Nasal Spray Flu Vaccine Fact Sheet for Parents

Arnica Nasal Spray Flu Vaccine Fact Sheet for Parents

In October and November children in Years One, Two, and Three will be given the nasal spray
flu vaccine at school. In the UK vaccinations are not mandatory so you have the right to refuse
the vaccination if you do not want your child to have it due to safety concerns.

To ensure that children are not accidently given the vaccine without parental consent some
parents choose to keep their children off school on that day. In addition, some parents choose
to keep their children off school for the whole of that day in order that they are not potentially
breathing in air contaminated with the nasal vaccine.

Some parents also keep their children off school for three days after the flu spray is administered to other children at the school to avoid the peak shedding window and possible spreading of the flu virus.
Here is a summary of the main facts and concerns so that you can make your own informed
decision as to whether the nasal spray is something you want your child(ren) to have:

Safety
The nasal spray flu vaccine (Fluenz Tetra or FluMist Quadrivalent), currently recommended for
Early Years children (1), contains genetically modified strains of influenza with no long-term
safety studies.

Shedding (Spreading of the viruses in the vaccine)

The nasal spray flu vaccine is a live attenuated vaccine that uses a weakened pathogen to illicit
an immune response/reaction. It contains four strains of live influenza virus designed to
replicate in the nasal passages of the recipient (2).
This means that recently vaccinated children can easily ‘shed’ (spread) the same weakened pathogens to others. The issue of shedding is of particular concern to those classed as ‘at risk’ and ‘immune compromised’ such as dialysis patients, chemo and radiotherapy patients, those with rare genetic immune disorders, and anyone more susceptible to cross infection.

Given that the ‘virus has the potential for transmission’ peaking at ‘two to three days post vaccination in clinical studies’ it would be sensible for schools to administer the vaccination on a Friday, or before half term. Then those children who would prefer to avoid it can avoid the worst of the shedding, although it will sit in children’s noses for 28 days. (3)

Dr Graham Downing has found several studies that prove shedding is a serious issue.
One study found that the viruses in live vaccines are shed at levels similar to infection, with children being infectious for longer than adults. Another says that 44% of children vaccinated with the live influenza vaccine were shedding the virus and putting others at risk.
He concludes that although viral transmission is complex it has been demonstrated that infection from one person to another occurs at viral shedding levels similar to those of children post vaccination. (4, 5, 6, 7,8, 9, 10, 11)

Risk to others of flu transmission

By sneezing and touching door handles, etc, recently vaccinated children from Years One, Two,
and Three will spread the viruses around the school putting the health of staff, other pupils, and
their families at risk. Public Health England claims that shedding from a recently vaccinated
person is negligible but it has been proven, in both school and laboratory settings, that flu
vaccine strains have been transmitted to other children and staff. (12)
Even the manufacturers advise that people who are immune-compromised should not come into contact with a recently vaccinated child (13) which suggests that there is indeed risk of transmission.

Only 3% Effective

The benefits of this vaccine do not necessarily outweigh the risks because it is not known if it
even protects anyone from influenza.
In 2015 the flu vaccine was effective in just 3% of cases (14). Dr Tom Jefferson, the lead author of the Cochrane Review on Vaccine for Preventing Influenza in Healthy Children, says ‘influenza vaccines are about marketing not science’. (15, 16,17)
Belgium has recently followed the USA in discontinuing FluMist (18) and The US Centre for Disease control highlighted its ineffectiveness:
“Health officials have advised doctors not to use AstraZeneca’s FluMist in the upcoming flu season based on three years of US data showing that the nasal spray vaccine is not effective at preventing influenza. … In the past year, among children aged 2 to 17, FluMist was only 3% effective, meaning it offered ‘no protective benefit’, the CDC said. That compared with conventional flu shots, which were 63 percent effective against any flu virus among children in this age group.” (19)

School is an inappropriate setting for vaccinations

FluMist is a new vaccine and therefore has an inverted black triangle symbol (▼) displayed in
on the package leaflet, which means it requires active surveillance. It should, therefore, only be
administered in medical establishments such as GP surgeries, community health clinics, or
hospitals where a nurse will have full access to medical records. Parents should also be present
during the procedure so they can seek specific advice regarding their individual child’s health,
particularly if there are reactions to the vaccine. (20)

By administering it to children in schools, the Nasal Spray Flu Vaccine Programme directly
violates the Secretary of State’s declaration in The Health Protection (Vaccination) Regulations
2009 which states there is no provision for imposing or enabling any restriction or requirement
which has, or would have, a significant effect on a person’s rights. (21)

Are the people administering the vaccination at school going to screen children for the following issues first?

