Government health agencies ignored COVID-19 vaccine safety signals and withheld records on the monitoring of adverse events related to the vaccines — a “monumental betrayal,” according to a new peer-reviewed paper by Children’s Health Defense (CHD) researchers.
“The Pharmacovigilance Betrayal of the COVID-19 Era” was published May 30 in Medical Research Archives, the official journal of The European Society of Medicine.
Brian Hooker, Ph.D., CHD’s chief scientific officer; Karl Jablonowski, Ph.D., CHD’s senior research scientist; and CHD staff attorney Risa Evans co-authored the paper.
The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) failed to perform effective pharmacovigilance of the mRNA COVID-19 vaccines, according to the paper.
“The FDA and CDC fell short in their obligation to surveil pharmaceutical harms … betraying their core obligations and the American people,” the paper stated.
The FDA and CDC also tried to sidestep CHD’s Freedom of Information Act (FOIA) requests, filed in 2022. The FOIA requests sought records on how the agencies discussed and investigated safety signals. However, “the agencies have yet to produce such records, and the lawsuits seeking the records are currently stayed,” Evans said.
In 2023, CHD separately sued the FDA and the CDC to obtain the records.
Commenting on the paper’s publication, Jablonowski said:
“This is a paper that had to be written. The more time that passes, the more people will forget — and forgetting is the recipe for repeating.
“Pharmacovigilance is the public’s last defense against vaccine injury. Without an adequate system, we are flying blind on vaccine safety. If we cannot monitor the safety of injections, we shouldn’t be injecting.”
The paper was published a week after the Make America Healthy Again (MAHA) Commission released its 100-day report. The report identified factors — including vaccines and problems with vaccine safety monitoring — that may contribute to the chronic disease epidemic in the U.S.
‘Pharmacovigilance behind closed doors should give everyone pause’
The new paper specifically focuses on the failure of the FDA and CDC to monitor vaccine safety data from two U.S. government-run databases — the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD).
Surveillance databases like VAERS and VSD are crucial tools for identifying uncommon adverse events that might not show up in clinical trials, which usually involve “a few hundred” or “few thousand” participants and are “orchestrated by the pharmaceutical company that stands to profit.”
According to the paper:
“By the time it is approved by the FDA, if a bad reaction is uncommon, we’re not going to see it in a few-thousand-person study — but, like how not every single cigarette causes cancer, the dangers are still real. In essence, the clinical trial never ends, it’s just that our children become the subjects of the uncontrolled experiment.”
VAERS — a passive surveillance system that vaccine injury victims or their physicians can submit reports to — contains 1.6 million reports for the COVID-19 vaccines, the paper states.
According to Albert Benavides, a VAERS expert and founder of VAERSAware.com, “As of today, COVID-19 vaccines account for 78% of all deaths in VAERS.”
By 2022, VAERS data showed that the COVID-19 vaccines were associated with more injuries and deaths than all conventional vaccines combined in the previous three decades.
Although the FDA and CDC “promised to study VAERS in a manner that would help determine which of these reported adverse events were caused by the shots,” information CHD obtained through legal actions indicates that those agencies “failed to keep that crucial promise.”
The FDA and CDC, which co-administer VAERS, are required to use distinctly different data-mining methods to identify safety signals in the database and to “collaborate to investigate any detected signals” to determine whether there is a causal relationship between the safety signal and the vaccine in question.
However, information CHD obtained through its FOIA requests showed that the FDA and CDC did not fulfill this obligation for the mRNA COVID-19 vaccines. “When CHD peeked behind closed doors, we did not find vigilance at work,” the paper stated.
Instead, the FDA and CDC used the same data-mining method — Empirical Bayesian data mining. With the exception of for four months in 2022, the CDC did not use its assigned data mining method, Proportional Reporting Ratios (PRR).
Jablonowski explained that Empirical Bayesian data mining “is a complicated statistical approach,” whereas PRR “is really a matter of simple math: dividing what you observe from something you think is similar. The further the ratio is away from 1.0, the more dissimilar — and therefore unexpected — the results are.”
Evans said that for any potential safety signals detected through either method of data mining, the FDA and CDC “promised to investigate whether the adverse events associated with the signals were caused by the shots.”
FDA records obtained by CHD, collected over 18 months, showed that while the agency identified “consistent alerts” for serious adverse events, including deaths, for the Janssen (Johnson & Johnson) COVID-19 vaccine, it identified “almost no safety signals for the Moderna and Pfizer-BioNTech mRNA products.”
