Regular readers are no doubt familiar with the Informed Consent Action Network (ICAN), the legal and propaganda arm of Del Bigtree‘s antivaccine empire. It just so turns out that I’m on ICAN’s email list, because I’m on a lot of quack and antivaccine email lists, the better to monitor what the disinformation peddlers are doing every day in their relentless effort to degrade public health, resulting in unnecessary suffering and death, particularly now, during the COVID-19 pandemic. ICAN has one basic schtick, and almost everything it does is a variation of that schtick. Basically, ICAN exists to sue government entities or send legal threats based on dubious legal reasoning or highly legalistic parsing of language used by government agencies regarding vaccination. For instance, a couple of months ago, ICAN was bragging over a great “victory” it thought it had achieved over the Centers for Disease Control and Prevention (CDC) in getting it (supposedly) to remove from its website statements that vaccines do not cause autism. Amusingly (to me and other vaccine advocates), this “victory,” when critically examined, turned out nothing of the sort, and even then it was short-lived. In another example of this technique, pre-pandemic this time, ICAN used abusive Freedom of Information Act (FOIA) requests to obtain government documents that Bigtree distorted and cherrypicked to “question” the clinical trials that led to the approval of the MMR vaccine decades ago. Basically, the ICAN repertoire consists mainly of abusive FOIA requests that it uses to cherry pick and misrepresent the science used by the government to evaluate vaccines, lawsuits over the content of government websites and publications, and legal threats based on legalistic parsing of language. When these techniques work, ICAN loudly declares “victory” and claims that the government is lying about vaccine safety, after which it uses the “victory” to raise funds. Rinse. Lather. Repeat.
This brings us to a recent ICAN email about the Michigan Department of Health and Human Services (MDHSS). Given that Michigan is my home state and I’ve lived and worked here for 13 years after a couple of decades away, I could not let this pass. Basically, no one, not even ICAN or Del Bigtree, promotes antivaccine propaganda and disinformation in my state without getting a taste of some Insolence, be it Respectful or not-so-Respectful (and, given that this is Del Bigtree, I’m opting for not-so-Respectful). I’ll start by quoting from ICAN’s email:
CAN 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.
The text of the letter sent by ICAN to MDHSS is…something else. Yes, it is a letter, and it does contain text, but otherwise…wow. Unfortunately, it does take advantage of what I like to refer to as an “unforced error” on the part of MDHSS and other health departments that they really, really should know about and not do any more:
A. Michigan’s Social Media Posts Falsely Claim COVID-19 Vaccine Approved
The Michigan Department of Health and Human Services’ Facebook page includes the following graphic and messaging:
This graphic is accompanied by the language: “On the journey to FDA approval, each COVID-19 vaccine had to pass through the same thresholds of research & testing as every other vaccine. And it’s important to know that 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. Discover all the facts at Michigan.gov/COVIDvaccine.” https://www.facebook.com/michiganhhs/posts/10157742846626746 (emphasis added).
B. Michigan’s Department of Health Social Media Posts Violate Federal Law
This Facebook message violates federal law by falsely claiming that the FDA has approved each of the COVID-19 vaccines. 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”). The EUAs for these products expressly provide that they are not approved and that it is a violation of federal law to represent that they are approved.
The federal statute that authorizes the FDA to grant an emergency use authorization, Section 564 of the Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. 360bbb-3, states that “[t]he Secretary may establish conditions on advertisements and other promotional descriptive The Secretary, through the FDA’s authorizations for each of the three COVID-19 vaccines currently in use pursuant to the EUAs 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.” See https://www.fda.gov/media/144636/download (“All descriptive printed matter, advertising, and promotional material relating to the use of the Moderna COVID-19 Vaccine clearly and conspicuously shall state that: This product has not been approved or licensed by FDA”) (emphasis added).1
And it is true. The three vaccines currently in use in the US, the vaccines by Moderna, Pfizer/BioNTech, and Johnson & Johnson, have not as yet received full FDA approval. They are being distributed under what is referred to as an “emergency use authorization,” which allows the FDA to approve the use of a medication or intervention on an emergency basis, as described on the FDA website:
An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to FDA.
