The New Nasal Flu Vaccine for Children: Worth The Risk?

ER Editor: Two takeaways from this research piece by The Irish Citizens Journal below on a fairly new nasal flu vaccine being currently pushed on Irish children:

  • It was originally removed from use because its effectiveness had not been demonstrated.
  • Europeans get less information in the package leaflet about the vaccine than do Americans. Hence this article is based on information found in the US version.

Quite aside from possible health risks to children, these are sobering thoughts.

A reminder to readers: In a recent public speech given by Dr. Dolores Cahill in Dublin two weeks ago, she highlighted the fact that, despite there being only ONE IRISH PERSON UNDER TWENTY-FIVE having died with/of ‘Covid’ and NO-ONE UNDER SIXTEEN, the Irish government is ordering 600,000 of doses of nasal flu vaccination for its 4-12 year olds. So we’re wondering if this is the vaccine she was referring to. We’re reposting the video of her rousing speech below. Reference to this vaccine can be found around 23:00 minutes onwards. As she says, with satisfactory, proven treatments available for covid (which is not ‘flu but a coronavirus like the common cold), there is no reason to be making vaccinations mandatory for either flu or covid, and warns parents against sudden changes being made to the law concerning vaccines and their children:

Readers may also be interested in this page from FB, Vaccination Information Network – UK (VINE UK), and in a specific post from 2018 regarding this flu vaccine, commenting on how this vaccine has been given widely in UK schools without first issuing relevant safety information to parents. (We apologise for the technical glitch in not being able to relocate this specific post.) See also a post from Stop Flu Vaccines in UK Schools on Facebook from 2016, showing a sample letter that parents can write to their school principal withdrawing permission for their child to get this vaccine.

See also this: AstraZeneca Makes First Shipment Of Flumist Quadrivalent Vaccine In U.S. And FluMist Flopped for Kids During Recent Flu Seasons.

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The New Nasal Flu Vaccine: Worth The Risk?

THE IRISH CITIZENS JOURNAL

The intention of this research is to highlight the possible risks associated with the live attenuated nasal flu vaccine for children.

What is Live Attenuated Influenza Vaccine (LAIV)?

LAIV is a type of influenza vaccine in the form of a nasal spray. The CDC stopped recommending the use of LAIV as its effectiveness could not be proven. This recommendation was reversed in February 2018, for the 2018-2019 influenza season.

Unlike most influenza vaccines, which are inactivated vaccines. LAIV is administered intranasally, while inactivated vaccines are administered by intramuscular injection.

LAIV is sold under the brand name FluMist Quadrivalent in the United States and the brand name Fluenz Tetra in Europe.

Source: Wikipedia

Please do your own research. If you have any questions speak with your GP or public health nurse or local health office.

After reviewing both the EU and USA Package Leaflets, the first thing we noticed is the difference in the amount of information supplied. There seems to be a lot more information and details available in the US leaflet. We also noted that the EU version of the leaflet omitted any reference to the possibility of shedding. For this reason we have used the USA version of the information leaflet as the primary source of information for our research, which details some disturbing statistics and information regarding the effect of the vaccine. We set about compiling a list of the effects and risks associated with taking the drug.

We have published an information flyer with our findings in regards to the Nasal Flu Vaccine being offered in Ireland from October 2020.

Download Flyer A5 (pdf)

Download Flyer A5 (A4 page setup – pdf)

Download The Drug Insert Card (USA)

Download The Package Leaflet (EU)


Page1

Page2

Correction: The flu vaccine for children will be available from the middle of October 2020 and not September as stated on the leaflet. Assumption: The HSE has not confirmed that the vaccine will be added to the School Programme. Information about the flu vaccine for children will also be made available from www.hse.ie/flu in the coming weeks.


Does the child really need a vaccine to prevent flu deaths in children when they’re so rare? In fact, only six per million young people (aged 0–18 years) died worldwide during the 2009 swine flu “pandemic”.

(1) Not Effective: The vaccine proved to be only 3 per cent effective. This 3 percent estimate means no protective benefit could be measured.

