In the US, vaccination has become viewed as routine; a rite of passage we must all take in order to be our most healthy.
This standard, routine intervention had led to a tolerance among parents (and doctors) of a revoltingly deficient exchange of information regarding the procedure of vaccination.
An erosion of informed consent – which we must teach ourselves how to reclaim.
In this post, I offer you a list of some examples of what my informed consent is established on with several resourceful and educational links.
Please feel free to add to this list in the comment section!
Informed Consent and Why It Is Essential
I hear the word ‘informed consent’ thrown around a lot, but I’m not entirely sure many understand what the term encompasses.
What informed consent is NOT (in terms of vaccination): Claiming you are an expert in immunology, thinking you know more then your doctor, generally mistrusting medicine.
Informed consent is a process of communication between a patient and physician that results in the authorization to undergo a specific medical intervention.[*]
According to the American Medical Association, this communications process is both an ethical obligation and a legal requirement in all 50 states.[*]
(Just FYI, Medicare & Medicaid Services uphold the legality and ethical consideration of informed consent)
Shockingly, (according to a study reviewing 7 pediatric practices) the median time spent on the exchange of vaccine information is less then 2 minutes at well child visits (with a cumulative discussion of vaccination within the first 2 years of life estimated to be less then 10 minutes). [*]
Established timetable during a well-child visit examined in the study referenced[*]:
(time listed in minutes)
4.9 = physical exam
1.9 = vaccine discussion
9.5 = discussed other health concerns
0 = vaccine administration (performed by a nurse 1.6 minutes)
This is deplorable.
Informed consent can only be effectively exercised if the patient (or caregiver) possesses enough information to execute it.[*]
I’m going to go out here on limb and state that two minutes is not enough to impart disclosure of relevant information on each vaccine administered at that visit.
Our children deserve better then this.
Informed consent should be imperative because it is intended to protect each patient’s right to self-determination, bodily integrity and our voluntary choice in the decision making process.[See AMA Ethical Opinion 8.08]
Here are a few key points to start in developing your consent on vaccination:
1 - Do I know which disease I am vaccinating against?
This question seems simple enough – yet, it may take some time and research on the parent’s part.
Firstly, you may expect your child to be administered two injections, however these may consist of combination vaccines combined into a single injection – resulting in 7 vaccines (ex MMR-V and DTaP at 12 months) in 2 simultaneous ‘shots’. [*][*]
To start, contact your doctor prior to any visit to obtain information on which vaccines are going to be recommended. This will provide you with enough time to become familiar with each vaccine and the corresponding disease (particularly the prevalence, transmission, symptoms, treatment).
Once you begin to read and become familiar with each disease/vaccine, you are much better prepared to work on a list of any questions you have to present and discuss with your doctor at the visit.
Some good points to ask regarding the disease itself:
You can reference the CDC’s Pinkbook for more information on these questions. I would also use a second source to confirm here.
A quick side note: It is helpful to save some links that you come across in the beginning of your research that you can reference easily.
Links that are helpful:
2 - Do I know which vaccines are Recommended vs. Required?
Not all recommended vaccines are required for school attendance; in fact, all 50 states offer some type of exemption (click here to learn more about exemptions).
All states allow for a medical exemption, while 48 offer non-medical exemption (the exceptions are Mississippi and West Virginia).
Which vaccines are required for school is dependant upon which state you reside in.[*]
If you do decide to file an exemption, due to differences in State laws, it imperative to become familiar with your own State’s requirements before writing your exemption.
Click here to find your state and learn more in depth about what is required for vaccine exemption.
If you only want to consider the vaccines that are required by your State for school attendance, then click below to go to an interactive CDC database for your state to learn more:
This tool provides state vaccination requirements, state exemptions, and links to state web sites reporting requirements.
3 – Have I evaluated the state of health of my child at the time of vaccination?
Although the AAP instructs medical professionals to vaccinate sick children on schedule (even if they exhibit symptoms of runny nose, fever, ear infection, a cough, and mild diarrhea), logic on this advice is lost on me. [*]
Firstly, if a vaccine is administered to a sick child and an adverse vaccine reaction occurred it would be challenging (dare I say impossible?) to discern if the reaction was due to the vaccine or if it was due to a pre-existing condition.
Secondly, certain factors during illness (such as medication taken during illness, interrupted sleep patterns and stress) have been illustrated in affecting an adequate antibody response to vaccination/illness.[*][*][*]
A few examples in recent publications: one study illustrated that children who have been administered a fever reducer resulted in significantly fewer antibodies after vaccination.[*]
If you do decide to vaccinate a child that is ill, I would advise learning more about which medications should be avoided.
A child who is sick or has been recently sick may be at increased risk for having a serious vaccine reaction. You may consider asking your doctor to give your child a physical exam to make sure your child is healthy before vaccination.[*]
4 – Does age at the time of vaccination effect vaccine-induced immunity?
Questioning whether to wait until the child is older (over 24 months of age) is a valid concern when it comes to vaccination.