Of course, ICAN, being ICAN, and thus as antivaccine as it gets given that the organization was founded and is run by Del Bigtree, the producer of the antivaccine propaganda movie VAXXED, this is a highly slanted description of the situation. All three vaccines clearly met the threshold for an EUA. An objective look at the data used to support the EUAs for the vaccines clearly suggests that these vaccines will all eventually win full FDA approval. On the other hand, it was clearly an unforced error on the part of the MDHHSS to use the word “approved” to describe these vaccines. An EUA is not the same thing as FDA approval. State departments of health really, really need to be more careful with their pro-vaccine messaging. MDHHS could just as easily said that the vaccines were authorized by the FDA or had been authorized by the FDA for use under an EUA without being any less positive in its messaging about the COVID-19 vaccines. Imprecise and overenthusiastic language on government websites is catnip to ICAN, which exists primarily to exploit legalistic language in order to spread fear and uncertainty about vaccines.
But what about this next bit of ICAN’s letter:
This is not the only false or inaccurate statement in the messaging. Contrary to your post, the three COVID-19 Vaccines are still undergoing clinical trials, which are expected to continue for more than a year more, before they are ready for approval and licensure by the FDA. As such, it is incorrect to claim that these EUA authorized products “had to pass through the same thresholds of research & testing as every other vaccine.” To be clear, 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.” See https://www.fda.gov/media/146305/download; https://www.fda.gov/media/144414/download; and https://www.fda.gov/media/144638/download.
These FDA documents, each of which is specific to one of the vaccines issued an EUA, contains a passage like this:
FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, and available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product. All of these criteria must be met to allow for the product to be used during the COVID-19 pandemic.
ICAN is clearly trying to imply that vaccines like this issued an EUA during a pandemic are not safe. Basically, was MDHHS a bit too enthusiastic when it said that EUA authorized products “had to pass through the same thresholds of research & testing as every other vaccine”? Yes. Was it wrong? Not exactly. All three of these vaccines actually did undergo the full range of pre-approval testing normally required by the FDA for full licensure and approval, up to and including phase 3 randomized clinical trials with tens of thousands of participants. It’s just that the post-trial monitoring normally required was not required for the EUA because of the gravity of the pandemic and the likelihood that delaying the distribution of the vaccines for a year could have resulted in hundreds of thousands of unnecessary deaths. Similarly, considering these vaccines to be still “experimental” is a legal, not a scientific description. Scientifically and medically, after a successful phase 3 clinical trial, these vaccines are no longer “experimental” (particularly in light of having been given to many tens of millions of people now with an excellent safety record), but legally they are, simply because that’s how federal law defines “experimental” with respect to treatments and preventatives not yet fully approved by the FDA. ICAN, being ICAN, is simply deceptively (and disingenuously) taking advantage of that distinction in order to fulfill its mission: Spreading fear, uncertainty, and doubt about vaccines, in this case the COVID-19 vaccines, which have been far more effective and safe than I had expected that they would be.
Further, to claim that all three vaccines’ clinical trials have proven to be “100% effective in preventing hospitalization and death” is 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.” See https://www.fda.gov/media/144673/download; https://www.fda.gov/media/146338/download; and https://www.fda.gov/media/144416/download. 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.” https://www.fda.gov/media/144673/download. 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.” See https://www.fda.gov/media/144673/download. 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. See https://www.fda.gov/media/146338/download (emphasis added). 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. See https://www.fda.gov/media/144416/download.
Again, this is an unforced error on the part of the MDHHS. All it had to do was to say, in essence, what, ironically, ICAN says in its letter, by adding to its statement that the vaccines were 100% effective in preventing death from COVID-19 a qualifier that says something like, “at the time of the interim analysis used to apply for the EUAs.” Alternatively, MDHHS could have simply said that clinical trials had demonstrated that the vaccines were “highly effective in preventing hospitalizations and deaths from COVID-19,” a statement that is unequivocally true from a scientific standpoint to the point that even ICAN would have had a hard time contesting it using even its most tortured legalistic parsing of the language.
So MDHHS had little choice but to alter its messaging:
Predictably, ICAN was still not satisfied and issued a second letter. Unsurprisingly, ICAN didn’t like that MDHHS left the part about the COVID-19 vaccines having to meet the same threshold as any other vaccine, a statement that is true scientifically but probably overstating the legal situation, but it also didn’t like this:
Additionally, the post 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.” https://www.fda.gov/media/144636/download.2 It is highly misleading for a health agency to state in unambiguous terms what the FDA has not yet proven or stated itself.
