than 18 years could self-administer the intranasal treatment or administer it to eligible patients aged 2 to 49 years, when given instructions and no additional guidance.¹

“A self-administered option for [Influenza Vaccine Live] would leverage the unique attributes of the product, providing a convenient new choice for individuals and families who want to protect their loved ones against flu,” said Ravi Jhaveri, MD, division head, infectious disease, Virginia H. Rogers Professor in Infectious Diseases, professor of pediatrics, infectious diseases, Northwestern University School of Medicine, Chicago, Illinois.¹

“Vaccination rates for children and adults under 50 years of age declined in the 2022-2023 flu season, highlighting a need for more accessible solutions. 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.”¹

AstraZeneca expects a Prescription Drug User Fee Act (PDUFA) date to be during the first quarter of 2024, which could make Influenza Vaccine Live, Intranasal available in the United States for the 2024/2025 flu season, should it be approved at that time.¹

The nasal spray should not be given to those with a severe allergy to eggs or any inactive ingredient in the vaccine, those who have ever had a life-threatening reaction to influenza vaccinations, or are 2 to 17 years of age and take aspirin or medicines that contain aspirin.¹

Children or adolescents should not be given aspirin for 4 weeks after getting Influenza Vaccine Live, Intranasal, unless a health care professional says otherwise. Children aged younger than 2 years have an increased risk of wheezing after getting the nasal spray.¹

References:

1. US Food and Drug Administration accepts for review AstraZeneca’s Supplemental Biologics License Application for self-administration of FLUMIST QUADRIVALENT (Influenza Vaccine Live, Intranasal). AstraZeneca. Press release. October 24, 2023. Accessed October 31, 2023. https://www.astrazeneca-us.com/media/press-releases/2023/us-food-and-drug-administration-accepts-for-review-astrazenecas-supplemental-biologics-license-application-for-self-administration-of-flumist-quadrivalent-influenza-vaccine-live-intranasal.html
2. FluMist Quadrivalent. FDA. Updated July 6, 2023. Accessed October 31, 2023. https://www.fda.gov/vaccines-blood-biologics/vaccines/flumist-quadrivalent
3. Flu protection without the injection. AstraZeneca. Accessed October 31, 2023. https://www.flumistquadrivalent.com/nasal-spray-flu-vaccine.html?source=FMQ_N_C_234&umedium=cpc&uadpub=GOOGLE&ucampaign=NEWUSA_GO_SEM_B_EX_FluMist-DTC-Action-Core-Sams&ucreative=Core&uplace=flumist&outcome=NAME&cmpid=1&gclid=Cj0KCQjwy4KqBhD0ARIsAEbCt6i2lCWN-c9cIxloOulF4vX3wNxWcCEuSvJVA6x0sri7xB8V5Kafvb8aArXCEALw_wcB&gclsrc=aw.ds