Children’s Flumist - Vaccine Facts for Parents

This year, the HSE has rolled out a new Flumist vaccine drive for children aged 2 to 12.

Health Freedom Ireland have put together an easy to follow guide for parents to properly understand this vaccination and to allow you to make a fully informed decision on whether this vaccine is suitable for their child.

We like to remind parents that vaccines in Ireland are not mandatory and that HFI are an organisation who support full informed decisions around vaccination.

What is the vaccine being offered to my child?

The vaccine that the HSE is offering to children aged 2 to 12 for 2020/2021 flu season is the Influenza vaccine called Fluenz Tetra Nasal Spray Suspension Vaccine¹

How is it administered?

This nasal spray vaccine is administered and delivered via the nostrils of the child.

Live vaccine

It is important to understand that this vaccine is a live vaccine.
A live vaccine means that the chosen flu strains contained within the vaccine are weakened but active viruses.
This means that these viruses have the propensity to "shed" from a recently vaccinated individual to an unvaccinated or vulnerable individual.²
You need to be aware that a recently vaccinated individual could pose a risk to immunocompromised individuals that they come in contact with up to 14 days after administration.³
Source: https://www.medicines.org.uk/emc/product/3296/pil#gref

What's in the vaccine?

The ingredients contained within the vaccine are as follows⁴

Sucrose (type of sugar)
Dipotassium Phosphate (emulsifier)
Potassium Dihydrogen Phosphate (type of salt)
Gelatin (porcine, Type A) (pork/pig gelatin)
Arginine Hydrochloride (amino acid)
Monosodium Glutamate Monohydrate (Type of salt, commonly known as MSG used as a food additive)

The viruses contained within the vaccine are Live attenuated influenza viruses for the following four strains**⁵

A/Guangdong-Maonan/SWL1536/2019 (H1N1)pdm09 - like strain
(A/Hawaii/66/2019, MEDI 326775) 107.0±0.5 FFU*** (SWINE FLU)

A/Hong Kong/2671/2019 (H3N2) - like strain
(A/Hong Kong/2671/2019, MEDI 325078) 107.0±0.5 FFU***

B/Washington/02/2019 - like strain
(B/Washington/02/2019, MEDI 323797) 107.0±0.5 FFU***

B/Phuket/3073/2013 - like strain
(B/Phuket/3073/2013, MEDI 306444) 107.0±0.5 FFU***

How is it made?

These virus strains have been propagated/grown in fertilised hens' eggs and have been produced in VERO cells (African green monkey kidneys cells⁶) using a technique called reverse genetic technology.

This is very important information if a child has an egg allergy.

Individuals who have had a previous ICU admission for severe anaphylaxis to egg and who understand the risk and voluntarily choose to receive the vaccine should be referred for specialist assessment with regard to vaccine administration in hospital.⁷

It should be noted that the vaccine also contains genetically modified organisms (GMOs)⁸

Ireland and the EU have strict regulations around GMO food products due to concerns around this type of genetic engineering being harmful to health.⁹

How effective is the vaccine?

The vaccine has been used in the USA since 2012 and the UK since 2013.

However in 2015 the vaccine was withdrawn from the US market as it was not effectively slowing the spread of influenza.

As a result, the American Academy of Pediatrics and Centers for Disease Control and Prevention (CDC) did not recommend using the nasal spray in 2016-’17 or 2017-’18 flu seasons due to poor effectiveness against H1N1 strains (swine flu).¹⁰

The flumist vaccine has not been fully reinstated in the US.

Further studies have also shown effectiveness is approx 45% against influenza strain A & B and 25% effective against the swine flu (H1N1).

From the official website for Fluenz Tetra it also states that in 2017/18, the vaccine effectiveness for 2-17-year-olds receiving Fluenz Tetra was 26.9% against A(H1N1) and 60.8% against influenza B. There was no significant effectiveness against A(H3N2)¹¹.

What are the side effects?

Side effects of the vaccine, listed within the SmPC, are as follows¹²https://www.medicines.org.uk/emc/product/3296/smpc

List of adverse reactions

Very common (at least 1 in 10):
Decreased appetite
Nasal congestion/rhinorrhoea*
Malaise (tiredness)*

Common (at least 1 in 100):
Pyrexia (fever)*
Headache*
Myalgia (muscle aches and pains)*

Uncommon (at least 1 in 1000) :
Epistaxis (nosebleed)
Rash
Hypersensitivity reactions - Including facial oedema (swelling), urticaria(hives) and very rare anaphylactic reactions.

Post marketing reported side effects:

Very rare reports of Guillain-Barré syndrome and exacerbation of symptoms of Leigh syndrome (mitochondrial encephalomyopathy - stroke like episodes, form of dementia) have also been observed in the post-marketing setting with Fluenz Tetra.

Covid 19 symptoms and Fluenz Tetra Side Effects

Parents should be aware that the side effects to the Fluenz Tetra vaccine can mimic the symptoms of COVID 19.

If your child begins to display flu-like symptoms after being vaccinated it is likely that the GP will instruct for your child to take a Covid-19 test.

