AND FLUENZ TETRA NASAL SPRAY VACCINE · 2018. 11. 5. · • Fluenz Tetra is a seasonal influenza vaccine that should be administered annually, during the autumn, ahead of the flu

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INFLUENZA IN CHILDRENAND FLUENZ TETRA NASAL SPRAY VACCINE

Prescribing Information is available at the end of this presentation.

www.fluenztetra.co.uk


RNAOVERVIEW OF INFLUENZA

• Influenza is an acute viral infection in the respiratory tract1

• There are three types of influenza virus: A, B and C (A and B are responsible for most clinical illness)1

• New influenza strains emerge when viral RNA change during replication2

• Every year the World Health Organization (WHO) recommends which strains should be included in influenza vaccines1

• Influenza occurs globally with an annual attack rate estimated at 5%-10% in adults and 20%-30% in children3

• Worldwide, annual epidemics are estimated to result in about 3 to 5 million cases of severe illness and about 290,000 to 650,000 deaths4

REFERENCES: 1. Department of Health. Immunisation Against Infectious Disease. (The Green Book.) Chapter 19: Influenza. London: The Stationery Office. 2017. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/663694/Greenbook_chapter_19_Influenza_.pdf. Last accessed July 2018. 2. Treanor J. N Eng J Med 2004;350(3): 218–220. 3. World Health Organization. Biologicals. Influenza. November 2017. www.who.int/biologicals/vaccines/influenza/en/. Last accessed June 2018. 4. World Health Organization. Influenza (Seasonal). 31 January 2018. Available at: http://www.who.int/en/news-room/fact-sheets/detail/influenza-(seasonal). Last accessed June 2018.

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http://www.who.int/biologicals/vaccines/influenza/en/


HOW PROTECTING CHILDREN COULD REDUCE THE OVERALL BURDEN OF INFLUENZA

• Influenza causes absenteeism and lost productivity, with children missing school or nursery and their parents or guardians missing work1

• Children contribute considerably to the spread of flu to their nursery and school friends, families, and communities by shedding greater quantities of the virus for longer periods of time than adults2,3

• A dynamic transmission model has shown that vaccinating as few as 50% of 2 to 18 year olds with live attenuated influenza vaccine (LAIV) could result in a substantial reduction (up to 84%) in the annual incidence of influenza-related morbidity and mortality across the population4

• The dynamic transmission model has also shown that vaccinating 80% of 2 to 18 year olds could reduce general practice consultations, hospitalisations and deaths arising from influenza A and B infections by up to 95%4

3REFERENCES: 1. Ambrose CS, Antonova EN. Eur J Clin Microbiol Infect Dis 2014;33(4): 569-575. 2. Usonis V, et al. BMC Infect Dis 2010;10: 168. 3. Heikkinen T, et al. Eur J Pediatr 2006;165: 223-228. 4. Pitman RJ, et al. Vaccine2012;30: 1208-1224. 5. Pitman RJ. Vaccine 2013;31: 927-942.

Paediatric vaccination of 2 to 18 year olds appears to be a highly cost-effective intervention that directly protects those targeted

for vaccination, with indirect protection extending to both the

very young and the elderly5


THE NATIONAL INFLUENZA IMMUNISATION PROGRAMME TIMELINE

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REFERENCES: 1. Department of Health. Immunisation Against Infectious Disease. (The Green Book.) Chapter 19: Influenza. London: The Stationery Office. 2017. 2. Allsup S, et al. Vaccine 2004;23(5):639-645. 3. Shindo N, Briand S. Bulletin of the World Health Organization. 2012;90:245-247A. Available at: http://www.who.int/bulletin/volumes/90/4/12-104653/en/. Last accessed July 2018. 4. Department of Health. The influenza immunisation programme 2010/11. 23rd June 2010. 5. Pharmafile. AstraZeneca’s Fluenz chosen for wider flu immunisation. 26 July 2012. 6. Joint Committee on Vaccination and Immunisation. Statement on the annual influenza vaccination programme - extension of programme to children, 25 July 2012. 7. Department of Health, Public Health England & NHS England. Flu Plan Winter 2014/15. 8. Department of Health, Public Health England, NHS England. The national flu immunisation programme 2016/17. 9. Department of Health, Public Health England & NHS England. The national flu immunisation programme 2017/18. 10. Department of Health / Public Health England / National Health Service. Annual Flu Letter. 26 March 2018. The national flu immunisation programme 2018/19. Available at: https://assets.publishing.service. gov.uk/government/uploads/system/uploads/attachment_data/file/694779/Annual_national_flu_programme_2018-2019.pdf. Last accessed: June 2018.

