ARE THE SYSTEMS MONITORING VACCINE SAFETY ACCURATELY REPORTING ISSUES?

By Jefferey Jaxen

The first-ever mRNA vaccines were rushed to trial and authorized under emergency use authorization (EUA). The public was assured a ‘robust’ safety net would be set in place to detect adverse reactions. Now that the shots from Pfizer, Moderna and J&J have been unleashed upon the public, we are learning the truth about the largest medical experiment in human history.

The New York Times spotlighted the FDA’s struggle to get safety monitoring systems running. According to numerous federal health officials speaking to NY Times, the much-touted system the government designed to monitor any dangerous reactions won’t be capable of analyzing safety data for weeks. Or maybe months: 

“F.D.A. officials acknowledged that a promised monitoring system, known as BEST, is still in its developmental stages. They expect it to start analyzing vaccine safety data sometime soon — but likely not until after the Biden administration reaches its goal of vaccinating 100 million people.”

On March 12, the U.S. boasted it had topped 100 million Covid-19 vaccine doses administered. News from FDA officials about a fully functional monitoring system was absent. It was unknown if the “patchwork of programs” that were reportedly “hampered by limited size and gaps in data collection” are still experiencing issues. 

For those paying attention, the NY Times story wasn’t the first admission of vaccine safety reporting failures and shortcomings. The Vaccine Adverse Events Reporting System (VAERS) has relied on the expertise and discernment of medical practitioners to recognize and report health issues that arise after vaccination. Unfortunately, there are still several in the medical community either uneducated on what constitutes a possible vaccine injury or unwilling to report it. Therefore, since the inception of the program, which was an outgrowth of the 1986 National Childhood Vaccine Injury Act, many have hypothesized that the system captures only a fraction of actual injuries. 

That all changed in 2007. The public and government oversight agencies received proof of possible under reporting. 

As a workaround at the time, the idea of automating adverse reaction reporting to VAERS via medical records was proposed. Although not a new suggestion or even difficult to achieve, the concept had been long-ignored. 

In 2007, the Agency for Healthcare Research and Quality, an agency within U.S. Health and Human Services (HHS), stopped ignoring it. In 2007, the agency provided an approximately $1 million grant to automate VAERS reporting at Harvard Pilgrim Health Care. 

The result was the successful automation of adverse event reports at Harvard Pilgrim: 

“Preliminary data were collected from June 2006 through October 2009 on 715,000 patients, and 1.4 million doses (of 45 different vaccines) were given to 376,452 individuals. Of these doses, 35,570 possible reactions … were identified.“

The conclusion was that “fewer than 1% of vaccine adverse events are reported” to VAERS.

These results should have been concerning to HHS, since they show that over only a three-year period, there were 35,570 reportable reactions in just 376,452 vaccine recipients. 

After automating adverse events reports at Harvard Pilgrim, the developers of this system asked the CDC to take the final step of linking VAERS with the Harvard Pilgrim system so that these reports could be automatically transmitted into VAERS. 

Instead, the CDC refused to cooperate. As the Harvard grant recipients explained: 

Unfortunately, there was never an opportunity to perform system performance assessments because the necessary CDC contacts were no longer available and the CDC consultants responsible for receiving data were no longer responsive to our multiple requests to proceed with testing and evaluation.

After three years and spending $1 million of taxpayers’ money, the CDC refused to even communicate with the HHS’ Harvard Medical School grant recipients. Given HHS’s statutory mandate to assure safer vaccines, CDC should have rushed forward with automating VAERS reporting. Yet instead CDC ignored requests by the HHS’s Harvard grant recipients.

Back to the present-day Covid vaccine rollout. Anaphylaxis was the initial safety signal – first in the U.K. then in America. The public first learned of it through stories that grabbed global headlines. 

A study published in the Journal of the American Medical Association (JAMA) looked at Mass General Brigham (MGB) employees who received their first dose of an mRNA COVID-19 vaccines. 

Of the 64,900 employees, 52 805 completed at least 1 symptom survey, acute allergic reactions were reported by 1,365 employees overall. Anaphylaxis was confirmed in 16 employees, with 7 cases from the Pfizer-BioNTech vaccine and 9 cases from the Moderna vaccine.

According to CDC numbers during the time of the study, the rate of anaphylaxis was 4.7 and 2.5 cases/million doses for Pfizer and Moderna respectively.

The study’s authors write: 

“…severe reactions consistent with anaphylaxis occurred at a rate of 2.47 per 10 ,000 vaccinations…The incidence rate of confirmed anaphylaxis in this study is larger than that reported by the Centers for Disease Control and Prevention…”

If the HHS’s Harvard Pilgrim investigation showed that “fewer than 1% of vaccine adverse events” are reported, extrapolating the recent JAMA study’s findings out to the greater vaccine adverse reaction reporting, the result is perhaps predictable. 

Rather than 2.5 to 4.7 cases per million, the JAMA study’s 2.47 per 10,000 would equate to 247 per million when viewed at a larger population level. Interestingly, comparing the CDC’s rate of 2.5 to 4.7 for Covid vaccinations with the rate of 247 per million shows that reporting may still only be capturing roughly 1-2% of reactions for anaphylaxis – one of many adverse health conditions being monitored, following vaccination.  

An anaphylactic allergic reaction is required to be reported and is a relatively instant reaction after vaccination happening anywhere from 15 minutes to four hours after the shot according to the CDC.

What about safety issues that occur the next day? The next week? After a few years? Since many of the placebo groups in numerous Covid vaccine trails have been or are planning on being vaccinated, the control group is vaporizing before our eyes. Any idea of ‘robust’ safety monitoring within the original trail designs are now essentially dead ends.

Do you trust the government’s safety reporting of vaccine responses?