ICAN Request of CDC V-Safe Data Doesn’t Show Causal Evidence

In today’s Medium article, I’ll address the false claim that 7.7% of 10 million people within the V-Safe data pool from ICAN needed medical treatment due to Covid-19 vaccination. So without further a do let’s get into the article.

CDC’s V-Safe Surveillance System

➡️ ICAN Court Request & Data

So ICANN has released an entire table [1] of V-Safe self-reported data from 10 million people, whoever the claims of ICAN and their followers are trying to make the association that Covid-19 related vaccinations have caused 7.7% of the reports. The first red flag is these reports have no causal evidence with a vaccine. Causation means either the production of an effect, or else the relation of cause to effect. Causes produce or occasion an effect [2].

The reports from V-Safe indicate no miscarriages, no deaths, and no severe side effects, in fact, the screenshot below only indicates “severe” pain as a consequence of vaccination:

The next screenshot shows us the other generic “symptoms” that have been reported to the V-Safe system:

None of this proves the vaccines are unsafe or ineffective. Just another attempt by AV advocates to misinterpret data they don’t understand. All they would have to do is look at the CDC’s website for common side effects and all would be there to publicly see.

References: [1] https://www.icandecide.org/v-safe-data/
[2] https://jech.bmj.com/content/55/6/376
[3] https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/after.html
[4] https://www.verywellhealth.com/when-to-expect-covid-19-vaccination-side-effects-5176621

➡️ Proper Interpretation of V-Safe Data & Better Systems

Original preliminary findings from a NEJM study conducted in 2021 did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines, all data was taken from 35,691 v-safe participants 16 to 54 years of age identified as pregnant.

There is a better system around, one that can be referred to as extremely reliable is the Vaccine Safety Datalink [2], which uses electronic health data from nine large healthcare organisations within the USA, including various Kaiser Permanente systems and Harvard Pilgrim Health Care in Massachusetts to name two. Causal evidence can be derived from this system.

A study posted in the JAMA [3] science journal on 3rd September 2021 looked at adverse events surveillance of 11.8million people (more than the reports in V-Safe). One stat from the study for example shows venous thromboembolism of excess cases to be approximately 7.5 per million doses.

The conclusion from the JAMA study: “In this interim analysis of surveillance monitoring of more than 11.8 million doses of 2 mRNA vaccines in a diverse population and weekly analyses from December 14, 2020, to June 26, 2021, no vaccine-outcome association met the prespecified threshold for a signal. Incidence of selected serious outcomes was not significantly higher 1 to 21 days postvaccination compared with 22 to 42 days postvaccination for any of the outcomes. ”

References: [1] https://www.nejm.org/doi/full/10.1056/nejmoa2104983
[2] https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.html
[3] https://jamanetwork.com/journals/jama/fullarticle/2784015

➡️ Problems With Self-reporting Systems like V-Safe & VAERS

V-Safe has been criticised by experts [1] before because the system is passive and relies heavily on people reporting issues that may or may not be vaccine-related. The focus should have been on active surveillance that scans large volumes of electronic health data and compares adverse events in people who receive the vaccine to those who didn’t. As V-Safe is an opt-in system there is no control group for comparison (a bit like an RCT study).

V-Safe alongside other self-reporting systems much like VAERS cannot infer causality [2] with a vaccine, and also cannot find out from VAERS data if a vaccine caused the adverse event same for V-Safe. However, with V-Safe, no deaths or adverse events have been reported so far, adding more proof the vaccines are safe and that’s from over 10 million reports.

It’s also worth noting that VSD looks at data for 3% of the U.S. population [3], or roughly 12 million people — everything from medical and pharmacy claims to vital records. National Geographic [4] has stated that analysis is done every week, so any adverse reaction is noted very quickly. So it’s unlikely that any “long-term effects” will arise after vaccination.

References: [1] https://www.nbcnews.com/health/health-news/covid-vaccine-safety-system-has-gaps-may-miss-unexpected-side-n1265986
[2] https://vaers.hhs.gov/faq.html
[3] https://www.healthpartners.com/plan/blog/expert-answers-to-the-top-three-concerns-about-covid-19-vaccine-safety/
[4] https://www.nationalgeographic.com/science/article/vaccines-are-highly-unlikely-to-cause-side-effects-long-after-getting-the-shot-

➡️ ICAN’s found — the dubious Del Bigtree

Where do we start? So Del produced a film in 2016 that used false evidence from disgraced Andrew Wakefield trying to draw associations between vaccines and autism, the documented Lancet [1] study that features in the film was retracted from Lancet after Wakefield acknowledge he fake some of the data. There’s plenty of data out there to causally state that vaccines cannot cause autism post-vaccination, I’ve even documented a huge amount of evidence on this as well [3].

During the pandemic, Del Bigtree like many anti-vaxxers adopted the most common AV claims from promoting distrust in expertise, misrepresenting research results and encouraging the public to let the disease run its course [3]. He’s even told people to completely refuse vaccination and get naturally infected instead [3], which is a really delusional idea, especially at the start of the pandemic, he’s falsely accused Dr Fauci of “leading a cabal of conspirators of wanting to vaccinate the whole world population under a false pretence.” [3].

After Del Bigtree got banned from many streaming platforms and social media such as YouTube [4], he continued to make money from his exploits of promoting AV propaganda [4].

The above is just the tip of the iceberg of the number of claims this individual has made.

References: [1] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)60175-4/fulltext
[2] https://lawrence-robinson.medium.com/107-studies-shows-no-link-between-vaccines-autism-literature-review-7c2c669bbd58
[3] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7648494/
[4] https://counterhate.com/research/pandemic-profiteers/

➡️ Conclusion
It’s safe to say that ICAN/Del Bigtree get their claims very wrong, V-Safe cannot draw causal evidence to vaccines and cannot be used as conclusive proof that Covid-19 vaccines are unsafe, especially after the JAMA study proves there’s no safety signal post-vaccination that we need to worry about.

💥 Thanks for reading, Lawrence. Please consider a small contribution, in the form of a beer as all articles are created in my small amount of spare time: https://www.buymeacoffee.com/LawrenceRob



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Lawrence Robinson

Passionate about evidence-based scientific information and tackling falsehoods that thrive on social media.