In Orphania: Pt. 1

At least 57 children are reported to have received a 2 to 3X dose of the Pfizer/BioNTech Covid vaccine in the first twelve days alone.

At least 59 VAERS entries submitted after the authorization of the Pfizer/BioNTech Covid vaccine for children indicate inadvertent administration of the product indicated for teens and adults (2 being of the Moderna vaccine). The 59 children described in these reports received two to three times the payload of mRNA coding the spike protein authorized for children under 12.

25 other VAERS entries, submitted by an unnamed pharmacy (or multiple pharmacies) in Puerto Rico, report accidentally adding only .13mL of sodium chloride solution before injecting the result into children (the correct volume is 1.3mL). If the correct dose volume of .2mL was still used, these 25 children received ~1.4 times the payload of vaccine product - the mRNA coding the spike protein, the PEG coating, and the tromethamine stabilizer¹ - authorized for children.

At least six other entries describe accidentally drawing from vials with no diluent in the same week; and at least three describe using incorrect dose sizes (1.5 times the payload). Six more (from Puerto Rico, again) describe incorrectly adding only .3mL instead of 1.3mL (~1.3 times the payload).

The corresponding records which have been located as of November 22 (currently reported vaccinations dating until November 12):

Inadvertent use of 12+ Covid vaccine - 20-30 μg mRNA (*Moderna, 50-100 μg)

1863797 1863792 1862383 1861653 1861581 1861571 1861547 1861476 1861437 1861372 1861078 1860824 1858521 1858329 1858202 1858178 1858168 1857948 1857939 1857839 1857819 1857784 1857588* 1855575 1855078* 1854931 1854362 1853859 1853745 1852026 1851831 1851785 1851373 1851215 1851053 1850949 1850891 1850156 1849694 1849528 1847382 1846954 1846828 1846825 1846716 1846361 1846265 1846223 1843687 1843655 1843615 1843571 1843567 1843563 1843555 1843408 1840529 1840376 1840366

(Total: 59)

.13mL (near-non)dilutions - ~14.2 μg mRNA - 11/6-7, “a pharmacy” in Puerto Rico:

1862379 1862097 1862118 1861889 1861875 1861865 1861848 1861836 1861815 1861805 1861662 1861652 1861643 1861629 1861620 1861599 1861580 1861569 1861551 1861522 1861461 1861446 1861399 1861357 1861075

(Total: 25)

Non-dilutions - 15.4 μg mRNA (*11/9, California)

1864519 1862527 1858236* 1858228* 1856928* 1856927*

(Total: 6)

.3mL “half”-dilutions - ~12.9 μg mRNA - 11/9, Puerto Rico

1860562 1860561 1860560 1860559 1860557 1860555

(Total: 6)

.3mL “Overdoses” (15 μg mRNA)

1858458 1858416 1858149

(Total: 3)

Just how common is accidental adult-dosing of kids? The reports above, of course, likely under-count total incidents. In the first place I only managed to browse all reports back to around 1853---. For older reports in the last week, I relied on search. Not all reports use the word “adult;” older reports last week which use “12 +” instead will thus have been missed. Reports where the child’s age was not specified will have been missed. Reports that were not yet submitted will have been missed. Reports that never will be submitted - that were not even noticed - will have been missed.² In all likelihood, adult-dosing is rampant, and will not be fixed by practice or better messaging.³

Ending the accidental adult-dosing of children would require an entire remodel of the current delivery system to ensure that the adult product is not administered in the same physical locations as child Covid vaccines or of any other childhood vaccines. Until then, kids will keep getting injected with triple the approved dose.

source: Pfizer-BioNTech Fact Sheet for healthcare providers, “orange cap” (accessed November 22, 2021)

Pfizer/BioNTech Covid vaccine vials are topped with purple, grey, and orange-coded lids. Purple and grey vials are intended for recipients 12 years and above; most sites will only be using one or the other. Purple vials require dilution on site after thawing; grey vials are pre-diluted.

Orange represents vials for children 5 - 11. Most sites will be using orange alongside with one of the colors for adults; typically purple for the US.⁴

Merely picking the correct color will not ensure that recipients receive the appropriate final dosage in viable form. A hundred other steps must be followed for each product - hence why the chart for selecting the correct vial shares space with the over-complicated instructions for thawing. After thawing, each product has its own different volumes for dilution and dosage, and different total doses per vial. But since child and “adult” Pfizer/BioNTech Covid vaccines are being administered at the same sites, by the same clinicians, over and over, mixing up both the dilutions and the products themselves is inevitable. Of course children are being given adult doses. The entire process is a designed point of failure.⁵

source: Pfizer-BioNTech Fact Sheet for healthcare providers, “orange cap” (accessed November 22, 2021)

Despite this seemingly unfathomable complexity, the difference between the two vials is easy to ground in absolutes:

