Why I will not be getting the COMIRNATY Vaccine at this time

The FDA approved Pfizer’s vaccine today and now the question on everyone’s mind is:

“What excuse do the anti-vaxxers have now for choosing to not take the vaccine?”

That is the wrong question. The right question is:

“What reasons do people have for choosing to not take the vaccine?”

Notice I didn’t put a segregating label on those that choose to not get the vaccine. They are people and they have concerns, it doesn’t help anyone to alienate anyone else.

Notice that I changed the word “excuse” to “reasons”. People do not come up with excuses in this situation. People have concerns and people do not have “excuses” for their concerns, they have reasonings for their concerns.

I am one of these people and I’m always up to talk about everything because that is always a chance for me or someone else to learn something and boy do I love learning!

I have previously written my 30 reasons for not wanting to get the COVID vaccines and now my reason number nine is officially no longer applicable. While my 29 other reasons are still standing and valid, I must now address the new information and documentation of the FDA approved COVID vaccine. There are more reasons as well other than what I have posted myself. In this article however, I am choosing to focus directly on the statements made by the FDA.

I realize that this is a long article, and most people aren’t interested in why I’m not getting the vaccine or what any information released on the (now) FDA approved vaccine might say. They’re just interested in people getting the vaccine to “save lives” and “get back to normal”.

I am not one of these people. I require informed consent. Regardless of what people say I want to make sure that I’ve read all of the materials so that I myself can make an informed decision on whether or not the vaccine is right for me, especially something that is an irreversible change to my body? I only have one body, I’m not taking the chance of any averse reactions possibly affecting it with this.

As such, I have done the legwork to trudge through all of the new documentation and see what’s there. I have pulled a lot of information that concerns me and it is much to read and most people don’t have the attention span, if you are one of these people here is my reasoning (all from FDA provided info) for still not getting the vaccine in TL;DR (too long; didn’t read) format.

TL;DR

• Possible Myocarditis and Pericarditis – I don’t want heart problems, sorry.
• The vaccine may not protect all vaccine recipients – what if I get serious/averse side effects and the vaccine still doesn’t protect me?
• COMIRNATY has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility. – ok so we don’t know what the potential of the vaccine is to cause cancer or how it affects male fertility. Sorry but I don’t want cancer or my fertility affected since my one goal in life is to be a dad, no way am I risking that.
• Data during the clinical trials utilized the PCR tests – I’ve seen some concerning information that the PCR tests are less than perfect. I’m not sure how that affects the data within the table.
• Despite its FDA approval, the vaccine is still in clinical trials
• The duration of effectiveness against COVID is currently unknown — I don’t want to continue to get vaccine shots or boosters again and again and especially since the vaccine is still in clinical trials to see what happens after a 3rd shot on individuals.
• We don’t know all of the possible side-effects of the vaccine and serious or unexpected side effects may occur, especially as use of the vaccine becomes more widespread – this point should speak for itself.
• This is a big quote I listed below: “To date, only a small number of severe cases [of COVID-19] have occurred during the study, which makes it difficult to evaluate whether the vaccine reduces the severity of COVID-19.”
• Another big quote: “While it is hoped this will be the case, the scientific community does not yet know if the Pfizer-BioNTech COVID-19 Vaccine will reduce such transmission.” If we don’t know whether it reduces spread, then why take it?
• Refute the above points if you like, (good luck, they’re statements straight from the FDA) but the one big point that still sticks with me is that we simply do not know the long-term effects and since anything could happen, I must protect myself from the risk until the long-term effects of the vaccine are known.

Anywho, that TL;DR essentially summarizes the below information for those of you who don’t have the time/desire to read all the below. If I had to guess you probably won’t, I hope you prove me wrong.

So, now that the Pfizer vaccine has been approved they are now calling it COMIRNATY.

Since it has been approved we now have updated information on the vaccine from the FDA. I have reviewed the information publicly available to me and these are the things that still lead me to my concerns. All sources will be directly linked and direct quotes. Direct quotes from the documentation will be italicized and any comments from me will be in regular formatting.