Again, this is legalese. Based on the massive phase 3 clinical trials used to justify the EUAs for the three COVID-19 vaccines, plus the experience of over 100 million doses of the Moderna and Pfizer/BioNTech vaccines, from a scientific standpoint, it is unequivocally true that the vaccines have been demonstrated to be safe and effective. However, from a legal standpoint, you can’t say that the vaccines have been “proven safe and effective” if the vaccines have not been fully approved by the FDA. Again, ICAN is doing what it’s best at, using legal definitions instead of scientific definitions in order to imply that the MDHHS has been either lying or promoting incorrect information. ICAN’s purpose in this is clearly to undermine faith in government agencies charged with combatting the COVID-19 pandemic.
Unsurprisingly, another email from ICAN showed that it’s doing the same thing with other states, in this case New York. The letter ICAN is touting first mentions that ICAN had pulled the same schtick with New York, “thanking” the state for “removing prior ads which, inter alia, claimed that the COVID-19 vaccines were approved by the FDA.” Then there’s this:
A. NYSDOH’s Social Media Posts Falsely Claim No Serious Side Effects Have Been Reported
The New York State Department of Health’s Facebook page includes the following graphic:
B. NYS’s Social Media Post Is False and Misleading
This graphic and its accompanying message falsely claim that “no serious vaccine side effects have been reported.” This is plainly false. In the vaccines’ clinical trials, there were serious adverse events documented following vaccination found by the trial investigators to not only be “linked” to the vaccines, but in fact related to the vaccines. For Pfizer’s vaccine, these include shoulder injury, ventricular arrhythmia, and lymphadenopathy. See https://www.fda.gov/media/144245/download at 41. 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. See https://www.fda.gov/media/144434/downloadat 43-44.
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.” See https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html; see also https://www.nbcnews.com/health/health-news/more-allergic-reactions-covid-vaccine-reported-overall-remain-rare-n1253007 (“Since the report was finalized Dec. 23, eight more cases of vaccine-related anaphylaxis were confirmed, the CDC said, bringing the total number so far to 29.”).
In fact, in the approximately two months since the EUAs were issued, 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. See attached. Based on the Code of Federal Regulations, a serious adverse event is defined as occurring if one of the following is reported: death, life-threatening illness, hospitalization or prolongation of hospitalization, permanent disability, congenital anomaly, or birth defect. See https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr. Notably, it is established that this passive system collects a drastically low percentage of actual adverse events that occur, with one study finding that only 1% of vaccine adverse events are reported to VAERS. See https://digital.ahrq.gov/sites/default/files/docs/publication/r18hs017045-lazarus-final-report-2011.pdf.
It was sloppy of the NYSDOH to say that “no” serious adverse events have been reported after COVID-19 vaccination. Of course, there have been. Vaccine advocates have been warning for months, since before any vaccine was approved, that antivaxxers would weaponize any and all adverse event reports and reports of death after the vaccines, whether coincidental or not. I’ve been writing repeatedly about how antivaxxers have been using reports to the VAERS database to falsely imply that the adverse events reported had been caused by the vaccines, all while pointing out that the actual rate of adverse events reported have been below the expected baseline rate, given the massive numbers of vaccines being administered. Of course, antivaxxers’ response to that observation is to cite the claim that because it is a passive reporting system “only 1%” of adverse events are ever reported to VAERS, a false claim that also ignores all the active reporting systems monitoring vaccine safety and the unprecedented attention by governments to the safety of COVID-19 vaccines.
Unsurprisingly, ICAN also neglects to note that the frequency of the serious adverse events reported in the clinical trials were either not statistically different between the control and experimental groups or were clearly not due to the vaccine. Certainly the vaccines could cause mild to moderate adverse events, such as shoulder swelling, fever, etc., but these were not considered serious. More recently, a meeting of the Advisory Committee for Immunization Practices (ACIP) at the CDC found no concerning safety signals from the Moderna and Pfizer/BioNTech vaccines.
State departments of health really do need to be aware that there is an antivaccine organization like ICAN, sitting there like a vulture, waiting to swoop in on any imprecision or excess (or even not so excess) exuberance in language promoting COVID-19 vaccination with legal threats, no matter how legalistic the interpretation of the language used has to be to justify the threat. It’s the M.O. of ICAN. State health departments thus need to be especially careful with all their publications and social media posts about COVID-19 vaccines, lest they slip up and leave an opening for Del Bigtree and his fellow antivaccine activists to pounce, as Michigan and New York did.
I will conclude by noting another prominent part of the M.O. of ICAN by posting an image of what appears at the end of after every self-congratulatory email sent by the organization:
That’s because, for ICAN and other antivaccine groups, it’s not just about spreading fear, uncertainty, and doubt about vaccines. It’s also about the grift. Always. Threatening to sue state departments of health is good for fundraising.