Note from the editor: This article was originally published on CareyMartell.com
Today I write about a very important topic that is mostly personal but is relevant to the larger issues at work in America today. The vast majority of the public forum in America has moved away from the publishing of letters in local newspapers where residents debated issues and shared their thoughts. Most local newspapers no longer publish this discourse between residents, and instead the conversation has moved online to groups such as on Facebook and reddit. Unfortunately, many of the people who administrated these groups do not hold themselves to the same professional standard as past newspapermen once did. Some of them seem motivated with a desire to actually disrupt the public forum and use censorship to do so.
I encountered one of these people last night and he was an admin of a Facebook group. The original version of this article named him and asked for his removal as an admin. The essay achieved this goal and he is no longer an admin of the group, and so his information has now been removed from the contents of this article.
This version of the essay I am re-publishing, because the information is important and I want to have an easy way to share it.
The Post That Sparked My Essay: a School Teacher Told Kids They Needed to be Vaccinated
A post was made by a Newberg resident concerned that teachers were telling her children they needed to go get vaccinated.
(Before we go further, let me just point out this fact; I’ve had both doses of the Pfizer vaccine. I am not an “anti-vaxxer” just because I understand the topic and know things you may not.
Truthfully, I didn’t really want to get it, because in 2004 I experienced a severe allergic reaction to the anthrax vaccine that ended my career in the US military. Yet I got the vaccine because I have an upcoming surgery and I was required to be vaccinated for the surgery.
As I am in the at-risk group of people who could potentially have undesired side effects from the Pfizer vaccine, I became well read on the topic so I could make the best possible choice based on the evidence available. My involvement in this Facebook thread was to pass on some of this knowledge to help others do the same.
So, if you try to dismiss all of the factual information I provide here as being a “conspiracy”, you are going to be sorely disappointed; others will read what I have written here, and the documents I have cited from the FDA and CDC that demonstrate I am telling the truth in what I say in this essay).
This is the FB post that was made into the Newberg-Dundee group,
A parent expressed concern that a teacher is telling her kid to get vaccinated. This is a legitimate concern given that no covid-19 vaccine has passed the phase trials for anyone under 16 years old, and that any administration of the Pfizer vaccine to anyone younger than 16 years old is considered off-label (In the context of this discussion, terms such as ‘off-label’ and ‘approved‘ are all legal definitions, by the way, just so that everyone reading this is on the same page. I will get into the finer details of what these terms legally mean later in this essay). The administration of the Pfizer vaccine to those younger than 16 are only permitted under an Emergency Usage Authorization (EUA) and the age restrictions under this EUA is to 12 years old. The children in question for this discussion are younger than 12 and so this is a relevant fact to bring up in discussion on the topic.
However some posters were claiming that the children should be “taught” to listen to science, which is a fallacious claim made to dismiss legitimate concerns as being ‘non-scientific’.
In reality, the ‘science’ is that no covid-19 vaccine has cleared the necessary trials to be approved for issuance to those below age 16. I pointed this out with a quotation from an ABC news article, ‘FDA-approved Pfizer vaccine not OK for off-label use in kids, official says’, dated August 24, 2021 ( a few weeks ago at the time of this posting, and the info is accurate reflection of the situation as I write this essay).
From the ABC news article,
As you can see, the ABC News article that I linked to features a quote from Janet Woodcock that makes it clear the Pfizer vaccine is not approved for children this young, using the words “should not be given” and “not recommending“. I don’t know how that can be more clear. The FDA is the one that makes these decisions and here is the commissioner saying the Pfizer vaccine is not approved for children this young and to not administer the vaccine to them.
Yet, despite linking to this article, as you can see in the screenshot of the FB post I made, another person still replied to my post with the erroneous claim the Pfizer vaccine is “fully approved for 12 and up“. They clearly did not bother to read the article before responding to me, and dismissed the quotation outright.
This is precisely why I was inserting myself into the discussion; actual false information about the vaccines is being spread in the group, and I am the one who was correcting them.