Statements of Concern for Me From the Package Insert for Comirnaty

5 WARNINGS AND PRECAUTIONS SECTION

5.2 Myocarditis and Pericarditis

Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 12 through 17 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long- term sequelae. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis.

^I am in the higher observed risk group

5.5 Limitation of Effectiveness

COMIRNATY may not protect all vaccine recipients.

^what happens if I get it and it doesn’t protect me? What if I have potential side-effects affecting my body and it still doesn’t protect me?

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions…

^Hm, not sure how I like this. My math and science people will understand the power of variables and how as you continue to add variables (widely varying conditions) one cannot be certain of the information being recorded and/or which variable affected what to what extent. Make sense? If you’re doing science, usually you do your best to keep everything down to one variable. I understand that in vaccine clinical trials science how that may be next to impossible so I’m not saying they need to get it down to one variable. What I’m saying is that there is more room for error and quite a bit of chances for the data to not show everything accurately for one reason or another. This is not a “GOTCHA!” point, this is just something to be aware of, like I said this is probably what you’d expect in vaccine clinical trials.

6.2 Postmarketing Experience

The following adverse reactions have been identified during postmarketing use of COMIRNATY, including under Emergency Use Authorization. Because these reactions 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: myocarditis, pericarditis

Gastrointestinal Disorders: diarrhea, vomiting

Immune System Disorders: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema)

Musculoskeletal and Connective Tissue Disorders: pain in extremity (arm)

^Don’t want any of that, sorry.

8.1 Pregnancy

Available data on COMIRNATY administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.

^This would make me think that it should not be recommended to pregnant women.

8.2 Lactation

Risk Summary

It is not known whether COMIRNATY is excreted in human milk. Data are not available to assess the effects of COMIRNATY on the breastfed infant or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for COMIRNATY and any potential adverse effects on the breastfed child from COMIRNATY or from the underlying maternal condition.

^This would make me think that pregnant women should not get the vaccine while breastfeeding.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

COMIRNATY has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility.

^Carcinogenicity = cancer, Genotoxicity = the property of chemical agents that damages the genetic information within a cell causing mutations, which may lead to cancer.
Well there are three more risks right there

Table 6: Vaccine Efficacy – First Severe COVID-19 Occurrence in Participants 16 Years of Age and Older With or Without* Prior SARS-CoV-2 Infection Based on Protocol† or Centers for Disease Control and Prevention (CDC)‡ Definition From 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Population During the Placebo-Controlled Follow-up

Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19

^As far as I’m aware, the PCR test used is less than perfect.
(The linked study basically says: In light of our findings that more than half of individuals with positive PCR test results are unlikely to have been infectious, RT-PCR test positivity should not be taken as an accurate measure of infectious SARS-CoV-2 incidence. Our results confirm the findings of others that the routine use of “positive” RT-PCR test results as the gold standard for assessing and controlling infectiousness fails to reflect the fact “that 50-75% of the time an individual is PCR positive, they are likely to be post-infectious”)

Statements that concern me from the August 23, 2021 Approval Letter – Comirnaty

POSTMARKETING REQUIREMENTS UNDER SECTION 505(o)

We have determined that an analysis of spontaneous postmarketing adverse events reported under section 505(k)(1) of the FDCA will not be sufficient to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis.

Furthermore, the pharmacovigilance system that FDA is required to maintain under section 505(k)(3) of the FDCA is not sufficient to assess these serious risks.

Therefore, based on appropriate scientific data, we have determined that you are required to conduct the following studies:

(To save space on the page of this article I’m going to omit the due dates to the sections of the studies. See the PDF linked above for this information.)

