And, without public comment.
America’s Frontline Doctors (AFLD) filed suit on 21 July in U.S. District Court in Northern Alabama, seeking injunctive relief from the court that the FDA be enjoined (prevented) “from continuing to authorize the emergency use of the so-called “Pfizer-BioNTech COVID-19 Vaccine,”1 “Moderna COVID-19 Vaccine”2 and the “Johnson & Johnson (Janssen) COVID-19 Vaccine”3 (collectively, the “Vaccines”)4 pursuant to their respective EUAs, and from granting full Food and Drug Administration (“FDA”) approval of the Vaccines.”
That lawsuit, which makes a number of claims calls into question a great deal of data that has been pushed to the public since the beginning of the Covid “pandemic” in March of 2020. Specifically, however, one section of the lawsuit calls into question why the FDA is ignoring the huge numbers of deaths, injuries and hospitalizations that are reportedly tied to the Covid shots. The government’s own database – VAERS – shows a huge increase in reported vaccine deaths since the rollout the Covid shots.
The government operated VAERS database is intended to function as an “early warning” system for potential health risks posed by vaccines. It is broadcasting a red alert. Of the 262,000 total accumulated reports on 1772 are not related to Covid-19. The database indicates that the total reported vaccine deaths in the first quarter of 2021 represents a 12,000% to 25,000% increase in vaccine deaths, year-on-year.”
In addition to the VAERS database information – which critics say is suspect because it relies on self-reporting, generally by health practitioners – a whistleblower with access to Centers for Medicare and Medicaid Services (CMS) databases has stated in an affidavit that the actual number of Covid shot deaths, based on those government databases, is more like 45,000 as of early July 2021. In part of her declaration, the whistleblower notes that her number is based on querying the CMS data for deaths that occurred within 3 days of injection. In other words, the numbers she calculated do not capture deaths that could be related to the Covid shots that occurred after that three day window.
Plaintiffs’ expert Jane Doe45 is a computer programmer with subject matter expertise in the healthcare data analytics field, and access to Medicare and Medicaid data maintained by the Centers for Medicare and Medicaid Services (CMS) (see Declaration of Jane Doe at Exhibit D). Over the last 20 years, she has developed over 100 distinct healthcare fraud detection algorithms for use in the public and private sectors. In her expert opinion, VAERS under-reports deaths caused by the Vaccines by a conservative factor of at least 5. As of July 9, 2021, VAERS reported 9,048 deaths associated with the Vaccines. Jane Doe queried data from CMS medical claims, and has determined that the number of deaths occurring with 3 days of injection with the Vaccines exceeds those reported by VAERS by a factor of at least 5, indicating that the true number of deaths caused by the Vaccines is at least 45,000.
In additional to the AFLD lawsuit, Senator Ron Johnson weighed in with a number of federal agencies, including the FDA, on Sunday asking them not to move towards approval of the vaccine without at least conducting the public comment hearing. Here’s an excerpt from his letter:
As you are well aware, I first raised the issue of vaccine safety signals coming from FDAand Centers for Disease Control and Prevention’s (CDC) Vaccine Adverse Event Reporting System (VAERS) in a meeting with National Institutes of Health Director Collins on April 27,2021. Since then, I have written four oversight letters on the subject of vaccine safety, effectiveness, and adverse events. To date, I have received little to no substantive response. This lack of transparency is unacceptable.
As of August 20, 2021, VAERS is reporting 12,791 worldwide deaths associated with the three Covid-19 vaccines available under an FDA Emergency Use Authorization (EUA). Of those deaths, 4,632 occurred on Day 0, 1, or 2 following vaccination. As the CDC and the FDA are quick to point out, VAERS reports do not prove causation. But this number of deaths, particularly with 36.2% occurring within 2 days of vaccination, should raise serious concerns.
It should also be noted that the 12,791 deaths related to Covid-19 vaccines reported on VAERS over the period of 8 months, compares to 8,966 deaths related to all other vaccines reported on VAERS since the inception of VAERS – a period of 31 years. And this does not raise alarm bells within your agencies, or cause you to reconsider assembling an independent safety panel of outside experts?
In addition to deaths, VAERS is also reporting 16,044 permanent disabilities, 51,242 hospitalizations, and 571,831 total adverse events related to the Covid-19 vaccines. I am receiving a growing number of letters from doctors and nurses detailing the vaccine injuries they are witnessing and treating, together with the suppression and censoring of this information they are experiencing.
[emphasis ours]