(2) Effects: Effects of the vaccine are identical to the symptoms of flu: a runny or stuffy nose, headaches and muscle aches, sore throat, loss of appetite, chills and fever, and earache.

(3) Shedding & Community Transmission: 80 per cent of vaccinated children shed at least one vaccine strain. Children have the ability to shed/spread the virus up to 28 days from the day they are given the vaccine. This greatly increases the risk of another flu pandemic.

(4) Affects on Memory & Behaviour: The mean percentages of the delivered doses detected were as follows: nasal cavity 89.7%, stomach 2.6%, brain 2.4%, and lung 0.4%.  Extensive research has shown that various metals, viruses, chemicals like MSG and pharmaceuticals enter the brain via the olfactory (nasal) tract and, from there, travel directly to the most vulnerable parts of the brain—those affecting memory and behaviour.

(5) Hospitalisation & Respiratory Tract: 2% of children aged between 2 years and five years require Hospitalizations, Most hospitalizations observed were due to gastrointestinal (nausea, vomiting, diarrhea) and respiratory tract infections and another 2% developed  wheezing requiring bronchodilator therapy or accompanied by respiratory distress or hypoxia.

(6) Possible Cause Of Immune System Disorders: Hypersensitivity reactions (including anaphylactic reaction, facial edema, and urticaria)

(7) Possible Cause Of Nervous System Disorders: Guillain-Barré syndrome, Bell’s Palsy, meningitis, eosinophilic meningitis, vaccine-associated encephalitis.

(8) Vaccine Warning On Insert Card: Recipients or their parents/guardians should be informed by the healthcare provider that the vaccine  is an attenuated live virus vaccine and has the potential for transmission to immunocompromised household contacts.

The burden of proof for both safety and efficacy of vaccines falls onto those who would advocate them. Yet, to this day, no such proof has been offered.


The Story Of Bobby Hunter

Bobby Hunter was described as a ‘happy-go-lucky’ boy up until he inhaled a nasal spray given to him and his classmates as a flu deterrent which left him with narcolepsy and cataplexy.

The conditions mean Bobby can either fall asleep at the drop of a hat or collapse on the ground in a terrifying seizure, during which he is still aware of what’s going on around him.

However, according to the European Medicines Agency, narcolepsy and cataplexy are both known to be ‘potential risks’ of the flu spray Bobby was given, based on information supplied to them by manufacturers.

Read The Full Story Here


Reason for our assumption LAIV may be added to the School Immunisation Programme 2020-2021 Academic Year.

An internal document issued by the HSE to provide information and support to staff working on the School Immunisation Programme states “MMR is a live vaccine and must not be administered within four weeks of varicella or yellow fever live vaccines. MMR can be given on the same day or at any interval before or after any other live vaccine, including the Live Attenuated Influenza Vaccine (LAIV/ Fluenz).

School Immunisation Programme Staff Information Support - MMR


Potential Dangers & Risks (Snippits From The Insert Card)

FluMist Quadrivalent should be based on careful consideration of the potential benefits and potential risks.