Purple (undiluted): 180 μg of mRNA in .45mL of suspension

Orange (undiluted): 100 μg of mRNA in 1.3mL of suspension

When the healthcare worker adds (or forgets to add) additional liquid, they get a new resulting volume. When they take out a portion of that resulting volume, they take out a corresponding portion of the total mRNA (and PEG, and buffers). If they do these steps correctly, a recipient aged 12 and above receives 30 μg of MRNA; a child aged 5 - 11 receives 10 μg.⁶

Purple, correct final dose: 30 μg of mRNA

Orange, correct final dose: 10 μg of mRNA

Using the normal “adult” volume of diluent thus leads to the following two “most likely” possibilities for purple Pfizer/BioNTech vials accidentally injected into children:

Purple (12+)

Adult-sized dilution, adult-sized dose

180 μg X .3mL/1.8mL = 30 μg

Adult-sized dilution, child-sized dose

180 μg X .2mL/1.8mL = 20 μg

The VAERS reports of accidental adult-dosing listed above do not always specify dose, but those that are specific on the matter mention both .3mL (adult-sized) and .2mL (child-sized) dose volumes, as predicted.⁷ But an interesting series of 4 reports from Maryland, Delaware, and “unknown” (interesting because the state changes, but the style of entry does not) indicate combining use of the “child-sized” 1.3mL value for sodium chloride diluent with the .2mL value for dose on the adult product.⁸

soruce: openvears.com

Predicting the “resulting volume” of incorrect dilutions such as this, however, brings up a point of difficulty. When the sodium chloride diluent is added to the original suspension, the suspension dissolves, and the resulting volume is less than the separate beginning (suspension + diluent) volume. For purple vials, 1.8mL of .9% sodium chloride added to .45mL of suspension yields 1.8mL of diluted vaccine - the “resulting volume” which we used above to calculate doses of mRNA. For orange vials, 1.3mL of .9% sodium chloride added to 1.3mL of suspension yields 2mL of diluted vaccine - the original suspension already being more “diluted” (in the new Tris buffer) to begin with.⁹

For erroneous volumes of diluent (besides 0), the “resulting volumes” will more or less be a guess.

Purple (12+)

Child-sized dilution (1.3mL), child-sized dose (“1843571 style”)

180 μg X .2mL/1.45mL(?) = 24.8 μg(?)

Here, the product was more concentrated, but the smaller injection volume limited mRNA to less than the normal adult dose. This demonstrates that the effects of changing dilution and dose can work in cross-directions. When the procedure is so complex and requires endless repetition and switching on the front lines, with no built-in quality checks, the resulting possible errors are limitless - including an undiluted injection of ~120 μg from a purple vial.¹⁰ The process was too complicated to begin with; any new procedures for the child product were guaranteed to degrade results, but the addition of the new value for dilution may have particularly thrown clinicians off their game.

Under the original regime, all vials of the Pfizer/BioNTech Covid vaccine were diluted with the same volume of sodium chloride: 1.8mL. The orange vials unnecessarily and confusingly require a different volume: 1.3mL. Adults receiving Pfizer/BioNTech vaccines after November 1, including triple-dose “boosters,” now must worry about the accidental use of the 1.3mL value for their purple vial, just as occurred in the 4 reports for children above:

Purple (12+)

Child-sized dilution (1.3mL), adult-sized dose

180 μg X .3mL/1.45mL(?) = 37.2 μg(?)

Example erroneous (.13mL) dilution, adult-sized dose

180 μg X .3mL/.57mL(?) = 94.7 μg(?)

Kids correctly receiving doses from orange vials, of course, can still be exposed to errors in preparation, such as use of .13mL or .3mL sodium chloride instead of the required 1.3mL during dilution. These mis-translations of the 1.3mL value, already reported in 31 of the VAERS entries above, might merely be growing pains with the new product - or they might continue indefinitely, depending on clinician turnover and general work culture at clinics.

The following is the math used to estimate the quantities of mRNA injected in the reports above, with best-guess “resulting volumes” (the undiluted volume of the suspension in orange vials, again, is also 1.3mL):

Orange (5-11)

Erroneous .13mL dilution, child-sized dose (“pharmacy” in Puerto Rico)

100 μg X .2mL/1.41mL(?) = 14.2 μg(?)

Erroneous .3mL dilution, child-sized dose (“unknown” in Puerto Rico)

100 μg X .2mL/1.55mL(?) = 12.9 μg(?)

Undiluted, child-sized dose (“unknown” in California)

100 μg X .2mL/1.3mL = 15.4 μg

Child-sized dilution, adult-sized dose (“1858458” style)

100 μg X .3mL/2mL = 15 μg

As we can see, as long as the reported suspension volume actually equals 1.3mL (the wording in the Fact Sheet is a bit vague), the orange vial is “safer” in of itself (as long as the dilution and dose are not both wrong at the same time).

But the very changes that foster that “safety” - the use of different suspension, dilution, and dose volumes - have exploded the quality management hazards going forward for recipients being injected with product from the purple vials, adults and children, correctly or erroneously.