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THE NATIONAL INFLUENZA IMMUNISATION PROGRAMME

• Immunisation is one of the most successful and cost-effective public health interventions and a cornerstone of public health1

• Following a recommendation in 2012 by the Joint Committee on Vaccination and Immunisation (JCVI) the annual influenza vaccination programme was extended to include all children, not just those at risk2

• The aim is to provide individual protection to the vaccinated children themselves and reduce transmission of flu across all ages2

• Implementation of the programme began the following year with pre-school children offered vaccination through GP practices and a number of pilots for school aged children. In 2015/16 the programme began nationally in primary schools in a phased roll-out starting with the youngest school-aged children first. In 2018/19 the programme will include all children aged two and three years old and those in reception class and school years 1 to 52

• In 2012 the JCVI recommended that the nasal spray vaccine (LAIV) should be offered to eligible children2

• The UK became the first country to offer a comprehensive programme to extend the influenza vaccine to all eligible children, free of charge3

REFERENCES: 1. Department of Health NHS England. Public health functions to be exercised by NHS England. Service specification No. 13A. Seasonal influenza immunisation programme for children (2014-15 programme). 2013. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/256499/13a_seasonal_influenza_children.pdf. Last accessed June 2018. 2. Department of Health / Public Health England / National Health Service. Annual Flu Letter. 26 March 2018. The national flu immunisation programme 2018/19. Available at: https://assets.publishing.service. gov.uk/government/uploads/system/uploads/attachment_data/file/694779/Annual_national_flu_programme_2018-2019.pdf. Last accessed: June 2018. 3. Gov.UK Press Release. Flu vaccination programme extended to all children. 25 July 2012. Available at: https://www.gov.uk/government/news/flu-vaccination-programme-extended-to-all-children. Last accessed June 2018.

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ANNUAL MANUFACTURING PROCESSOF INFLUENZA VACCINES

• Influenza vaccines are developed through a highly specialised manufacturing process

• The process is undertaken annually to ensure that vaccines protect against changing influenza virus strains

• The World Health Organization (WHO) recommend which virus strains are most likely to cause impact in the upcoming winter season (in the Northern & Southern Hemisphere)1

REFERENCES: 1. Recommended composition of influenza virus vaccines for use in the 2018-2019 northern hemisphere influenza season. Available at: www.who.int/influenza/vaccines/virus/recommendations/en. Last accessed: May 2018. 6


ANNUAL MANUFACTURING PROCESSOF INFLUENZA VACCINES

• The influenza nasal spray vaccine is grown in eggs1

• Once the strains are known, the complex manufacturing process begins:1

REFERENCES: 1. Department of Health. Immunisation Against Infectious Disease. (The Green Book.) Chapter 19: Influenza. London: The Stationery Office. 2017. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/663694/Greenbook_chapter_19_Influenza_.pdf. Last accessed July 2018. 7


INTRODUCING FLUENZ TETRA

• Fluenz Tetra is a live attenuated intranasal influenza vaccine (LAIV) containing four live vaccine strains of influenza1

• Administered as a spray directly into the nose of the recipient, Fluenz Tetra is a needle-free influenza vaccine available in the UK1,2

• Fluenz Tetra is indicated to help prevent influenza in individuals 24 months to


FLUENZ TETRA NASAL SPRAY1

• As influenza virus strains tend to change from year-to-year, it is necessary to vaccinate each year in order to offer effective protection against influenza

• Fluenz Tetra is a seasonal influenza vaccine that should be administered annually, during the autumn, ahead of the flu season

