Why the Safety of the Vaccine Schedule Will Always be in Question
Jan 17, 2013

There is no doubt in my mind that the safety of vaccines will always be in question. It’s a good thing actually. Since vaccines are administered to almost every child born in the United States, vaccine safety should be rigorously tested and held to a higher standard than any other medical treatments on the market. And they are.
Consider this. Vaccines safety testing is a long and arduous process.

• It can take 10 or more years and an average of $800 million of manufacturers’ money before a new vaccine is thoroughly tested, licensed and made available to the public.
•  The FDA ensures that each batch is safe, pure, potent and effective and once a vaccine is being administered, post-licensing monitoring is conducted to identify any possible side-effects.
• The Vaccine Safety Datalink (VSD) has collected statistics from more than 7 million people who have received vaccines.
• In 1990, the CDC and the FDA established the Vaccine Adverse Event Reporting System (VAERS), which gathers information about any side effects patients have experienced. Since VAERS accepts any reported information without determining a cause and effect relationship, this information is investigated further and used to identify possible safety concerns.
• Clinical Immunization Safety Assessment Centers (CISA), which were started in 2001, also conduct clinical research about vaccine adverse events (VAE) to help ensure there are no safety concerns.
• Finally, all vaccines are subjected to concomitant studies before they are approved for use. This means that all new vaccines must be tested in conjunction with existing ones to ensure there are no negative interactions. Regulatory agencies such as the Food and Drug Administration (FDA) are careful to look for any side effects associated with concomitant use before approving a new vaccine.

Despite these safeguards, some people have remained concerned over the safety of the full childhood immunization schedule. Even after repeated reports that vaccines are generally very safe and serious adverse events are quite rare, people still wonder if the large number of vaccines might overload a child’s immune system. They continue to raise questions as to whether the immunization schedule can be tied to such chronic health conditions as asthma, allergies, developmental disorders, autism and other conditions. This is why the National Vaccine Advisory Committee (NVAC) recently commissioned the Institute of Medicine (IOM) to examine the safety of the entire recommended childhood immunization schedule.
To do this, the IOM analyzed all the current research literature on this topic, reviewed the studies and verified enormous amounts of data. After which they reached an undeniable conclusion. The recommended schedule is safe.
The report, released just yesterday, is quite extensive and conclusive. It can be read in it’s entirety here. It covers everything from how the committee conducted their research, to the specific questions they were addressing, to their definitive conclusion that the schedule is safe.  However, even though this report is the most comprehensive of it’s kind, I can’t help but wonder

Will this research matter to the people it should matter to most?

While the report should be reassuring to all parents, providers and stakeholders, it appears to be business as usual for the die-hard vaccine critics. In fact, I believe the single most contentious recommendation made in the report has to do with the utopian idea of designing a study that compares the vaccinated to the unvaccinated. Among the details of the report, the committee reinforced their recommendation that

“randomized clinical trials to determine baseline data of unvaccinated vs. vaccinated children would be unethical and unfeasible. If any data of that nature is collected, it should be done on a retrospective basis.”

However, this appears to be the one and only study that will appease the vaccine critics (maybe because they realize how unlikely it is to ever be conducted). They hold firm to their belief that a study of vaccinated vs. unvaccinated will prove that the unvaccinated are healthier than their vaccinated counterparts and they actually make these statements regularly without evidence to support their assertions.  Meanwhile, they conveniently ignore any study that demonstrates that the unvaccinated are more likely to contract a vaccine preventable disease than the vaccinated. And because this is the one recurring demand from the anti-vaccine crowd, it simply won’t go away.
To be honest, I actually wish this kind of study could be done and this safety issue finally put to rest.  I would suspect others feel the same way.
Unfortunately, the reality is that the overwhelming scientific evidence suggests that it would be unethical to willfully withhold vaccines and leave children vulnerable and unprotected against deadly diseases.  Of course, the IOM recommendation does leave the door open a jar, by stating that perhaps we could go back and collect data from unvaccinated individuals retrospectively.  However, now we’re left wondering; even if such a study were feasible, wouldn’t the variables leave us with a weak and inconclusive study?
I can only suspect that if such a study were to be conducted, children would bear the unfortunate consequences of contracting vaccine preventable diseases and possibly end up hospitalized or dead.  Then, the vaccine critics would simply find a way to discredit the study.  Some might call the study unethical. They would call it a conspiracy.
So we are left to wonder,

Who will this report convince?

Certainly not the people who believe in big government or big pharma conspiracy theories. Or those that remain convinced that an organic lifestyle – free from pesticides, preservatives, and vaccines – is the only way to ensure good health. No. These are the people who would rather forego immunizations and gamble on a “natural” immune system that may, or may not, be enough to protect their children from some horrible, and often deadly diseases rather than risk an extremely adverse event.
Unfortunately, for the few people who’ve made the decision not to vaccinate their children at all, this report probably won’t make a bit of difference.  Most of the extreme anti-vaccine individuals I’ve encountered lack the ability to properly analyze the data, complete an unbiased risk/benefit analysis or put their prejudices aside long enough to evaluate the science for what it is intended to be. Objective, unbiased, and chock full of undeniable evidence.
While it may not be possible to change the minds of a few, I do believe that this particular IOM report will serve as crucial evidence to many.  Parents will continue to question the safety of vaccines – as they should.  But there are plenty of people who are smart enough to properly educate themselves about vaccines.  They will read the IOM report and respect the conclusions.  I believe that if people are wise enough to understand the difference between what they want to be true and what the scientific evidence proves to be true, they will have confidence in the childhood immunization schedule.

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