Let’s discuss the next set of covid-19 related claims I posted corrections for. Other commenters claimed that the vaccine is necessary to give to children anyway, because they might die from covid-19 and that getting vaccinated will make them immune to covid-19. These new claims that were made are a gross misrepresentation of the facts, as the people who are at risk of death from covid-19 are those who have pre-existing health problems that make them susceptible to severe reactions from covid-19; that is, immune compromised individuals.
Despite erroneous media claims suggesting otherwise, the Pfizer vaccine is actually not as useful to this category of individuals (immune compromised) as to healthy people, because vaccines are not a treatment for infections. Vaccines are a modern method of inoculation to assist a person with developing antibodies against an infection without being exposed to the full infection. Vaccines rely on a person having a healthy immune system in order for the vaccine to be effective at reducing complications during infection, because it relies entirely on a person to be able to produce useful antibodies. If your immune system has problems generating useful antibodies, a vaccine is not going to cure this. This is not just my opinion and there is data (which I cite a few paragraphs down) to support this.
Thus, the argument that children who are at risk means the vaccine will help them is not necessarily credible; there must be something unique about a vaccine that means it will allow immune-compromised people to make good antibodies, and this requires evidence to prove. As you will read in abit further into this essay, that evidence does not exist because immune-compromised people were not used in the initial Pfizer trials that led to its recently approval status.
As immune compromised individuals were not included in the initial trials of the Pfizer vaccine, there is not actually a lot of data on how effective they are in this population group, with the data that exists so far suggesting it is not. (I will cite sources for all of this later in this essay).
In any case, I replied to these claims, with posts which the former admin removed with a claim they are “fake news”. Read them for yourself,
And here is the evidence to support my claim that there is little evidence to suggest immune-compromised people are benefited by the Pfizer vaccine.
The article I quoted is, ‘How Effective Are COVID-19 Vaccines in Immunocompromised People?‘ published on the American Society for Microbiology website. The ASM is an organization that publishes one of the most respected peer-review journals in the field of virus research.
The part of the article I highlighted is,
You can read the full article for yourself. I did not misquote the article in my Facebook post and the information I quoted is relevant to the discussion because other posters made the false claim that the vaccines will make immune-compromised children “immune” to covid-19. The best data we have on the topic does not support that claim and actually refutes it. Therefore, the claim others made to ignore the FDA warnings and administer the Pfizer vaccine to an immune-compromised child anyway, is an incredibly misleading declaration to make.
Why FDA Approved Status and Emergency Usage Authorization (EUA) are Not the Same Thing
Let’s discuss the next removed post.
The article I quoted is, ‘FDA Approves First Covid-19 Vaccine‘ which is posted on the FDA website itself. It is a press release that alerts the public that the Pfizer vaccine has been approved for use on people 16 years and older.
My comment was removed for “fake news” because I pointed out that this approval is not for children younger than 16. Yet this is a factually true statement; it’s only authorized for administration to children younger than 16 as part of an Emergency Usage Authorization.
Let’s get into the nuts and bolts of what these things mean now, as many Americans don’t seem to actually understand what these things are.
- “Approval” is a legally defined term for when a medicine has passed specific rigorous testing standards set by the FDA and has been approved by the FDA for a specific usage under these standards. Medicine that has been authorized for off-label usage as part of an Emergency Usage Authorization is NOT the same thing as ‘approval’.
That this is what ‘Approval’ means in relation to medicine is not a fact anyone can contest. What appears to confuse many people is that they assume that, because people in the general public have been able to receive the vaccine for half a year (since last December), that must means it’s “approved”. In actuality, the Pfizer vaccine has only recently been “approved”, thus why the FDA issued this press release on August 23, 2021 announcing that it has now recently been approved.
Obviously, the Pfizer was not “approved” prior to August 23, 2021. If it had been then they wouldn’t have made this announcement on August 23, 2021 to inform the public it had been approved on August 23,2021.
From the CDC article,
Previously to August 23, 2021, the Pfizer vaccine was only authorized for administration as part of an EUA. While many Americans are unaware of the difference in what this means, if you actually read the legal information about what EUA are from the FDA website you will understand that EUA is not the same thing as “approval”.
‘CDER’ is The Center for Drug Evaluation and Research, and information about the specific process can be found on this page. The point is that ‘approval’ has a special meaning within the context of this topic.
