Have you seen the promotional materials for the investigational COVID-19 vaccines put out by the State of Michigan, in particular the Michigan Department of Health and Human Services (MDHHS)?
It is misinformation and much of it violates federal law.
Michigan for Vaccine Choice believes that Michigan citizens deserve clear, truthful, transparent, and lawful COVID-19 vaccine information so that each individual can make informed decisions regarding vaccination - so we took action.
The FDA has authorized the use of three investigational COVID-19 vaccines under an emergency use authorization [“EUA”]. Federal law places conditions on the promotion of the investigational COVID-19 vaccines authorized under an EUA as these vaccines are authorized not approved and safety and efficacy studies are currently ongoing. Allison Lucas, an attorney for Michigan for Vaccine Choice who consulted with the FDA on the matter states, "Because these vaccines are unapproved and investigational, federal law provides clear restrictions on how they can be described, advertised, and promoted and also requires disclosure that the vaccines are not approved or licensed by FDA".
Michigan for Vaccine Choice understands the importance of MDHHS and its delegates disseminating information on the investigational COVID-19 vaccines. Unfortunately, the content being used by MDHHS to promote the investigational COVID-19 vaccines to the public is false and misleading and violates federal law because their content:
- lacks the FDA disclosures required of EUA products;
- falsely claims that the investigational COVID-19 vaccines are approved by FDA;
- makes false claims regarding the EUA vaccine safety process;
- falsely claims the investigational COVID-19 vaccines prevent spread of SARS-CoV-2; and
- makes false claims regarding the safety and efficacy of the investigational COVID-19 vaccines.
Michigan For Vaccine Choice issued a Letter, through its attorney, to Michigan officials including MDHHS on March 9, 2021, making them aware of the violations and requesting that the state immediately remove all false and/or misleading COVID-19 vaccine materials and publicly issue corrections within five business days.
What can you do to help?
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