4. Study C4591009, entitled “A Non-Interventional Post-Approval Safety Study of the Pfizer-BioNTech COVID-19 mRNA Vaccine in the United States,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY. (Final Report Submission Due: 10/31/2025)
   
5. Study C4591021, entitled “Post Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY. (Final Report Submission Due: 09/30/2024)

6. Study C4591021 substudy to describe the natural history of myocarditis and pericarditis following administration of COMIRNATY. (Final Report Submission Due: 09/30/2024)
   
7. Study C4591036, aprospective cohort study with at least 5 years of follow-up for potential long-term sequelae of myocarditis after vaccination (in collaboration with Pediatric Heart Network). (Final Report Submission Due: 05/31/2027)

8. Study C4591007 substudy to prospectively assess the incidence of subclinical myocarditis following administration of the second dose of COMIRNATY in a subset of participants 5 through 15 years of age. (Final Report Submission Due: 05/31/2024)
   
9. Study C4591031 substudy to prospectively assess the incidence of subclinical myocarditis following administration of a third dose of COMIRNATY in a subset of participants 16 to 30 years of age. (Final Report Submission Due: 12/31/2022)

I’m going to sum up the above required studies for you:

4- Study to obtain the data regarding the occurrence of myocarditis and pericarditis following administration of COMIRNATY. We don’t know how often these two things happen.

5- Same as #4 but in Europe. We don’t know how often these two things happen in Europe

6- Study to see what happens to people with myocarditis and pericarditis following administration of COMIRNATY. We don’t know what happens after people get those two things.

7- Study to see the effects on people who have recovered from myocarditis following administration of COMIRNATY. We don’t know how badly people get these to things and the lasting effects that they get should they get them.

8- Study of subclinical myocarditis after the second dose of COMIRNATY on kids. We don’t know the effect on kids.

9- Study to obtain the data regarding the occurence of subclinical myocarditis after a third dose of the vaccine. We don’t know what a third does does.

So effectively, nobody knows how often or the extent to which this could happen to individuals so far. Me no likey unknowns.

POSTMARKETING COMMITMENTS SUBJECT TO REPORTING REQUIREMENTS UNDER SECTION 506B

10. Study C4591022, entitled “Pfizer-BioNTech COVID-19 Vaccine Exposure during Pregnancy: A Non-Interventional Post-Approval Safety Study of Pregnancy and Infant Outcomes in the Organization of Teratology Information Specialists (OTIS)/MotherToBaby Pregnancy Registry.” (Final Report Submission Due: 12/31/2025)

11. Study C4591007 substudy to evaluate the immunogenicity and safety of lower dose levels of COMIRNATY in individuals 12 through <30 years of age. (Final Report Submission Due: 05/31/2024)

12. Study C4591012, entitled “Post-emergency Use Authorization Active Safety Surveillance Study Among Individuals in the Veteran’s Affairs Health System Receiving Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine.” (Final Report Submission Due: 12/31/2023)

13. Study C4591014, entitled “Pfizer-BioNTech COVID-19 BNT162b2 Vaccine Effectiveness Study – Kaiser Permanente Southern California.” (Final Report Submission: 06/30/2023)

And here’s a summery on this batch of studies needed

10- A study on vaccine exposure on pregnant women and any defects that the child may have as a result of the vaccine (we should probably know the effect [if any] this has on children in the womb).

11- A study on the immune response of a lower dose of the vaccine

12- A study on the safety of the vaccine administered to those in the Veteran’s Affairs Health System

13- I actually have no idea about this one. If someone can send me info on it, please do!

Statements that concern me from the VACCINE INFORMATION FACT SHEET FOR RECIPIENTS AND CAREGIVERS ABOUT COMIRNATY (COVID-19 VACCINE, mRNA) AND PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19)

COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine may not protect everyone.

The duration of protection against COVID-19 is currently unknown.

^So, not only are we being encouraged to take a medicine with no long-term data (aka track record) but we will also likely be encouraged to take boosters. We don’t know the long-term data of boosters either. Double the unknown long-term risk there you know. And also more short term risk since we don’t know the effects through clinical trails of taking a 3rd “booster” shot as well.

