The World Health Organization (WHO) has declared “vaccine hesitancy” one of the top 10 health threats of 2019.[1] 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.[2] And yet, public confidence in the safety and efficacy of vaccines has seen a decline over the past decade.[3]

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.[4] The table below shows the adverse events reported for each MMR vaccine.[5]

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.”[6]

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.[7] The table below lists the number of serious adverse events reported to VAERS in 2018.

Note: Submitting a report to VAERS does not mean that healthcare personnel or the vaccine caused or contributed to the adverse event (possible side effect).

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[8] and all-cause mortality.[9]

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.[10] 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.”[11]

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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[5] Supplementary Table 6