ICAN misuses v-safe data to mislead about COVID-19 vaccines


This article, about how ICAN misuses v-safe data, was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about vaccination’s social and legal policies. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

The Informed Consent Action Network (ICAN), an anti-vaccine organization, has claimed that V-Safe data that it obtained access to shows COVID-19 vaccines are unsafe. ICAN misrepresented CDC’s obligations about v-safe data and its treatment of it and is making claims that, at best, overstate what v-safe shows – while ignoring the extensive evidence from all around the world on COVID-19 vaccines.

This post may come across as a bit cranky, and it likely is. This is Yom Kippur, I am fasting, and this is not how I wanted to spend my fast evening. But countering anti-vaccine misinformation that can harm and kill people is important, I already did the groundwork – I was thinking of writing about the earlier press release from ICAN – so here goes.

What is v-safe?

COVID-19 is subject to the usual multiple monitoring systems applied to vaccines in the United States, the Vaccine Adverse Event Reporting System that anti-vaccine activists like to misuse, the Vaccine Safety Datalink, and CISA. There are several others, and the vaccines are monitored in other countries as well, and we have abundant data about them. 

But the CDC wanted to go beyond previous efforts to monitor COVID-19-19 vaccine safety, so it created v-safe. v-safe, which I used for myself and my family, is a phone-based health check where you have to register, and in increasing intervals, after the vaccines, you get a quick message with a link to a very short survey: first daily, then weekly, then in longer intervals. 

If there is a reported issue, CDC staff were to follow up and help the person also file a report to VAERS, connecting the two systems. 

ICAN legal proceedings and v-safe

ICAN filed not one, but two lawsuits to demand the data from v-safe. I am not quite sure why they filed the second one, because their first lawsuit was still pending and it seems they could have just tried to get the remedy through that one. But it filed a FOIA request twice for the data from v-safe, and then filed two lawsuits, one in December 2021 and one in May 2022. ICAN acknowledged in its second complaint that CDC “never objected” to giving it the data, but it, apparently, did not want to wait on CDC’s time, or just wanted to show its followers that it is acting. Whatever their reasons, they sued twice.

In the complaint, ICAN also seemed to me to have misrepresented CDC’s position on V-Safe data. ICAN said in its December 2021 complaint that “[t]he CDC’s v-safe Protocol stresses the importance of this data and that it “is anticipated that v-safe data will be shared with the scientific community and with the public through manuscripts and public reports.” Despite these claims, deidentified v-safe data is not yet available to the public.”

And again in its May 2022 complaint that “[t]he CDC’s v-safe Protocol stresses the importance of this data and that it “is anticipated that v-safe data will be shared with the scientific community and with the public through manuscripts and public reports.” Despite these claims, v-safe data is not yet available to the public.”

The CDC v-safe protocol document does have that language, but that language does not say the raw data would be made public. It says the data will be shared through manuscripts and public reports – and as I will demonstrate below, that was done. When ICAN implied that the protocol says raw data will be shared, ICAN is misrepresenting the protocol.

On September 15, ICAN published an article titled “Breaking News: ICAN Obtains Court Order Requiring CDC to Release V-Safe Data that Includes Over 137 Million Health Entries Made After COVID-19 Vaccines.” 

Here, too, ICAN is misrepresenting what happened. The order linked to is a scheduling order, and ICAN itself in its complaint acknowledged that CDC did not object to giving the data – it just took time, possibly because it’s a large amount of data and the CDC has other priorities. In the scheduling order, the parties agreed on the schedule for giving them the data and the judge signed onto the schedule, making the agreed schedule an order. 

To reiterate — the judge did not order CDC to give the data. CDC agreed to do it, and the order just set the schedule.

CDC did not do it as fast as ICAN wanted it to – hence, probably, two requests and two different lawsuits – but presenting this as a legal win is a bit weird. I suspect that in part the CDC was concerned and wanted to make sure that ICAN did not accidentally get private information, since although Oracle – who is hosting the site – gets the data without personal identifying information, CDC gets it with (p. 9), and that could take time. I realize ICAN does not value people’s privacy in this, but I am glad CDC does. 

Out of curiosity, I went and checked Pacer on the first lawsuit – and that too has a scheduling order with dates somewhat later. It just doesn’t look like a second lawsuit was needed. 

ICAN’s latest article and claims about v-safe

On October 3, 2022, ICAN published a second article about v-safe titled “Breaking News: ICAN Obtains V-Safe Data.” In that article ICAN stated that it “deployed its legal team, headed by Aaron Siri, to obtain the v-safe data.” It said that “After suing the CDC twice and following months of legal wrangling, the CDC finally capitulated, resulting in a court order that required it to produce this data. 

