LA Dept. of Health's COVID-19 Vaccine Promotional Material Violates Terms of EUA
In doing so, millions of Louisianans have been denied informed consent.
When the Food and Drug Administration (FDA) issues an Emergency Use Authorization for a medical product, the agency includes “Conditions of Authorization” for the drug manufacturer and its authorized distributors. The following stipulations outline the conditions for authorization for the COVID-19 vaccines and bivalent vaccines in the most recent letter of authorization, under the heading “Conditions Related to Printed Matter, Advertising, and Promotion” (below is Pfizer’s. Moderna’s “Conditions for Authorization” is identical):
X. All descriptive printed matter, advertising, and promotional material, relating to the use of the Pfizer-BioNTech COVID‐19 Vaccine and Pfizer-BioNTech COVID‐19 Vaccine, Bivalent shall be consistent with the authorized labeling, as well as the terms set forth in this EUA, and meet the requirements set forth in Section 502(a) and (n) of the FD&C Act and FDA implementing regulations.
Y. All descriptive printed matter, advertising, and promotional material relating to the use of the Pfizer-BioNTech COVID‐19 Vaccine or Pfizer-BioNTech COVID‐19 Vaccine, Bivalent clearly and conspicuously shall state, as applicable, that:
The Pfizer-BioNTech COVID‐19 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 (COVID-19) for use in individuals 12 years of age and older, in individuals 5 through 11 years of age, or in individuals 6 months through 4 years of age as appropriate; or
The Pfizer-BioNTech COVID‐19 Vaccine, Bivalent 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 (COVID-19) for use in individuals 12 years of age and older, in individuals 5 through 11 years of age, or in individuals 6 months through 4 years of age as appropriate; and
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
In a letter addressed to Louisiana Secretary of Health, Dr. Courtney Phillips, we point out that the Louisiana Department of Health’s (LDH) descriptive printed matter, advertising, and promotional material for COVID-19 vaccines and bivalents has been in violation of the EUA’s condition for authorization since the drugs have been available. Images like the one below make no reference to the required information as stipulated by the EUA’s conditions of authorization, but remains blatantly false and misleading as we pointed out in an article entitled: It’s Time to Protect Louisiana Children.
Additionally, LDH provides printed material and digital toolkits to parents, partners, healthcare providers, and pharmacies that do not include the language and information specified by the terms of the EUA.
Ironically, one bullet point in the LDH toolkit for partners states:
“Help LDH combat misinformation by sharing the facts about the impact of COVID-19 and how getting vaccinated and boosted can protect individuals from severe COVID-19 outcomes.”
None of the material provided by LDH conforms to the specifications of the EUA.
Further, LDH has intentionally misrepresented the licensing status of the emergency use authorized drugs, which are legally distinct products from fully FDA approved drugs. In March of 2022, when asked about the availability of FDA approved COVID-19 vaccines in Louisiana in a public records request, LDH’s response was:
At this time, Louisiana has not received any shipments of the Pfizer COVID-19 vaccine packaged under its brand name, Comirnaty. We have also not received any shipments of the Moderna COVID-19 vaccine packaged under its new brand name, SpikeVax. CDC has not stated when these two vaccines, packaged to reflect their branded names, will be available to us. In Louisiana, we have the FDA-approved 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). CDC has not given us the timelines on when the newly branded/packaged vaccines will be available for distribution. Both FDA-approved vaccines are available throughout Louisiana. To get a current list of COVID-19 vaccine providers, go online to vaccines.gov.
Not only has the material provided by LDH violated terms specified in the EUA, the citizens of Louisiana have been denied fully informed consent for these drugs. LDH has provided inaccurate information relating to COVID-19 vaccines for more than two years now to parents, healthcare providers, and pharmacists.
Read the letter to Secretary Phillips here.
We have requested that LDH:
Remove all material in violation of the terms of the EUA,
Inform all third-party providers, educational institutions, and facilities that use LDH’s material, and
Announce the error to the public.
By failing to comply with the specifications of the EUA, the Louisiana Department of Health has egregiously violated the bedrock of medical ethics and human rights: informed consent. We intend to seek legal recourse should LDH not comply with our request.
