A GUIDE FOR FLUENZ TETRA - 2020-2021 INFLUENZA SEASON
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FLUENZ TETRA ®
A GUIDE FOR
IMMUNISATION TEAMS
2020-2021
INFLUENZA SEASON
The contents of this booklet are intended for UK immunisation teams.
Prescribing Information can be found on the back page.
Please remember Fluenz Tetra has a
maximum shelf life of 18 weeks.1
Please check the expiry date (day,
month, year) on individual sprayers
before administration.1
Discard any unused vaccine at the end
of the vaccination season to prevent
the use of expired vaccine.1
Please refer to your latest local
guidelines in regards to social distancing
when planning and carrying out your
childhood flu vaccination sessions
Reference
1. Fluenz Tetra nasal spray suspension Influenza vaccine (live attenuated, nasal) Summary of Product Characteristics. https://www.medicines.org.uk/emc/product/3296/smpc.
2
Contents
Introducing Fluenz Tetra 4
Key facts 4
How is Fluenz Tetra produced? 6
What are the cohorts for the 2020-2021 flu season? 7
Who can/cannot receive Fluenz Tetra? 8
Vaccine uptake in recent flu seasons 9
Vaccine effectiveness 10
Fluenz Tetra tolerability 10
What support resources are available? 12
The importance of vaccination against flu 13
Why vaccinate children? 13
What are the 2020-2021 uptake targets? 14
Other frequently asked questions 15
3
Introducing Fluenz Tetra
Key facts
Fluenz Tetra is indicated for the prophylaxis of Annual strains:
influenza in children and adolescents from 24 months The WHO recommends that the quadrivalent vaccines
to less than 18 years of age.1 The use of Fluenz Tetra for use in the 2020-2021 northern hemisphere
should be based on official recommendations.1 influenza season contain the following:4
Fluenz Tetra is administered as a spray directly into • A/Guangdong-Maonan/SWL1536/2019 (H1N1)
the nose of the recipient (once in each nostril).1 For pdm09-like virus*
further administration information, please refer to the
• A/Hong Kong/2671/2019 (H3N2)-like virus
Summary of Product Characteristics and also the
resources on www.fluenztetra.co.uk. • B/Washington/02/2019 (B/Victoria lineage)-like virus
Fluenz Tetra is a live attenuated intranasal influenza • B/Phuket/3073/2013 (B/Yamagata lineage)-like virus
(flu) vaccine.1 Attenuated means that the live flu virus
strains in Fluenz Tetra are weakened – they are also
cold-adapted and temperature-sensitive.1,2 This means
that the viruses are adapted to cold so that they
multiply in the lower temperatures in the nasopharynx
to induce protective immunity.1-3
*The H1N1 strain in this year’s vaccine is: A/Hawaii/66/2019 MEDI 326775 (confirmed as an
A/Guangdong-Maonan/SWL1536/2019 pdm09-like virus)1 which complies with the WHO
recommendation (Northern Hemisphere) and EU decision for 2020/21 season4,5
References
1. Fluenz Tetra nasal spray suspension Influenza vaccine (live attenuated, nasal) Summary of
Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/3296/smpc.
2. Department of Health. Immunisation Against Infectious Disease. (The Green Book.)
Chapter 19: Influenza. London: The Stationery Office. April 2019. Available at: https://
assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/
file/796886/GreenBook_Chapter_19_Influenza_April_2019.pdf. 3. Murphy BR, Coelingh K.
Viral Immunol. 2002;15(2):295-323. 4. World Health Organization. Influenza. Recommended
composition of influenza virus vaccines for use in the 2020-2021 northern hemisphere influenza
season. 28 February 2020. Available at: https://www.who.int/influenza/vaccines/virus/
recommendations/2020-21_north/en/. 5. European Medicines Agency. Biologics Working
Party Ad hoc Influenza Working Group. EMA/CHMP/BWP/134670/2020. 08 May 2020.
Available at: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/
biologics-working-party-bwp-ad-hoc-influenza-working-group-amended-european-union-
recommendations/2021_en.pdf.
4
Fluenz Tetra presentation
Supplied as a 0.2 ml suspension in a single-use nasal applicator.1 Each pack of 10 vaccine
applicators1 is 106 mm (length) by 176 mm (width) by 29 mm (depth).
