At the time of my last article, Vaccine Injury Reporting Favors the Vaccine, Not the Consumer, I was still awaiting a response to my follow up questions regarding the Vaccine Adverse Event Reporting System (VAERS) from the Louisiana Department of Health (LDH). I had suspicions that LDH was not acknowledging the experimental nature of these drugs and that they were not appropriately reporting vaccine adverse events (AE), but the answers I received are shocking and further undermine confidence in this government entity.
Emergency Use = Experimental
LDH refuses to acknowledge that the vaccines under Emergency Use Authorization (EAU) are experimental, yet provide a source in the follow up email that states otherwise. Let me explain. The Food and Drug Administration’s (FDA) Pfizer Briefing Document published just prior to the issuance of the EUA states:
“In the event an EUA is issued for this product, it would still be considered unapproved and it would be under further investigation (under an Investigational New Drug Application) until it is licensed under a Biologics License Application (BLA).”
The Briefing Document refers to the drug as investigational a total of five times, but it is very important to note that it specifically states it will remain under further investigation until it is licensed. Indeed, the latest amended EUA specifies the actual Investigational New Drug application (IND) number the drugs are under in section III(G).
On its website, the FDA defines investigational this way:
LDH’s incompetence on full display
To support their claim that the drugs are not experimental, LDH provided a link to an FDA document entitled Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19, which states:
“An investigational drug can also be called an experimental drug.”
As proof that the drugs are not experimental, LDH provided a document that states otherwise. The incompetence is stunning.
The importance of Adverse Event Reporting
“Licensure of a COVID-19 vaccine will be based on review of additional manufacturing, efficacy, and safety data, providing greater assurance of the comparability of licensed product to product tested in the clinical trials, greater assurance of safety based on larger numbers of vaccine recipients who have been followed for a longer period of time, and additional information about efficacy that addresses, among other questions, the potential for waning of protection over time.”
Yes, duration of protection was one of the known data gaps listed in the FDA Briefing Document, as were effectiveness against variants, transmission, and mortality. The clinical trials, phases 1-3, were not designed to determine any of this information making post market surveillance essential.
VAERS reporting is supposed to be mandatory!
Thus the importance of VAERS reporting. It is stated in the FDA Briefing Document, the Fact Sheet for Providers, and on the CDC website that healthcare workers have a mandatory duty to report adverse events following COVID-19 vaccination. Specifically for these experimental vaccines, the documents state that reactions are to be reported “irrespective of attribution to vaccination.”
In the current Fact Sheet for Recipients for 5-11 year olds, following the list of possible risks, is this disclaimer:
“These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials.”
But what if public health agencies like LDH promote a false narrative that the drugs have already been found to be safe and effective and refuse to acknowledge their experimental nature?
Misinformation straight from the top
With unbelievable condescension, State Health Officer Dr Joseph Kanter, during the recent proposed rule change hearing before the House Health and Welfare committee on December 6th, repeated this line from the follow up email we received:
“The “e” in EUA stands for emergency, not experimental.”
The false narrative that these drugs have completed all drug trials that determine safety and efficacy creates a dangerous environment in hospitals and clinical settings where vaccine administrators are unaware of their informed consent and AE reporting obligations. As witnessed in the VAERS hearing on November 8th, nurses from across the state shared that adverse events were occurring at a steady rate but were not being reported, even though it’s required by law. The brainless Louisiana media continues to perpetuate this harmful narrative unabated. What happened to journalistic curiosity?
Ignoring facts doesn’t make them go away
The follow up email from LDH only gets worse. Of the thousands of reports submitted to VAERS by Louisiana citizens, LDH indicates they have investigated NONE of them, instead referring me to the U.S. Department of Health and Human Services. While I readily acknowledge that a VAERS report in no way determines causality, the reports deserve notice and follow-up. To discount them outright and only acknowledge reports made to an 800 number that is not advertised to the general public defies medical ethics.
Who has investigated the almost 5,000 adverse event reports submitted directly to VAERS by Louisiana citizens? LDH also indicates in the follow up email that they do not submit a VAERS report for calls made to their 800 number, rather “LDH’s reporting process does not replace the need for healthcare providers to also report all COVID-19 vaccination related adverse events/reactions to VAERS, which is jointly managed by the CDC and FDA.”
LDH flagrantly violates EUA rules
Then, I received another email from LDH that clearly violates the FDA’s EUA which requires that “[a]ll promotional material relating to the COVID-19 Vaccine clearly and conspicuously … state that this product has not been approved or licensed by the FDA...” The email from LDH reads:
“Due to its new FDA approval, the Louisiana Department of Health (LDH) and Centers for Disease Control and Prevention (CDC) recommend all children ages 5 and older be vaccinated against COVID-19. We know families have been anxiously awaiting this announcement and that others may still have questions. As the holiday season approaches, please join us and a panel of experts for a conversation on the safety and importance of vaccinating children against COVID-19!”
These actions indicate a disturbing level of incompetence and malfeasance.
Following the recent proposed rule change hearing, Dr Kanter tweeted that antivax activists descended on Louisiana to “intentionally spread vaccine disinformation.” Governor Edwards, who tweeted misinformation can be “deadly,” doubled down on the state’s claim that there have been zero deaths in Louisiana associated with COVID-19 vaccination, even while LDH acknowledges that they have not investigated the 60+ deaths reported to VAERS by Louisiana citizens, instead instructing me to contact the U.S. Department of Health and Human Services (HHS) directly.
Spreading misinformation is a disservice to yourself and your neighbors, & it can be deadly.
Over 14,800 of our fellow Louisianans lost their lives to COVID. ZERO Louisianans have died from the COVID vaccines. These vaccines prevent unnecessary suffering. Let’s use them. #lagov pic.twitter.com/MrZZwpPH1e
— John Bel Edwards (@LouisianaGov) December 7, 2021
These are just two of many reports from Louisiana.
How and who determined that these reports are unrelated to the vaccine?
VAERS ID# 1093986-1, a 45 year old woman, was vaccinated on March 10th and reportedly died on March 11th. The report reads:
“Received a phone call stating that the patient complained of not feeling well on 3/11/21 while at work and that the patient died that night while at home.”
VAERS ID# 0930466-1 is an 82 year old woman who reportedly died the same day as her vaccination. The report reads:
“Fever, shortness of breath and chest pain that resulted in a heart attack a few hours after vaccination”
Clearly, someone is spreading misinformation. It is malfeasance to make claims of safety while a drug is still being investigated and while thousands of adverse event reports are being ignored, especially in light of the very real possibility that the shot will be required of school children. LDH continues to host vaccination events focused on children in mostly minority communities, paying them to partake in an experimental drug while making claims that violate FDA regulations.
The ethical issues are staggering.
I sent a letter to Secretary of Health Dr Courtney Phillips requesting her resignation and that of State Health Officer Dr Joseph Kanter. You can read it here. I would encourage everyone to contact Governor Edwards and demand accountability of his Secretary of Health and State Health Officer. Our greatest treasure, our children, deserve better.
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