Restoring Trust in Public Health: Transparency Urgently Needed in Reporting Adverse Vaccine Effects

This is the final piece in an eight-article series on “Restoring Trust in Public Health: Lessons from COVID-19.” Four years of the Biden-Harris administration has left Americans rightly skeptical of public health institutions. This series highlights key findings from several congressional oversight reports, including the final report of the U.S. House Select Subcommittee on the Coronavirus Pandemic, and offers lessons for Congress and the new administration on ways to restore trust in public health.

In its final, comprehensive report, the House Select Subcommittee on the Coronavirus Pandemic concluded that with regard to the COVID-19 vaccines, the federal government’s reporting on adverse events has been neither transparent nor sufficient to protect the American people. 

As reports of adverse events mounted, federal officials were slow to respond. In fact, the safety problem worsened in 2021 when President Joe Biden attempted to impose his vaccine mandate: a policy that disregarded the reality of the natural immunity of previously infected people, the personal decision-making at the heart of the doctor-patient relationship, and the unknown short-term and long-term side effects of the vaccines themselves. 

During the pandemic, it was soon apparent that America’s capacity for quickly reporting and responding to safety issues with the COVID-19 vaccines was defective. While, for example, Israel and France were quick to identify the risk of myocarditis (heart inflammation) among young, vaccinated males, neither the Centers for Disease Control and Prevention nor the Food and Drug Administration were able to respond nearly as fast.

In fact, in May 2021, the CDC reported that the rates of myocarditis among vaccine recipients was at expected “baseline rates.” However, the subcommittee noted that only after the release of Israeli data did the CDC admit that myocarditis rates were “higher than expected.”

Inadequate Reporting and Response

The main system for public reporting of adverse events is the Vaccine Adverse Event Reporting System. As the subcommittee reports, as of November 2024, there were a total of 1,844,839 adverse event reports for COVID-19 vaccines: 216,646 hospitalizations; 72,161 reports of permanent disabilities; 38,068 deaths; and 9,167 deaths reported within just two days of vaccination.

The large number of adverse vaccine reports is profoundly disturbing because this public register of adverse events and deaths over just four years has dwarfed the record of all other vaccines combined going back to 1990. It is equally disturbing that, given the sheer number of adverse reports, federal officials have been sluggish in their response.

The Vaccine Adverse Event Reporting System was established in 1990 to keep an accounting of such events and is jointly managed by the CDC and the FDA. Physicians and drug manufacturers are required to report adverse vaccine events. The system is designed as “passive surveillance”—a system designed to be open to anyone who wishes to report such an event—in contrast to “active surveillance”—a system designed to proactively detect and investigate adverse vaccine consequences and respond quickly. 

This reporting system is insufficient and clearly inadequate. Obviously, a negative report in and of itself does not prove that a vaccine caused the adverse event. As the subcommittee observes: “Anyone can submit a report to VAERS, and these reports are automatically published and available publicly. Therefore, a report on VAERS has likely not been proven to be caused by a vaccine.”  

Slow Adjudication and Poor Compensation

While vaccines are generally safe and effective, they are not safe and effective for all persons. In 1986, Congress enacted the National Childhood Vaccine Injury Act to compensate injured parties through a special judicial process for 16 different vaccines the CDC had recommended over the years.

In 2005, Congress created the Countermeasures Injury Compensation Program to encourage rapid vaccine development. It allowed for injury claims to be adjudicated by the Department of Health and Human Services and limited liability for vaccine manufacturers.

The select subcommittee outlined the current policy challenge we face: “Since vaccines are an important tool to protect public health, it is imperative to preserve the public’s trust in vaccination and, therefore, compensating for these rare but inevitable harms is of vital importance. Conversely, limiting the liability of manufacturers also promotes the expeditious development of new and innovative vaccine technology which saves lives.”

In the case of the COVID-19 pandemic, policymakers clearly failed to establish the proper balance between compensation for those harmed and limited legal liability for manufacturers.  

COVID-19 vaccine injuries are covered under the Countermeasures Injury Compensation Program and are adjudicated under the HHS administrative process, an agonizingly slow process. According to the subcommittee report, as of November 2024, of the 13,520 claims filed, 10,082 were still pending.

Additionally, of the 3,438 decisions that have been made, 3,373 resulted in a claims denial. Only 18 claims for COVID-19 vaccine injury adjudicated under the program resulted in compensation, and the average award was a relatively small figure of $24,514.

The system is also maddeningly opaque. As the subcommittee reports, “The details of each CICP [Countermeasures Injury Compensation Program] decision are not made public, which means that the rationale of each case’s compensation award or decision are indiscernible to the public and other claimants in the program.”

Worse, the program has been poorly staffed. In his Feb. 15, 2024, testimony before the subcommittee, Commander George Reed Grimes, director of HHS’s Division of Injury Compensation Programs, told Congress that at the inception of the pandemic, the program had only four staff members to handle thousands of claims. After Congress allocated more money in 2022, the agency was able to increase its staff to 35 to adjudicate claims, increasing the claims resolution rate from 0 to 90 per month. At that rate, however, thousands of claims would remain unadjudicated for a long time.   

Better Safety Reporting and Injury Compensation

The COVID-19 episode is a black mark on the federal government’s performance in collecting and reporting adverse vaccine events and in adjudicating vaccine injuries.

In fulfilling his promise for full transparency, new HHS Secretary Robert Kennedy Jr. should immediately release all safety and effectiveness data related to the COVID-19 vaccines, including the data of vaccine manufacturers as well as any and all safety and effectiveness data on relevant therapeutics used to mitigate COVID-19. This is something Sen. Ron Johnson, R-Wis., chairman of the Senate Permanent Subcommittee on Investigations, and others have been requesting for years but have never received.  

We clearly need to upgrade America’s response to vaccine injury. Going forward, it is well past time to modernize and enhance the process for reporting adverse vaccine events and provide for a fairer, more transparent, and more effective adjudication of injury claims.   

The new HHS secretary, working with Congress, can restore public trust by making significant changes to improve vaccine safety and compensation for any who are injured by government-approved vaccines while still affording certain  protections to pharmaceutical manufacturers to continue to encourage the development of new and effective vaccines.

Other articles from this series:

Preventing Waste and Fraud in National Emergency Assistance

Prioritizing Science Over Manipulative Messaging

Next Time, Don’t Close Schools Needlessly in a Pandemic

Play It Straight on Vaccine Effectiveness

Full Transparency and Cooperation with Congressional Inquiries

Lessons From Flawed COVID-19 Mask Mandates

Don’t Trade Lives and Livelihoods for Lockdowns Unsupported by the Data

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