There were no alerts “for widely recognized adverse events such asmyocarditis, pericarditis or anaphylaxis,” the paper stated. Instead, the records listed only “3 clinically relevant signals for the mRNA platform: a rash, exposure via breast milk, and drug ineffectiveness.”
The data collected by the CDC during the four months it analyzed data using the PRR method “returned 743 clinical safety signals, including death, stroke, heavy menstrual bleeding, and myocarditis.”
According to Jablonowski, the FDA and CDC may have turned a blind eye to safety signals because of conflicts of interest.
Proper pharmacovigilance “would have slammed the brakes on the rollout at the first signs of myocarditis in young men,” Jablonowski said. “It is a foregone conclusion that the royalties collected by the National Institutes of Health — $400 million from Moderna and $750 million Pfizer-BioNTech — would have been less had the FDA and CDC protected America.”
“The extent to which the Agencies have investigated these signals is still unknown,” the paper stated. “Pharmacovigilance behind-closed-doors should give everyone pause. It is simply too important to not do transparently.”
“You have to try to do something in order to fail at it,” Jablonowski said. “The CDC and FDA didn’t fail to protect us, they just never tried. That they never tried is a dereliction.”
VAERS, VSD have drawn criticism for deficiencies in vaccine safety monitoring
In CHD’s ongoing litigation against the CDC, the agency has claimed it has no records of certain internal email communications related to its follow-up investigation of safety signals associated with COVID-19 vaccines.
Similarly, in CHD’s lawsuit against the FDA, the agency claimed its records are exempt from FOIA disclosure and that it is overwhelmed by a high number of COVID-19 vaccine-related FOIA requests.
Documents shared with CHD last year showed that the CDC hid data connecting the mRNA COVID-19 vaccines to an increased incidence of myocarditis.
VAERS and VSD have been criticized for deficiencies in monitoring vaccine safety. In an interview on CHD.TV last year, Benavides suggested VAERS is “throttling” and “undercounting” deaths connected with the COVID-19 vaccines.
A 2011 Harvard study found that less than 1% of all adverse events are reported to VAERS. That same year, VAERS stopped making full reports public. The agency only recently began making the reports public again.
A 2023 investigation by The BMJ revealed that VAERS runs two parallel systems — but only one is publicly accessible.
The MAHA report also criticized the databases, stating that VAERS provides “incomplete” data, as doctors aren’t required to submit reports to the system, while VSD is not publicly available and is “geared towards studying short-term outcomes” instead of links between vaccines and longer-term chronic disease.
According to Evans, instead of investigating safety signals found in databases such as VAERS, “the agencies have continued to use their VAERS-monitoring efforts to tout the safety of the COVID-19 shots.”
Evans cited a 2023 CDC and FDA letter to Florida Surgeon General Joseph Ladapo claiming that most adverse events reported to VAERS resulted from pre-existing conditions.
Evans also referenced Congressional testimony delivered last year by Dr. Peter Marks, former director of the FDA’s Center for Biologics Evaluation and Research. Marks claimed that numerous false reports are submitted to VAERS and that the FDA’s monitoring of VAERS showed that the COVID-19 vaccines were safe.
Evans said government health agencies’ and officials’ insistence that there were no serious safety signals associated with the COVID-19 shots was costly to the public.
“It should not have taken two lawsuits and over two years to obtain the records,” Evans said. “Rather, HHS should disclose records of vaccine safety-monitoring to the public regularly and as a matter of course, including raw data, analyses, follow-up investigations and communications.”
“The public funds and is supposed to benefit from the agencies’ activities, and the public has a right to full transparency without having to resort to expensive and time-consuming FOIA litigation,” Evans added.
Last month, the FDA announced that Pfizer and Moderna must add stronger warnings about the risk of heart damage — including myocarditis — to their COVID-19 vaccine labels. In March, HHS announced the creation of a new CDC sub-agency focusing on vaccine injuries.
Also last month, FDA Commissioner Marty Makary announced that U.S. health agencies will shift away from VAERS and VSD. Instead, public health agencies will use electronic patient records to track real-time vaccine injury data.
But for Jablonowski, more is needed than just a change in surveillance systems.
“The lack of tools was not what endangered, injured, and killed Americans,” Jablonowski said. “The lack of integrity did.”
