NEW YORK AND MICHIGAN’S DEPARTMENTS OF HEALTH COMPLY WITH ICAN’S LEGAL DEMANDS AND REMOVE “MISINFORMATION” REGARDING THE COVID-19 VACCINES FROM THEIR PUBLIC MARKETING MATERIAL

Starting with New York, ICAN achieved another victory in its ongoing campaign to ensure the government does not spread false information about vaccines.  New York State’s Department of Health prepared a social media campaign pushing the COVID-19 vaccines.  One of the ads falsely stated that the vaccines “went through the same rigorous approval process that all vaccines go through” and that “the vaccine is safe and effective. It was approved by the FDA, the CDC, and by NY’s independent vaccine panel.”  ICAN, through its attorneys, wrote to Dr. Howard Zucker, Commissioner of New York State’s Department of Health, and to Governor Andrew Cuomo, demanding they remove the false graphics and messaging regarding COVID-19 vaccines.  They quickly complied and removed the relevant false messaging.

On January 26, 2021, ICAN’s attorneys sent a letter to NYS DOH and Governor Cuomo informing them that they were violating federal law.  As part of Governor Cuomo’s #VaccinateNY campaign, NYS’s COVID-19 website provides materials to encourage and “educate” people about the COVID-19 vaccines. The social media materials are meant to be shared by New Yorkers to help spread the word and included the following poster:

Above this social media graphic, Cuomo and the NYS DOH provide the following “Sample Message” for individuals to use on social media: “The vaccine is safe and effective.  It was approved by the FDA, the CDC, and NY’s independent vaccine panel. Let’s #VaccinateNY!”

This social media messaging – intended to be shared and spread widely – made the false claim 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 the 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.”

Moreover, one would imagine that the Commissioner of the NYS DOH and the Governor would know that the CDC does not “approve” vaccines and that it would be false for them to claim that the CDC approved any COVID-19 vaccine.  Even worse, the three COVID-19 vaccines are still undergoing clinical trials, hence they were also spreading misinformation when they claimed that these EUA authorized products “went through the same rigorous approval process that all vaccines go through.”

Amazingly, just a few weeks later, on February 19, 2021, ICAN’s attorneys had to send anther letter to the NYS Health Commissioner and Governor Cuomo informing them that the following Facebook page now also contained false information regarding the COVID-19 vaccine and demanded that it be removed:

The post stated that “no serious side effects related to the vaccines have been reported,” however this information is plainly false.  In the vaccines’ clinical trials, there were serious adverse events that the trial investigators found were not only be “linked” to the vaccines, but in fact related to the COVID-19 vaccines. For Pfizer’s vaccine, these include shoulder injury, ventricular arrhythmia, and lymphadenopathy.  For Moderna’s vaccine, these include intractable nausea and vomiting, facial swelling, rheumatoid arthritis, Dyspnea with exertion, peripheral edema, Autonomic dysfunction, and B-cell lymphocytic lymphoma.

Further, post-authorization, there have been numerous serious adverse reactions related to the COVID-19 vaccines. The CDC, for example, has acknowledged that serious vaccine side effects related to the COVID-19 vaccines have been reported, including “[a]naphylaxis, an acute and potentially life-threatening allergic reaction.” Additionally, in the approximately two months since these vaccines have been in use, the CDC’s Vaccine Adverse Events Reporting System (“VAERS”) has received just under 16,000 reports of adverse events following COVID-19 vaccination and over 3,000 reports of serious adverse events related to a COVID-19 vaccination through February 12, 2021.

The NYS Health Commissioner and the Governor should be aware of the above information safety information.   They nonetheless made the false claim that there are no serious side effects related to the COVID-19 vaccines when the data clearly shows otherwise.  Even worse, the three COVID-19 vaccines are still undergoing clinical trials, so the data on serious adverse events is still being collected.

New York State and Governor Cuomo 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, New York State took it down.  This is another victory that should serve to remind New York State, Governor Cuomo, and others that someone is watching.  ICAN’s message should be heard loud and clear: you may not spread “misinformation” about vaccines.

As for Michigan, ICAN achieved a similar victory.  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 Fact Sheets 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.

Again, in less than 48 hours, MDHHS’s post was again revised to remove the claim about the vaccines passing the same thresholds or research and testing as other vaccines, and currently reads as follows:

ICAN’s attorneys contacted MDHHS once more to explain that vaccines have not proven to be effective against death.  Importantly, ICAN also notified MDHHS that it had written to the CDC about its claim that the vaccines are “safe and effective” and demanding that the CDC refrain from making this statement at least until the FDA itself actually makes this claim.

When granting EUAs for the vaccines, the FDA concluded that:

Based on the safety and effectiveness data … it is reasonable to believe that [] 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 [] COVID-19 Vaccine outweigh the known and potential risks of the vaccine… (emphasis added).

Contrary to the CDC’s statements that “COVID-19 vaccines are safe and effective,” the FDA has not found nor stated that the vaccines are “safe and effective.”  Rather, since it has not yet been proven that they are safe and effective, a standard required for licensure, the FDA has never made this statement and would not make this statement until licensed.  Instead, as quoted above, the FDA has only concluded thus far that “it is reasonable to believe” they “may be effective” and that with regard to safety, only that at present it appears “the known and potential benefits … outweigh the known and potential risks.”

ICAN will continue to do the FDA’s job for it and ensure that the public is only receiving accurate and proven data about vaccines.