“You should not get FluMist Quadrivalent if you have a severe allergy to eggs; have ever had a lifethreatening reaction to influenza vaccinations; or are 2 through 17 years old and take aspirin or
medicines containing aspirin – children or adolescents should not be given aspirin for 4 weeks after getting FluMist Quadrivalent unless your healthcare provider tells you otherwise.

Children under 2 years old have an increased risk of wheezing (difficulty with breathing) after getting FluMist Quadrivalent.

Tell your healthcare provider if you or your child are currently wheezing; have a history of
wheezing if under 5 years old; have had Guillain-Barré syndrome; have a weakened immune system or live with someone who has a severely weakened immune system; have problems with your heart, kidneys, or lungs; have diabetes; are pregnant or nursing; or are taking Tamiflu®, Relenza®, amantadine, or rimantadine. Your healthcare provider will decide if FluMist Quadrivalent is right for you or your child.” (22)

The prescribing information says: ‘Inform vaccine recipients or their parents/guardians that
FluMist Quadrivalent is an attenuated live virus vaccine and has the potential for transmission
to immunocompromised household contacts’. (23)

The 2015 landmark ruling upholds GMC guidelines for parental choice:
“The law in relation to consent has changed following the handing down of the Supreme Court
judgement in Montgomery vs Lanarkshire in March this year. Legally, clinicians, including dentists, must now take reasonable care to ensure that patients are aware of any material risks involved in a proposed treatment and of reasonable alternatives. This case now brings the law in relation to the disclosure of risks when obtaining consent to treatment in line with the guidance issued by regulatory bodies such as the GMC and GDC. What the judges in Montgomery said was that the extent of information given to a patient about the risks of a proposed treatment is not to be determined by the clinician or what other clinicians in the same situation would do. Rather the test is what the particular patient sitting in front of the clinician wants to know. Patients must be told of material risks.

The Montgomery case clarifies that clinicians must recognise a patient's legal and ethical right to autonomy and informed choice and sweeps away any notion that doctor (or dentist) knows best. Patients must be fully informed about the risks to them that any procedure carries and be permitted to decide whether to proceed at all or whether they wish to pursue alternative options or no treatment at all.” (24)

We feel that full parental consent for the nasal spray vaccine isn’t possible if the consent letter
sent out by the school doesn’t include full information about the vaccine from the patient
information leaflet which is included in the packaging of the vaccines.
In order for parents to make an informed choice and therefore give full consent we feel that schools should provide all parents and caregivers full information about the ingredients, risks etc.

Risk of Side Effects

Receiving the vaccine could cause your children to contract the viruses, which are being squirted
up their noses. The nasal spray flu vaccine is a live attenuated vaccine containing four strains of
live influenza virus.
Children are therefore at risk of getting ‘the most common side effects’ and may end up missing school due to ‘runny or stuffy nose, sore throat, and fever over 100°F’. (25)

Contains Pork Gelatine

Vegans, Vegetarians, and Muslims should be aware that the spray vaccine contains a highly
processed form of gelatine derived from pigs. Although certified as acceptable by some faith
groups, including representatives from Jewish and Muslim communities, there is considerable
diversity in the Muslim community, and some scholars from the majority Hanafi community in
England have stated that porcine gelatine is not permissible. (26) Luman Ali, from the
Federation of Muslim Organisations, said: “Pork is not allowed to be ingested at all – it’s
something Muslims feel extremely uncomfortable about.” (27)

Long Term Effects

The nasal flu spray is a new vaccine so it is yet unclear what the long-term effects are but
medical experts in the UK are already saying that it can cause narcolepsy (constantly falling
asleep) and cataplexy (seizures triggered by giggling). (28)

In addition, the packaging leaflet included with the vaccine lists Guillain-Barré syndrome and exacerbation of symptoms of Leigh syndrome (mitochondrial encephalomyopathy) as possible side-effects. (29)

Report Adverse Reactions

Report all vaccine side effects via the Governments’ yellow card scheme
yellowcard.mhra.gov.uk/

