Anti-vaccine parents and the package insert paradox


Hey, anti-vaxxers, help me out here!

You’re big fans of vaccine package inserts, right? You’re constantly waving them in parents’ faces insisting that they “reveal” the “truth” about vaccine dangers, right?

So why do you ignore the package insert when it talks about the benefits, efficacy and safety of vaccines?

[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]You’re big fans of vaccine package inserts, right? So why do you ignore the package insert when it talks about the benefits, efficacy and safety of vaccines?[/pullquote]

According to Stop Mandatory Vaccination:

The risks for each vaccine are stated right on the vaccine package inserts but these inserts are not given to parents or even to adults considering the suggested vaccines for them. It is also doubtful that the doctor or nurse dispensing the vaccine has fully read the product insert

A full list of contraindications and adverse events listed in the package inserts is available on the Immunization Action Coalition website. While the incidence of any particular adverse reaction listed on the insert may not be unacceptable in the eyes of the manufacturer or the CDC, every parent has both the duty and right to know what they are so that they can decide whether the benefit outweighs the risk for their child or themselves. (my emphasis)

The folks at Stop Manadatory Vaccination, seem to believe that package inserts are so important because they are:

  • Accurate
  • Filled with valuable information
  • Scrupulously honest

Let’s take a look at the package insert for the MMR (mumps, measles, rubella) vaccine. It includes nearly two pages of possible vaccine side effects. Nothing is too small or too rare to be listed.

Looks scary, right?

But there’s more!

According to the package insert, the MMR is highly effective!

Clinical studies of 284 triple seronegative children, 11 months to 7 years of age, demonstrated that M-M-R II is highly immunogenic and generally well tolerated. In these studies, a single injection of the vaccine induced measles hemagglutination-inhibition (HI) antibodies in 95%, mumps neutralizing antibodies in 96%, and rubella HI antibodies in 99% of susceptible persons.

According to the package insert, the MMR has been extensively tested!

Efficacy of measles, mumps, and rubella vaccines was established in a series of double-blind controlled field trials which demonstrated a high degree of protective efficacy afforded by the individual vaccine components. These studies also established that seroconversion in response to vaccination against measles, mumps, and rubella paralleled protection from these diseases.

According to the package insert, the MMR dramatically improves public health!

The impact of measles, mumps, and rubella vaccination on the natural history of each disease in the United States can be quantified by comparing the maximum number of measles, mumps, and rubella cases reported in a given year prior to vaccine use to the number of cases of each disease reported in 1995. For measles, 894,134 cases reported in 1941 compared to 288 cases reported in 1995 resulted in a 99.97% decrease in reported cases; for mumps, 152,209 cases reported in 1968 compared to 840 cases reported in 1995 resulted in a 99.45% decrease in reported cases; and for rubella, 57,686 cases reported in 1969 compared to 200 cases reported in 1995 resulted in a 99.65% decrease.

The package insert mandates scrupulous attention to safety, acknowledges risks, emphasizes informed consent and asks for detailed explanations of any adverse reactions:

The health-care provider should inform the patient, parent, or guardian of the benefits and risks associated with vaccination. For risks associated with vaccination see WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.

Patients, parents, or guardians should be instructed to report any serious adverse reactions to their health-care provider who in turn should report such events to the U.S. Department of Health and Human Services through the Vaccine Adverse Event Reporting System …

In fact, if you read the entire package insert, you would almost certainly opt to vaccinate your child!

See the paradox?

You claim that package inserts offer vital, scrupulously honest information about vaccines. They do.

So why aren’t you vaccinating?