The World Health Organization (WHO) has declared “vaccine hesitancy” one of the top 10 health threats of 2019. In the same year, the United States has seen their largest measles outbreak of the 21st century. Vaccines are widely considered to be one of the greatest success stories in public health. And yet, public confidence in the safety and efficacy of vaccines has seen a decline over the past decade.
Is this decline in confidence responsible for an increase in vaccine hesitancy? And if so, what can be done to remedy this situation? Turning our attention to vaccine policy, there are several areas in which improvements can be made to strengthen vaccine programs and, in doing so, increase public confidence in immunizations in general.
Proposed Policy #1: Require inert placebos to evaluate vaccine safety
In the world of pharmaceutical drugs, controlled trials are considered the “gold standard” by which to evaluate safety and efficacy. The way it works is simple: the experimental group receives the drug, while a control group receives a placebo – an inert substance (e.g. sugar pill). After the trial is over, health outcomes are compared between the experimental group and the control group. If the drug is found to be safe and effective, it is allowed onto the market.
According to the Centers for Disease Control and Prevention (CDC): “Before vaccines are approved by the Food and Drug Administration (FDA), they are tested extensively by scientists to ensure they are effective and safe.”
That sounds fine in theory, but what the CDC fails to mention is that clinical trials used to evaluate vaccine safety are not required to use inert placebos (i.e. saline injections) in their control group. Instead, the experimental (vaccine) group is compared to a “placebo” group that typically receives either another vaccine, or aluminum adjuvant (a known neurotoxin). This makes it nearly impossible to scientifically determine the true safety profile of a vaccine. Pharmaceutical companies that manufacture vaccines are able to do this because the FDA classifies vaccines as “biologics” and not pharmaceutical drugs. Biologics are not required to undergo “gold standard” randomized, controlled trials before being brought onto the market.
Let’s look at an example, to understand how this is problematic. One MMR (measles-mumps-rubella) vaccine (MMR-RIT) was compared to another (MMR II) in a phase 3, randomized, noninferiority, lot-to-lot consistency study published in 2019. The table below shows the adverse events reported for each MMR vaccine.
The data in this table shows that about half of the children in the study had one or more adverse event in the 42 days following vaccination. Within 6 months of being vaccinated: 2% of children had one or more “serious” adverse event; 6% had an adverse event that prevented normal, everyday activities; 10% had an adverse event prompting an emergency room visit, and around 3% of children developed one or more new onset chronic diseases following vaccination (e.g. autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia, and allergies).
It’s important to note that these children received other vaccines (e.g. Hepatitis A and varicella) along with their MMR vaccine. Because vaccines are generally not tested against an inert placebo group, we have no way of knowing to what extent these vaccines are responsible for the adverse events mentioned above. Requiring the use of inert placebos in clinical trials used to assess vaccine safety would solve this problem.
Proposed Policy #2: Automate the Vaccine Adverse Event Reporting System (VAERS)
“Public and professional confidence in vaccination depends on reliable post marketing surveillance systems to ensure that rare and unexpected adverse effects are rapidly identified.”
The Vaccine Adverse Events Reporting System (VAERS) is a passive surveillance system designed to capture vaccine adverse events once a vaccine has been put onto the market. Unfortunately, fewer than 1% of vaccine adverse events are reported to VAERS. The table below lists the number of serious adverse events reported to VAERS in 2018.
An attempt to create an automated system to facilitate detection and clinician reporting of vaccine adverse events, in order to improve the safety of national vaccination programs, found that 1.4 million doses (of 45 different vaccines) given to 376,452 individuals resulted in 35,570 possible reactions. In other words, 2.6% of vaccinations given may have resulted in an adverse reaction. The team behind this project concluded that it is possible to automatically detect adverse events in defined ways, and to electronically report them to VAERS. Automating VAERS with electronic support would yield more meaningful data on the safety profile of vaccines.
Proposed Policy #3: Compare health outcomes of vaccinated vs. unvaccinated populations
It is widely accepted that vaccines are effective at protecting against the infectious diseases they are intended to prevent. Despite this benefit, the possibility exists that vaccines may also have “non-specific effects” that could potentially increase the risk of negative health outcomes and all-cause mortality.
The only study that has been done in the United States comparing the health outcomes of completely unvaccinated children to fully vaccinated children found that the unvaccinated children had higher rates of chickenpox and pertussis (whooping cough). The fully vaccinated children, on the other hand, had higher rates of chronic disease, neurodevelopmental disorders, and allergies as can be seen in the infographic below.
