Experts Admit Vaccines Aren’t Adequately Studied Before or After Licensure

Researchers with ties to vaccine makers want to use the funds collected to compensate people with vaccine injuries to pay for post-authorization “safety studies.”

By Megan Redshaw

For decades, Americans have been assured that vaccines undergo thorough and rigorous testing. Vaccines are the epitome of sound science—so much so that this science cannot be questioned and adverse events rarely exist.

Yet in a paper recently published in the New England Journal of Medicine, an architect of the U.S. vaccination program and his co-authors admit that pre-licensure clinical trials cannot fully characterize a new vaccine's safety profile and studies aren’t performed after a vaccine hits the market to ensure its safety.

In other words, children are exposed to more than 84 doses of at least 19 different vaccines before the age of 18, and the only safety studies these recommendations are based on are inadequate prelicensure clinical trials that are limited in sample size, use short follow-up durations, and are not equipped to detect all potential adverse events. 

Although the Centers for Disease Control and Prevention’s (CDC) vaccine advisory panel acknowledges that resources are needed to conduct post-authorization safety studies, funding is limited.

The solution, the authors say, is not to stop the alarming number of vaccines given to children until they’re actually proven safe; it’s to amend the tax code so that money can be taken from the Vaccine Injury Compensation Program (VICP) to perform the safety research U.S. health agencies should have been requiring pharmaceutical companies to conduct this entire time. 

The VICP is funded by an $.75 excise tax on each dose of routinely recommended vaccines, which goes into a special trust fund. The thought process behind robbing the VICP is that the entire immunization program could be improved with this research, and it could prevent injuries in the first place. 

On its face, the authors appear to be calling for better science and safer vaccines. After all, they publicly admitted that safety studies before and after a vaccine is licensed are lacking, and the CDC is in “set it and forget it” mode. 

In reality, the authors—who all have ties to vaccine makers and the CDC—are concerned about the vaccine hesitancy that took off during the COVID-19 pandemic and the growing number of people who are no longer satisfied with just “trusting the science.” They fear a repeat of what happened with the MMR vaccine, thimerosal, and autism. 

Thimerosal is an organic mercury compound used since the 1930s as a vaccine preservative. It’s approximately 50% mercury by weight and produces ethylmercury as a metabolite. This metabolite then changes to inorganic mercury in the body and accumulates primarily in the brain and kidneys, which are not fully developed in young children.

Mercury and mercuric compounds such as methylmercury, ethylmercury, and thimerosal have long been considered nephro- and neurotoxicants. Never, under any circumstance, should mercury in any form be injected into a child. 

According to the paper's authors, MMR vaccines and thimerosal did not cause autism. However, because the results of “more than a dozen well-conducted epidemiologic studies” from the Institute of Medicine were not available for years after the idea was first publicly raised, people stopped getting this vaccine for their children and demanded thimerosal-free vaccines. 

“The slow speed of science contributed to widespread public concern and consequent decreases in immunization coverage, as well as outbreaks of measles,” the authors wrote.

In other words, quicker studies from chosen institutes reaffirming the safety of vaccines will decrease vaccine hesitancy. 

Although the CDC still holds the view that the body “eliminates thimerosal easily,” does not “stay in the body for a long time,” and the medicinal use of products containing thimerosal has a record of being “very safe,” this contradicts more than 75 years of research from independent scientists who have consistently found thimerosal to be harmful and court cases that have awarded monetary damages to children who developed autism after receiving MMR and thimerosal-containing vaccines. 

A quick look at the paper's authors suggests the call-to-action in this paper isn’t about making vaccines safer. 

Dr. Stanley Plotkin, vaccinologist and co-author of the article, is a paid consultant to biotechnology companies and vaccine makers, including Sanofi Pasteur, GlaxoSmithKline, Merck, Pfizer, Inovio Pharmaceuticals, Variations Bio, Takeda Pharmaceutical Company, Dynavax Technologies, Serum Institute of India, CureVac, Valneva SE, Hookipa Pharma, and NTxBio.