• Patients need to be reminded to return annually for a influenza vaccine

• Fluenz Tetra is administered as a nasal spray; it must not be injected

REFERENCES: 1. Fluenz Tetra Summary of Product Characteristics. https://.www.medicines.org.uk/emc. Accessed June 2018. 9

https://.www.medicines.org.uk/emc


HOW FLUENZ TETRA WORKS

Fluenz Tetra is a live attenuated influenza vaccine (LAIV)

REFERENCES: 1. Murphy BR & Coelingh KC. Viral Immunol 2002;15: 295-323. 2. Ambrose CS, et al. Vaccine 2012;30: 886-892.10

1 Replication of the vaccine1 2 Immune status after 10–14 days1

Lungs ≈37˚C

Fluenz Tetra is sensitive to temperature:No replication in the lungs

Activation of the immune system

The live flu virus strains in Fluenz Tetra are cold-adapted, temperature-sensitive, and weakened. As a result, they replicate in the nasopharynx1,2

Live flu virus strains induce protective immunity. The strains in Fluenz Tetra are updated every year based on WHO recommendations

IgA-antibodies on the mucous membraneSystemic

IgG-antibodies

Cellular immune response


RELATIVE EFFICACY OF FLUENZ VSTRIVALENT INACTIVATED VACCINE (TIV)

Compared with TIV, Fluenzrecipients experienced 48% fewer cases of influenza caused by any strain1

A meta-analysis was conducted using five placebo-controlled trials (4 were 2-season trials) and three single-season TIV controlled trials to evaluate the efficacy of LAIV against culture-confirmed influenza illness compared with placebo or trivalent inactivated vaccine

REFERENCES: 1. Ambrose CS, et al. Vaccine 2012;30: 886-892.11

Adapted from Ambrose CS, et al. 2012

Flu caused by any strain

FluenzTIV


EFFICACY OF FLUENZ TETRA

A study comparing the safety and immunogenicity of Fluenz Tetra with that of two trivalent Fluenz vaccines, each containing a B strain from a different lineage, in children aged 2 to 17 years demonstrated:1

REFERENCES: 1. Block SL, et al. Pediatr Infect Dis J 2012;31(7): 745-751.12

• Fluenz Tetra had an immunogenicity and tolerability profile comparable with those of Fluenz (except fever which was more common after dose 1 in Fluenz Tetra vs. Fluenz - 5.1% vs. 3.1%)

• Fluenz Tetra induced robust antibody titres to influenza B strains from both lineages and met the pre-determined definition of non-inferiority for all four strains (2 Type A + 2 Type B)

• Clinical experience with Fluenz is relevant to Fluenz Tetra because both vaccines are manufactured using the same process and have overlapping compositions


FLUENZ TETRA STORAGE1

• Store in a refrigerator (2⁰C − 8⁰C)• Do not freeze• Keep the nasal applicator in the outer carton in

order to protect from light• Before use, the vaccine may be taken out of the

refrigerator once for a maximum period of 12 hours at a temperature not above 25⁰C

• If the vaccine has not been used after this 12 hour period, it should be discarded

REFERENCES: 1. Fluenz Tetra Summary of Product Characteristics. https://.www.medicines.org.uk/emc. Accessed June 2018.13



PRE-ADMINISTRATION CHECKLIST FORFLUENZ TETRA NASAL SPRAY VACCINE1

Check that the following eight questions have been asked before administering Fluenz Tetra:

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1. Age – Is the recipient at least 24 months and less than 18 years old?

2. Is the recipient allergic to any of the following?• Severe allergic reaction (e.g.

anaphylaxis) to eggs or to egg proteins (e.g. ovalbumin)

• Gentamicin• Gelatin (porcine, Type A)• Sucrose• Dibasic potassium phosphate • Monobasic potassium phosphate• Arginine hydrochloride• Monosodium glutamate monohydrate• Water for injections

3. Is the recipient clinically immunodeficient?4. Is the recipient in close contact with people

who are immunodeficient?5. Does the recipient have severe asthma or

active wheezing?6. Is the recipient on salicylate therapy

(e.g. aspirin)?7. Is the recipient pregnant or breastfeeding?8. Is the recipient receiving influenza antivirals?