2. Now, let’s look at what an EUA is. From the ‘Emergency Use Authorization of Medical Products and Related Authorities Guidance for Industry and Other Stakeholders guidance document listed on the FDA website,
Pay close attention to the sections I have highlighted. EUAs are expressly made to allow non-approved medicines to be legally administrated as emergency usage when there are no “adequate, approved and available alternatives“. Nothing about EUA authorization makes a previously un-approved medicine to now be “approved”. These are legal definitions for what “approval” and “non-approval” mean, not the definitions you find in the dictionary.
And yes, the legal definitions do matter because the average person believes “approved” to be medicine that has passed rigorous health standards to acquire this status of “approved” and the Pfizer vaccine DID NOT HAVE THIS STATUS until August 23, 2021 and this approved status is ONLY for people age 16 and up! Furthermore, there are legal consequences to taking a medicine under an EUA usage, because you waive your legal rights to sue if anything goes awry (I will discuss this more further in the essay, with citations).
An EUA is not a fast-track process to grant ‘approved’ status to a drug. Yet this is what many people mistakenly believe it is. There is an actual, separate fast-track process for drug approval that is wholly unrelated to an EUA.
Having said all of this, it is beyond dispute that the former admin removed my posts with a false claim of them being ‘fake news’. He either did not understand what I was saying OR alternatively, simply did not agree with the evidence-based information I shared and he decided to censor me simply because he disagreed with the evidence.
Why the Pfizer Vaccine May Not be Effective for Immune-Compromised People
Here is the next post that was censored,
Everything I said here is true.
The article I shared is, Immunocompromised people make up nearly half of COVID-19 breakthrough hospitalizations, published on August 21, 2021 on the University of Michigan Department of Medicine website. The article is authored by Jonathan Golob, MD, PhD Assistant Professor of Internal Medicine, Division of Infectious Diseases. Dr. Golob contributed work on Pfizer vaccine trials. Therefore, to suggest this is ‘fake news’ is 100% erroneous.
The article cites information from, Media Statement from CDC Director Rochelle P. Walensky, MD, MPH, on Signing the Advisory Committee on Immunization Practices’ Recommendation for an Additional Dose of an mRNA COVID-19 Vaccine in Moderately to Severely Immunocompromised People, which says,
To add to this, at the bottom of the article written by Dr. Golob (which I previously cited), is the following,
This is an acknowledgement that there is little data to suggest the Pfizer covid-19 vaccine is effective at assisting immunocompromised people who become infected, because very little research has been done using immune-compromised people (a problem with the Fast Track approval process the FDA is using for the Pfizer vaccine) in the Pfizer trials. This is something not widely reported in the media, but should be. That is, the population group that is most benefited by a vaccine was not included in the initial studies used for Fast Track approval of the Pfizer vaccine.
Why Does Any of This Information Matter?
To remind people, the only reason I brought this information up is because people were claiming that children who are younger than 16 should be given the Pfizer vaccine if they are immune-compromised. Raising this information is therefore relevant to my counter-claim that their claim is misleading and that parents should actually learn the full facts before making such a choice, since it’s not approved for children and there is little evidence that the vaccines are very effective for this population category, which is why the CDC is encouraging multiple booster shots for immune compromised individuals — this guidance isn’t really based on hard facts but rather in the hope it will improve effectiveness for them to develop useful antibodies. But due to the rushed nature of the approval process, they don’t have a lot of information on the topic to back up this claim. That has to be stated for an accurate assessment of what is being advised to be understood.
Now you might say to yourself, “Why does it matter if they have a lot of evidence or not to support the claim?”. It matters because novel medicines can have unintended side-effects, especially in children. There have been multiple children who have suffered severe consequences due to a poor reaction to the Pfizer covid-19 vaccine, here are just a few notable cases that were widely reported.
- Japan Stops Some Vaccinations After Deaths
- Report: 13-year-old dies in sleep after getting COVID-19 vaccine; CDC investigating
- Michigan boy dies 3 days after getting Pfizer COVID-19 vaccine, CDC is investigating
- Teen boy dies a few days after receiving second COVID vaccine shot
Now, does this mean that every child who gets the Pfizer covid-19 vaccine is going to have a horrible reaction and die from it?
