The US government has until recently collected data on adverse events related specifically to the COVID-19 vaccine in multiple ways.

HHS has had the VAERS system for ages. VAERS stands for Vaccine Adverse Events Reporting System, and it provides a way for doctors and patients to report adverse events that may be related to vaccination, it is monitored to see if patterns develop that may signal safety issues.

Because it is self-reported information it isn’t based on a random sample–if you choose to report a problem by definition you have had an unusual experience, associated it with the vaccine, and taken the time to seek out VAERS and fill out forms. Hence VAERS is less a research tool than a safety monitor. Because adverse events are self-reported spurious reports may be frequent, but if a problem pops up regularly it requires deeper research in case it is vaccine-related.

VAERS has been flooded with reports–which is unusual in itself–that either indicate lots of problems or simply that people are more sensitive than usual and making reports with this particular vaccine where they might not for others.

For the COVID vaccine, the CDC added another layer of monitoring–an app that allows people to track their vaccine-related experiences in a user-friendly manner and to look at the data collected. It is no more or less reliable than VAERS, but it does add a layer of monitoring and additional data. This can increase the usefulness of safety monitoring. In fact, it is vital for safety monitoring because nobody is tracking a randomized controlled group over time to look at alternative outcomes.

In other words, it is the only data we are collecting.

We already know that even by optimistic assessments the COVID vaccine is unusually dangerous. Adverse events take place at a rate of about 1 in 800 doses, compared to 1 in millions for most vaccines. And, as the first mRNA vaccine it makes special sense to track adverse events. As a new technology, you would expect the public health community to do a particularly deep dive into potential problems.

Yeah, well, it’s a big no on that one. The CDC has just closed down its own data collection system called V-Safe.

"In George #Orwell’s 1984, characters were told by The Party to “reject the evidence of your eyes and [your] ears.” Now, the @CDCgov isn’t even allowing that evidence to be collected for viewing (and prospective rejecting)."
~ David Gortlerhttps://t.co/j49Wc6LzJh

— Brownstone Institute (@brownstoneinst) August 24, 2023

The Centers for Disease Control and Prevention (CDC) V-safe website quietly stopped collecting adverse event reports with no reason or explanation. The V-safe website simply states: “Thank you for your participation. Data collection for COVID-19 vaccines concluded on June 30, 2023.” If you go there today, V-safe directs users to the FDA’s VAERS website for adverse event reporting, even though officials continually derided VAERS as “passive” and “unverified.”

VAERS and V-safe are mutually exclusive safety collection databases operated by the FDA and CDC, respectively. VAERS is an older way of collecting safety data where one can fill out a form online, or manually, or by calling a toll-free number, whereas V-safe is a device “app” which requires online registration. Both VAERS and V-safe collect personal information, lot numbers, dates and associated information, but V-safe was an active collection system geared towards a younger app-using demographic.

Now think for a moment. What do we know about COVID vaccine adverse events? What, in particular, is especially troubling about them aside from their unusual frequency?

Well, how about this: they are more likely and more problematic in young people. Just the sort of people most likely to know about and use this app. This means that the CDC has stopped collecting data from the very group of people from whom we would need it most.

The Pfizer and Moderna clinical trial reanalysis by Fraiman and colleagues indicated the mRNA vaccines were associated with an additional serious adverse event for every 800 people vaccinated,4 far more than the 1-2 for each million reported for vaccines in general.10 Fraiman says he and his colleagues asked the FDA to warn the public based on their reanalysis, and replicate their study, but this has not happened.

“It seems to me that doctors have a much higher tolerance for covid vaccine side effects because there’s been this sense that if you don’t take the vaccine, you die. Obviously, that is completely the wrong way to think about it,” says Stabell Benn.

“We don’t want to create a lot of unnecessary anxiety and we can’t say there is now proof that the vaccines cause these events because the data are of poor quality, but we can say there is a danger signal, and the medical profession needs to be alerted to this,” she adds.

Collecting safety data for any medical device or intervention should always be a high priority, but under these circumstances, one would expect that public health officials would be especially interested. While we are constantly being assured that these vaccines are safe and effective, the reality is that under any definition the introduction of an entirely new technology rushed into production without long-term safety research is experimental. That billions of people were forced or induced to inject a substance using a never-tried technology is rather shocking, and at a minimum, you would expect the powers that be to follow the progress of the intervention basically forever.

David Gortler, the author of this Brownstone Institute piece, was an FDA medical officer. Here is his take:

As a drug safety expert, I personally can’t cite another example of any agency or manufacturer halting collection of safety data. It seems even worse because mRNA technology is relatively new with long-term manifestations unknown. On top of this, both manufacturers and the FDA refuse to share the list of ingredients, such as lipid nanoparticles, which could affect individuals differently and take a long time to manifest clinically.

Safety Data Collection Should Never Stop

Now, contrast that with the fact that the National Highway Traffic and Safety Administration (NHTSA) will still accept a safety report for a 30-year-old Ford Bronco II. Indeed, this is an oddly specific example, but only because I drove this exact vehicle as a family hand-me-down as a student, through my residency, fellowship, for my tenure as a Yale professor on the mean streets of New Haven and even during my years at the FDA as a medical officer /senior medical analyst.

The COVID-19 vaccine has been around for 2 years and is based on entirely novel technology. We keep being told about safety and effectiveness–we know that their predictions about effectiveness were wrong–but the CDC seems especially incurious about safety issues. And, without doubt, there are red flags galore.

Despite those alarming clinical findings, the CDC has concluded that collecting new safety reports is somehow no longer in the interest of America’s public health. Existing data from the V-safe site showed around 6.5 million adverse events/health impacts out of 10.1 million users, with around 2 million of those people unable to conduct normal activities of daily living or needing medical care, according to a third-party rendering of its findings. In other words, despite mRNA shots still being widely available and the CDC promoting its continued use, it’s “case closed” with regards to collecting new safety reports, under today’s federal public health administration.

This is unforgivable, and yet no explanation has been given.

Peer countries have been scaling back vaccine efforts, especially for the cohort of people who are most directly targeted by the V-Safe system, The CDC has gone in the opposite direction. They still push vaccines for people 6 months to death and are now turning off a key data collection system intended to monitor the safety of the vaccine.

This is despite millions of reported adverse events, including a spike in deaths reported that is unprecedented.

Throughout the pandemic, the public health establishment has been uniquely incurious about the effectiveness of new drugs, and non-pharmaceutical interventions such as masks and other barriers, and now are shutting down data collection on vaccine adverse events. It would have been ridiculously easy to do a randomized controlled trial on mask mandates, yet the CDC failed to do so even years after the pandemic began. They instead rely on seat-of-the-pants guesses and wishcasting to make recommendations while attacking anybody who disagrees with their assessments.

In other words, the CDC has a narrative, and they believe the best way to support that narrative is ignore evidence.

Very on brand.