Stop Flu Vaccines in UK Schools

Stop Flu Vaccines in UK Schools is a dedicated group for sharing information about the UK
nasal spray vaccination programme in Primary schools.
www.facebook.com/groups/955752364541276/

Petitions

Please sign both petitions against mass vaccination in UK Primary schools:
petition.parliament.uk/petitions/119978
www.change.org/p/department-of-education-secretary-of-state-justine-greening-stop-vaccination-with-theinfluenza-nasal-spray-vaccine-in-our-schools

About Arnica

Arnica is a support group for parents, led by parents. We believe in a holistic approach to
health and recognize a grass roots need for debate and practice. We feel that boosting immunity
naturally is key to good health and that the sharing of information and experiences support our
choices.

Join us for debate and support at: www.facebook.com/groups/arnica/
For further information go to: arnica.org.uk/

References

1. For the first time, the youngest primary school children in 17,000 schools will be eligible to receive the free nasal spray vaccine, making this the largest vaccination programme ever in England.
www.gov.uk/government/news/wintercampaign-starts-with-largest-flu-vaccination-programme (Accessed: 21 January 2016)

2. Each vial of Fluenz Tetra vaccine mist contains 10 million ‘genetically modified organisms’ for each nostril of each of four strains of reassorted live attenuated. That’s 80 million viruses per dose, designed to replicate inside a child’s nasal passages.
Summary of product characteristics, Fluenz Tetra nasal spray suspension influenza vaccine (live attenuated, nasal), 4.4 Special warnings and precautions for use, updated 3rd Sept 2015 www.medicines.org.uk/emcmobile/medicine/29112/spc (Accessed: 21 January 2016)

3. ‘The highest proportion of subjects in each group shed one or more vaccine strains on Days 2-3 post vaccination. Although some of the children who received the Fluenz vaccine remained contagious for up to 28 days.’ FluMist Quadrivalent, Package Insert, PDF, Page 15, Transmission Study
www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM294307.pdf (Accessed: 21
January 2016)

4. J Infect Dis. 1979 Oct;140(4):610-3. Viral shedding patterns of children with influenza B infection. Hall CB, Douglas RG Jr, Geiman JM, Meagher MP.

5. Exhaled Aerosol Transmission of Pandemic and Seasonal H1N1 Influenza Viruses in the Ferret. Frederick Koster et al
Published: April 03, 2012. DOI: 10.1371/journal.pone.003311.

6. Correlation of pandemic (H1N1) 2009 viral load with disease severity and prolonged viral shedding in children Chung-Chen Li et al Medscape CME.

7. PNAS. Pathogenesis and transmission of swine origin A(H3N2)v influenza viruses in ferrets. 2012 Melissa B. Pearcea, etaldoi: 10.1073/pnas.1119945109 1.

8. Journal of General Virology (2011), 92, 2871–2878. Outbreak of swine influenza in Argentina reveals anon-contemporary human H3N2 virus highly transmissible among pigs. Javier A. Cappuccio, et al.

9. PLOS ONE. Replication and Transmission of H9N2 Influenza Viruses in Ferrets: Evaluation of Pandemic Potential. Hongquan Wan equal contributor August 13, 2008. DOI: 10.1371/journal.pone.0002923.

10. American Journal of Epidemiology 2008. Vol. 167, No. 7 DOI: 10.1093/aje/kwm375. Meta-Analysis Time Lines of Infection and Disease in Human Influenza: A Review of Volunteer Challenge Studies. Fabrice Carrat et al.

11. Vaccine. 2008 Sep 8;26(38):4940-6. doi: 10.1016/j.vaccine.2008.07.013. Epub 2008 Jul 26. Shedding and immunogenicity of live attenuated influenza vaccine virus in subjects 5-49 years of age. Block SL1, Yogev R, Hayden FG, Ambrose CS, Zeng W,Walker RE.