Rubbertip
Rubber tipprotector
protector
Rubber tip protector
Rubber tip protector Barre
Rubber tip protector
Barrel Barrel
Dose Barrel
Barrel divider
Vaccine
Dose
divider Vaccine
Vaccine
EXP XX/XX/XX
EXP XX/XX/XX
Plunger Vaccine
Vaccine EXP XX/XX/XX
Plunger
If you have any questions about Fluenz Tetra, please contact
AstraZeneca Medical Information on 0800 783 0033 or
email: Medical.InformationUK@astrazeneca.com, or visit their
website: medicalinformation.astrazeneca.co.uk
Reference
1. Fluenz Tetra nasal spray suspension Influenza vaccine (live attenuated, nasal) Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/3296/smpc.
5 5
How is Fluenz Tetra produced?
Oct-Jan Nov-Mar
Deliveries continue to
Collection of global
the end customer; majority
data from prior
of vaccination takes place
season; assess
strain performance
Sept-Oct
Every batch to be used in the
Feb-Mar
UK is tested and then
released by an WHO identifies virus
independent laboratory; strains for inclusion in
Public Health England next season’s vaccine
open ordering; deliveries begin
Deliveries Planning
Aug Testing Jan-Jul
Summary of Product & Release Production Bulk vaccine manufacturing
Characteristics for of each individual
current strains issued strain; testing
by regulators of potency
Jul May-Sept
Clinical trials to Strains are added
ensure safety together to make
and immune final bulk vaccine;
response to vaccine sprayers filled
For illustrative purposes only; these timings are approximate and may vary year-on-year
6
What are the cohorts for the
2020-2021 flu season?
The NHS Seasonal Flu Immunisation Programme offers a free nasal spray
flu vaccine to all eligible children in England aged 2 and 3 years old, school
children in Reception to Year 7, and those clinically at risk aged 2-17 years.*1
There may be some variance across the UK within the other devolved
nations: please check the respective communications for Wales, Northern
Ireland and Scotland.
If a child is not eligible for the nasal spray flu vaccine, they may
be offered an alternative injectable vaccine.1
* For definitions of clinically at-risk please refer to Chapter 19 of The Green Book.2 Age eligibility as of 31st August 2020.
References
1. Whitty C, Doyle Y & Powis S. The national flu immunisation programme 2020 to 2021- update. 05 August 2020. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/
attachment_data/file/907149/Letter_annualflu_2020_to_2021_update.pdf. 2. Department of Health. Immunisation Against Infectious Disease. (The Green Book.) Chapter 19: Influenza. London: The Stationery Office.
April 2019. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/796886/GreenBook_Chapter_19_Influenza_April_2019.pdf.
7
Who can/cannot receive Fluenz Tetra?
Fluenz Tetra is indicated for prophylaxis of influenza in children and adolescents from 24 months to
Other warnings and precautions for use:1
Close association with severely immunocompromised Gelatine: This nasal spray flu vaccine contains a highly
individuals (e.g. bone marrow transplant recipients processed form of gelatine (porcine, derived from pigs),1
requiring isolation) should be avoided for vaccine which is used globally in many essential medicines.2
recipients as far as possible for 1–2 weeks Very sensitive scientific tests have shown that the flu
following vaccination.1 vaccine does not contain any detectable DNA from pigs.
This analysis indicates that the gelatine is so degraded
Flu antivirals may potentially affect the efficacy of the
that the original source cannot be identified.3
vaccine.1 Therefore, the vaccine should not be administered
until at least 48 hours after flu antivirals are stopped.1 Flu Some faith groups accept the use of porcine gelatine
antivirals may also affect the response to the vaccine if in medical products2 – the decision is, of course, up
taken in the two weeks following vaccination.1 to the parents or guardians of your patient. For further
information about porcine gelatine and the nasal
Severe asthma and active wheezing: Fluenz Tetra
influenza vaccine, see2 Vaccines and porcine gelatine:
should not be administered to children and adolescents
https://assets.publishing.service.gov.uk/government/
with severe asthma or active wheezing because these
uploads/system/uploads/attachment_data/file/751199/
individuals have not been adequately studied in
Vaccines_porcine_gelatine.pdf.