If the response is ‘Yes’ to any of the above questions, please refer to the ‘Pre-administration checklist for Fluenz Tetra nasal spray vaccine’ before administering the nasal spray.

REFERENCES: 1. Fluenz Tetra Summary of Product Characteristics. https://.www.medicines.org.uk/emc. Accessed June 2018.



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2

3

FLUENZ TETRA ADMINISTRATION1

15REFERENCES: 1. Fluenz Tetra Summary of Product Characteristics. https://.www.medicines.org.uk/emc. Accessed June 2018.

Check the vaccineBefore the vaccine is administered:

Check its appearance

This can vary, but should fit the following description: colourless to pale yellow, clear to opalescent suspension with or without small white particles.

Fluenz Tetra has a maximum shelf life of 18 weeks. Check the expiry date (day, month, year) on individual sprayers before administration. Discard any unused vaccine at the end of the vaccination season to prevent use of expired vaccine.

Prepare the applicatorPrepare the applicator by removing the rubber tip protector.

Do not remove the dose-divider clip at the other end of the applicator.This splits the 0.2 ml dose so that an equal 0.1 ml quantity can be delivered to both nostrils.

Position the applicatorWith the recipient in an upright position, place the tip just inside the first nostril to ensure the vaccine is delivered into the nose.



FLUENZ TETRA ADMINISTRATION1

16REFERENCES: 1. Fluenz Tetra Summary of Product Characteristics. https://.www.medicines.org.uk/emc. Accessed June 2018. 2. Department of Health. Immunisation Against Infectious Disease. (The Green Book.) Chapter 19: Influenza. London: The Stationery Office. 2017. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/663694/Greenbook_chapter_19_Influenza_.pdf

4 Depress the plungerWith a single motion, depress the plunger as quickly as possible until the dose-divider clip stops it going any further.

The recipient can breathe normally when they are receiving the vaccine, they do not have to actively inhale or sniff.

Please note: The vaccine does not need to be re-administered if the patient sneezes, or blows their nose following administration.2

Remove the dose-divider clipIn order to administer the vaccine to the second nostril, pinch the dose-divider clip to remove it from the applicator.

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6 Spray into the other nostrilPlace the tip just inside the second nostril and with a single motion depress the plunger as quickly as possible to deliver the remaining 0.1 ml dose of the vaccine.

Make sure any unused product or waste material is disposed of in accordance with local requirements for medical waste.



POST-ADMINISTRATION

When should a second dose be administered?

The Fluenz Tetra Summary of Product Characteristics states that for children who have not previously been vaccinated against seasonal influenza, a second dose of Fluenz Tetra should be given after an interval of at least 4 weeks.1


Please Note: Green Book and national guidelines advice may differ and should be checked. Please refer to: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/663694/Greenbook_chapter_19_Influenza_.pdf.



TOLERABILITY PROFILE

• Approximately 125.6 million doses of Fluenz/Flumist & Fluenz Tetra/FlumistQuadrivalent have been distributed worldwide since the 2003/2004 flu season until the end of the 2017/2018 flu season1

• In clinical studies, the tolerability profile of Fluenz Tetra was similar to the tolerability profile of Fluenz2

REFERENCES: 1. AstraZeneca. Data on File FLU-018-JUL2018 . 2. Fluenz Tetra Summary of Product Characteristics. https://.www.medicines.org.uk/emc. Accessed June 2018. 18



FLUENZ TETRA CONTRAINDICATIONS

Fluenz Tetra recipients should be at least 24 months and less than 18 years of age1

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Patients should not receive Fluenz Tetra if they are hypersensitive (allergic) to:

• Severe allergic reaction (e.g. anaphylaxis) to eggs or to egg proteins (e.g. ovalbumin)

• Gentamicin• Sucrose• Dibasic potassium phosphate• Monobasic potassium phosphate• Gelatin (porcine, Type A)• Arginine hydrochloride• Monosodium glutamate monohydrate• Water for injections

REFERENCES: 1. Fluenz Tetra Summary of Product Characteristics. https://.www.medicines.org.uk/emc. Accessed June 2018.