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine. In most of these people, symptoms began within a few days following receipt of the second dose of vaccine.

Then they go on to say “The chance of having this occur is very low.” Interesting because above they say that they have no data regarding this and that studies still need to be done.

Side effects that have been reported with COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine include:

• severe allergic reactions
• non-severe allergic reactions such as rash, itching, hives, or swelling of the face
• myocarditis (inflammation of the heart muscle)
• pericarditis (inflammation of the lining outside the heart)
• injection site pain
• tiredness
• headache
• muscle pain
• chills
• joint pain
• fever
• injection site swelling
• injection site redness
• nausea
• feeling unwell
• swollen lymph nodes (lymphadenopathy)
• diarrhea
• vomiting
• arm pain

Most of the above are normal and non-concerning. The three that concern me the most are the severe allergic reactions, myocarditis, and pericarditis.

What’s more concerning to me are the statements that come after the list of side effects:

These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials.

So we don’t know all of the possible side effects still and they may be serious. Also, this says that the FDA approved vaccine is still being studied in clinical trials. While I have pasted a lot of statements above that are a justified cause of concern for myself, the above three sentences alone are enough for me.

Combined they basically say to me, “we still don’t know everything about this vaccine, some bad things could happen, we’re still checking out the possibilities”. Why would I ever take a medicine that says that on it’s fact sheet?

Statements that concern me from the Pfizer-BioNTech COVID-19 Vaccine EUA Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers)

Limitation of Effectiveness

Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

Adverse Reactions in Post Authorization Experience

Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema), diarrhea, vomiting, and pain in extremity (arm) have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine outside of clinical trials.

Myocarditis and pericarditis have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine outside of clinical trials.

Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.

So there’s an interesting tidbit in this fact sheet for vaccination providers… first I have to inject a statement from the fact sheet that I thought was irrelevant to this article (from page 4)—

Dosing and Schedule

The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.

Ok so yeah, that makes sense. Tomato/tomato, potato/potato, COMIRNATY/Pfizer-BioNTech COVID-19 Vaccine. Nothing off about that really and that’s why I didn’t think anything about that statement when I read it before.

However, what I came to find on page nine of the vaccine administrator’s fact sheet is this the below information. Which I have no idea why they need to include since the vaccine is FDA approved and yet they kept the information in the fact sheet anyway?

• FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine, which is not an FDA-approved vaccine.
• The significant known and potential risks and benefits of Pfizer-BioNTech COVID-19 Vaccine, and the extent to which such risks and benefits are unknown.

Interesting stuff right? I think it may be because COMIRNATY is approved for those who are older than teenagers and that Pfizer-BioNTech is under the EUA for children from 12-15. Though, if that’s the case it’s kind of a mute double bind? Again, it says on this sheet under this for a second time (on page 12):

AVAILABLE ALTERNATIVES

COMIRNATY (COVID-19 Vaccine, mRNA) has the same formulation as the Pfizer-BioNTech COVID-19 Vaccine. These vaccines can be used interchangeably to provide the COVID-19 vaccination series.⁴

⁴ The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.

The product was FDA approved and difference doesn’t impact safety or effectiveness and yet it still contains the above statements? Maybe it’s just weird legal stuff, but it at the very least raises an eyebrow for me. If the names are interchangeable as it says, then the above statements can also be read as:

• FDA has authorized the emergency use of the COMIRNATY Vaccine, which is not an FDA-approved vaccine.
• The significant known and potential risks and benefits of COMIRNATY Vaccine, and the extent to which such risks and benefits are unknown.

This is really just the law tying itself in knots in weird ways. The Pfizer-BioNTech COVID-19 vaccine and COMIRNATY are legally distinct but have the same formula and are interchangeable. Either way, whether you give this weight or not, does it really need to be this confusing?

