When COVID-19 vaccines arrived on the scene in Louisiana in December 2020, they were accompanied by a letter from the Food and Drug Administration (FDA) granting emergency use (EUA). Within the EUA is a list of “Conditions of Authorization,” established under federal law, that both the vaccine manufacturer and the vaccine’s authorized distributors are required to comply with, including stipulations that:
- COVID-19 vaccine and bivalent vaccine recipients must be given a Fact Sheet in lieu of a package insert. There have been several viral videos of pharmacists unfolding the accompanying vaccine package insert only to discover that it is completely blank. This is intentional. Only FDA-approved medications have a printed insert. The Fact Sheet serves to provide a truncated informed consent, essentially informing the patient what is currently known about the drug, as EUA drugs are technically experimental. The Fact Sheet also stipulates that patients must be made aware that the drug is being issued under emergency use and is not FDA-approved.
- All descriptive printed matter, advertising, and promotional material relating to the use of COVID-19 vaccines and bivalent vaccines “clearly and conspicuously shall state, as applicable, that the vaccine has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019…”
In February, Health Freedom Louisiana informed the Louisiana Department of Health (LDH), an authorized distributor of all COVID-19 vaccines, that the promotional material they provide to the public, health systems, pharmacists, and other entities across the state, violates the “Conditions of Authorization” stipulated in the letter granting the EUA. For example, the image below, which can be found on the LDH website and its various social media platforms, makes no mention that COVID-19 vaccines are authorized for emergency use and are not FDA-approved as stipulated in the EUA.
The statement in the above image is also blatantly false, an issue we brought to the attention of the Louisiana Legislature in August 2022:
Unlike car seats, there is no data to support any statement that covid vaccination in infants and children has a proven or substantiated record of saving lives. As a matter of fact, it is known that covid vaccination will fail to prevent infection and transmission, that any protection provided is short lived, and repeated boosters will be necessary in the future.
After the second dose, Moderna’s clinical trial for children ages 2-5 showed a vaccine effectiveness of 28.5% (Table 62). Would you put your child in a car seat knowing it was only 28% effective? Other data presented in the Pfizer FDA Briefing document indicate negative efficacy, with confidence intervals about or near -300. (Tables 19 and 20). Would you put your children in car seats knowing it would actually cause harm to them?
Additionally, unlike car seats, covid vaccines are immune from liability, meaning parents of children injured or killed by their use cannot sue for damages.
Earlier this month, Health Freedom Louisiana informed LDH once again that communication (printed matter covered under the EUA) they provided regarding COVID-19 vaccines violates the conditions stipulated in the EUA. In a display of incredible incompetence, LDH’s legal department answered a public records request, which essentially asked where and when FDA-approved COVID-19 vaccines became available in Louisiana, with the following:
“Louisiana Immunization Program has received CDC distribution guidance regarding Comirnaty (Pfizer) and Spikevax (Moderna) vaccines, but we have not distributed the vaccines to our providers yet. Currently, in Louisiana, we have the FDA-approved (EUA) COVID-19 vaccines from Pfizer and Moderna available to providers, although they are not packaged under their respective branded names. It will take some time for the transition to the new packaging of these vaccines to reflect their product names (Pfizer-Comirnaty, Moderna-SpikeVax).”
What this response tells us is: to date, no FDA-approved COVID-19 vaccine has been distributed in Louisiana, although LDH – in violation of federal law – is stating otherwise.
Again, with incredible disregard for the consumer and informed consent, LDH ignores the EUA, which states the two products are “legally distinct“ (pg 20). The two products being legally distinct has significance in regards to the experimental nature of EUA products and the means by which compensation is sought for injuries that result from their use.
- Section G of the EUA specifies that Pfizer (and Moderna) are still reporting findings to the FDA via an Investigational New Drug application. According to the FDA, “an investigational drug can also be called an experimental drug and is being studied to see if your disease or medical condition improves while taking it.”
- Unlike typical FDA approved or licensed drugs, emergency use authorized COVID-19 vaccines are covered under the PREP Act, meaning the manufacturer has no liability for any harm that may result from the use of their product. This effectively removes Seventh Amendment protections and the right to seek recourse in a civil court. Instead, recipients must file for compensation through a government program called the Countermeasures Injury Compensation Program(CICP) within a year of receipt of the drug. (To date, of the 543 COVID-19 vaccine claims reviewed by CICP, 19 have been determined to be eligible for compensation yet no compensation amount has been determined or distributed, with 10,653 other claims pending review.)
To date, there has been ZERO legislative oversight of LDH’s unfettered promotion of COVID-19 vaccines. The ramifications of this agency’s continued disregard for the law and its duty to provide informed consent to Louisianans and the healthcare systems it serves are tremendous. We believe it negates the immunity provided to the agency under the PREP Act as it continues to act with “willful misconduct,” despite repeated warnings. As such, we encourage those individuals harmed by COVID-19 vaccines to consider legal action against LDH.
On March 21st, Health Freedom Louisiana filed a formal complaint with the FDA and requested an investigation of LDH’s continued violation of the terms specified in the COVID-19 vaccine EUA.
After pointing out their incompetence, the tweet was deleted.
It will take so much more than a deleted tweet to correct the harm caused by this agency’s willful misconduct. As we noted in our recent communication with LDH:
The Louisiana Department of Health provides guidance on COVID-19 vaccine products to countless people, health systems, state agencies, and the legislature. The number of people provided with this blatantly false information is so significant that action must be taken to correct it. We demand a public acknowledgement that the COVID-19 vaccine products available in Louisiana to date are not FDA approved. Louisianans, health systems, medical professionals, and state agencies including the legislature, must be made aware that LDH has been providing information that violates FDA’s “Conditions of Authorization” set forth in the EUA.
Were you or someone you know informed that the COVID-19 vaccine received was FDA-approved? We would love to hear about it. Let us know.