Editor’s note: This article is part of a series of articles by The Defender responding to the latest media coverage of vaccines.
President-elect Donald Trump’s nomination last month of Robert F. Kennedy Jr. to lead the U.S. Department of Health and Human Services has reignited the public debate about vaccine safety and triggered an avalanche of mainstream news reports on the topic.
For the most part, media outlets have repeated the narrative promulgated by U.S. public health agencies that vaccines are “safe and effective.” End of story. No nuance, no citing of actual vaccine safety trials.
What almost all of the latest news reports neglect to mention is that about six months ago, one of the country’s staunchest, most high-profile defenders of vaccine safety — known in some circles as the “godfather of vaccines” — published a paper suggesting that the “safe and effective” narrative isn’t as ironclad as the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) claim.
In an article published in July in the New England Journal of Medicine (NEJM), Dr. Stanley A. Plotkin, vaccinologist and emeritus professor of pediatrics at the University of Pennsylvania, and his co-authors identified gaps in vaccine safety testing, inadequacies in vaccine clinical trials and a lack of scientific knowledge about the biological mechanisms causing many common vaccine-related injuries.
The authors wrote:
“Postauthorization studies are needed to fully characterize the safety profile of a new vaccine, since prelicensure clinical trials have limited sample sizes, follow-up durations, and population heterogeneity.”
Plotkin’s NEJM paper didn’t make mainstream media headlines. However, some in the medical field took note.
“This admission comes after decades of the medical establishment insisting that vaccines are among the most thoroughly studied and safest medical interventions,” Dr. Joseph Mercola wrote in August, calling the paper a “stunning reversal” of decades of claims insisting vaccines are safe and dismissing safety concerns.
Mercola said the admission “contradicts previous claims by vaccine proponents that clinical trials provide robust evidence of safety prior to approval.”
The NEJM article also noted that the biological mechanisms underlying common vaccine-related adverse events — including Guillain-Barré syndrome and myocarditis — are unknown and that for over three-quarters of vaccine-related health outcomes, there is not enough evidence to prove — or disprove — a causal link with vaccines.
“This flies in the face of repeated assurances that vaccine safety is settled science,” Mercola wrote.
Attorney Aaron Siri, who has litigated several vaccine-related cases against government health agencies and vaccine makers, used the recent news reports on vaccines and vaccine safety to refocus attention on Plotkin’s paper in a post on X.
Siri wrote that clinical trials “virtually never have a placebo control, typically review safety for days or weeks after injection, and often have far too few participants to measure anything of value.”
Dr. Stanley Plotkin, the world’s leading vaccinologist, and his disciples, have just capitulated. After decades of claiming vaccine safety is robustly studied, they just admitted it is not, neither before nor after licensure. But don’t be fooled – read my stack or this long tweet… pic.twitter.com/FAxYgmy678
— Aaron Siri (@AaronSiriSG) July 10, 2024
Several experts told The Defender they believe Plotkin and his co-authors didn’t go far enough, because they didn’t address the relationship between the CDC’s childhood vaccine schedule and the rise of childhood chronic disease.
Experts also questioned the authors’ proposed solution — using funds budgeted for the National Vaccine Injury Compensation Program (VICP) to fund vaccine safety studies — arguing that it would draw funds away from vaccine injury victims and shift the burden of paying for such studies from Big Pharma to the government.
Plotkin helped develop vaccines for rubella and rabies and was a consultant for vaccine manufacturers, including for the development of COVID-19 vaccines.
Dr. Meryl Nass, founder of Door to Freedom, described Plotkin as the “living dean of vaccinology.” Nass said Plotkin’s co-authors — Dr. Walter Orenstein, Dr. Robert Chen and Daniel Salmon, Ph.D. — are also heavyweights in the field of vaccinology.
NEJM article admits ‘progress in vaccine-safety science’ has ‘been slow’
According to the NEJM article, while the U.S. “benefits from a robust federal immunization program that has been successful in controlling and eliminating many diseases,” the COVID-19 pandemic brought forth “widespread vaccine hesitancy.”
This hesitancy “suggests that the public is no longer satisfied with the traditional safety goal of simply detecting and quantifying the associated risks after a vaccine has been authorized for use,” the NEJM article stated. Instead, the public “wants public health authorities to mitigate and prevent rare but serious adverse reactions.”
These vaccine side effects “no longer seem rare when vaccines are given to millions or billions of people,” the article noted. “Progress in vaccine-safety science has understandably been slow,” which has “adversely affected vaccine acceptance,” the authors wrote.