AUTHORITY FOR ISSUANCE OF THE EUA

For the authorized uses, although limited scientific information is available, based on the totality of the scientific evidence available to date, it is reasonable to believe that the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY may be effective for the prevention of COVID-19 in individuals as specified in the Full EUA Prescribing Information.

Limited scientific information… available to date? This is saying “based on what we know so far”. Sometimes the information not available to science at the time is groundbreaking and can change everything. Don’t underestimate the power of the unknowns, the point is we don’t know how bad the unknowns are till we know what they are.

It’s reasonable to believe that it may be effective? Well I don’t want to believe it’s effective, I want to know it’s effective AND with limited/non-serious life altering side effects.

Statements that concern me from the Q&A for Comirnaty

The FDA conducted a rigorous evaluation of the of post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of Pfizer-BioNTech COVID-19 Vaccine and determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support Information is not yet available about potential long-term health outcomes.

I’m 26, my risk is higher for myocarditis and pericarditis.

Statements that concern me from the Comirnaty and Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions

FDA evaluated and analyzed the safety and effectiveness data from clinical trials conducted in tens of thousands of study participants and manufacturing information submitted by Pfizer-BioNTech.

Didn’t I just find in the recipient fact sheet that the possible side effects of the vaccine are still being studied in clinical trials (page 5)? How can they evaluate and analyze the safety and effectiveness data from the clinical trials if the clinical trials have yet to be finished?

Data are not yet available to inform about the duration of protection that the vaccine will provide.

^Makes sense, we haven’t had it for long. The duration of the vaccine could be a month, or even nothing.

To date, only a small number of severe cases [of COVID-19] have occurred during the study, which makes it difficult to evaluate whether the vaccine reduces the severity of COVID-19.

^So we don’t actually know whether or not the vaccine makes COVID-19 less severe like people have been telling me.

Most vaccines that protect from viral illnesses also reduce transmission of the virus that causes the disease by those who are vaccinated. While it is hoped this will be the case, the scientific community does not yet know if the Pfizer-BioNTech COVID-19 Vaccine will reduce such transmission.

^”hoped” and “does not yet know” if it will reduce such transmission. This is science y’all, I don’t want a “hope” or a
we don’t know”– I want a know, I’m sorry I’m such a stickler for wanting to know things vs hoping.

Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.

^If some more adverse reactions, some of which may be serious, may sprout over time then I would like to wait and see if any do and what they are.

Although this technology has not been used in any FDA-licensed preventive vaccine, FDA scientists have expertise with this technology as it has been used to develop other preventive investigational vaccines that have been tested in human clinical trials.

^The above point isn’t really a “gotcha” or anything, I just want information regarding these other preventive investigational vaccines that were developed and tested in human clinical trials. I wonder why this information isn’t linked for people to peruse since they’re mentioning it? Make it easy for me to find out about this stuff, ya know?

The pharmacovigilance plan includes a plan to complete longer-term safety follow-up for participants enrolled in ongoing clinical trials.

^another place saying that the clinical trials are still in place and we don’t know everything about the vaccine yet, especially the long-term effects.

In Summary

Now, I have pulled up all of my reasons for concern. These reasons do not mean that I will never get the vaccine. If you’ll remember, the title of this article is called “Why I will not be getting the COMIRNATY Vaccine at this time“. I am definitely open to getting the vaccine once all of my questions/concerns are answered/addressed.

There are just too many unknowns for me right now. I’m sorry. I’m selfish, I know, please forgive me.. but I will not jeopardize my future family from making an irreversible change to my body without knowing everything I need to know. It’s just too much risk. I only have one mission in life and I will obtain that at any cost and while doing my best to be as informed as possible regarding such matters that happen like COVID or anything relevant that could affect my dream happening in my country and my world.

Just because the vaccine isn’t right for me doesn’t mean that the vaccine isn’t right for you. Read all of the materials and information available to make an informed decision for yourself.

Always just follow your heart, it will never steer you wrong.

Wishing you all the best,
FCP 🙃

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