Are vaccine makers violating federal law when they point out there are duplicate reports, mistaken claims of causality and other flaws in the federal government's Vaccine Adverse Events Reporting System (VAERS)? No, that's not true: The law cited by the person making the claim includes no such penalty provision. VAERS, set up by Congress to help improve vaccine safety by serving as an early warning device, accepts reports from anyone with an internet connection, which is why it contains errors, falsehoods and duplicates. It is not designed to precisely quantify vaccine side effects.
The claim appears in a January 6, 2022, American Buddhist Net video (archived here) under the title "Do your best. Speak the truth." It was captioned:
By saying there are errors in the VAERS system they are violating the 1986 Act
Here is how the post appeared at the time of writing:
(Source: americanbuddhist.net screenshot taken Sat Jan 8 at 00:57:41 2022 UTC)
In the video, a guest on a streaming video compares purported injuries by COVID-19 vaccines to faulty gas tanks on AMC Gremlins (which stopped production of the car) and to pre-COVID vaccines that had to be discontinued due to serious side effects.
The video guest's claims recycle previously debunked declarations by those who misunderstand or misuse VAERS data. Declarations that VAERS "proves" thousands of deaths and injuries caused by COVID vaccines ignore the multiple disclaimers on the VAERS website.
VAERS' operators point out it's designed only to be an early warning system, not a database from which users can derive proven numbers of vaccine injuries. Anyone can file a report, not just vaccine makers, who do not run VAERS. It is wide open because designers of the system wanted a low-friction way for patients, family, medical staff and others to quickly report any medical event post-vaccination. That way, if clusters of similar reactions pop up in the mass of data, public health officials can investigate: tossing duplicates and verifying facts of each case to determine if there is an unexpected side effect that needs to be addressed or just coincidence among millions of vaccine patients.
The Food and Drug Administration and Centers for Disease Control and Prevention, which do control and operate the VAERS system, make clear on their website the system's purpose and limitations:
When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established. Reports of all possible associations between vaccines and adverse events (possible side effects) are filed in VAERS. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine ... VAERS reports can be submitted voluntarily by anyone, including healthcare providers, patients, or family members. Reports vary in quality and completeness. They often lack details and sometimes can have information that contains errors.
But Martin (who holds a Ph.D. in exercise physiology and claimed in a January 10, 2022, email to Lead Stories that he is currently an active expert briefer of U.S. intelligence officials on these matters) has both mis-stated the meaning of VAERS data and who controls it.
Martin says vaccine manufacturers are breaking the law when they pointing out that the VAERS system includes errors (such as duplicates and false correlations) when responding to claims it shows widespread injuries caused by COVID vaccines. Martin declares, in the video, that they are violating the National Childhood Vaccine Injury Act of 1986, which aimed to encourage research by protecting vaccine developers from some lawsuits while establishing a fund to compensate those injured.
At the 27-second mark of the video, Martin says:
The fact is that as much as the CDC and the FDA try to hide behind what they reportedly say is the error in the VAERS database ... what they don't seem to realize is that by saying that there are errors, they are violating the 1986 Act.
There is no specific section of the Act that supports Martin's statement about VAERS.
Martin goes on to say:
... If you go back and read that, what you find is that the manufacturers of vaccines are required to keep VAERS accurate. That's actually a statutory requirement. So if they're telling you that it's not accurate, they're admitting to violating the law ... Read the law. You cannot on the one hand say you're going to get the indemnity shield and on the other hand, say VAERS can't be trusted ... the immunity is pierced because it's the manufacturers' legal responsibility to make sure VAERS is accurate.
The only penalty listed in the act to which Martin refers is in the portion that requires vaccine makers to keep manufacturing and testing records as follows:
(b) SANCTION.--Any vaccine manufacturer who intentionally destroys, alters, falsifies, or conceals any record or report required under paragraph (1) or (2) of subsection (a) shall--
(1) be subject to a civil penalty of up to $100,000 per occurrence, or
(2) be fined $50,000 or imprisoned for not more than 1 year, or both.
Such penalty shall apply to the person who intentionally destroyed, altered, falsified, or concealed such record or report, to the person who directed that such record or report be destroyed, altered, falsified, or concealed, and to the vaccine manufacturer for which such person is an agent, employee, or representative. Each act of destruction, alteration, falsification, or concealment shall be treated as a separate occurrence.
The act clearly, in the introductory paragraph, directs the Secretary of Health and Human Services to set up a system of collecting adverse reaction reports. Nowhere in the act are vaccine makers declared responsible for VAERS' contents.
Lead Stories on January 10, 2022, contacted the CDC, VAERS and pharmaceutical makers Pfizer and Moderna for comment on Martin's claims. Only Pfizer responded, referring all questions about Martin's declarations to VAERS.
Lead Stories will update this article when the others reply.
