FLUMIST approved for self-administration in the US
FLUMIST, the only needle-free nasal spray flu vaccine in the US, has been approved for self-administration by adults up to 49 years old or caregiver administration for individuals 2-17 years old. This FDA approval, based on a usability study, makes FLUMIST the first self-administered influenza vaccine, allowing for at-home use.
The approval aims to increase vaccine accessibility and potentially boost vaccination rates, which have declined by 3.3% in US adults since 2020-21. FLUMIST Home will enable direct-to-home delivery for adults 18 and older through an online pharmacy system. The vaccine will also remain available in healthcare settings.
Seasonal influenza causes up to 1 billion infections annually, with 3-5 million severe cases. It impacts school attendance and work productivity, with 47% of school days and 1-2 workdays missed annually due to flu.
FLUMIST, l'unico vaccino antinfluenzale spray nasale senza ago negli Stati Uniti, è stato approvato per la somministrazione autonoma agli adulti fino a 49 anni o per la somministrazione da parte di un caregiver per individui di età compresa tra 2 e 17 anni. Questa approvazione da parte della FDA, basata su uno studio di usabilità, rende FLUMIST il primo vaccino antinfluenzale autoadministrato, permettendo un utilizzo domiciliare.
L'approvazione mira ad aumentare l'accessibilità al vaccino e potenzialmente a migliorare i tassi di vaccinazione, che sono diminuiti del 3,3% negli adulti statunitensi dal 2020-21. FLUMIST Home permetterà la consegna a domicilio per gli adulti di età pari o superiore a 18 anni attraverso un sistema di farmacia online. Il vaccino rimarrà inoltre disponibile negli ambulatori sanitari.
L'influenza stagionale provoca fino a 1 miliardo di infezioni all'anno, con 3-5 milioni di casi severi. Influisce sulla frequenza scolastica e sulla produttività lavorativa, con il 47% dei giorni scolastici e 1-2 giorni lavorativi persi ogni anno a causa dell'influenza.
FLUMIST, la única vacuna contra la gripe en spray nasal sin aguja en EE. UU., ha sido aprobada para autoadministración por adultos de hasta 49 años o para la administración por cuidadores para individuos de 2 a 17 años. Esta aprobación de la FDA, basada en un estudio de usabilidad, convierte a FLUMIST en la primera vacuna contra la gripe autoadministrada, lo que permite su uso en casa.
La aprobación tiene como objetivo aumentar la accesibilidad de la vacuna y potencialmente aumentar las tasas de vacunación, que han caído un 3,3% en adultos estadounidenses desde 2020-21. FLUMIST Home permitirá la entrega a domicilio para adultos de 18 años o más a través de un sistema de farmacia en línea. La vacuna también seguirá estando disponible en entornos de atención médica.
La influenza estacional causa hasta 1 mil millones de infecciones anualmente, con 3-5 millones de casos graves. Afecta la asistencia escolar y la productividad laboral, con el 47% de los días escolares y 1-2 días laborales perdidos anualmente debido a la gripe.
FLUMIST는 미국에서 유일한 바늘 없는 비강 스프레이 독감 백신으로, 49세 이하 성인이 자가 투여할 수 있도록 승인되었습니다. 2세에서 17세 개인을 위한 보호자 투여도 가능하게 되었습니다. 이 FDA 승인은 사용성 연구에 기반하여 FLUMIST를 최초의 자가 투여 독감 백신으로 만들며, 가정에서의 사용을 허용합니다.
이 승인은 백신 접근성을 늘리고, 2020-21년 이후 미국 성인의 백신 접종률이 3.3% 감소한 상황에서 접종률을 높이기 위한 것입니다. FLUMIST Home은 18세 이상의 성인을 위해 온라인 약국 시스템을 통해 직접 가정으로 배달할 수 있게 해줍니다. 이 백신은 의료 환경에서도 여전히 사용할 수 있습니다.
계절성 독감은 매년 최대 10억 건의 감염을 초래하며, 300-500만 건의 중증 사례가 발생합니다. 이는 학교 출석과 직장 생산성에 영향을 미치며, 매년 독감으로 인해 47%의 학교 수업과 1-2일의 근무일이 결석됩니다.
FLUMIST, le seul vaccin antigrippal en spray nasal sans aiguille aux États-Unis, a été approuvé pour auto-administration par des adultes jusqu'à 49 ans ou par un soignant pour des individus de 2 à 17 ans. Cette approbation de la FDA, basée sur une étude d'usabilité, fait de FLUMIST le premier vaccin antigrippal administré par le patient, permettant une utilisation à domicile.
L'approbation vise à accroître l'accessibilité du vaccin et potentiellement à augmenter les taux de vaccination, qui ont diminué de 3,3 % chez les adultes américains depuis 2020-21. FLUMIST Home permettra une livraison directe à domicile pour les adultes de 18 ans et plus via un système de pharmacie en ligne. Le vaccin restera également disponible dans les établissements de soins de santé.
