Claim: Section 13.1 on Vaccine Inserts Removed to Hide that Vaccines not Tested to Cause Cancer

[Mick West]

This popped up on Facebook today. The claim in the red box is:

13.1 States vaccines have not been tested for carcinogenic, mutagenic potential or for impairment of fertility

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Vaccines have a "package insert" which is a huge dump of federally mandated information. Section 13 seems to be covered by §201.57 :
https://www.ecfr.gov/cgi-bin/text-idx?SID=0185abe9343eee9cdac5e03d9acf39b8&mc=true&node=se21.4.201_156&rgn=div8

(14) 13 Nonclinical toxicology. This section must contain the following subsections as appropriate:

(i) 13.1 Carcinogenesis, mutagenesis, impairment of fertility. This subsection must state whether long term studies in animals have been performed to evaluate carcinogenic potential and, if so, the species and results. If results from reproduction studies or other data in animals raise concern about mutagenesis or impairment of fertility in either males or females, this must be described. Any precautionary statement on these topics must include practical, relevant advice to the prescriber on the significance of these animal findings. Human data suggesting that the drug may be carcinogenic or mutagenic, or suggesting that it impairs fertility, as described in the “Warnings and Precautions” section, must not be included in this subsection of the labeling.

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Misinterpreting vaccine package inserts is a constant source of misinformation in the anti-vaccine community. There are multiple detailed articles on the topic listed at the end of this article:
https://vaxopedia.org/2017/10/24/are-vaccines-evaluated-for-mutagenicity-carcinogenicity-or-impairment-of-fertility/
Which also discussed "The Section 13 Vaccine Conspiracy?" However this "conspiracy" is not that section 13 is missing, but rather that it's there, and states that testing has not been done.

More importantly, why do some folks talk about Section 13.1 of a vaccine’s package insert like it is Area 51 or Agenda 21?
...
Then why do anti-vaccine folks scare parents into thinking that vaccines are missing necessary testing when the package insert states that they are “not evaluated for mutagenicity, carcinogenicity or impairment of fertility?”

Probably because it sounds scarier than saying that vaccines have a low risk of inducing tumors and that there are very specific guidelines and rules for when a manufacturer needs to perform fertility studies.

That means that if a package insert says that it has “not been evaluated,” it is simply because it was not necessary or appropriate. It is not because they just didn’t want to do it and left those tests out.

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For example, here's the section 13 for Gardasil:
https://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf

GARDASIL has not been evaluated for the potential to cause carcinogenicity or genotoxicity.
[also lists animal studies showing no effect on fertility]

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Non-clinical studies are studies done using animals. There's also a section 14, listing clinical studies done on people. In the case of Gardasil it discusses how to prevents cancer.

Despite all the discussion of how people are misreading the insert, there seems to be an unanswered question here (or at least a difficult-to-google question): WHY is section 13 missing in some vaccine inserts?

It is actually missing in the Pneumovax 23 insert:
https://www.merck.com/product/usa/pi_circulars/p/pneumovax_23/pneumovax_pi.pdf

I suspect the reason might be essential that it was not applicable, and was omitted because it was confusing people into thinking the product was unsafe. But now we've got this conspiracy theory that they are deliberately hiding information.

So why was it omitted, and what bit of the law allows it to be omitted?

 

[Mick West]

All the flu vaccines listed here seem to have the section. The shortest being:

http://labeling.seqirus.com/PI/US//Fluvirin/EN/Fluvirin-Prescribing-Information.pdf

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility FLUVIRIN® has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

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Others offer more details if there actually were animal studies:
http://labeling.seqirus.com/PI/US/Flucelvax/EN/Flucelax-Prescribing-Information.pdf

13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
FLUCELVAX QUADRIVALENT has not been evaluated for carcinogenic or mutagenic
potential, or for impairment of male fertility in animals.
FLUCELVAX (trivalent formulation) administered to female rabbits had no effect on fertility
[see Use in Specific Population (8.1)]

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https://www.vaccineshoppe.com/image.cfm?doc_id=14055&image_type=product_pdf

13 NONCLINICAL TOXICOLOGY Flublok Quadrivalent has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals. A developmental toxicity study conducted in rats vaccinated with Flublok (trivalent formulation) revealed no evidence of impaired female fertility (see Pregnancy [8.1]).

