PREAMBLE

Earlier this morning [Saturday, September 19] I came across a video from the PEI Department of Health and Wellness titled, “Influenza Illness and Immunization: Learning Module 2020, Part I & 2.” It’s a 38 minute slide show with commentary accompanying each slide. I’ve embedded the entire video at the end of this article.

One of the stated objectives on the  very first slide is to promote the vaccines that’s been purchased by the PEI Government for the 2020-21 flu season:

There is strong promotion of the influenza vaccine throughout the slideshow presentation, with the commentator stating at one point: “You need to get a flu vaccination every year,” because, as she explains, the virus can mutate from year to year and antibodies from previous flu vaccinations won’t work, and even if  the influenza strains remain unchanged, antibodies from vaccinations apparently diminish in the body over the course of months, not years.

The video continues from a presentation presumably meant for everyone to Part II, for those who will be doing the jabbing:

In PEI vaccinations are voluntary as a rule. However, given that we are currently under a Health Emergency Order which was recently renewed by Executive Council for another month [The Public Health Act only allows the declaration of a public health emergency for a maximum of 30 days] and can be extended indefinitely by Executive Council with new Orders, simply stating, “…on the advice of the Chief Medical Officer.”

A Health Emergency Declaration gives the government far-reaching powers, essentially the right to do almost anything on the stated claim of protecting public health, including: (1) enter your house without a search warrant or prior warning; (2) confiscate your dwelling and force you and your family to reside elsewhere; (3) compel (by force if necessary) a person to be injected with a vaccination….etc., to name just a few.

The PEI Government clearly believes the risks associated with this upcoming Influenza season’s vaccine fall short of the risks associated with not getting the vaccine.  The risks of possibly contracting influenza as a result of not getting the vaccine, or spreading influenza to others – especially for the identified priority groups – is regarded as far greater than any risk to a given individual. It is therefore not surprising to see this presentation strongly encouraging all Islanders to get the flu vaccination –  the government is making it free for everyone, even those without a PEI Health Card.

I couldn’t help but wonder – given such a strong push for uptake of a product that has already been purchased in sufficient supply to offer it to every Islander over 6 months old – whether all the information about the vaccine that a person would want and need to properly assess risk was provided.  I checked – it wasn’t.

1. Flu Vaccine 2020-21: Properly Assessing Risk

Part I  of the presentation provides all the background information about the seasonal flu you would expect: how it’s spread; typical symptoms; how the annual vaccine ‘choices’ are made by the World Health Organization, or vaccines are ‘tweaked’ based on new strains expected in the upcoming flu season; information is provided about how vaccines work to produce antibodies; statistics are given on lab-confirmed cases, hospitalizations and deaths from the flu in previous years in PEI (last year there were 5 deaths; the year before 9), etc. It’s an interesting and informative presentation which I’d encourage you watch.

My interest is only in whether the vaccine is safe – what’s in it, what ‘safety studies’ have been done proving it’s safe, etc. I’m interested in assisting the PEI government to provide Islanders with written information in understandable language so Islanders can properly assess the potential risks of getting the flu shot this year.

The Health PEI presentation stresses in Part II that it is essential for Islanders to have full and accurate information so they can truly make an informed decision whether or not to get the flu vaccine:

For the coming flu season, the vaccine purchased by the PEI Government combines four strains into one vaccine:

There is also a Trivalent Vaccine being offered (three flu strains), and a vaccine with 4 times the antibodies available for people 65 or over; however, I’m focusing only on the Quadravalent vaccine. That’s the vaccine for general administration, as both an injection and a nasal inhalant.

2.  Health PEI’s Risk Assessment of  the Quad Vaccine

Reviewing both Part 1 and 2 of the presentation offers the following information regarding risks. To start with, any individual with the following status and/or conditions should not get the vaccine:

As well, there are contraindications which should be made known to anyone contemplating getting the vaccine:

Other than information about the possibility of some red swelling around the injection site, the only other concern raised by Health PEI is the rare chance of anaphylaxis:

Notwithstanding the risks outlined to those charged with the responsibility of informing people of the risks and benefits of the vaccine in Part II, in Part I, a slide makes the reassuring and unequivocal statement that the vaccine is safe and well tolerated:

3.  Risk Factors Not Mentioned by Health and Wellness

The Department of Health and Wellness presentation informs those administering the vaccine that they should review the two key sources providing information and guidance on this season’s Influenza vaccine: (1) Advisory Committee Statement “Summary of the NACI Seasonal Influenza Vaccine Statement for 2020–2021″; and (2) the Vaccine Monograph.