This comparative study by Mawson et al. was a pilot study. More robust studies examining overall health outcomes of completely unvaccinated vs. fully vaccinated cohorts are necessary to ensure that the CDC recommended vaccination schedule is not preventing childhood infections at the cost of increased risk for chronic disease.
Proposed Policy #4: Make vaccine manufacturers liable for vaccine injuries
In 1986, Congress passed the National Childhood Vaccine Injury Act which shielded pharmaceutical companies from lawsuits for injuries and deaths caused by vaccines. Since 1988, over $4 billion dollars of taxpayer money has been used to compensate those injured or killed by vaccines through the Vaccine Injury Compensation Program – a federal program that has taken on vaccine liability for the pharmaceutical industry.
“The pharmaceutical industry is now the most poorly regarded industry in Americans’ eyes, ranking last on a list of 25 industries that Gallup tests annually.”
Today in the United States, most vaccines are essentially liability-free products for the pharmaceutical industry that manufacturers them. If consumers are unable to sue for injuries and deaths caused by vaccines, then there is little financial incentive for pharmaceutical companies to create safer vaccines.
Making pharmaceutical companies liable for injuries and deaths caused by vaccines acts as a natural check and balance, ensuring the safety of a pharmaceutical product manufactured by the least trusted industry in the United States.
The Nuclear Option
Rather than implementing the above-mentioned policies, governments could instead enact legislation to mandate vaccines for children (followed by adult mandates) and censor any information on social media and the internet that criticize the shortcomings of national vaccination programs. My hope is that a more rational approach to reducing vaccine hesitancy will prevail.
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The title of this report is misleading – the author is clearly leaning towards a vaccine freedom stance by carefully looking at all of the current data regarding vaccines, injuries, and chronic disease encountered by their use. He is spot on that the industry is hiding behind fraudulent information and marketing schemes, and the latest attempts to silence the growing skepticism regarding vaccines by blocking web sites, and taking down google searches is very problematic – as it not only cheapens the attempts of medicine to disregard the facts relating to vaccine problems, it strips Americans of their rights, and censors authors and reporters who have posted on such problems over the past few decades.
Not misleading but very clever. He is speaking to the industry itself.
Great article. I hope this one gets out there.
I would also like to see testing for contraindications and vulnerabilities of individuals to specific vaccines before vaccination. Also, the judgment of individual risk to specific diseases and a modified and individualized vaccine plan for each child. Not every vaccine for every child when the risk of some diseases is low. For example, look at HepB. The risk for most babies of contracting HepB is extremely low. Vaccinating every baby without checking for the potential risk that vaccines on the individual baby is irresponsible medicine.
The only solution to this is to end vaccines forever. Ddt caused polio. Rockinfellows stop spraying waited for polio cases to drop; then gave the vaccine. The vaccine was false credited to having conquered polio. Humans have a right never to be vaccinated no matter if science proves unvaccinated people cause others harm. We have the right to live as nature intends because nature has the best record of all in providing for healthy immunity. Proof that humans don’t need vaccines, is in the fact that we exist. 4 million years unvaccinated and getting stronger untill vaccines weakened immunity and caused deliberate brain damage.
Great article – would also love to see:
-extending testing for longer periods following vaccination to monitor side-effects
-testing safety on pregnant women
-testing the safety of vaccines administered together with other vaccines
-testing the effects of cumulative vaccination and test the safety of the vaccine schedule in it’s entirety.
Thank you. No one knows that an 8 week old baby receives 8 vaccines at one visit (6 injections) and that there are ZERO studies on the safety of giving those 8 vaccines at the same time. I am almost 47 and I had 11 vaccines in my lifetime – children currently according to the CDC recommended immunization schedule (doctors push all as mandatory) has 72 doses between birth and age 18 – 50 of those doses between birth and age 5. When I say doses that does not mean injections – we have to remember that many vaccines have 3 or more vaccinations in one injections, like MMR for example is measles, mumps and rubella, MMRV is measles, mumps, rubella and varicella or Dtap which is diphtheria, tetanus and pertussis. An 8 week old baby is given dtap, hepb , rotavirus (scariest one out other than HPV and now covid), Hib, PCV and polio – That is 8 vaccines in 6 injections and the amount of aluminum in those 6 injections is too much for a 200 pound man. https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html