clinical studies.1
Pregnancy and breast-feeding: Fluenz Tetra is not
Salicylate therapy: Children or adolescents receiving
recommended during pregnancy and should not
salicylate therapy must not be given Fluenz Tetra as
be used during breast-feeding.1
there is an association between the use of salicylates
and Reye’s syndrome during influenza infection.1 For the
same reason, salicylates must not be given for 4 weeks
following vaccination unless medically indicated.1
Vaccine uptake in recent flu seasons
In the 2019-20 season in England, an estimated 2,876,531 out of 4,764,192 eligible children in school
(reception and years 1-6) were vaccinated with an influenza vaccine,* giving a vaccine uptake of 60.4%,
compared with 60.8% in 2018-19 (reception and years 1-5).4
For 2-3 year olds vaccinated in GP surgeries, an estimated 590,041 out of 1,346,654 eligible children
were vaccinated with an influenza vaccine* in the 2019-20 season, giving a vaccine uptake of 43.8%4
This compares with 44.9% in the 2018-19 season.5
*This figure includes children who were vaccinated with either LAIV (nasal spray) or IIV (an injection given to those unsuitable for a nasal spray vaccine)
References
1. Fluenz Tetra nasal spray suspension Influenza vaccine (live attenuated, nasal) Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/3296/smpc. 2. Public Health England:
Vaccines and porcine gelatine: 2019. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/824013/PHE_vaccines_porcine_gelatine.pdf. 3. Public Health
England. The children’s flu vaccination programme, the nasal flu vaccine. Fluenz and porcine gelatine. Your questions answered. December 2014. Available at: https://assets.publishing.service.gov.uk/government/
uploads/system/uploads/attachment_data/file/386842/2902998_PHE_FluPorcine_QAforParents_FINAL_CT.pdf. 4. Public Health England. Seasonal influenza vaccine uptake in children of primary school age: winter
season 2019 to 2020. Final data for 1 September 2019 to 31 January 2020. June 2020. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/894772/
Childhood_flu_annual_report_2019_20.pdf 5. Public Health England. Seasonal influenza vaccine uptake in GP patients: winter season 2019 to 2020. Final data for 1 September 2019 to 29 February 2020. June 2020.
Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/894970/Annual-Report_SeasonalFlu-Vaccine_GPs_2019-20_FINAL.PDF.
9
Vaccine effectiveness Fluenz Tetra tolerability
Due to the changing nature of influenza viruses, WHO Fluenz Tetra was licensed based on trivalent Fluenz
monitors their epidemiology worldwide and makes vaccine tolerability data.5 The tolerability for Fluenz is
recommendations on the strains to be included for the relevant to Fluenz Tetra because both use the same
forthcoming winter (for both the northern and southern manufacturing process. The only difference between
hemispheres).1,2 Influenza vaccines are then them is the addition of a fourth influenza strain
manufactured using virus strains which are in (a second B strain) to Fluenz Tetra.5
line with these recommendations.1,3
In clinical studies, the tolerability profile of Fluenz Tetra
The effectiveness of flu vaccines varies from year to was similar to that of Fluenz.5 Safety data regarding the
year, depending on variables such as the closeness use of Fluenz Tetra are based on data from Fluenz Tetra
of the match between the composition of a vaccine clinical studies in 2,231 children and adolescents 2 to
and the circulating strains, the type of vaccine and 17 years of age, Fluenz clinical studies in over 29,000
the age of the individual being vaccinated.1 children and adolescents 2 to 17 years of age and
Fluenz post-authorisation safety studies in over 84,000
Detailed information on the vaccine effectiveness
children and adolescents 2 to 17 years of age.5
of Fluenz Tetra can be found here:
Additional experience has occurred with marketed
https://www.gov.uk/government/publications/
use of Fluenz.5
influenza-vaccine-effectiveness-seasonal-estimates.
Since the programme started in 2013, Public Health
England (PHE) continues to recommend the nasal
spray flu vaccine as part of the childhood influenza
vaccination programme.4
References
1. Department of Health. Immunisation Against Infectious Disease. (The Green Book.) Chapter 19: Influenza. London: The Stationery Office. April 2019. Available at: https://assets.publishing.service.gov.uk/government/
uploads/system/uploads/attachment_data/file/796886/GreenBook_Chapter_19_Influenza_April_2019.pdf. 2. World Health Organization. Influenza. 2019. Available at: https://www.who.int/influenza/en/. (Accessed
July 2019). 3. World Health Organization. Influenza. Recommended composition of influenza virus vaccines for use in the 2020-2021 northern hemisphere influenza season. 28 February 2020. Available at: https://
www.who.int/influenza/vaccines/virus/recommendations/2020-21_north/en/. 4. Whitty C, Doyle Y & Powis S. The national flu immunisation programme 2020 to 2021- update. 05 August 2020. Available at: https://
assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/907149/Letter_annualflu_2020_to_2021_update.pdf. 5. Fluenz Tetra nasal spray suspension Influenza vaccine (live
attenuated, nasal) Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/3296/smpc.
