Back to: How to Read an Insert Training Course
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Remember when we talked about manufacturer liability? The National Vaccine Childhood Injury Act required all vaccine providers by law to give patient or parents the Vaccine Information Statement (VIS) prior to every dose of a vaccine.
What is a Vaccine Information Statement? Per the CDC:
How is a VIS provided? Per the CDC:
Is the VIS the same as the manufacturer insert? No. It is a birds-eye view of the insert and does not include all information provided by the manufacturer. Per the CDC, the original law governing vaccine information materials was amended in 1993 to save manufacturers + practitioners time. See comparison below:
Are all healthcare providers required to provide VIS for all vaccines? No. Per the CDC, providers are only required to provide VIS for the below listed vaccines:
Do VIS provide proper informed consent? No. Per the CDC:
Do VIS conflict with manufacturer guidance? Yes. Per the CDC:
Let’s look at an example. Below is the VIS + Manufacturer Insert for DTAP. What do you notice?
The adverse reaction section on the DTAP Vaccine Information Sheet:
The adverse reaction section on the DTAP Manufacturer Insert:
As a parent, if you received a Vaccine Information Sheet from a healthcare provider that listed “Sudden Infant Death Syndrome (SIDS)” as a potential adverse reaction, would that concern you? Yes, the VIS does state death may occur, however it does not properly identify what the manufacturer has disclosed: that SIDS has been connected to the DTAP vaccine and is routinely given to babies starting at two months old, four months old, and six months old.
According to the NIH, SIDS was the leading cause of death in children between 1 month and 1 year of age in 2013. Also, the majority (90%) of SIDS deaths occur before a child is 6 months old, with most happening between 1 month and 4 months of age.
If this upsets you, you aren’t alone. Head to the next section to learn about informed consent.