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The PNEUMOVAX 23 insert (with the omitted section 13) says "Copyright © 1986, 2011" - so I wonder if it's an older drug where labelling requirements are different.

201.56(d)(4) says:
https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=0185abe9343eee9cdac5e03d9acf39b8&mc=true&n=pt21.4.201&r=PART&ty=HTML#se21.4.201_157

(4) Omit clearly inapplicable sections, subsections, or specific information. If sections or subsections required under paragraph (d)(1) of this section are omitted from the full prescribing information, the heading “Full Prescribing Information: Contents” must be followed by an asterisk and the following statement must appear at the end of Contents: “* Sections or subsections omitted from the full prescribing information are not listed.”

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This matches the Pneumovx 23 insert:

 

[Mick West]

The Pneumovax 23 and Variva inserts seems to be the only ones from Merck that omits section 13
https://www.google.com/search?q=site%3Amerck.com+-"13+nonclinical+toxicology"+"14+clinical+studies"

There's actually one (Primaxin) that omits sections 14 (Clinical studies) and 15 (References), but has section 13.
https://www.merck.com/product/usa/pi_circulars/p/primaxin/primaxin_iv_pi.pdf

So clearly there's some regulatory mechanism and reasoning for omitting these sections.

 

[Vicente]

So clearly there's some regulatory mechanism and reasoning for omitting these sections.

Yes, they can be omitted when no such studies have been performed. However, neither the public nor the regulator know whether they have actually been performed becasue the manufacturer may dhoose to omit studies that are not public and produced resultas that would not help marketing their products.

I cannot make the logical connection between matter not investigated ("has not been evaluated for carcinogenic...") and "safe". Please elaborate!

 

[Mick West]

Yes, they can be omitted when no such studies have been performed.

Do you have a reference for this? Like a someone explaining the details?

I cannot make the logical connection between matter not investigated ("has not been evaluated for carcinogenic...") and "safe".

There isn't a connection. The "safe" determination was obviously arrived at via other means. That's not really the topic here. The topic is if there's a conspiracy to remove this section to mislead the public.

Given the very limited times it has been omitted, I'd say not. But it would be good to actually find out exactly WHY it was omitted in this case, and not in others like Seqirus

 

[deirdre]

But it would be good to actually find out exactly WHY it was omitted in this case, and not in others like Seqirus

The Pneumovax 23 and Varivax inserts seems to be the only ones from

In addition to not having sections 9 and 10, some vaccines don’t have a section 13. It is not a conspiracy. Some older vaccines, like Varivax, do not have to have a section 13 per FDA labeling rules.

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https://vaxopedia.org/2017/07/10/how-to-read-a-package-insert-for-a-vaccine/

 

[deirdre]

here is their original application dated June 1983 http://wayback.archive-it.org/7993/20170723151551/https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM218554.pdf

and here is the prior page with a few more links on them changing the insert data over the years
http://wayback.archive-it.org/7993/20170723031125/https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm179996.htm


This information is linked on the fda site.. they must just use wayback for old stuff storage. https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm179996.htm

 

[deirdre]

I'd also like to point out to readers - that the Federal Regulations vaccine inserts fall under are for "prescription medication". There's a big difference between a one time vaccine shot and say getting a presciprion for blood pressure or whatever, that you are taking daily and possibly for long periods of time.

That's probably why section 9 and 10 are missing from Pneumonax-23 too. You cant really overdose if you aren't dosing yourself at home.

And i wouldnt worry too much about fertility as the CDC recommends Pneumonax-23 for 65 and older, although the Pneumonax page does say 50 and older. Still, not many fertility issues to worry about over 50!