Continued in Part 2.

1. Tromethamine will become the standard stabilizer used in vials intended for recipients aged 12 and above, as of the verbiage included in the November, 19 reissue of the FDA Letter of Authorization (pdf). It likely is not yet included in currently available “purple cap” vials for adults.

One wonders if, with the conspicuously-timed adoption of this new buffer, Pfizer/BioNTech is intentionally trolling the anti-vax crowd. Tromethamine is a common stabilizer which happens to also be safe for use in lowering blood acidity, as an alternative to bicarbonates. Both uses are decades old. Pfizer/BioNTech’s decision to replace the custom salt solution stabilizer with a drug used “for blood issues” exactly while rolling out the injection to children was guaranteed to provoke conspiracy theories that the new stabilizer is meant to prevent or disguise cardiac damage in children. However, tromethamine’s pharmacology has nothing to do with preventing or directly repairing cardiac damage (though low blood pH can potentially result in cardiac issues, the mRNA transfection does cause low blood pH).

2. The legal requirements for reporting incorrect doses are more intimidating than the requirements for reporting adverse events. But these are “healthcare workers” who are injecting an experimental bioweapon into children. I think they have intuited by now that everything is on the table, including total abdication of their responsibility to report to VAERS.

3. At least one of the VAERS reports makes reference to implementing a Pfizer “action item” (or similar term) to mark syringes in orange in advance. This suggests Pfizer is already aware of the issue. However, orange tape will not fix the problem (what later prevents a clinician from forgetting to only use vials with orange tape?).

4. (Allow a bit of a hedge on “typically purple,” pending further research.)

5. Even if that design is unintentional. Neither the American manager nor the American corporation understands quality management; outside of the brief effort to compete with the Japanese at the end of the century, they never have and never will. It is mode of thought which becomes biologically impossible any moment a given human exists within the borders of this country. See “Afterward to the Genesis Mishap.” However, in the case of the logistical algorithms for administering the Pfizer/BioNTech Covid vaccines, the sheer unlikelihood of consistent results seems peculiarly obvious.

6. See Letter of Authorization (Reissued) November 19, 2021 (pdf), Accessed November 22. Note that the distinction of the grey and purple-capped versions of adult product is not well-discussed. Emphasis added:

[The ages 12+] BioNTech COVID-19 Vaccine does not contain a preservative. Each 0.3 mL dose of the Pfizer- BioNTech COVID-19 Vaccine contains 30 μg of modRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2. Each dose of the Pfizer-BioNTech COVID-19 Vaccine also includes the following ingredients: lipids (0.43 mg (4-hydroxybutyl)azanediyl)bis(hexane-6,1- diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylee glycol)-2000]-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol), 0.01 mg potassium chloride, 0.01 mg monobasic potassium phosphate, 0.36 mg sodium chloride, 0.07 mg dibasic sodium phosphate dihydrate, and 6 mg sucrose. The diluent (0.9% Sodium Chloride Injection) contributes an additional 2.16 mg sodium chloride per dose. […]

The [ages 5-11] Pfizer-BioNTech COVID-19 Vaccine that uses Tris buffer and that is supplied in multiple dose vials with orange caps is supplied as a frozen suspension; each vial must be diluted with 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine. Each dose of the Pfizer-BioNTech COVID-19 Vaccine contains 10 μg of a modRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2. Each dose of the Pfizer-BioNTech COVID-19 Vaccine also includes the following ingredients: lipids (0.14 mg (4- hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.02 mg 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 0.03 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.06 mg cholesterol), 10.3 mg sucrose, 0.02 mg tromethamine, and 0.13 mg tromethamine hydrochloride. The diluent (0.9% Sodium Chloride Injection, USP) contributes 0.9 mg sodium chloride per dose.

7. For example, 1846828 and 1840529 indicate only using a .2mL dose of the adult product.

8. 1843571, 1843567, 1843563, 1843555

9. From the Fact Sheet for healthcare providers, “purple cap” (pdf):

Prior to Dilution
• The Pfizer-BioNTech COVID-19 Vaccine multiple dose vial with a purple cap contains a volume of 0.45 mL and is supplied as a frozen suspension that does not contain preservative […]

Dilution
Dilute the vial contents using 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP (not provided) to form the Pfizer-BioNTech COVID-19 Vaccine. […]

After dilution, 1 vial contains 6 doses of 0.3 mL.

From the Fact Sheet for healthcare providers, “orange cap” (pdf):

Prior to Dilution
• The Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vial with an orange cap and a label with an orange border contains a volume of 1.3 mL and is supplied as a frozen suspension that does not contain preservative. […]

Dilution
Dilute the vial contents using 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP (not provided) to form the Pfizer-BioNTech COVID-19 Vaccine.[…]

After dilution, 1 vial contains 10 doses of 0.2 mL.

10. https://openvaers.com/covid-data/covid-reports/1752999