ICAN vs V-safe Covid Vaccine Data Legal Battle

More COVID vaccine transparency was made to the public after a legal victory on August 22, 2022, requiring the CDC to release its v-safe COVID vaccine data.

This is reminiscent of the legal battle for the release of vaccine data from Pfizer, resulting in a court ordered release of the data.

What is V-safe?

With the COVID vaccine rollout, the FDA and CDC developed a new safety monitoring system called v-safe which is a smart-phone app.  The v-safe smart-phone based app was deployed to allow vaccine recipients to report any adverse effects after receiving the shot.

The CDC advised reporting adverse events from the vaccine could be done through v-safe or VAERS,  (Vaccine Adverse Event Reporting System).  For both reporting systems, events are found to be grossly underreported as both monitoring systems require lengthy and time-consuming data entry.  Data suggests only 1% of serious events are submitted to VAERS.

The goal of the app was to “rapidly characterize the safety profile of COVID-19 vaccines when given outside a clinical trial setting and to detect and evaluate clinically important adverse events and safety issues that might impact policy or regulatory decisions.”

The Legal Case

The plaintiff is a non-profit organization called, Informed Consent Action Network (ICAN), advocating for transparency and informed consent.  ICAN “intends to make all v-safe data immediately available to the public so that independent scientists can immediately analyze that data. It believes that we need all hands-on deck, both inside and outside the government, to address serious and ongoing issues with the vaccine program, including waning immunity, adverse reactions, etc. Locking out independent scientists from addressing these issues is, at best, irresponsible and unethical.”

ICAN sued the CDC twice for v-safe data to be released to the public. These two court filings can be reviewed – the first was filed December 28, 2021, and the second May, 17, 2022.  After months of litigation, the CDC was court ordered to produce the data. The first batch of data, which amounted over 19 months from tens of millions of users, was mandated to be released on September 30, 2022.

V-Safe Users and Reporting

Of all COVID vaccine recipients, there were approximately 10.1 million users who chose to register on the v-safe app, accounting for less than 4% of people who have received the vaccine. Recipients registered via v-safe before vaccination and symptoms. Statistically, this means adverse effects may be at a higher magnitude if all vaccine recipients registered and were followed. This is significant as recorded data is from a small percent of vaccine recipients.

How does reporting in v-safe work?  V-safe users report an adverse event following vaccination through pre-populated check-box fields. For the pre-populated fields, there were a limited number of options to choose from for reporting.  However, a free-text response could also be submitted.  For the first week, v-safe would send you a text message every day to ask how you were feeling, after which v-safe would do occasional health check-ins.  Someone from the CDC could call you for any questions. If a serious adverse event is reported, the CDC would contact the person who was then encouraged to file a VAERS report. Deaths are not able to be recorded via v-safe.

CDC’s Refusal of Freedom of Information Act Requests

Data in v-safe is deidentified and stored on a secure server, meaning it can easily be shared with the public as it contains no personal health information. The CDC was issued three different FOIA (Freedom of Information Act) requests for the release of all de-identified information.

1. The CDC first refused to release the data because “information in the app is not deidentified” although the stored data was already de-identified.
2. In response to the second FOIA request, the CDC produced some documents but no communications.
3. In response to a third FOIA request, the CDC refused to produce the documents and instead closed the request administratively.

The denial and refusal of these FOIA requests led to the CDC being sued twice resulting in months of legal battles and ultimately a victory for the public.

What Did the Data Show?

The first batch of data released from the CDC only included the reports of pre-populated fields in the app and not free text fields, therefore, effects at this point are not the full picture and the free text fields have the potential to reveal more insight.  In the first batch, there were 144 million rows of health entries by v-safe users. ICAN took the raw v-safe data from the CDC and developed a user-friendly interface that can be viewed here.

       V-safe data revealed the following:

Out of 10.1 million users, 35 % or 3.4 million individuals were impacted

Percent of adverse health events by vaccine brand were:

• • Moderna (48.28%), Pfizer (43.08%), J&J (4.72%), 3 other brands (3.87%)
• Women were disproportionately affected than men
• Approximately, 13,000 infants under 3 years old had over 33,069 reported events
• Symptoms:
  • 3 million reported symptoms
  • Symptoms were 61% mild, 33% moderate, 6% severe
• Fatigue: 1 million moderate, 1.1 million severe
• Muscle/body aches: 3.3 million moderate, 7 million severe
• Headache: 4 million moderate,  0.7 million severe
• Pain: 3 million moderate,  0.5 million severe
• Joint pain: 9 million moderate,  0.4 million severe
• Over 7.7% of users had a health event requiring medical attention, emergency room intervention and/or hospitalization
• Over 30% experienced an event requiring them to miss work, school and/or prevented normal daily activities. Of this number,
  • 13% missed work/school
  • 12% were unable to perform normal activities
  • 8% required medical attention

 What Does the Data Mean?

Data released from the initial batch of v-safe data reveals a clear safety signal as 7.7% had a health event requiring medical attention, emergency room intervention and/or hospitalization.

A recent study reviewing Pfizer’s original clinical trials showed a 36% higher risk of serious adverse events after the Pfizer vaccine and a 6% higher risk after the Moderna vaccine.

Data published in a pharmacovigilance report by the World Council for Health revealed the number of adverse events for all influenza vaccines totaled 44,618 over an unknown period of time compared to 1.8 million for the COVID vaccines over 2 years. This is a 190% difference in adverse events comparing influenza vaccines to 2 years of COVID vaccines.   The COVID vaccine is clearly not following the normal magnitude of adverse events compared to the typical flu vaccine.

With over 31,000 reports of COVID vaccine-associated deaths reported on VAERS, the vaccine has not been recalled compared to the recall of the Swine Flu and Polio vaccines after 53 and 10 reported deaths respectively.

More data will be released to the public regarding the safety of the vaccines. It is wise to continue reviewing the data and evidence as it is released, especially when it comes to giving it to children on a regular basis.

While this was another big legal victory for transparency for the American public, one must wonder:

• Why has it taken months of litigation for this information to be made available to the public when informed consent is of critical importance before any intervention?
• Why did Pfizer want their vaccine data hidden for 75 years?
• Why is our nation’s health protection agency, in charge of matters of safety and health of the public, fighting to keep this vaccine data hidden?
• If this is the data for less than 4% of vaccine recipients, what might data look like for all vaccine recipients?

Have an awesome day!  Dr D