La grippe saisonnière provoque jusqu'à 1 milliard d'infections par an, avec 3 à 5 millions de cas graves. Elle a un impact sur la fréquentation scolaire et la productivité au travail, avec 47% des jours d'école et 1 à 2 jours de travail perdus chaque année en raison de la grippe.
FLUMIST, der einzige nadelfreie Nasenspray-Grippeimpfstoff in den USA, wurde für die Selbstverabreichung durch Erwachsene bis zu einem Alter von 49 Jahren oder die Verabreichung durch einen Betreuer für Personen im Alter von 2 bis 17 Jahren genehmigt. Diese FDA-Genehmigung, die auf einer Benutzerstudie basiert, macht FLUMIST zum ersten selbstverabreichten Influenza-Impfstoff und ermöglicht die Verwendung zu Hause.
Die Genehmigung zielt darauf ab, die Zugänglichkeit des Impfstoffs zu erhöhen und möglicherweise die Impfquoten zu steigern, die bei US-Erwachsenen seit 2020-21 um 3,3% gesunken sind. FLUMIST Home ermöglicht die Lieferung direkt nach Hause für Erwachsene ab 18 Jahren über ein Online-Apothekensystem. Der Impfstoff bleibt auch in Gesundheitseinrichtungen verfügbar.
Saisonale Influenza verursacht jährlich bis zu 1 Milliarde Infektionen mit 3 bis 5 Millionen schweren Fällen. Sie beeinflusst die Schulbesuche und die Arbeitsproduktivität, wobei jährlich 47% der Schultage und 1-2 Arbeitstage aufgrund der Grippe verpasst werden.
- FLUMIST approved as the first self-administered influenza vaccine in the US
- Expanded accessibility through at-home use and caregiver administration
- Potential to increase vaccination rates and reduce healthcare system burden
- Introduction of FLUMIST Home for direct-to-home delivery
- Influenza vaccination rates have declined by 3.3% in US adults since 2020-21 season
- age range for self-administration (18-49 years old)
Insights
The FDA's approval of FLUMIST for self-administration marks a significant milestone in influenza prevention. This needle-free nasal spray vaccine, now available for self-use in adults up to 49 years and caregiver administration for ages 2-17, could potentially increase vaccination rates. With influenza causing up to 1 billion infections annually and vaccination rates declining by
The convenience of home administration may boost uptake, particularly among those who miss regular well-care visits. However, it's important to monitor for any adverse effects or misuse that may arise from self-administration. The impact on public health could be substantial if this leads to increased vaccination rates, potentially reducing the 3-5 million severe cases and associated economic burden of influenza.
The approval of FLUMIST for self-administration presents a unique market opportunity for AstraZeneca. As the only self-administered influenza vaccine in the US, it could capture a significant market share, especially among younger adults and families seeking convenient vaccination options. The FLUMIST Home delivery service further enhances accessibility, potentially expanding the customer base.
However, the success will depend on factors such as pricing, insurance coverage and public awareness campaigns. The
The self-administration approval for FLUMIST is a game-changer for public health strategies. It addresses key barriers to vaccination, such as healthcare access and convenience. With 47% of school days and 1-2 work days missed annually due to influenza, increased vaccination could significantly reduce societal and economic burdens.
However, this shift towards self-administration requires robust public education to ensure proper usage and storage. There's also a need to monitor for potential disparities in access and uptake across different socioeconomic groups. While this approval could boost overall vaccination rates, it's important to maintain traditional vaccination channels for those who prefer or require professional administration. The long-term impact on influenza prevalence and severity will be a key metric to watch in the coming years.
Only influenza vaccine approved for self- or caregiver-administration at home, expanding options for influenza protection
The approval by the US Food and Drug Administration (FDA) was based on a comprehensive submission, which included results from a usability study demonstrating that individuals over 18 years of age could self-administer or administer FLUMIST to eligible individuals 2-49 years of age.1
Ravi Jhaveri, MD, Division Head, Infectious Disease; Virginia H. Rogers Professor in Infectious Diseases, Professor of Pediatrics (Infectious Diseases), Northwestern University School of Medicine,
Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, said: “The approval of FLUMIST for self-administration is an important step forward in making vaccines more accessible to fight the high annual burden of influenza. For more than 20 years, FLUMIST has been the only nasal spray flu vaccine licensed in the US and now it is also the only vaccine to help individuals, families and communities access an influenza vaccine conveniently through self- and caregiver administration outside of traditional healthcare settings.”
Seasonal influenza causes up to 1 billion infections each year and may result in severe outcomes for about 3-5 million patients including hospitalizations, complications and death.2 Influenza has been shown to impact school attendance and employment with
Once available, individuals 18 and older will be able to have FLUMIST delivered directly to their homes via FLUMIST Home. FLUMIST Home will utilize an online pharmacy where eligible individuals complete a questionnaire that is reviewed by a pharmacist prior to receiving their vaccine for shipment. FLUMIST will continue to be available in offices and pharmacies for administration by healthcare professionals. More information is available at www.FluMist.com.
