Vaccine Information Statements For Dummies
Before any doctor gives your baby vaccines, you should be given Vaccination Information Sheets (VISs) to read.
Developed by the CDC, they inform vaccine recipients, their parents or legal representative, about the benefits and risks of vaccines. (1) Federal Law requires their use. This is a result of the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. 300aa-26. (1) Before 1986, parents didn’t have any right to printed information about vaccines.
VISs sound like a good system. Parents get concise and easy to understand information on a vaccine’s risks and benefits so they can make an informed decision.
Is that really how it works? Let’s examine the nuts and bolts of VISs.
VISs are only required for vaccines covered under the Vaccine Injury Compensation Program (VICP) and even then only if a FINAL version of a VIS exists. (1)
The CDC’s, Vaccination Information Sheet (VIS): Myth Exposed! states, “The law does not require that a vaccine be withheld if a VIS for it does not yet exist.” “…providers should not delay use of a vaccine because of the absence of a VIS.” (2) Note the CDC makes “not” bold.
Federal law does not require informed consent for vaccines. The government feels that VISs should adequately inform parents in spite of the fact that they are not informed consent forms. (3)
The information in VISs is often at odds with package inserts. “Package inserts generally tend to include all adverse events that were temporally associated with a vaccine during clinical trials, whereas ACIP tends to recognize only those likely to be causally linked to the vaccine.” (3)
Let’s take a look at the Hepatitis B VIS to see just how at odds its adverse events section is with the package inserts’. From the VIS, the ACIP experts say the only risks are soreness and fever. Severe allergic reactions occur at one per 1.1 million doses. That seems like a pretty safe vaccine. Now read the “Adverse Events” sections in the package inserts, GlaxoSmithKline’s ENGERIX-B, starts on page 8, and Merck’s Recombivax HB, starts on page 7.
ENGERIX-B reports 40 unique adverse events from clinical studies and Recombivax HB reports 47. As stated in the adverse events sections, these studies only allow healthy individuals to participate and they cannot adequately detect rare adverse events due to the small number of participants. Once a vaccine is put into use in the real world, where the sick and vulnerable populations are not excluded from being given the vaccine, adverse events continue to be monitored. ENGERIX-B reports an additional 37 unique adverse events from postmarketing reports and Recombivax HB reports an additional 54.
In total, ENGERIX-B lists 77 unique adverse events and Recombivax HB lists 101. Now those probably aren’t all attributed to the vaccines, but do you think the experts at the ACIP got it right when then say that only 3 of those count?
Surprisingly, many doctors ignore Federal law and don’t provide VISs to parents at all. A 2001 AAP Periodic Survey of Fellows revealed that before every dose of each vaccine, 40% of pediatricians do not distribute VISs and about 50% don’t bother to discuss the risks and benefits. (4) This 2007 study revealed the CDC knows about this problem but still chose not to support a change which would help physicians follow the law. Is the CDC’s goal really education leading to an informed decision, or is it just vaccination compliance?
Summary: VISs are required for most, but not all vaccines. They do not fulfill informed consent but the government feels that’s all you need. The information is cherry-picked by experts at the ACIP and a lot of physicians don’t use them as required by law.
Stayed tuned for an in-depth look at what each VIS says, or perhaps, what it doesn’t…
(1) Fact Sheet for Vaccine Information Statements
www.cdc.gov/vaccines/pubs/vis/vis-facts.htm
(2) Vaccine Information Statements (VIS): Myth Exposed!
www.cdc.gov/vaccines/pubs/vis/vis-misconception.htm
(3) Questions & Answers: Vaccine Information Statements
www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/E/vis-q&a.pdf
(4) AAP Periodic Survey #48
www.aap.org/research/periodicsurvey/ps48b.htm
Comments
5 Comments on Vaccine Information Statements For Dummies
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MinorityView on
Sun, 6th Apr 2008 5:53 am
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concerned parent on
Thu, 10th Apr 2008 4:39 pm
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Jim Witte on
Wed, 21st May 2008 8:20 pm
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concerned parent on
Thu, 22nd May 2008 4:07 pm
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concerned parent on
Thu, 22nd May 2008 4:52 pm
‘The information in VISs is often at odds with package inserts. “Package inserts generally tend to include all adverse events that were temporally associated with a vaccine during clinical trials, whereas ACIP tends to recognize only those likely to be causally linked to the vaccine.”’
I wonder if this is why doctors frequently tell parents that their children’s illnesses following vaccines are not connected. Doctors might believe that the ACIP is correct about causal linkages. But parents who get hold of a copy of the product insert might lose faith in their doctor. I guess the solution is to ban the distribution of product inserts, right?
I believe the most disturbing discrepancy between the VIS and package insert is that all 50 of the package inserts I have examined contain the following statement: “this product has not been tested for mutagenesis, carcinogenesis or impairment of fertility”.
@ concerened parent
” all 50 of the package inserts I have examined contain the following statement: “this product has not been tested..”
Does ACHAMP or somewhere else have scanned copies of the VIS sheets for all the commonly used vaccines? “Smoking guns”, or perhaps Lyn Redwoods phrase “bullets all over the floor” is more appropriate..
1) Link to the Johns Hopkins school of public health website that has all the package inserts http://www.vaccinesafety.edu/package_inserts.htm
2) Link to the CDC website that has all the VIS sheets http://www.cdc.gov/vaccines/Pubs/vis/default.htm
Oops, I see you already have the Johns Hopkins link on your site. Since the pkg inserts are PDFs it was easy to search for one of the key phrases “carcinogenesis, mutagenesis or impairment to fertility” in each pkg insert.
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