The package inserts for vaccines are not as useful as many parents believe, especially if you are trying to do research about vaccines.
No, it is not because your pediatrician won’t let you read them, after all, package inserts for each and every vaccine are easy to find.
And it certainly isn’t because package inserts are hiding information that would keep you from getting your kids vaccinated if you were more aware of it.
Again, vaccine package inserts are easy to find.
It is that some of the information in the vaccine package insert is not what you think it is. For example, in addition to Data from Clinical Studies, the Adverse Reactions section includes side effects that are voluntarily reported and for which “it may not be possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.”
What does that mean?
Just because a side effect is in the package insert, depending on the section, it doesn’t automatically mean that it was caused by the vaccine. That is why autism and SIDS are listed as adverse events for the Tripedia vaccine.
Adverse events reported during post-approval use of Tripedia vaccine include idiopathic thrombocytopenic purpura, SIDS, anaphylactic reaction, cellulitis, autism, convulsion/grand mal convulsion, encephalopathy, hypotonia, neuropathy, somnolence and apnea. Events were included in this list because of the seriousness or frequency of reporting. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequencies or to establish a causal relationship to components of Tripedia vaccine.
In fact, many studies have shown that there is no causal relation between vaccines and autism or vaccines and SIDS.
Package inserts are useful, but you should understand why and how they were written if you are going to add them to your vaccine research.
For more information:
- Package Inserts
- Argument by Vaccine Package Inserts – debunking myths
- Package Inserts – Understanding What They Do (and Don’t) Say
- Vaccine Package Inserts: Not all you should be reading
- Anti-vaccine parents and the package insert paradox
- Myths That Keep People From Vaccinating Their Kids