Information in this section is taken EXCLUSIVELY from one of these two sources.

+   Pregnant Women

The National Action Committee on Immunization (NACI) Seasonal Influenza Vaccine Statement for 2020-21 lists “pregnant women” as the first priority group to receive the vaccination, so it’s not surprising that the Department of Health and Wellness also targets pregnant women as a priority target group to receive the vaccination.

This is concerning. The product monograph for the vaccine says this about the vaccine and pregnant women:

The Department of Health and Wellness talks about the added advantage to the child in the womb from the vaccine, with the woman doing the commentary with the slideshow saying at the slide noting pregnant women are a priority group that, “Getting vaccinated can protect the baby after birth.”

In fact, the company is clear that no safety studies on fetal development have been undertaken and impacts are unknown. As well, the company recommends that babies younger than 6 months not receive the vaccine:

To pregnant Islanders brave enough to offer themselves as guinea pigs, and their preborn child tragically suffers harm – although proving a causal connection may be a challenge in court –  the company would appreciate hearing from you and has set up a Pregnancy Exposure Registry to inform recommendations on a go-forward basis:

+   Lactating Women

There is no mention of lactating women in the government presentation, or information concerning the caution which the company calls for with respect to administering the vaccine to lactating women. The vaccine monograph, however, states the following:

The monograph goes on to say:

” Data are not available to assess the effects of Fluzone Quadrivalent on the breastfed infant or on milk production/excretion.”

and:

“The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Fluzone Quadrivalent and any potential adverse effects on the breastfed child from Fluzone Quadrivalent or from the underlying maternal condition.”

Again, it should be kept in mind that this vaccine is not recommended for babies 6 months or younger, and it is simply not known if there will be harmful impacts from babies younger than 6 months receiving vaccine in breast milk.

+  People with Severe Asthma

People with severe Asthma are not recommended to receive the vaccine because “…these individuals have not been adequately studied in clinical trials.” There was no mention of this in the Health and Wellness presentation:

+ Absence of  Other Safety Studies 

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Fluzone Quadrivalent has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals.

+ Ingredients in the Vaccine

When adverse reactions happen with vaccines it is not the antigen that is the culprit, but one or more (or a combination) of the non-antigenic material also present in the injection. The Department of Health and Wellness presentation has the following slide:

Some people argue that using thimerosal (a form of mercury) and formaldehyde are unsafe. Health Canada and the CDC claim there is no evidence of any harmful effects from the injection of trace amounts of these products into our bodies. Nonetheless, it is important to know what else is in the vaccine for full and informed consent.

+ Adverse Events Reported in “Post-Marketing”

The Product Monograph for the Quadravalent Influenza vaccine does not provide the prevalence rate for the following “adverse reactions” reported in vaccination campaigns, but notes those that are listed were “…included based on one or more of the following factors, frequency of reporting, or strength of evidence for a causal relationship Flozone…”: 

SUMMARY

There’s a big difference between respecting the true requirements of a voluntary vaccination program based on a fully-informed population and trying to convince people to get vaccinated out of a sense of ‘duty’ to others and a blanket assurance that the vaccine is safe – especially when a full disclosure of information is not forthcoming about all the risks.

Will you develop an adverse reaction from the flu shot if you get it this year? Probably not, but you might.

Why pregnant women are targeted for vaccinations when no safety studies have been done, and the company itself recommends only pregnant women determined to have a ‘need’ (whatever exactly that means isn’t explained) is baffling. If the company making money selling the vaccine is saying there may be risks which have not been studied, why is our government saying it is safe, without qualification?

When there are so many uncertainties about why so many more young children are growing up with autoimmune disorder, asthma and allergies, or are on the autism spectrum, caution should exercised until causal connections for these population health impacts and trends are found. I’m not saying vaccinations are contributing to these negative health trends in children, but they might be, so it may be wise to follow the ‘precautionary principle’ and play it safe.

There should also be upfront information warning that if you are a breast-feeding mom, there have been no safety studies, and if you have severe asthma, don’t get the vaccine.