New federal initiatives are welcome progress toward understanding and recording injuries from vaccination. Action Alert!
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THE TOPLINE
- HHS is improving vaccine injury reporting and care through a new NIH clinic, proposed physician reimbursement for reporting, better electronic records, and a VAERS overhaul.
- Underreporting and gaps in safety research limit informed consent. Patients need clear information about benefits, risks, and uncertainties to make informed decisions.
- These reforms need meaningful follow-through. We need transparent research, effective implementation, and a fairer compensation process for vaccine-injured patients.
Patients cannot make fully informed medical decisions when important information about potential harms is missing. That is why ANH welcomes new federal efforts to improve vaccine injury reporting and research. These changes address problems we have raised for years; we must ensure there is meaningful follow-through and implementation.
In an October 8 announcement, the Department of Health and Human Services (HHS) outlined four initiatives:
- A new NIH clinic will evaluate and care for patients experiencing health problems following vaccination while investigating potential causes.
- A proposed Medicare policy would reimburse physicians for time spent reporting suspected vaccine injuries to the Vaccine Adverse Event Reporting System (VAERS).
- Federal standards will require electronic health records to capture vaccine-related adverse events so that information follows patients between providers.
- A VAERS overhaul will make reporting easier, including on mobile devices, and improve tools for investigating potential safety signals.
Major Blind Spots in Injury Reporting
ANH has repeatedly warned that the current reporting system has major blind spots. VAERS depends on someone recognizing a possible problem and submitting a report. Although certain reports are legally required, the system does not automatically capture every concerning health event after vaccination.
We’re not just talking about a few missed cases here or there; this is a substantial problem. A CDC-authored study estimated that VAERS captured only 13 percent of anaphylaxis cases following influenza vaccination. Across the vaccines studied, reporting sensitivity for this potentially life-threatening allergic reaction ranged from 13 to 76 percent.
As we previously reported, an HHS-funded Harvard Pilgrim project explored using electronic medical records to identify possible adverse events and help clinicians report them. Its final report warned that fewer than 1 percent of vaccine adverse events were reported. The project pointed toward a better approach, but researchers said further system testing and evaluation could not proceed because CDC contacts became unavailable or stopped responding. This apparent lack of concern for improving their systems is all the more reason to welcome this recent initiative.
Questions About Long-term Health Effects
There are questions worth exploring. We reported recently on congressional testimony from attorney Aaron Siri on an unpublished study from the Henry Ford Health System that found, among other things, vaccinated children were 2.5 times more likely to develop a chronic health condition than unvaccinated children. This isn’t definite proof of causation, but like any emerging safety signal, the potential of causation is something that can only be evaluated if the signal is not ignored. Siri told Congress that the study was unpublished largely for political reasons: lead author Lois Lamerato, PhD, admitted she did not want to make doctors “uncomfortable,” while co-author Dr. Marcus Zervos feared he might lose his job if the study was published.
Another largely overlooked issue is the potential for delayed effects from vaccination, which are even less likely to be captured by adverse event reporting systems. UK-based oncology researcher Emeritus Professor Angus Dalgleish has testified before Congress about the connection between COVID vaccination and the high prevalence of ‘turbo’ cancers and relapses in patients that were previously clear.
Longstanding Gaps in Safety Research
The truth is that the need for stronger evidence has been recognized for decades. In 1994, the Institute of Medicine, now part of the National Academies of Sciences, Engineering, and Medicine (NASEM), acknowledged: “The lack of adequate data regarding many of the adverse events under study was of major concern to the committee.”
Nearly two decades later, its 2013 review of the childhood immunization schedule said that key elements, including the number, frequency, timing, order, and age at administration of vaccines, “have not been systematically examined in research studies.” It also identified limited evidence concerning children potentially more susceptible to adverse reactions.
Informed Consent and Fair Compensation
Informed consent is a cornerstone of medical ethics and patient-centered healthcare. Patients need understandable information about expected benefits, known risks, and uncertainties relevant to their circumstances. Research gaps should prompt investigation and honest discussion. These pillars of medical ethics are seemingly brushed aside when it comes to vaccination. This has been true for decades but was brought into stark relief during the COVID pandemic, when anyone who dared question the safety or efficacy of the COVID vaccines risked having their career ruined.
We’ve also reported on the broken vaccine injury compensation system (you can read our previous coverage for more details). The current system fails to track vaccine injuries effectively and then creates a Kafkaesque nightmare for patients to receive just compensation for the injuries that arise from following government-issued public health advice.
HHS should publish clear implementation timelines and show whether these initiatives improve reporting and patient care. ANH supports stronger independent safety research, transparent findings, and a process that gives injured patients timely help. Informed consent and fair treatment of injured families are obligations that public health policy must fulfill.
Action Alert!