Children and adolescents who are clinically immunodeficient, or receiving immunosuppressive therapy must not be given Fluenz Tetra, this includes:

• Acute and chronic leukaemias• Lymphoma• Symptomatic HIV infection• Cellular immune deficiencies• High-dose corticosteroids• Fluenz Tetra is also contraindicated

in children and adolescents younger than 18 years of age receiving salicylate therapy

As with all vaccines, appropriate medical treatment and supervision should be at hand in case of an anaphylactic reaction; these have been reported infrequently with this vaccine1



FLUENZ TETRA IS NOT RECOMMENDED FOR CHILDREN WITH SEVERE ASTHMA OR ACTIVE WHEEZING

Fluenz Tetra SmPC:1

Fluenz Tetra should not be administered to children and adolescents with severe asthma or active wheezing because these individuals have not been adequately studied in clinical studies

Influenza: The Green Book clarifies the definition of severe asthma patients as:2

• Those with a history of active wheezing in the past 72 hours (or increased bronchodilator use in the previous 72 hours) at the time of vaccination who are currently taking or have been prescribed oral steroids in the last 14 days

• Who are currently taking a high dose of an inhaled steroid – Budesonide >800 mcg/day or equivalent (e.g. Fluticasone >500 mcgs/day) – such children should only be given LAIV on the advice of their specialist

REFERENCES: 1. Fluenz Tetra Summary of Product Characteristics. https://.www.medicines.org.uk/emc. Accessed June 2018. 2. Department of Health. Immunisation Against Infectious Disease. (The Green Book.) Chapter 19: Influenza. London: The Stationery Office. 2017. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/663694/Greenbook_chapter_19_Influenza_.pdf 20

Please Note: Green Book and national guidelines advice may differ and should be checked. Please refer to: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/663694/Greenbook_chapter_19_Influenza_.pdf.



ADVICE FOR FAITH COMMUNITIES

• The nasal spray influenza vaccine contains a highly processed form of gelatine (porcine, derived from pigs), which is used globally in many essential medicines1

• Some faith groups accept the use of porcine gelatine in medical products- the decision to have the nasal spray influenza vaccine is, of course, up to the parents/guardians of a child

• For further information about porcine gelatine and the nasal influenza vaccine, see https://www.gov.uk/government/news/vaccines-and-gelatine-phe-response




FLUENZ® TETRA▼nasal spray suspension Influenza vaccine (live attenuated, nasal)Consult Summary of Product Characteristics before prescribing.Indication: Prophylaxis of influenza in individuals 24 months to less than 18 years of age. Presentation: Nasal spray, suspension. Dosage and administration: 0.2ml (administered as 0.1ml per nostril). Children not previously vaccinated against seasonal influenza should be given a second dose after an interval of at least 4 weeks. Should not be used in individuals below 24 months of age because of safety concerns. Method of administration: Nasal administration only. Do not inject FLUENZ TETRA.Contraindications: Hypersensitivity to the active substances, any of the excipients (e.g. gelatin), gentamicin (a possible trace residue). Severe allergic reaction (e.g. anaphylaxis) to eggs or to egg proteins (e.g. ovalbumin). Children and adolescents who are clinically immunodeficient due to conditions or immunosuppressive therapy: (acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and high-dose corticosteroids). Not contraindicated for use in individuals with asymptomatic HIV infection; or individuals who are receiving topical/inhaled corticosteroids or low-dose systemic corticosteroids or those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency. Contraindicated in children and adolescents younger than 18 years of age receiving salicylate therapy because of the association of Reye’s syndrome with salicylates and wild-type influenza infection.Warnings and precautions: Medical treatment and supervision should always be readily available in case of an anaphylactic event following administration. FLUENZ TETRA should not be administered to children and adolescents with

FLUENZ TETRA PRESCRIBING INFORMATION

22© AstraZeneca 2018Date of preparation: July 2018. GB-12419

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 on 0800 783 0033.