  •  Do not administer FluMist Quadrivalent to persons who have had a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine [see Description (11)] including egg protein, gentamicin, gelatin, and arginine, or after a previous dose of any influenza vaccine.
  • Do not administer FluMist Quadrivalent to children and adolescents through 17 years of age who are receiving aspirin therapy or aspirin-containing therapy because of the association of Reye’s syndrome with aspirin and wild-type influenza infection
  • In clinical trials, risks of hospitalization and wheezing were increased in children younger than 2 years of age who received FluMist
  • Children younger than 5 years of age with recurrent wheezing and persons of any age with asthma may be at increased risk of wheezing following administration of FluMist Quadrivalent. FluMist Quadrivalent has not been studied in persons with severe asthma or active wheezing.
  • The 1976 swine influenza vaccine (inactivated) was associated with an elevated risk of Guillain-Barré syndrome (GBS). Evidence for causal relation of GBS with other influenza vaccines is inconclusive; if an excess risk exists, based on data for inactivated influenza vaccines, it is probably slightly more than 1 additional case per 1 million persons vaccinated [1]. If GBS has occurred within 6 weeks of any prior influenza vaccination, the decision to give FluMist Quadrivalent should be based on careful consideration of the potential benefits and potential risks
  • Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine
  • Caution should be exercised when FluMist Quadrivalent is administered to a nursing woman.
  • Most hospitalizations observed were due to gastrointestinal and respiratory tract infections and occurred more than 6 weeks post vaccination. In post-hoc analysis, rates of hospitalization in children 6 through 11 months of age were 6.1% (42/684) in FluMist recipients and 2.6% (18/683) in inactivated Influenza Virus Vaccine recipients
  • Unsolicited adverse reactions in children occurring in at least 1% of FluMist recipients and at a higher rate (≥ 1% rate difference after rounding) compared to placebo were abdominal pain (2% FluMist vs. 0% placebo) and otitis media (3% FluMist vs. 1% placebo).
  • Abdominal pain was reported in 12% of FluMist recipients compared to 4% of placebo recipients and decreased activity was reported in 6% of FluMist recipients compared to 0% of placebo recipients.
  • In adults 18 through 49 years of age in Study AV009, solicited adverse reactions occurring in at least 1% of FluMist recipients and at a higher rate (≥ 1% rate difference after rounding) compared to AF-SPG placebo include runny nose (44% FluMist vs. 27% placebo), headache (40% FluMist vs. 38% placebo), sore throat (28% FluMist vs. 17% placebo), tiredness/weakness (26% FluMist vs. 22% placebo), muscle aches (17% FluMist vs. 15% placebo), cough (14% FluMist vs. 11% placebo), and chills (9% FluMist vs. 6% placebo).
  • In Study AV009, unsolicited adverse reactions occurring in at least 1% of FluMist recipients and at a higher rate (≥ 1% rate difference after rounding) compared to placebo were nasal congestion (9% FluMist vs. 2% placebo) and sinusitis (4% FluMist vs. 2% placebo).
  • The following events have been spontaneously reported during post approval use of FluMist. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Cardiac disorders: Pericarditis Congenital, familial, and genetic disorders: Exacerbation of symptoms of mitochondrial encephalomyopathy (Leigh syndrome) Gastrointestinal disorders: Nausea, vomiting, diarrhea Immune system disorders: Hypersensitivity reactions (including anaphylactic reaction, facial edema, and urticaria) Nervous system disorders: Guillain-Barré syndrome, Bell’s Palsy, meningitis, eosinophilic meningitis, vaccine-associated encephalitis
  • Do not administer FluMist Quadrivalent to children and adolescents through 17 years of age who are receiving aspirin therapy or aspirin-containing therapy because of the association of Reye’s syndrome
  • The safety and immunogenicity of FluMist Quadrivalent when administered concomitantly with inactivated vaccines have not been determined
  • Immune mechanisms conferring protection against influenza following receipt of FluMist Quadrivalent vaccine are not fully understood; serum antibodies, mucosal antibodies, and influenza-specific T cells may play a role.
  • FluMist and FluMist Quadrivalent are not approved for use in children younger than 24 months of age.

  •  FluMist Quadrivalent has not been evaluated for its carcinogenic or mutagenic potential or its potential to impair fertility.
  •  Vaccine recipients or their parents/guardians should be informed by the healthcare provider that FluMist Quadrivalent is an attenuated live virus vaccine and has the potential for transmission to immunocompromised household contacts.

Who should not get FluMist Quadrivalent?

  • have a severe allergy to eggs, gentamicin, gelatin, or arginine
  • have ever had a life-threatening reaction to influenza vaccinations
  • 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 or 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.

Who may not be able to get FluMist Quadrivalent?

  • 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

How is FluMist Quadrivalent given?

  •  FluMist Quadrivalent is a liquid that is sprayed into the nose.
  • You can breathe normally while getting FluMist Quadrivalent. There is no need to inhale or “sniff” it.
  • People 9 years of age and older need one dose of FluMist Quadrivalent each year.
  • Children 2 through 8 years old may need 2 doses of FluMist Quadrivalent if they have not been vaccinated against influenza before. Your healthcare provider will decide if your child needs to come back for a second dose.

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Original article

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