Important Safety Information
- You should not get FLUMIST if you: have a severe allergy to eggs or to any inactive ingredient in the vaccine; have ever had a life-threatening reaction to influenza vaccinations; or are 2 through 17 years old and take aspirin or medicines containing aspirin – children or adolescents should not be given aspirin for 4 weeks after getting FLUMIST unless your healthcare provider tells you otherwise.
- Children under 2 years old have an increased risk of wheezing (difficulty with breathing) after getting FLUMIST.
- Tell your healthcare provider if you or your child: are currently wheezing; have a history of wheezing if under 5 years old; have had Guillain-Barré syndrome; have a weakened immune system or live with someone who has a severely weakened immune system; have problems with your heart, kidneys, or lungs; have diabetes; are pregnant or nursing; or are taking antiviral drugs for the treatment of influenza.
- The most common side effects are runny or stuffy nose, sore throat, and fever over 100 °F.
Approved Use
FLUMIST is a vaccine that is sprayed into the nose to help protect against influenza. It can be used in children, adolescents, and adults ages 2 through 49 years. FLUMIST may not prevent influenza in everyone who gets vaccinated.
Please see full Prescribing Information for FLUMIST, including Patient Information.
You may report side effects related to AstraZeneca products.
Notes
Influenza
On average, about
About FLUMIST Live Attenuated Influenza Vaccine
FLUMIST is a live attenuated influenza vaccine (LAIV), which is administered as a nasal spray for the prevention of influenza. FLUMIST is an Advisory Committee on Immunization Practices (ACIP) and American Academy of Pediatrics (AAP) recommended influenza vaccine option. FLUMIST was originally approved in the US in 2003 and since then almost 200 million doses have been distributed around the world.1
Human Factors Usability Study for FluMist Self Administration
In FDA-required human factors/usability studies, AstraZeneca evaluated if individuals 18 through 49 years of age could appropriately administer FLUMIST when given instructions for use. The results showed that
AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in
References
- FluMist Prescribing Information. March 2024.
- World Health Organization. Influenza (Seasonal. URL: https://www.who.int/news-room/fact-sheets/detail/influenza(seasonal)#:~:text=There%20are%20around%20a%20billion,infections%20are%20in%20developing%20countries.
-
McLean , HQ, Peterson, SH, King, JP, Meece, JK, and Belongia, EA. School absenteeism among school-aged children with medically attended acute viral respiratory illness during three influenza seasons, 2012-2013 through 2014-2015. Influenza Other Respi Viruses. 2017; 11, 220–229. https://doi.org/10.1111/irv.12440 - Blanchet Zumofen, MH., Frimpter, J. & Hansen, S.A. Impact of Influenza and Influenza-Like Illness on Work Productivity Outcomes: A Systematic Literature Review. PharmacoEconomics 41, 253–273 (2023). https://doi.org/10.1007/s40273-022-01224-9
-
Centers for Disease Control and Prevention. Flu Vaccination Coverage,
United States , 2022–23 Influenza Season. URL: https://www.cdc.gov/fluvaxview/coverage-by-season/2022-2023.html?CDC_AAref_Val=https://www.cdc.gov/flu/fluvaxview/coverage-2223estimates.htm - Anderson EL. Recommended solutions to the barriers to immunization in children and adults. Mo Med. 2014 Jul-Aug;111(4):344-8. PMID: 25211867; PMCID: PMC6179470.
- Centers for Disease Control and Prevention. Key Facts About Influenza (Flu). URL: https://www.cdc.gov/flu/about/keyfacts.htm
-
Centers for Disease Control and Prevention. Preliminary Estimated Influenza Illnesses, Medical Visits, Hospitalizations, and Deaths in
the United States — 2022–2023 Influenza Season. URL: https://www.cdc.gov/flu-burden/php/data-vis/2022-2023.html?CDC_AAref_Val=https://www.cdc.gov/flu/about/burden/2022-2023.htm - Burgess, T.H., Murray, C.K., Bavaro, M.F., Landrum, M.L., O'bryan, T., Rosas, J.G., Cammarata, S.M., Martin, N.J., Ewing, D.F., Raviprakash, K., Mor, D., Zell, E.R., Wilkins, K.J., & Millar, E.V. (2015). Self-administration of intranasal influenza vaccine: Immunogenicity and volunteer acceptance. Vaccine, 33 32, 3894-9 . DOI:10.1016/j.vaccine.2015.06.061
View source version on businesswire.com: https://www.businesswire.com/news/home/20240920930101/en/
Media Inquiries
Brendan McEvoy +1 302 885 2677
Jillian Gonzales +1 302 885 2677
US Media Mailbox: usmediateam@astrazeneca.com
Source: AstraZeneca
FAQ
What is the new approval for FLUMIST in the US?
How will FLUMIST be available for home use?
What is the impact of seasonal influenza according to the FLUMIST press release?
What are the age restrictions for FLUMIST self-administration?