If influenza antiviral agents and FLUENZ TETRA are administered concomitantly, revaccination should be considered based on clinical judgment. Fertility, Pregnancy and Lactation: Not recommended during pregnancy. Should not be used during breast-feeding. No data on the effects of FLUENZ TETRA on male and female fertility. Undesirable effects: Refer to SmPC for complete information on side effects. Very common: decreased appetite, headache, nasal congestion/rhinorrhoea, malaise. Common: myalgia, pyrexia. Uncommon: hypersensitivity reactions (including facial oedema, urticaria and very rare anaphylactic reactions), epistaxis, rash. Very rare reports of Guillain-Barré syndrome and exacerbation of symptoms of Leigh syndrome (mitochondrial encephalomyopathy) have also been observed in the post-marketing setting. Legal category: POM. Marketing authorisation number:EU/1/13/887/004 Presentation & basic NHS cost: Fluenz Tetra nasal spray suspension pack of 10: £180.00 Marketing Authorisation Holder: AstraZeneca AB, SE-151 85 Södertälje, Sweden Further information is available from: AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, UK.FLUENZ is a trademark of the AstraZeneca group of companies. Date of preparation: 03/2017 INF 17 0017

severe asthma or active wheezing because these individuals have not been adequately studied in clinical studies. Do not administer to infants and toddlers below 24 months of age because of safety concerns regarding increased rates of hospitalisation and wheezing in this population. Vaccine recipients should be informed that FLUENZ TETRA is an attenuated live virus vaccine and has the potential for transmission to immunocompromised contacts. Vaccine recipients should attempt to avoid, close association with severely immunocompromised individuals (e.g. bone marrow transplant recipients requiring isolation) for 1-2 weeks following vaccination. Where contact is unavoidable, the potential risk of transmission of the influenza vaccine virus should be weighed against the risk of acquiring and transmitting wild-type influenza virus. No data exists regarding the safety in children with unrepaired craniofacial malformations. Drug interactions: Salicylates must not be used for 4 weeks following vaccination unless medically indicated. Co-administration of FLUENZ TETRA with the live attenuated vaccines: No clinically meaningful changes in immune responses to measles, mumps, varicella, orally-administered poliovirus or FLUENZ TETRA have been observed. Immune response to rubella vaccine was significantly altered. This might not be of clinical relevance with the two dose immunisation schedule of the rubella vaccine. Co-administration of FLUENZ TETRA with inactivated vaccines has not been studied. Concurrent use with antiviral agents active against influenza A and/or B viruses has not been evaluated. Based upon the potential for influenza antiviral agents to reduce the effectiveness of FLUENZ TETRA, it is recommended not to administer the vaccine until 48 hours after the cessation of influenza antiviral therapy. Administration of influenza antiviral agents within two weeks of vaccination may affect the response of the vaccine.

INFLUENZA IN CHILDRENOVERVIEW OF INFLUENZAHOW PROTECTING CHILDREN COULD REDUCE THE OVERALL BURDEN OF INFLUENZATHE NATIONAL INFLUENZA �IMMUNISATION PROGRAMME TIMELINETHE NATIONAL INFLUENZA �IMMUNISATION PROGRAMMEANNUAL MANUFACTURING PROCESS�OF INFLUENZA VACCINESANNUAL MANUFACTURING PROCESS�OF INFLUENZA VACCINESINTRODUCING FLUENZ TETRAFLUENZ TETRA NASAL SPRAY1HOW FLUENZ TETRA WORKSrelative EFFICACY of fluenz VS�TRIVALENT INACTIVATED VACCINE (TIV)EFFICACY OF FLUENZ TETRAFLUENZ TETRA STORAGE1PRE-ADMINISTRATION CHECKLIST FOR�FLUENZ TETRA NASAL SPRAY VACCINE1FLUENZ TETRA ADMINISTRATION1FLUENZ TETRA ADMINISTRATION1POST-ADMINISTRATIONTOLERABILITY PROFILEFLUENZ TETRA CONTRAINDICATIONSFLUENZ TETRA IS NOT RECOMMENDED FOR CHILDREN WITH SEVERE ASTHMA OR ACTIVE WHEEZINGADVICE FOR FAITH COMMUNITIESFLUENZ TETRA PRESCRIBING INFORMATION

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AND FLUENZ TETRA NASAL SPRAY VACCINE · 2018. 11. 5. · • Fluenz Tetra is a seasonal influenza vaccine that should be administered annually, during the autumn, ahead of the flu