The FDA document, Vaccines, and Related Biological Products Advisory Committee Meeting is the basis of this article. It is available for download at this link.
The Pfizer Biontech BNT162b2 vaccine for the 5-11-year-old children has a buffer different from previous Pfizer COVID-19 vaccines. The chemical is Tris-sucrose or tromethamine, or trometamol.
To provide a vaccine with an improved stability profile, the Pfizer-BioNTech COVID-19 Vaccine for use in children 5-11 years of age uses tromethamine (Tris) buffer instead of the phosphate buffered saline (PBS) as used in the previous formulation and excludes sodium chloride and potassium chloride. page 14.
Buffers are used to stabilize the acid-base balance of vaccines. Anything injected into anybody should have a neutral acid-base balance to prevent injury to the surrounding cells. Tromethamine is the buffer in the Moderna mRNA COVID-19 vaccine.
Tromethamine (or Trometamol) is used as a biological buffer in topical, oral, or injectable drugs and cosmetics. You can get sensitized with tromethamine in any of the products it is in and develop an allergic response in the future.
People who are allergic to x-ray or CT scan dyes and MRI contrast agents due to the tromethamine in them may develop an allergic reaction to the Pfizer Biontech vaccine for the 5-11-year-olds. That’s because x-ray contrast or iodinated contrast medium (IOM) and MRI contrast, also called gadolinium-based contrast agents (GBCA), also contain tromethamine.
How common is that? In a CDC report about allergic reactions to the Moderna mRNA vaccine, two out of the ten patients that had anaphylactic reactions to the vaccine had a previous history of anaphylaxis to MRI or X-ray or CT-scan dye.
Are there any reports about children having allergic reactions to the Pfizer Biontech vaccine? It is in the FDA document. The FDA used the results of Phase 2 and 3 clinical trials of the Pfizer Biontech vaccine for the 5-11-year-olds.
Hypersensitivity Reactions to the Pfizer Biontech Vaccine for 5-11-year olds
Here is what the FDA found. It is on page 30.
Analyses in Cohort 2 showed an imbalance of AEs (adverse events) in the BNT162b2 group compared to the placebo with respect to hypersensitivity, with 9 participants in the vaccine group (0.57%) and 4 in the placebo group (0.51%) reporting unsolicited AEs in this category, primarily skin and subcutaneous disorders of rash and dermatitis.
Angioedema
Angioedema is a form of an allergic reaction, and it looks like this:
Angioedema was reported in 3 (0.19%) in the vaccine group compared to 1 (0.13%) in the placebo group. These events
included one participant with both angioedema and urticaria, and 3 participants with urticaria.
Henoch-Schonlein Purpura
As we read down the FDA report,
One participant, a 6-year-old female in the BNT162b2 group, had a non-serious AE of HenochSchonlein purpura which was diagnosed 21 days after Dose 1.
Henoch-Schonlein purpura (HSP) involves the skin, mucous membranes, and sometimes other organs. It usually affects children. HSP in the skin causes palpable purpura (small, raised areas of bleeding underneath the skin). The photo below is an example of an HSP rash.
Henoch Schonleon Purpura can also present with joint pain and abdominal pain. Kidney involvement is present in serious HSP. The kidneys will spill blood and protein in the urine (hematuria and proteinuria). Sometimes the kidney involvement proceeds to chronic kidney disease.
If a child develops a rash after vaccination, consult their pediatrician.
The table below shows the number of 5-11-year-old children that had angioedema, arthritis, and Hypersensitivity.
Chest Pain
Six participants in the Pfizer group complained of chest pains which resolved after 1-2 days. “No participants required a cardiac evaluation or ER visit, and none were hospitalized. In each case, the adverse event was considered to be noncardiac in origin.”
How did they know that the chest pain is not cardiac in origin if they did not test? Could it have been myocarditis? An EKG or a troponin should have been done!
Myocarditis after mRNA Vaccination in the Military talks about the need to test vaccinated people who develop chest pains since they may have myocarditis. Myocarditis needs observation until resolution. It is not good to have a child with myocarditis running and playing around due to the risk of death.
Low White Blood Cell Count
One participant was withdrawn from the study due to adverse effects of fever two days after Dose 1 and worsening of neutropenia or low white blood cell count. Neutropenia prevents the body from fighting viruses and bacteria.
Low white blood cell count and fever at the same time can be a sign of severe infection.
Myocarditis is Expected
FDA is expecting that excess myocarditis cases will happen in both male and female children. Some of them will need hospitalization and intensive care.
You can find that in the table below that shows a risk-benefit analysis based on six scenarios on page 34.
Of course, the FDA said that the benefits outweigh the risk.
In a report from the Expose, they quoted a Dr. Eric Rubin of Harvard University, a voting member of the FDA, who said that the only way to find out if the Pfizer vaccine is safe for 5 to 11-year-old children would be to give it to them.
“We’re never going to learn how safe the vaccine is unless we start giving it, and that’s just the way it goes.”
That sounds like Nancy Pelosi when she said about Obamacare, “We have to pass the bill and find out what is in it.” We know how that turned out.
Take Away Message
The Pfizer Biontech vaccine is released under emergency use authorization. Before deciding to vaccinate your child, know that influenza has a higher death rate than COVID-19 in children and that COVID-19 in that age group has a low mortality rate.
You can read those here: How Bad is COVID-19 in Children 5-11 Years Old?
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- The Durability Study of the Moderna COVID-19 Vaccine is Strange and Unusual
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References:
- Singh M., Winhoven S.M., Beck M.H. Contact sensitivity to octyldodecanol and trometamol in an anti-itch cream. Contact Dermatitis. 2007;56:289–290. [PubMed] [Google Scholar] [Ref list]
- CDC COVID-19 Response Team. Administration FDA Allergic reactions including anaphylaxis after receipt of the first dose of Moderna COVID-19 vaccine – United States, December 21, 2020-January 10, 2021. MMWR Morb Mortal Wkly Rep. 2021;70:125–129. [PMC free article] [PubMed] [Google Scholar] [Ref list]
- Vaccines and Related Biological Products Advisory Committee Meeting
October 26, 2021 - Cabanillas B, Novak N. Allergy to COVID-19 vaccines: A current update. Allergol Int. 2021;70(3):313-318. doi:10.1016/j.alit.2021.04.003
- Gillespie, J & McKnight, A. (1976). Adverse effects of Tris hydrochloride, a commonly used buffer in physiological media. The Journal of physiology. 259. 561-73. 10.1113/jphysiol.1976.sp011482.
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