Research scientist and author James Lyons-Weiler, Ph.D., told The Defender, “The types of studies that can determine causality are not even attempted beyond a short period of initial safety testing in randomized clinical trials.”
Nass suggested that, unlike current practice, “When the epidemiologic data show that a particular adverse event occurs soon after a vaccination, at a rate, say, 10 or more times more often than it should, it should be considered a vaccine adverse effect unless proven otherwise.”
Instead, “Vaccine safety experts usually demand much more evidence than is required to identify an adverse reaction to a drug or food or other consumer product,” Nass said. This contributes to a likely undercount of vaccine-related adverse events, she added.
Nass said the authors’ focus on the underlying mechanisms of common vaccine injuries is misleading, as knowledge of the underlying mechanisms is “not a critical component of a vaccine safety assessment.”
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NEJM cites ‘inadequate funding’ for vaccine safety research
The NEJM article suggested that a lack of federal funding for studying vaccine safety also has contributed to growing public skepticism toward vaccines.
“There are currently no resources earmarked for postauthorization safety studies beyond annual appropriations, which must be approved by Congress each year,” the authors wrote.
This is the case despite the rapid expansion of the childhood vaccination schedule in the last two decades. The CDC’s budget for vaccine safety monitoring “has remained stagnant during that period, at about $20 million per year.”
“Although these resources have been used efficiently, this inadequate level of funding has adversely affected the speed and completeness of the science,” the NEJM article stated.
Wayne Rohde, author of “The Vaccine Court: The Dark Truth of America’s Vaccine Injury Compensation Program” and “The Vaccine Court 2.0,” said more is needed than just additional funding. Rohde said the childhood vaccination schedule itself “has never been studied in its entirety” for safety.
According to the Informed Consent Action Network (ICAN), “None of the vaccine doses the CDC recommends for routine injection into children were licensed by the FDA based on a long-term placebo-controlled trial.”
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Using VICP to fund vaccine injury research would benefit Big Pharma
The authors of the NEJM article suggested that further studies of vaccine safety could be funded by dipping into monies earmarked for VICP — a government program that handles injury claims for 16 vaccines on the childhood vaccination schedule — though not for vaccines like the COVID-19 shots, which are considered “emergency countermeasures.”
Noting that VICP is “funded by an excise tax on each dose of routinely recommended vaccines,” the NEJM article suggests that VICP’s trust fund, which totaled $4.3 billion as of April 2023, could be used “for vaccine-safety science and reduction of vaccine reactions.”
“Doing so would not interfere with existing funding for vaccine-injury compensation, since the program has always run a substantial surplus, using only about a third of available funds,” the NEJM article suggested.
The authors of the article didn’t address the low payouts VICP offers to vaccine injury victims. In a 2023 op-ed, Rep. Lloyd Doggett (D-Texas) noted that “After decades, the damages cap has never been increased.”
Rohde said there are growing calls for COVID-19 vaccine injuries to be covered under VICP, which would further strain the program’s finances.
“The current balance in the Vaccine Injury Trust fund will not be sufficient when COVID-19 vaccine injuries are permitted to be litigated in the VICP,” Rohde said. “Money will be required not only for damage awards to petitioners, but also to handle the massive influx of petitions.”
Under existing law, VICP funds can’t be used for other purposes, Rohde said.
“This practice is not allowed under current statute, nor should it be allowed. Once Pharma and their benefactors are allowed to reach in and snatch money designated for vaccine injury compensation and use it for other means, the practice would not end until the fund is completely liquidated,” Rohde said.
Nass said using the VICP to fund vaccine safety research would benefit pharmaceutical companies. She said the authors of the NEJM article “established two straw men: that vaccine safety is not being studied post-licensure and that establishing biological mechanisms of vaccine injuries is crucial.” She added:
“Their suggestion for solving the straw man problem is to transfer funds from the VICP and use them to research vaccine safety. This would save industry a lot of money, because currently, FDA can require vaccine manufacturers to conduct post-licensure studies of their products. In the authors’ proposal, such studies would become a federal responsibility.
“Are these authors trying to remove money from the VICP before it might become available to help pay for COVID vaccine injuries — which they surely know will cost the federal government a fortune? Or is this simply a play to expand their fiefdoms and their field? Either way, it is another scam.”
Lyons-Weiler called for long-term “randomized prospective placebo-controlled double-blinded gold-standard trials that are capable of testing the hypothesis of causality” with multiple phases — and suggested that these studies should not be funded by the government or pharmaceutical companies.
“It’s in the public interest for there to be independent research conducted by people without financial interest in the outcome of the studies on questions like long-term vaccine safety and the safety of the co-administration of multiple vaccines.”