The current test in use and being used on children can be invasive and can be considered a traumatic procedure for a child.

Children who should not receive the vaccine as per the HSE include

Source

• Any child who has experienced anaphylaxis following a previous dose of influenza vaccine or any of its constituents (except ovalbumin)

•People suffering from severe neutrophils. ie low white blood cells ( count less than

0.5 x 109/L)

•People taking combination checkpoint inhibitors (e.g. ipilumumab plus nivolumab for cancer treatment)

• Asthma - acute exacerbation of symptoms, increased wheezing and/or additional bronchodilator treatment in the last 72 hours

• Seek specialist advice if on regular oral steroids or previous critical care admission

•Children who have taken or used aspirin/salicylates

•Children who have taken Influenza antiviral medication in the previous 48 hours

• Pregnancy

• Significant immunosuppression due to disease or treatment

• Children who live with severely immunosuppressed persons requiring isolation

The following conditions are also precautions to the use of the nasal spray flu vaccine as per the HSE

• Children who required critical care admission for a previous severe egg anaphylaxis and who's parents choose to vaccinate, should be given LAIV in hospital under medical supervision as per the HSE advice.

.• No aspirin/salicylates for 4 weeks after vaccine due to risk of Reye’s syndrome

• Avoid antiviral medication for 2 weeks after vaccine

•Child suffering an acute severe febrile illness, the HSE advises to defer until recovery

Fluenz Tetra Controversy:

UK Court Settlement:

In 2020, a successful tribunal in Great Britain awarded a female child £120,000 after ruling that the child developed narcolepsy after receiving Fluenz Tetra in 2015

"The Tribunal reserved its judgment and later handed down its decision on 13th March 2020. It certified it was satisfied that X was severely disabled as a result of a qualifying vaccination, such that X was entitled to the £120k vaccine damage payment. Subsequently, the DWP confirmed they had decided not to appeal against this decision."

Further reports of narcolepsy: a young boy developed Cataplexy and narcolepsy in 2016 as a result of receiving the vaccine

Reporting of side effects
If your child experiences any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed above.
Reports of adverse reactions can also be made by the parent or vaccine recipient directly to the HPRA (Health Products Regulatory Authority) using the online reporting tool here:
https://www.hpra.ie/homepage/about-us/report-an-issue/human-adverse-reaction-form#

How do I know if my child has the flu?

Flu symptoms can come on very quickly. Your child may experience muscle aches and a high fever.

Headache is very common.

Your child may feel extremely weak and may find it hard to even get out of bed.

After a few days, they may develop a cough.

Flu symptoms can also include¹³

sore throat
difficulty sleeping
loss of appetite
diarrhoea or tummy pain
nausea and vomiting

What should I do if my child gets the flu?

As per HSE advice getting lots of rest and drinking plenty of liquids will make your child feel better. Please also note that antibiotics are not effective against the flu. ¹⁴

Is my child at risk of contracting the flu?

As per the 2018/2019 Irish epidemiological report it states 3,117 children aged between 0 and 14 were reported as having influenza in 2018/2019.¹⁵

This means approx 3 in 1,000 children could potentially contract flu (based on the Irish childhood population 1.1m).

The side effects of the vaccine include 'flu like symptoms' which occur in 1 in 100 children who receive the vaccine.

Of this, 1,246 where hospital admissions.

44% of these admissions were related to children with respiratory disorders such as asthma and other underlying health conditions.

644 children aged between 1 and 4 contracted flu which required hospitalisation.

442 children aged between 5 and 14 contracted flu which required hospitalisation.

26 of these hospital admissions were admitted to ICU.

24 (92%) of these children had several underlying medical conditions, and 50% had more than one underlying medical condition.

This means that for children with no underlying health issues, 2 children per 1 million children or 0.002 per 1000 children are at risk of experiencing complications from the flu.

For children with underlying health issues, 24 children per 1 million children or 0.024 per 1000 children are at risk of experiencing complications from flu.

There were 2 deaths in 2019. The report does not specify if these children had underlying health issues.

Out of a child population of approx 1 million children this equates to under 2 children per million or a 0.002 chance in 1000 of a child dying from flu.

Note: The vaccine is licensed for children aged 2 to 12 only.

Should I vaccinate my child with this vaccine?

You as a parent are the only person who can make this decision. You are in the best situation to weigh up your child's individual situation.

This page is intended to be a resource to help you find the answers to the questions you may have.

The following are some of the considerations of other parents, which you may find useful in making a decision.

Is my child at a high risk of contracting the flu?

Is my child at risk of serious side effects from the flu?

Will my child have a greater chance of suffering a side effect from the vaccine or from the flu?

How likely will the vaccine work at protecting my child from the flu?

Am I satisfied that this vaccine will protect my child and keep them safe?

The information contained in these topics is not intended nor implied to be a substitute for professional medical advice, it is provided for educational purposes only. You assume full responsibility for how you choose to use this information. Always seek the advice of your physician or other qualified healthcare provider in relation to any medical procedure or vaccination.Talk with your healthcare provider about any questions you may have regarding a medical condition.Nothing contained in these topics is intended to be used for medical diagnosis or treatment.