This is for several reasons:
According to WHO, early life immune responses have age-dependent limitations to all vaccines. In fact, antibody responses to most PS antigens are not elicited during the first 2 years of life. [*]
This is compounded by the fact that maternal antibodies negatively influence infant antibody responses. Specifically, IgG antibodies are actively transferred through the placenta - upon immunization, maternal antibodies bind to their specific epitopes at the antigen surface, competing with infant B cells and thus limiting B cell activation, proliferation and differentiation. [*]
The inhibitory influence of maternal antibodies on infant B cell responses affects all vaccine types. [*]
Additionally, antibody responses elicited before 12 months of age rapidly wane and antibody titers soon return close to baseline levels. Short-lived antibody responses are a hallmark of early life immunization with most [*]
Vaccines mediate protection through the induction of highly specific IgG serum antibodies. The reasons listed above can explanation on why you find vaccination in children (under 24 months) held in a series of 3 or 4 injections/boosters over a very short period of time (ex. Hep B, Polio, Hib, PCV, Rotavirus). [*]
5 - Am I familiar with my family history of vaccine reactions, severe allergies or autoimmune/neurological disorders?
Typically, an allergic response is not triggered the first time the body encounters the allergen (substance that causes an allergic reaction). In fact, some people can be exposed to the allergen several times before an allergy develops. (It is only after one or more episodes of exposure to an allergen that the immune system becomes sensitized and produces IgE antibodies to the allergens.)[*]
This is why it is important to know if there is a family history of vaccine reactions, severe allergies or autoimmune disorders BEFORE vaccination occurs.
If your child exhibited a reaction (even if it was mild) to vaccination in the past, it is important to tell your doctor. A child who has had a previous vaccine reaction may have an increased risk for a more severe reaction.[*]
Be sure to tell your doctor if your child or anyone in your family is allergic to eggs, gelatin, neomycin (a drug), or any other component that may be found in vaccines (you can find out more about each vaccine on the package insert).
If you are not satisfied with the answers you are given, get a second opinion from a trusted health care professional.[*]
6 - Do I have information about side effects and the clinical research completed on each vaccine?
Like any medication, vaccines cause side effects. The most common side effects are considered ‘mild’.[*]
This resource (click here) is extremely useful to quickly assess the side effects that have been associated with each vaccine that has been licensed in the US. (The information contained on this link is located on vaccines.gov and is copied directly from CDC's Vaccine Information Statements, which in turn are derived from the Advisory Committee on Immunization Practices (ACIP) recommendations for each vaccine.)
I would also recommend reviewing the package inserts (click here) to review the clinical data that was gathered in the licensure of each vaccine. To further that research, conduct a quick search on clinicaltrials.gov for each vaccine.
Once you have gathered the information regarding each disease (prevalence, treatment, symptoms and transmission) and the corresponding risk of vaccine reaction, you can make a superior decision in vaccinating.
7 - Do I know how to identify and report a vaccine reaction?
If you choose to vaccinate, whether according to the CDC/ACIP schedule or an alternative schedule, it is important to know how to identify and report a reaction.
Even if severe reactions occur rarely, they still do occur and it’s important to discuss how to how handle them properly with your doctor before you place yourself or your child at risk.
(I would advise additional research on your own as well as discussing this with your doctor.)
Here are a few bullet-points I’ve come across:
Monitor your child closely 72 hours after vaccination for unusual symptoms or behavior changes, which may indicate a vaccine reaction is occurring. (Vaccine reactions have been known to occur as long as four weeks after vaccination.)[*]
A vaccine reaction may include one or more of the following symptoms: [*]
•swelling, redness, and pain at the injection site
•difficulty breathing or wheezing
•paleness or changes in skin or lip color
•muscle weakness or limpness
•excessive sleepiness or lack of responsiveness
•rapid heart beat
•unusual irritability or other behavior changes
•prolonged crying (especially high-pitched screaming in infants)
•seizures or convulsions (shaking, twitching, jerking)
•vomiting or diarrhea
If you observe any of these symptoms -- or any other symptom that causes you concern -- get medical help right away.
If your child experiences serious health problems following vaccination, ask your doctor to report it to federal health authorities. Your doctor is required by law to report adverse reactions to vaccination within 30 days of vaccination. You may also report serious health problems following vaccination to the government yourself.[*]
Here is a good resource from the ACAAI (American College of Allergy, Asthma and Immunology) that discusses a few allergic reactions to vaccination. Here is another link regarding vaccine allergies.
Conclusion: Informed Consent and Supporting Others
Making an informed consenting choice is not about arriving at a destination of ‘informed’ versus ‘uniformed’, rather it is a title that you earn when you make the commitment to the journey of placing effort into learning more.
You can choose today to make a better, more informed choice in everything you do!
There are those of us that vaccinate, those of us who select, those who delay and those who decline completely – the beauty is in recognizing that no great, loving parent has ever been perfect.
Take comfort in knowing that we all do the best we can with the resources we have at that moment.
Our purpose is to help expand those resources (for ourselves and for others), connect to other great thinking minds and continue to progress!
THE DECISION TO VACCINATE IS YOURS AND YOURS ALONE.
The information provided here is for educational purposes only and is not to be construed as medical or legal advice.