REG - AstraZeneca PLC - FluMist approved for self-administration in US

AstraZenecaAnnouncement

20/09/2024 18:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20240920:nRST1259Fa&default-theme=true

RNS Number : 1259F  AstraZeneca PLC  20 September 2024

 

20 September 2024

 

FluMist approved for self-administration in the US

 

Only influenza vaccine approved for self- or caregiver-administration at home,
expanding options for influenza protection

 

FluMist has been approved in the US as the only self-administered influenza
vaccine. FluMist, a needle-free nasal spray, was approved to be
self-administered by adults up to 49 years of age or administered by a
parent/caregiver to individuals 2-17 years of age.(1)

 

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, Chicago, US, said: "For
the first time, families and caregivers will be able to protect themselves
against influenza with a needle-free, self-administered vaccine, from the
convenience of their own home. Each year, influenza poses a significant burden
for people, society and health systems; additional tools to increase access to
vaccinations, while also reducing disparities, are critical."

 

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 hospitalisations,
complications and death.(2) Influenza has been shown to impact school
attendance and employment with 47% of days of school and 1-2 days of work
missed annually.(3,4) Vaccination rates for influenza have declined in adults
in the US since the 2020-21 season by 3.3%.(5) In a US survey, a common reason
for adults not to receive a vaccination included failure to attend regular
well-care visits, while having access to at-home vaccination options were
shown to potentially increase influenza vaccination uptake.(6)

Once available, individuals 18 and older will be able to have FluMist
delivered directly to their homes via FluMist Home. FluMist Home will utilise
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 (http://www.FluMist.com) .

 

Notes

 

Influenza

On average, about 8% of the US population becomes ill from influenza each
season, with a range of between 3 percent and 11 percent, depending on the
season.(7) During the 2022-2023 influenza season, an estimated 31 million
people developed illness from influenza, 14 million visited a healthcare
provider for influenza, with 360,000 hospitalisations, and 21,000 deaths.(8)

 

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 100% of intended
users administered a full dose. In addition, data show that efficacy,
immunogenicity and adverse events with self-administration of FluMist are
similar to that seen with HCP-administered vaccination.(1,9) The FluMist label
has been updated to provide additional instructions for ordering and
administration for eligible self and caregiver use. Children 2-8 years of age
with an uncertain vaccination history may not be eligible for caregiver use
and should consult their healthcare provider for further information.(1)

 

AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical
company that focuses on the discovery, development, and commercialisation of
prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals,
including Cardiovascular, Renal & Metabolism, and Respiratory &
Immunology. Based in Cambridge, UK, AstraZeneca's innovative medicines are
sold in more than 125 countries and used by millions of patients worldwide.
Please visit astrazeneca.com (https://www.astrazeneca.com/) and follow the
Company on social media @AstraZeneca
(https://www.linkedin.com/company/astrazeneca/) .

 

Contacts

For details on how to contact the Investor Relations Team, please click here
(https://www.astrazeneca.com/investor-relations.html#Contacts) . For Media
contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html)
.

 

References

 

1.   FluMist Prescribing Information. March 2024.

2.   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
(https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal)#:~:text=There%20are%20around%20a%20billion,infections%20are%20in%20developing%20countries)
.

3.   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 (https://doi.org/10.1111/irv.12440)

4.   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
(https://doi.org/10.1007/s40273-022-01224-9)

5.   Centers for Disease Control and Prevention. Flu Vaccination Coverage,
United States, 2022-23 Influenza Season. URL:
https://www.cdc.gov/flu/fluvaxview/coverage-2223estimates.htm
(https://www.cdc.gov/flu/fluvaxview/coverage-2223estimates.htm)

6.   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.

7.   Centers for Disease Control and Prevention. Key Facts About Influenza
(Flu). URL: https://www.cdc.gov/flu/about/keyfacts.htm
(https://www.cdc.gov/flu/about/keyfacts.htm)

8.   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/about/burden/2022-2023.htm
(https://www.cdc.gov/flu/about/burden/2022-2023.htm)

9.   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

 

 

Adrian Kemp

Company Secretary AstraZeneca PLC

 

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  REAURVNRSAUKUAR