Health authorities continue to collect safety data on COVID

SOURCE: Brandon Drey, Daily Wire, 27 Aug. 2023

To support this claim, the Daily Wire article cited pharmacologist David Gortler’s article for the Brownstone Institute, in particular Gortler’s question “Does this mean that the CDC believes that the mRNA Covid-19 injections are so safe, there is no need to monitor adverse event reports any longer?”. He also added that “to the best of my knowledge, stopping the collection of public health information doesn’t have a clinical justification or scientific precedence”.

The Brownstone Institute, founded by entrepreneur Jeffrey Tucker, has been noted as a source of disinformation on COVID-19 and COVID-19 vaccines. Many of those who contribute to its content have been connected with other groups propagating COVID-19 disinformation, such as the Front Line COVID-19 Critical Care Alliance and the Health Advisory and Recovery Team.

This review explains how the claims by the Daily Wire and Gortler inaccurately represented the CDC’s recent decision about the v-safe program, misleading readers into believing that health authorities stopped monitoring the safety of COVID-19 vaccines.

What set off these claims was an announcement by the CDC that it closed enrollment in the v-safe program in May 2023. Launched in December 2020, the v-safe system was an app-based pharmacosurveillance system, where users could report any medical events or conditions that occurred post-COVID-vaccination. The CDC also stated that a new version of v-safe was under development, “which will allow users to share their post-vaccination experiences with new vaccines”.

However, Gortler’s question (“Does this mean that the CDC believes that the mRNA Covid-19 injections are so safe, there is no need to monitor adverse event reports any longer?”) implies that the halt to v-safe means public health authorities have decided to stop monitoring COVID-19 vaccine adverse events completely.

This isn’t true. The CDC and the FDA employ several vaccine monitoring networks apart from v-safe. One such example is the Vaccine Safety Datalink (VSD), a collaboration between the CDC and various healthcare institutions across the U.S. The VSD allows almost real-time monitoring of vaccination, using what is called “rapid cycle analysis”[1].

There is also the well-known and established VAERS system, which the v-safe website now directs users to. Both the Daily Wire and Gortler mentioned that the v-safe website directs users to VAERS, but neither made it clear that this effectively meant pharmacosurveillance of COVID-19 vaccine safety still continued—contradicting their implication that all adverse event monitoring had stopped.

This document, compiled by North Dakota State University and the North Dakota Department for Health and Human Services, lists several other vaccine monitoring programs apart from VSD, VAERS, and the now-on-hold v-safe.

The above demonstrates that the CDC’s pause on the v-safe program doesn’t mean health authorities stopped gathering safety data about vaccines, as the Daily Wire and Gortler claimed.

The Daily Wire’s choice to use the phrase “Vaccine Adverse Event Reports” in its headline evokes the name of the Vaccine Adverse Event Reporting System (VAERS), which could lead readers to believe that it is the VAERS database that the CDC shut down. This is not the case. As we explained above, v-safe is a separate program from VAERS and VAERS remains operational.

The Daily Wire also made other inaccurate claims. For instance, it said that VAERS “allegedly names the vaccines as the number one cause of more than 1.5 million adverse event reports”. This is a common misinterpretation of how VAERS can and cannot be used which formed the basis of much disinformation on vaccines. Health Feedback went over this on multiple occasions.

Briefly, VAERS collects reports from healthcare practitioners and the public about any medical events or conditions that occurred in people who received a vaccine. It doesn’t tell whether vaccination was the cause of that medical event. As Health Feedback explained in the past, correlation alone doesn’t imply causality. Claiming that VAERS identified the “cause of more than 1 million adverse event reports” is thus inaccurate.

The Daily Wire and Gortler also claimed that only 1% of adverse events were reported to VAERS, suggesting that the real number of adverse events is much higher. Neither provided adequate supporting evidence for this.

Gortler linked to a document penned by researchers at Harvard Pilgrim which is a grant report and not a published, peer-reviewed scientific study, contrary to what he and the Daily Wire claimed. This document indeed stated that “fewer than 1% of vaccine adverse events are reported”. But it didn’t provide supporting explanations, so it isn’t possible to validate the veracity of that estimate.

In fact, a CDC spokesperson told Reuters that the VAERS reporting rate varies. Indeed, anyone can contribute spontaneously. Therefore, the adverse event reporting rate may depend on the event severity and public awareness. For example, the reporting rate was “47% for cases of intussusception cases after the rotavirus vaccine and 68% for paralytic polio after the oral polio vaccine, while rates ranged from 13 to 76% for anaphylaxis”, according to Reuters.

Moreover, the grant report cited by Gortler dates from the period between 2007 and 2010, before the COVID-19 pandemic. Considering the much more frequent media coverage of COVID-19 vaccines in relation to other vaccines, one shouldn’t take it for granted that the reporting rate would be the same for COVID-19 vaccines and for the vaccines used in the period between 2007 and 2010.

More importantly, the regulations that govern adverse event reporting differ depending on the vaccines. The CDC explains that health practitioners are required to report to VAERS any serious adverse events following COVID-19 vaccines, which isn’t the case for other vaccines. Therefore, conclusions from the grant report cited by Gortler cannot be extrapolated to COVID-19 vaccines.

In summary, the Daily Wire’s article misled readers into believing that the CDC’s halting of enrolment into v-safe meant that health authorities had stopped collecting vaccine safety data. This isn’t the case, because both the CDC and the FDA have numerous safety monitoring tools like VAERS that are still up and running. Such surveillance programs enable scientists and public health authorities to detect unusual signals that may indicate a problem with vaccine safety and motivate additional investigations. Taken on their own however, adverse event reports don’t provide sufficient evidence to establish a causal relationship with vaccination.