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

Mick West

Administrator
Staff member
Metabunk 2019-04-01 08-25-42.jpg

This popped up on Facebook today. The claim in the red box is:
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
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.
For example, here's the section 13 for Gardasil:
https://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf
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
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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

Administrator
Staff member
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
Others offer more details if there actually were animal studies:
http://labeling.seqirus.com/PI/US/Flucelvax/EN/Flucelax-Prescribing-Information.pdf
https://www.vaccineshoppe.com/image.cfm?doc_id=14055&image_type=product_pdf
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
This matches the Pneumovx 23 insert:
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Mick West

Administrator
Staff member

Vicente

New Member
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

Administrator
Staff member
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

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

deirdre

Moderator
Staff member

deirdre

Moderator
Staff member
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!

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