A GUIDE FOR FLUENZ TETRA - 2020-2021 INFLUENZA SEASON

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A GUIDE FOR FLUENZ TETRA - 2020-2021 INFLUENZA SEASON
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.
A GUIDE FOR FLUENZ TETRA - 2020-2021 INFLUENZA SEASON
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.
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A GUIDE FOR FLUENZ TETRA - 2020-2021 INFLUENZA SEASON
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
A GUIDE FOR FLUENZ TETRA - 2020-2021 INFLUENZA SEASON
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.
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A GUIDE FOR FLUENZ TETRA - 2020-2021 INFLUENZA SEASON
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
A GUIDE FOR FLUENZ TETRA - 2020-2021 INFLUENZA SEASON
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
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A GUIDE FOR FLUENZ TETRA - 2020-2021 INFLUENZA SEASON
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.
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A GUIDE FOR FLUENZ TETRA - 2020-2021 INFLUENZA SEASON
Who can/cannot receive Fluenz Tetra?
    Fluenz Tetra is indicated for prophylaxis of influenza in children and adolescents from 24 months to
A GUIDE FOR FLUENZ TETRA - 2020-2021 INFLUENZA SEASON
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.
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A GUIDE FOR FLUENZ TETRA - 2020-2021 INFLUENZA SEASON
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.
10
The 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.
11
What 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

12
The 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.
14
Other 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?

15
Prescribing 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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