10The most common adverse events,* occurring
in at least 1 in 10 recipients, are:1
• Nasal congestion/rhinorrhoea
• Decreased appetite
• Malaise
Other common adverse events, which occur in
between 1 in 10 and 1 in 100 recipients, are:1
• Fever
• Muscle pain
• Headache
Uncommon side effects, which occur in
between 1 in 1,000 and 1 in 100, are:1
• Epistaxis
• Rash and hypersensitivity reactions
Occurrences of Guillain-Barré syndrome and
worsening of Leigh syndrome (mitochondrial
encephalomyopathy) have been reported very
rarely with Fluenz Tetra (both occur in fewer
than 1 in 10,000 recipients).1
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to AstraZeneca by visiting https://aereporting.astrazeneca.com or by calling 0800 783 0033.
Reference
1. Fluenz Tetra nasal spray suspension Influenza vaccine (live attenuated, nasal) Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/3296/smpc.
11What support resources are available?
There is a wide range of support materials available to download
or order from our patient and HCP websites:
• Materials for immunisation teams
www.sharegoodtimesnotflu.co.uk A wide range of materials, including flu vaccine
Comprehensive flu and vaccination awareness materials for parents/guardians is
information and resources for parents and available. They include:
immunisation teams, including educational
• Patient leaflet and dispenser (plus translations
videos and animations.
in Welsh, Polish, Punjabi, Urdu, Bengali
and Gujarati)
• Children’s educational activity sheet
www.fluenztetra.co.uk
• Practice and school managers’ guides
A hub for immunisation teams to download or order a
range of materials: • Fluenz Tetra guide for immunisation teams
• Pre-administration checklist for Fluenz Tetra
•R
oyal College of Nursing-accredited Nasal Spray
• Administration guide for Fluenz Tetra
Learning module
• Post-administration information tear-off pad
The RCN certificate will be emailed to you on
completion of the module. If you have already taken to provide to patients
the module in past years, you can refresh your • Post-vaccination stickers for patients
knowledge by revisiting the e-learning module, • Teaching and learning toolkit with versions for Early
section-by-section. Years, Foundation Stage and Key Stages 1 and 2
12The importance of vaccination against flu Why vaccinate children? Seasonal flu has an annual incident rate estimated at The highest rates of GP consultations for 5%–10% in adults and 20%–30% in children, globally.1 Influenza A were seen in children
What are the 2020-2021
uptake targets?
NHS England is aiming to increase vaccine
uptake rates, to a target of at least 75% in eligible
pre-school children, and at least 75% in eligible
school-aged children.*1
*There may be some variance across the UK within the other devolved nations: please check the respective communications for Wales, Northern Ireland and Scotland.
References
1. Whitty C, Doyle Y & Powis S. The national flu immunisation programme 2020 to 2021- update. 05 August 2020. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/
file/907149/Letter_annualflu_2020_to_2021_update.pdf.
14Other frequently asked questions
For answers to questions asked frequently by immunisation teams
and their patients, please see www.fluenztetra.co.uk/faqs.
Examples include:
Further questions immunisation teams may have:
• What can I do to improve vaccination uptake?
• How effective has the vaccination programme been since it
was launched?
• Can Fluenz Tetra be co-administered with other live vaccines?
• Once Fluenz Tetra has been removed from the fridge,
can it be returned to the fridge for later use?
• How and when should I order Fluenz Tetra?
• What training is available for Fluenz Tetra administration?
• Expired Fluenz Tetra has been inadvertently
administered. What should I do?
Questions patients/guardians may ask:
• Is Fluenz Tetra the only vaccine against flu?
• Does Fluenz Tetra contain thiomersal?
• Is there any latex in the Fluenz Tetra applicator?
• What are the symptoms of flu vs the common cold?
• My child was vaccinated last year. Do they need
a vaccination this year?
• Could my child get flu after being vaccinated?