The first batch of data, containing 144 million rows of health entries by v-safe users, has now been obtained by ICAN and you can search it using a user-friendly interface that ICAN worked around the clock to create.” (links removed, except to the interface; note that ICAN wants your email to access the interface). It claimed that the data “reveals shocking information that should have caused the CDC to immediately shut down its Covid-19 vaccine program.” 

What is this shocking information? 

“…over 7.7% of v-safe users, had a health event requiring medical attention, emergency room intervention, and/or hospitalization.  Over 25% had an event that required them to miss school or work and/or prevented normal activities.”

“There were also 71 million reports of symptoms in the pre-populated fields from the approximately 10 million users.  This is an average of over 7 symptoms reported per v-safe registrant.  Reported symptoms include, for example, over 4 million reports of joint pain, a very concerning immune reaction. While around 2 million of these joint pain reports were mild, over 1.8 million of the reports were for moderate joint pain and over 400,000 were for severe joint pain.  Since v-safe only included less than 4 percent of people that received a Covid-19 vaccine, tens of millions of Americans likely had an immune reaction to the Covid-19 vaccine in their joints that resulted in debilitating pain and potential long-term harm.

There were also approximately 13,000 infants under 2 years of age who were registered for v-safe.  For these 13,000 children, there were over 33,000 symptoms experienced that were significant enough to report, with the most common symptoms being irritability, sleeplessness, pain, and loss of appetite.  These are very concerning since babies cannot speak and hence these symptoms are how they often communicate that something is wrong.”

Why ICAN’s claims are misleading

  1. Much of the “shocking” information is not new. The number of those seeking medical care is higher than in previous sources, but in this article published in the Lancet Infectious Diseases in March 2022, v-safe data had reports of (transient, mostly mild) side effects in high percentages of participants, and over 30% of people unable to work. Note that ICAN does not tell you how long people were unable to work — a day or two of unpleasant symptoms is a known result of mRNA vaccines and not a serious medical problem. Note that the Lancet article includes joint pain. CDC reported similar or higher rates of these same events to the Advisory Committee on Immunization Practice (ACIP) on January 27, 2021, March 1, 2021, and so on. It reported on booster doses from v-safe (with fewer side effects) on November 19, 2021, and on children 5-11, for example, on May 19, 2022. It reported on younger children’s v-safe data on September 1, 2022.   In other words, v-safe data was not hidden; it was reported on and published multiple times since the vaccines were rolled out. And it consistently showed high rates of the same side effects. 

Why was that not a matter of concern? Because most of these side effects are short, transient, and passing, even if we assume they are vaccine-related. Even infants can deal with a day or so of fussiness after the vaccine. Infants may not be able to speak, but if their issues continue, the symptoms usually are going to, too, and the symptoms described by ICAN do not, in this description, show an issue. By presenting the numbers as they did, ICAN tried to present the data as – 1) previously hidden. 2) showing a problem. Both parts are false. 

  1. The question about medical care is whether a person received medical care – went to a doctor. ICAN did not break out which population the 7.7% covers; but some populations are more likely to see a doctor even for mild symptoms (I am thinking about people who are medically vulnerable or parents of infants, who are more likely – rightly – to seek medical care even for less severe issues). The people who missed work are within the range of, at least, the Lancet Infectious Diseases article
  2. Note that these comments assume that ICAN’s numbers are right. I did not check them, and previous experience – and some of ICAN’s claims here, as described above – suggest that ICAN is not a particularly reliable source.
  3. v-safe consists of people asked to report symptoms that come up after vaccines. In other words, “significant enough to report” is meaningless: people are expressly asked if they had any of those symptoms. 

Conclusion

v-safe was added to the United States’ already impressive apparatus of vaccine safety monitoring by the CDC because they take safety seriously. v-safe data has not been hidden but has been presented by CDC personnel repeatedly since the creation of the system, has been consistently monitored by an independent expert committee – and was the basis for publications, reflecting the CDC’s commitment to transparency about vaccine safety.

Neither raised concerns because the data shows exactly what the other many sources of vaccine oversight showed – high levels of transient, if unpleasant, side effects like temporary pain, fever, and fatigue that may interfere with daily activities for a day or two, but are rarely long-term. The rare more long-term issues appeared to have been primarily discovered through the other monitoring systems – though the separation should not be overstated, since issues reported to v-safe could have been followed by a report to VAERS, with the help of a CDC person. 

ICAN did not win more than rushing along the provision of information CDC already did not object to giving them – if that. There’s no way to know if their efforts changed the timeline. They did not get a court order telling CDC to release the data; CDC agreed to do that, and ICAN’s second complaint suggests the CDC never refused. 

ICAN has a history of misrepresenting FOIA lawsuits and their results, and it’s hard not to see this as another example of this, and at least an attempt to sensationalize already known facts to create fear, uncertainty, and doubt about vaccines. 

Dorit Rubinstein Reiss
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