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.
IOMreportcoverTo 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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12 responses to “Why the Safety of the Vaccine Schedule Will Always be in Question”

  1. Lara Lohne says:

    Christine, Great post and very on point. While it’s true the ‘die-hard’ anti-vaccine crowd will most likely refuse this data, I do believe they have felt the threat that it is to their entire belief system. Since the release of this report yesterday, the anti-vaccine rants on various blogs, including this one, have become particularly vicious, almost as though it is a one last attempt at survival for a dying animal. They refuse to accept irrefutable, scientific data, but become uber defensive in its wake. Just like a child caught in a lie will try to make their position and story more convincing with tears or shouts of indignation, so has the anti-vaccine activists appeared to be lashing out against this study giving even more evidence as to the safety and efficacy of vaccines and further weakening their position. Now, though, when they try to make a claim that the safety of the schedule has never been tested (even though it has) we have one more study under the belt to prove they are not as informed as they believe they are.

  2. Lawrence says:

    @Christine – unfortunately, it will be impossible to convince the anti-vax crowd that the kind of double-blind, placebo study that they demand is entirely unethical.
    You would need to take a few thousand (or more like 10 to 20 thousand) babies, sort them into blinded groups & give one real vaccines and the others get placebos.
    In the instance of outbreak or pandemic, it would be impossible for the parents to know if their children are actually protected (not to mention that schools would not be able to know if their students were actually vaccinated or not).
    Exactly how, in anyone’s mind, is this an ethical study?
    You know, they did something like this once before – it was called the Tuskegee Study & it is held up as the highest medical research wrong-doing of the 20th Century…yet this is what anti-vaccine cranks are demanding be done – to babies, no less.

  3. Lara Lohne says:

    I just came across this a couple of minutes ago and thought this would be a good place to share it. These parents are fortunate that their son will survive, and also that they finally understand the true horrors that these diseases that vaccinations can prevent actually bring with them.
    I hope it’s alright that I share it here, even though it isn’t exactly on topic.

  4. Lawrence says:

    @lara – that’s a very good piece & I’m glad the child survived…..it is a side of disease that the anti-vaccine crowd tends to ignore – because here is a child, because of a VPD, that may now suffer long-term consequences for the rest of his life.
    This isn’t an anecdote – this is a fact, because we know what the side effects are of these diseases….unlike the sheer speculation of the anti-vax side of things.

    • Lara Lohne says:

      I actually commend these parents. They were able to see the dangers without the loss of life and made the choice to protect their children as well as others around them. How I wish my mother had been as enlightened by the pain, suffering and permanent damage left behind when my siblings and I suffered through VPDs when I was growing up. It is unfortunate that some parents actually don’t learn from their mistakes.
      I honestly hope that their child makes a full, and complete recovery. It’s going to be a long process for them, but at the very least, their son is a living example of how devastating disease can be. There aren’t a lot of living examples anymore. This is fortunate and unfortunate. Fortunate because vaccinations have all but eliminated completely the diseases that cause these debilitating side affects, and unfortunate because since they are no longer common place, we have forgotten what it was really like when these diseases were inevitable for many people, because we didn’t have vaccines to prevent them.

  5. expires soon says:

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  6. lilady says:

    I give these parents a lot of credit for going public about the consequences of deliberately not immunizing their child(ren) against tetanus.
    Tetanus is not transmissible, but imagine their guilt if by not immunizing their child(ren) with DTaP vaccine, one of them contracted diphtheria or pertussis and transmitted those diseases to an infant who was too young to have received the DTaP primary series, and who, as a consequence, died.

  7. Lauren @ the VEC says:

    The Vaccine Education Center at The Children’s Hospital of Philadelphia has an informational sheet that answers common questions related to the immunization schedule: “Recommended immunization schedule: What you should know”, http://www.chop.edu/export/download/pdfs/articles/vaccine-education-center/recomm-immuniz-sched-eng.pdf

  8. […] news, I haven’t had a chance to get around to it except my story at dailyRx. As you may have already heard, the Institute of Medicine (IOM) published a report last Wednesday affirming the safety of the […]

  9. Give me Liberty says:

    I think the ones who are unable to let go of their bias are the vaccine pushers. With claimes that not giving 36 vaccines dose from birth to 2 years is some how dangerous. It isn’t. There are multiple countries around the world that do not use their infants as human pin cusions and do not have raging epidimics. They also have much healther children than in the USA. Countries like Iceland as well as many other EU nations only require 11 vaccine doses in infancy and none at birth. Their infant mortality is way lower than ours. We rank 34th in the developed world concerning infant mortality now. When kids only got 10 shots in infancy the USA ranked 12th in infant mortality. Another study found that kids on the regular schedule had way more hospital visits than those who followed what was called an under vaccinated schedule.
    Really tired of the strawman argument that if you are for a more reasonable vaccine schedule you are against all vaccines. It simily isn’t true. The current laws in many states requiring all or nothing is putting children at risk.
    I have the courage to say that my infant was vaccine injured and I regret allowing him to vaccinated too early. He now has sever neurological problems as a result to his reaction. He was healthy thriving and had gained over a pound before his first vaccine. I managed to keep the doctor from giving him newborn vaccines for 7 days. So unlike many parents I got to see a clear before and after vaccine reaction in my child. Immediately following the vaccine he passed out. After he woke back up he couldn’t keep milk down losing most of the weight he gained over the next few days then being reclassified as failure to thrive.

  10. Chris says:

    “Give me Liberty”, then move. I am sure there are many more countries more to your liking.

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