CDC No Longer Allowing Submission of COVID mRNA Vaccine Adverse Event Reports

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CDC No Longer Allowing Submission of

COVID mRNA Vaccine Adverse Event Reports  

 

by Dr. David Gortler 

 

The Center for Disease Control (CDC) V-safe website quietly stopped collecting adverse event reports with zero explanation.  The V-safe website simply states: “Thank you for your participation.  Data collection for COVID-19 vaccines concluded on June 30, 2023.”

V-safe now 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 the legacy method for collecting safety data where one can fill out a form online, 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.

Does this mean that the CDC believes that the mRNA Covid-19 injections are so safe there is no longer any need to monitor adverse event reports?  What is the argument against continued monitoring?

While CDC’s V-safe was stealthy and abruptly turned off, refusing to accept new safety reports, to this very day, CDC continues to urge everyone ages six months and older to stay up to date with COVID-19 vaccines and boosters.

As a drug safety expert, I personally can’t cite another example of any agency or manufacturer halting the 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 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.

Like mRNA shots, Bronco IIs are still available on the market and people are still using them up to this very day.  My highly recognizable Bronco II became an intermittent topic of conversation with friends and FDA colleagues who preferred fancier rides.

One day, I was informed by a patrolling security guard at the FDA that it was the oldest car on campus and that he couldn’t believe it was still running.  (I take good care of my stuff).

I didn’t know much about car safety (or mRNA “vaccines”) back then, but when a fellow-FDA-er informed me that my Bronco II had noteworthy safety problems and that the NHTSA still had their eye on this vehicle (rollover accidents were more common and more fatal) I addressed the problem: I got rid of the reliable relic, even though I really, really liked it.

  • The NHTSA is still accepting safety reports on things like my 30-year-old Ford Bronco II, but the CDC is no longer accepting new safety reports on 2-year-old novel mRNA vaccines, despite encouraging Americans to be “up-to-date.”

  • CDC No longer accepting safety reports despite rapidly increasing safety findings: [PICTURE OF OPEN VAERS graphic]

Unlike my old Bronco, mRNA injections have only been on the market for about two years, and according to the FDA Vaccine Adverse Event Reporting System (VAERS) database, mRNA “vaccines” have been named the primary suspect in over 1.5 million adverse event reports, of which there are  >20,000 heart attacks and >27,000 cases of myocarditis and pericarditis just in the USA alone.  Worldwide numbers would be greater.

According to many references, including an FDA-funded study out of Harvard, VAERS reports represent fewer than 1% of vaccine adverse events that actually occur.

Interestingly, the NHTSA link above on my Ford Bronco II only shows one parts recall, one investigation, and 23 complaints, but still features a button in the upper right-hand corner for submitting new reports.

Are mRNA Vaccine Injuries and Deaths an American Humanitarian Crisis?

Wikipedia defines a humanitarian crisis or humanitarian disaster as a:  “singular event or a series of events that are threatening in terms of health, safety or well-being of a community or large group of people.”  Based on VAERS and previous V-safe findings, adverse events from mRNA shots in the USA alone could be considered a humanitarian crisis.

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 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, its “case closed” with regards to collecting new safety reports under today’s federal public health administration.

A third-party website screenshot detailing the safety reports of mRNA shots as detailed in the shut-down CDC’s V-safe database

Will the CDC opine on the existing data or justify is halting collection of new safety data?  To the best of my knowledge, stopping the collection of public health information doesn’t have a clinical justification or scientific precedence — especially when it comes to an actively marketed product.

In George Orwell’s 1984, characters were told by The Party to reject the evidence of their eyes and ears.  Now, the CDC isn’t even allowing that evidence to be collected for viewing (and potentially rejecting).  It’s the wrong methodology for any product, let alone complex, novel mRNA technologies.

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Dr. David Gortler is a pharmacologist, pharmacist, FDA and health care policy oversight fellow, and FDA reform advocate at Brownstone Institute.  He was a professor of pharmacology and biotechnology at the Yale University School of Medicine, where he also served as a faculty appointee to the Yale University Bioethics Center.  While at Yale, he was recruited by the FDA and became an FDA medical officer/senior medical analyst. He was later appointed as senior advisor to the FDA commissioner for drug safety, FDA science policy, and FDA regulatory affairs. 


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