Dr. Plotkin in 2018 was deposed in a family court case and admitted there were gaps in vaccine safety data and shortcomings with clinical trials. But instead of trying to address those issues, he wrote an email to the CDC about the threat of “antivaccinationism.”

To fight back against “unscrupulous but clever“ anti-vaccination lawyers, Dr. Plotkin established a library at Children’s Hospital of Philadelphia to help pro-vaccination lawyers and witnesses disprove the “usual anti-vaccination accusations.” 

He also contacted the U.S. Food and Drug Administration and four major vaccine makers to help them shore up their vaccine package inserts. He then lobbied the Bill & Melinda Gates Foundation to support pro-vaccine organizations. 

Finally, he lobbied major medical organizations, such as the American Academy of Pediatrics, to train witnesses for similar lawsuits or to designate vaccine experts in future trials so that experts like himself would not be embarrassingly unprepared. 

“In conclusion, I want to say that the threat of antivaccinationism is real and that their access to the legal system is a clear and present danger, which we ignore at our peril, and more importantly, at the peril of our patients,” he wrote. 

Plotkin’s co-author, Dr. Walter Orenstein, is a nationally recognized expert on vaccine hesitancy and vaccine policy and was director of the National Immunization Program from 1988-2004. 

During this time, six vaccines were added to the CDC’s vaccination schedule for children, including the Haemophilus influenzae type b (Hib) Vaccine, Hepatitis B Vaccine, Varicella (Chickenpox) Vaccine, Hepatitis A Vaccine, Inactivated Poliovirus Vaccine (IPV) and the Pneumococcal Conjugate Vaccine (PCV7) for meningitis. 

No pre- or post-licensure studies show these vaccines are safe to give in combination with each other to small children or that support vaccinating a newborn against Hepatitis B—a disease spread primarily through sexual contact and shared needles.

From 2008 to 2011, Dr. Orenstein served as Deputy Director for the Immunization Program at the Bill and Melinda Gates Foundation, chaired the National Vaccine Advisory Committee, and participated in various World Health Organization (WHO) advisory groups. 

Dr. Robert Chen has worked in vaccine research for over 35 years, mostly at the CDC. He played a crucial role in creating the Vaccine Adverse Event Reporting System (VAERS). VAERS is the national vaccine safety surveillance system co-managed by the FDA and CDC, which is used to detect unusual or unexpected reporting patterns of adverse vaccine events. 

When authorizing a vaccine, VAERS is considered a robust system for detecting potential adverse events—allowing vaccine makers to enjoy a lowered safety threshold. However, when tens of thousands of people are injured, VAERS suddenly becomes a flawed system that’s unable to determine causality. 

According to the authors, VAERS reports do not include the “specific laboratory or clinical findings required for determining causality.” 

Other surveillance systems could be used to determine causality, but the public does not have direct access to these internal databases or the real-time monitoring data. In fact, there’s a public and private VAERS database, and the public only has access to the public version with initial reports.

Like Plotkins and Orenstein, Chen also works with Gates-funded initiatives. 

Finally, there’s Dr. Daniel Salmon, a vaccinologist at the Institute for Vaccine Safety. According to the Johns Hopkins Bloomberg School of Public Health, Dr. Salmon conducts studies to assess vaccine safety and increase vaccine compliance. 

According to the Institute of Vaccine Safety, Dr. Salmon looks at the rates of vaccine refusal, the reasons why parents refuse vaccines, the impact vaccine refusal has on healthcare providers, local and state policies, and the individual and community risks of unvaccinated children. 

If experts genuinely prioritized vaccine safety, they wouldn't approve a single shot without rigorous pre-licensure clinical trials and mandatory post-marketing research to ensure ongoing safety after approval.

They would conduct impartial research, not just studies designed to support the idea that vaccines are safe and adverse events are rare. They would require pharmaceutical companies to fund safety research for their own products and withhold licensure until adequate safety plans are in place. 

Finally, they would cease promoting experimental vaccines for infants and children and recognize existing data that shows vaccines can cause serious adverse events.

Instead of looking to science to undermine potential arguments that could cause vaccine hesitancy, they would acknowledge that there are valid reasons to be hesitant.