FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of September 2024
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
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by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information
to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
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assigned to the Registrant in connection with Rule 12g3-2(b):
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
FluMist approved for self-administration in US
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.
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 and
follow the Company on social media @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
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.
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
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
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
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
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
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
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
20 September 2024
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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