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ICAN
achieved another victory in its ongoing campaign to ensure the
government does not spread false information about vaccines. Michigan’s
Department of Health and Human Services posted a graphic and
accompanying message on its public Facebook page. The text falsely
stated that “on the journey to FDA approval, each COVID-19 vaccine had
to pass through the same thresholds of research & testing as every
other vaccine.” It went on to include additional, incorrect
information: “all three of the approved COVID-19 vaccines were proven to
be safe and 100% effective in preventing hospitalization and death in
the clinical trials.” ICAN, through its attorneys, wrote to the
Director and to the Chief Deputy of Health of MDHHS demanding they
remove the false graphics and messaging regarding COVID-19 vaccines.
They quickly complied within 48 hours and removed the relevant false
messaging. Soon
after ICAN successfully challenged the New York State Department of
Health’s false social media messaging regarding COVID-19 vaccines, on
March 8, 2021, ICAN’s attorneys sent a letter
to Michigan Department of Health and Human Services (MDHHS) informing
them that they were violating federal law. MDHHS’ posted the following
graphic and messaging on Facebook: This
social media messaging – intended for the public – made numerous false
claims. First, it claims that the FDA “approved” a COVID-19 vaccine.
This is categorically false. There
is no COVID-19 vaccine that has been “approved” by the FDA. The only
three COVID-19 vaccines currently in use are authorized by the FDA
pursuant to an emergency use authorization (“EUA”). In fact, the FDA authorization letters for both COVID-19 vaccines expressly provide that the vaccines are each “an investigational vaccine not licensed for any indication” and require 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.” In addition, the three COVID-19 vaccines are still
undergoing clinical trials, hence they were also spreading
misinformation when they claimed that these EUA authorized products “had to pass through the same thresholds of research & testing as every other vaccine...” ICAN had to point out to a health agency that the FactSheets for Recipients for each of these vaccines unambiguously state that the vaccines “ha[ve] not undergone the same type of review as an FDA-approved or cleared product.” Further, the Facebook post claimed that all three vaccines’ clinical trials have proven to be “100%
effective in preventing hospitalization and death.” This is also
categorically false. The FDA’s review memorandum on each of the
vaccines lists as one of the “Unknown Benefits/Data Gaps” “effectiveness
against mortality.” The FDA makes clear: “A
larger number of individuals at high risk of COVID-19 and higher attack
rates would be needed to confirm efficacy of the vaccine against
mortality.” Additionally, the FDA’s Review Memorandum
for Moderna’s vaccine states: “There were no deaths due to COVID-19 at
the time of the interim analysis to enable an assessment of vaccine
efficacy against death due to COVID-19.” It is also false to claim that these vaccines have been proven to prevent 100% of hospitalizations. In the Moderna trial,
one participant in the mRNA-1273 group, a participant >65 years of
age who had risk factors for severe COVID-19, was hospitalized due to
oxygen saturation of 88% on room air 2 months after receiving the second
dose of vaccine.” In the Janssen trial,
in a post hoc analysis of all COVID-19 related hospitalizations
starting 14 days after vaccination, including non-centrally confirmed
cases, there were 2 cases in the vaccine group. Likewise, the Pfizer trial
reported two serious cases of suspected but unconfirmed COVID-19, both
in the vaccine group, where both vaccine recipients were hospitalized. Michigan’s
Department of Health needed to be fact checked. We are pleased to tell
you that, after being notified that failure to remove the inaccurate
graphic and its false messaging would result in a lawsuit, MDHHS responded
and removed any reference to “approved” vaccines and to the completely
false claim that the vaccines are 100% effective in reducing
hospitalizations and death.” This is another victory that should serve
to remind MDHHS, and every other public health department, that someone
is watching. And if the FDA and our federal health authorities
will not ensure that the public is receiving true and accurate
information, ICAN will. ICAN’s message should be heard loud and clear: you may not spread “misinformation” about vaccines. To that end, the revised post, while clear of two false assertions, is still misleading: ICAN’s attorneys sent another letter
to MDHHS explaining that it is still not accurate to state that the
COVID-19 vaccines “had to pass the same thresholds of research &
testing as every other vaccine.” Every other vaccine that MDHSS is
referencing has been licensed and approved. In stating that the
COVID-19 vaccines have undergone the same review, MDHHS is not “clearly and conspicuously” stating that this product has not been approved or licensed by the FDA. Quite the opposite is true. Additionally, the post now states that the vaccines were “proven to be safe and effective.” In fact, the FDA has stated
this is not the case: “Based on the safety and effectiveness data, and
review of manufacturing information regarding product quality and
consistency, it is reasonable to believe that Moderna COVID'19 Vaccine may be effective. Additionally, it is reasonable to conclude, based on the totality of the scientific evidence available, that the known and potential benefits of Moderna COVID'19 Vaccine outweigh the known and potential risks
of the vaccine, for the prevention of COVID-19 in individuals 18 years
of age and older.” It is highly misleading for a health agency to
state in unambiguous terms what the FDA has not yet proven or stated
itself. We will keep you apprised of any response to the latest
letter. |
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