12. ‘With documented transmission of one Type B in one placebo subject and possible transmission of Type A viruses in four placebo subjects’ www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM294307.pdf (Accessed: 21 January 2016)

13. Whilst it is a weakened version of the virus, it is still possible to catch the flu from it. ‘Vaccine recipients should be informed that Fluenz Tetra is an attenuated live virus vaccine and has the potential for transmission to immunocompromised contacts.’
www.medicines.org.uk/emc/medicine/29112 (Accessed: 21 January 2016)
Vesikari T1, Karvonen A, Korhonen T, Edelman K, Vainionpää R, Salmi A, Saville MK, Cho I, Razmpour A, Rappaport R,O'Neill R, Georgiu A, Gruber W, Mendelman PM, Forrest B; CAIV-T Transmission Study Group.
www.ncbi.nlm.nih.gov/pubmed/16804427 (Accessed: 7 August 2016)

14. ‘The year’s flu vaccine effective in only 3% of cases’. www.bbc.co.uk/news/health-31155332 (Accessed: 7 August 2016)

15. The Cochrane Review on Vaccines for preventing influenza in healthy children published in 2012 reviewed 75 studies on flu vaccines with about 300,000 observations. It found "extensive evidence of reporting bias of safety outcomes from trials of live attenuated influenza vaccines (LAIVs) [which] impeded meaningful analysis" and ‘evidence of widespread manipulation of conclusions and spurious notoriety of studies’. www.cochrane.org/CD004879/ARI_vaccines-for-preventing-influenzain-healthy-children (Accessed: 21 January 2016)

16. Doshi, a postdoctoral fellow at Johns Hopkins University School of Medicine, argues that the vaccine might be less beneficial and less safe than has been claimed, and the threat of influenza appears overstated. ‘Expert questions US public health agency advice on influenza vaccine’, published 16th May 2013. www.bmj.com/press-releases/2013/05/16/expertquestions-us-public-health-agency-advice-influenza-vaccines (Accessed: 21 January 2016)

17. Is the government wrong about giving children the nasal spray flu vaccine? Luisa Dillner, 15th Oct 2015.
www.theguardian.com/lifeandstyle/2014/oct/05/government-wrong-nasal-spray-vaccine (Accessed: 7 August 2016)

18. www.lesoir.be/1293165/article/actualite/sciences-et-sante/2016-08-17/grippe-vaccin-nasal-est-inefficace

19. U.S. spurns AstraZeneca's nasal spray flu vaccine as ineffective. By Ben Hirschler and Julie Steenhuysen, 23rd June 2016.
www.dailymail.co.uk/wires/reuters/article-3657057/U-S-spurns-AstraZenecas-nasal-spray-flu-vaccine-ineffective.html
(Accessed: 13 July 2016)

20. www.gov.uk/guidance/the-yellow-card-scheme-guidance-for-healthcare-professionals (Accessed: 13 July 2016)

21. In accordance with section 45Q(3) of the Public Health (Control of Disease) Act 1984, the Secretary of State declares that he is of the opinion that these Regulations do not contain any provision made by virtue of section 45C(3)(c) of that Act which imposes or enables the imposition of a special restriction or requirement or any other restriction or requirement which has or would have a significant effect on a person’s rights. www.legislation.gov.uk/uksi/2009/38/pdfs/uksi_20090038_en.pdf
(Accessed: 21 January 2016)

22. www.flumistquadrivalent.com (Accessed: 13 July 2016)

23. www.azpicentral.com/flumistquadrivalent/flumistquadrivalent.pdf#page=1 (Accessed: 13 July 2016)

24. ‘Consent a new era begins’. By L D’Cruz & H Kaney, 24 July 2015.
www.nature.com/bdj/journal/v219/n2/full/sj.bdj.2015.555.html (Accessed: 7 August 2016)
‘Update on the UK law on consent’, BMJ 2015;350:h1481. www.bmj.com/content/350/bmj.h1481 (Accessed: 7 August
2016)

25. www.azpicentral.com/flumistquadrivalent/flumistquadrivalent.pdf#page=1 (Accessed: 13 July 2016)

26. www.nhs.uk/conditions/vaccinations/pages/child-flu-vaccine-questions-and answers.aspx (Accessed: 16 July 2016)

27. muslimnews.co.uk/newspaper/health-and-science/new-influenza-vaccine-containing-pork-gelatine-created-outcrymuslim-parents (Accessed: 16 July 2016)

28. www.dailymail.co.uk/news/article-3224953/Schoolboy-11-left-unable-smile-laugh-without-suffering-narcolepsy-fitsgiven-
nasal-spray-flu-vaccine-government-scheme.html (Accessed: 6 August 2016)

29. ‘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 with Fluenz.’See section 4.8: www.medicines.org.uk/emcmobile/medicine/29112#UNDESIRABLE_EFFECTS (Accessed: 10 September 2016)