No, of course not.
But YOUR child MIGHT DIE, if the conditions that caused these other kids to die from it are relevant to YOUR CHILD.
What are those conditions? We don’t really know, because the FDA and CDC has very little idea what factors are causing these deaths because the trials on children have not completed yet. This is why it’s not a wise choice for parents to get their kids vaccinated — especially when the FDA is literally telling people to not vaccinate young kids because they don’t have enough research on this population group. That is the point here.
As of right now when I write this essay, having any child under the age of 16 be vaccinated is like playing a dice game while not knowing all of the rules on how you can lose. Maybe some people want to gamble with their child’s life, but most people don’t. This is why this information is necessary to share.
The other thing people should be aware is that if you or your child suffer a negative consequence of this off-label usage of the Pfizer vaccine in anyone under the age of 16, no one will be held legally liable. This is because the PREP-Act makes all the parties responsible for manufacturing and distributing the drug that has been permitted to be used for off-label purposes as part of an EUA makes them immune to any legal action, such as wrongful death torts. If you suffer severe life altering consequences due to a bad reaction to the Pfizer vaccine while receiving it under an EUA, you’ll be stuck with the countermeasure injury program, whose claims can be denied by a paper pusher. If that happens you’ll be stuck in a lengthy and expensive litigation process to sue the government to gain any benefit at all. Most personal injury lawyers will not take these kinds of cases on a contingency basis due to the difficulty involved (I don’t have a citation for this, you’ll just have to take my word for it but I assure you, what I am telling you is the truth, coming from my own experiences with torts). The program is notorious for rejecting claims, acknowledging less than 10% of all cases.
To be sure, if anything goes wrong when you take the Pfizer vaccine as part of an EUA, no one will be held legally liable for any severe negative consequences. That means everything from hospital bills to death. You will have no ability to recover damages. You waive these protections when you take the vaccine for such off-label uses, even if part of an EUA. This part is NOT being told to parents and it definitely needs to be and the admin interfered with my ability to do that.
Lastly, in my post I pointed out that about many of the people who are hospitalized at present for covid-19 have been vaccinated. This is not “fake news”, either, as the NYT report in the article, In a Handful of States, Early Data Hint at a Rise in Breakthrough Infections,
“Breakthrough cases” is the preferred term the liberal US media has been using to describe a case where fully vaccinated people are still suffering severe reactions to covid-19 infection. With the headlines saying the cumbersome term ‘breakthrough cases‘, it is not as obvious to most people by what is meant. The full scope of the situation is also compromised because only 24 of the 50 states are tracking these ‘breakthrough cases’ and providing data on them.
(Undeniably, this is one of the main problems with using a EUA order to administer tens of millions of vaccinations to the general public– the US hospital system is not designed to conduct a population study for novel and experimental medicine. Not all states’ require hospitals to track the same information, not all state Departments of Health do either, and there is variance in they categorize the same events, which makes getting an accurate assessment of any negative consequences or ineffectiveness of the vaccines to be almost impossible using the US hospital system. It is simply not a controlled environment for a science-based study).
A high number of cases of fully vaccinated people still suffering a severe reaction to the covid-19 vaccine is not an exclusive phenomenon to the US, either,
- Science Magazine ( published by American Association for the Advancement of Science.) wrote an article about how most of the people hospitalized in Israel had been vaccinated with the Pfizer vaccine.
- In Britain, Reuters reports that 60% of hospitalized patients for covid-19 are unvaccinated — which means, 40% of the people hospitalized have been vaccinated.
I realize it is a lot to take in, but after coming this far you should be able to see that my posts were not misinformation and there is a problem of social media groups not being well managed by people who are quick to delete anything they disagree with on principle, and not engage in the process of civil discourse to understand what people’s positions are and what is said. The former admin is no longer in charge of the Facebook group in question here, but there are still many other groups that have similar kinds of issues.
Newberg, as well as other communities, have some major issues happening in the communities and residents should be able to discuss these things. If there is any great positive benefit, it is that I took the time to write this essay which may be able to help others understand the topic more clearly.