15Prescribing Information FLUENZ® TETRA nasal spray suspension Influenza vaccine (live responses to measles, mumps, varicella, orally-administered poliovirus or attenuated, nasal) trivalent Fluenz have been observed. Immune response to rubella vaccine was Consult Summary of Product Characteristics before prescribing. significantly altered. This might not be of clinical relevance with the two dose Indication: Prophylaxis of influenza in individuals 24 months to less than 18 years immunisation schedule of the rubella vaccine. Fluenz Tetra (influenza vaccine- of age. Presentation: Nasal spray, suspension. Dosage and administration: live attenuated, nasal) is identical to trivalent Fluenz with the only difference 0.2ml (administered as 0.1ml per nostril). Children not previously vaccinated being the addition of a fourth strain (a second B strain) to Fluenz Tetra. against seasonal influenza should be given a second dose after an interval of Co-administration of Fluenz Tetra with inactivated vaccines has not been at least 4 weeks. Should not be used in individuals below 24 months of age studied. Concurrent use with antiviral agents active against influenza A and/ because of safety concerns. Method of administration: Nasal administration or B viruses has not been evaluated. Based upon the potential for influenza only. Do not inject Fluenz Tetra. Contraindications: Hypersensitivity to antiviral agents to reduce the effectiveness of Fluenz Tetra, it is recommended the active substances, any of the excipients (e.g. gelatin), gentamicin (a not to administer the vaccine until 48 hours after the cessation of influenza possible trace residue). Severe allergic reaction (e.g. anaphylaxis) to eggs or antiviral therapy. Administration of influenza antiviral agents within two weeks to egg proteins (e.g. ovalbumin). Children and adolescents who are clinically of vaccination may affect the response of the vaccine. If influenza antiviral immunodeficient due to conditions or immunosuppressive therapy: (acute and agents and Fluenz Tetra are administered concomitantly, revaccination chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune should be considered based on clinical judgment. Fertility, Pregnancy and deficiencies; and high-dose corticosteroids). Not contraindicated for use in Lactation: Not recommended during pregnancy. Should not be used during individuals with asymptomatic HIV infection; or individuals who are receiving breast-feeding. No data on the effects of Fluenz Tetra on male and female topical/inhaled corticosteroids or low-dose systemic corticosteroids or those fertility. Undesirable effects: Refer to SmPC for complete information on side receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency. effects. Very common: decreased appetite, nasal congestion/rhinorrhoea, Contraindicated in children and adolescents younger than 18 years of age malaise. Common: headache, myalgia, pyrexia. Uncommon: hypersensitivity receiving salicylate therapy because of the association of Reye’s syndrome reactions (including facial oedema, urticaria and very rare anaphylactic with salicylates and wild-type influenza infection. Warnings and precautions: reactions), epistaxis, rash. Very rare reports of Guillain-Barré syndrome Clearly record name and batch number of administered product to improve and exacerbation of symptoms of Leigh syndrome (mitochondrial traceability. Medical treatment and supervision should always be readily encephalomyopathy) have also been observed in the post-marketing setting. available in case of an anaphylactic event following administration. Fluenz Tetra Legal category: POM. Marketing authorisation number: EU/1/13/887/004 should not be administered to children and adolescents with severe asthma or Presentation & basic NHS cost: Fluenz Tetra nasal spray suspension pack of active wheezing because these individuals have not been adequately studied 10: £180.00 Marketing Authorisation Holder: AstraZeneca AB, SE-151 85 in clinical studies. Do not administer to infants and toddlers below 24 months Södertälje, Sweden Further information is available from: AstraZeneca UK of age because of safety concerns regarding increased rates of hospitalisation Limited, 600 Capability Green, Luton, LU1 3LU, UK. FLUENZ is a trademark of and wheezing in this population. Vaccine recipients should be informed that the AstraZeneca group of companies. Fluenz Tetra is an attenuated live virus vaccine and has the potential for Date of preparation: 03/2020 transmission to immunocompromised contacts. Vaccine recipients should INF 20 0002 attempt to avoid, close association with severely immunocompromised individuals (e.g. bone marrow transplant recipients requiring isolation) for 12 weeks following vaccination. Where contact is unavoidable, the potential risk of transmission of the influenza vaccine virus should be weighed against Adverse events should be reported. the risk of acquiring and transmitting wild-type influenza virus. No data exists Reporting forms and information can be found at regarding the safety in children with unrepaired craniofacial malformations. www.mhra.gov.uk/yellowcard. Adverse events should also Drug interactions: Salicylates must not be used for 4 weeks following be reported to AstraZeneca by visiting https://aereporting. vaccination unless medically indicated. Co-administration of trivalent Fluenz astrazeneca.com or by calling 0800 783 0033. with the live attenuated vaccines: No clinically meaningful changes in immune ©AstraZeneca 2020 Date of preparation: September 2020. GB-22544
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