Although many, many of my posts lately have been about the vaccine issue, I view myself as a health care attorney who focuses on novel and unconventional treatments and technologies. The legal contexts may be different, i.e., medical board work, civil litigation, or federal criminal cases (FDA and health care insurance issues) but the overarching commonality is constant, unconventional health care and ensuring the broadest possible access to it.

In my FDA-related work, that basically pits me against the government and I advocate and litigate for greater access to unapproved treatments. (And that puts me at odds with many in vaccine concerned community on an issue like access to EUA vaccines, which I support one hundred percent, so long as it is not compulsory.) I think people should be allowed to get any treatment or medical intervention they can get their hands on regardless of the status, as long as there is proper informed consent (which raises issues as well, but I’ll leave that for another time).

One of the areas I work in is the stem cell field. I am following a bench trial on the FDA’s attempt to obtain an injunction against a clinic’s use of autologous (the person’s own) stem cells. I am listening to it on my iPad kind of like background music, and as I was writing this post on VAER’s I heard in the distance an FDA MD regulator being cross-examined on the fact that there were very few reported side effects from stem cell treatments.

Guess what the FDA regulator said in response? She said that everyone knows side effects of drugs are vastly underreported and thus side effects rates can’t be relied upon. It caused a momentary confusion in me and I thought I was having an auditory hallucination since I had spent so much time thinking about the underreporting of vaccine side effects. It reminded me of a cross-over episode in TV world (where the characters in one show appear in character in another show). Nothing more than life’s little strange ironies.

But on to the main topic. There is a great deal of media and social media attention about VAERS (Vaccine Adverse Event Reporting System), and my prior post on the Harvard Pilgrim study has engendered some interesting comments. I think it might be helpful to actually relate the basics about VAERS which might help avoid some confusion, for those who have not actually looked at the issue directly.

VAERS has its own website and it contains more than just the numbers of deaths and injuries from the COVID vaccines. It explains what it is and does, and at least by implication, what it does not do.

You can look it over yourself. Here is the link. https://vaers.hhs.gov/about.html

VAERS was created in 1990 to monitor adverse events from vaccines. (I am pretty sure as part of the vaccine compensation act).

You all know that it created a reporting system for vaccine adverse events/effects

So what’s an adverse event?

Here is as good a definition as any (not taken from the VAERS web site).

“Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment.” [International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.]

As everyone knows, (but few acknowledge when discussing the dangers of vaccines) an adverse event report filed with VAERS is a just report of an adverse event occurring after a vaccine injection. No single or group of VAERS report about a vaccine establishes a causal connection. It is not the purpose of VAERS to make, investigate or establish the scientific connection/causation or lack thereof between the administration of the vaccine and an adverse event. The VAERS database is just the database of all adverse events which meet the VAERS criteria, where each filing was by some person or entity, presumably with knowledge about something bad that happened to a person within some specified time period after receiving a vaccine.

More specific on the purpose of VAERS (from the website):

“(VAERS) is a national early warning system to detect possible safety problems in U.S.-licensed vaccines. VAERS is co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination. Anyone can report an adverse event to VAERS. Healthcare professionals are required to report certain adverse events and vaccine manufacturers are required to report all adverse events that come to their attention.

VAERS is a passive reporting system, meaning it relies on individuals to send in reports of their experiences to CDC and FDA. VAERS is not designed to determine if a vaccine caused a health problem, but is especially useful for detecting unusual or unexpected patterns of adverse event reporting that might indicate a possible safety problem with a vaccine. This way, VAERS can provide CDC and FDA with valuable information that additional work and evaluation is necessary to further assess a possible safety concern.”

What are the objectives of VAERS?

Here they are from the website:

“The primary objectives of VAERS are to:

Detect new, unusual, or rare vaccine adverse events;
Monitor increases in known adverse events;
Identify potential patient risk factors for particular types of adverse events;
Assess the safety of newly licensed vaccines;
Determine and address possible reporting clusters (e.g., suspected localized [temporally or geographically] or product-/batch-/lot-specific adverse event reporting);
Recognize persistent safe-use problems and administration errors;
Provide a national safety monitoring system that extends to the entire general population for response to public health emergencies, such as a large-scale pandemic influenza vaccination program.”

And of course, it is a self-reporting and uncurated system, meaning anyone can report an AE temporally associated with the vaccine, but presumably, only people with direct knowledge of the untoward event should do the reporting (unless it is the person’s job to make that report, I presume).

So what is considered the temporal relationship and what kind of things can be reported?

Well, that’s easy, the website has a downloadable pdf of the reportable events and how long after the vaccine shot, an AE should be reported (i.e. the maximum time limit after the shot and the time limit is shorter than you would think).
Here is the PDF: VAERS_Table_of_Reportable_Events_Following_Vaccination(2)

As you can see, the event has to have occurred anywhere between 7 and 42 days after the shot, depending on the vaccine and the event. e.g., 7 days max for the DTaP and others, up to 42 days after the shot for arthritis associated with the rubella shot.
In reviewing the chart, it seems to me that the only localized event reportable is shoulder injury from the shots.

For grins, I looked over the screen for reporting an AE because I wanted to see if anyone could file an AE about anyone. I wanted to see if I could file one for say Hank Aaron. FYI: here is the screen. https://vaers.hhs.gov/esub/index.jsp. I suppose you could, but you’d have to make up a lot of his information. And at the bottom, there is a notice that providing false information is a crime.
But basically, you have to give the date and type of vaccine and when the event started and other such information, and presumably, there is some kind of internal edit that wouldn’t process an entry if it is outside of the temporal association limits.

So the bottom line is that a VAERS report is just a description of some bad thing (including death) that happened to a person after receiving a vaccine within a certain period of time after receiving the shot, and that time or window depends on which shot and the kind of every, but the outside window or temporal connection is anywhere between 7 and 42 days.

That much you can glean from the VAERS website. What happens with the information once it gets posted?

And there we have the limits of my knowledge and investigations. Presumably, the CDC and perhaps the FDA look at all these reports. There were only six reported blood clotting problems with the J&J vaccine but that was enough for the FDA to put the vaccine on clinical hold for a week or so. Some criticized the action as being unnecessarily cautious. I assume they quickly picked up on the blood clot issue because of a similar issue with the Asta Zenaca vaccine in Europe and the common ingredient/method used both.

Are the several thousand reported deaths reported to VAERS being investigated? I don’t know, but I hope so.

Another Key Term: Background rate

Another important term in all this is background rate, meaning the rate that a percentage of the population will experience that particular event, say a blood clotting problem. There is a known number for that, and from what I read, the authorities determined that the 6 cases were within the background rate. A background rate above the reported adverse event rate doesn’t necessarily disprove that the AE was caused by the vaccine, but I think it is fair to say that public health authorities are looking for AE’s significantly greater than the background rate, in part because resources are limited. It seems to me that death in terms of the background rate is particularly tricky, obviously because it is an event that everyone eventually experiences and you would expect the background rate of death to have a straight relationship to age.

That brings up another point; early on, a disproportionate number of older people were dying of COVID than younger people. There was a lot of speculation as to why, and many in the vaccine community rejected these statistics basically claiming that the old were dying of co-morbidities (or had co-morbidities) so they don’t count as COVID deaths. (I think that is an erroneous argument). In terms of background rate, I guess the argument is that old people die a lot more than younger people; ie the background rate is higher because of age and more of them have co-morbidities. But I also hear that the old are dying at a much lower rate now, and the big difference is that the older got the vaccine first, and the purpose of the vaccine/the only benefit found/ was to stop people from dying of COVID, (and not necessarily prevent infection or transmission). I guess my saying that again puts me at odds with most of the vaccine concerned.

Now some hard truths and maybe a practical strategic suggestion that could help

The core mantra of the public health establishment is that vaccines are safe and effective and side effects are rare and of course, this is being repeated in the COVID vaccination world. But it is now a lot harder to sell that message during a pandemic where the world’s attention is on the disease and the focus has shifted to vaccines. AE’s and deaths are being reported in social media which is impacting decision-making both in individuals and in the public health policy context. The hard truth is that even if all or a significant percentage of the 3-5k VAERS reported deaths were caused by the vaccines, that would be one hundred times less than the reported number of deaths and orders of magnitude less than the death rate from the disease. I know that many of you don’t accept the COVID death numbers or the death rate, but that really doesn’t matter because those are the numbers upon which public health decisions will be made, and specifically, the decision about full approval/biological licensure of the COVID vaccine.

All medical interventions have risk, and some have a risk of death (I recall when bone marrow and stem cell transplants were done for advanced cancer, it carried something like a 2-4 percent fatality rate from the procedure). The COVID vaccines are going to be approved/biologically licensed despite the relatively small percentage of serious adverse events and even deaths, and I have no problem with that, given my background and many many years of fighting for access to treatment and allowing people to make up their own minds about their health care options. Of course, that makes the key issue mandates upon full biological licensure. And as you all know or fear, mandates are coming. Institutions have already told you all that. And of course, there will be many challenges to these mandates, but odds are they will fail under the expected process. The solution may be to change the expected process.

While drugs and vaccines are approved even if there is a measurable risk of mortality, the FDA has special conditions and warnings, the most severe of which is a black box warning on the labeling. If a very small but measurable adverse event is the possibility of death, that might warrant a black box or other lesser warning. I would propose as a strategic goal a nationwide effort to raise the issue of a black box warning on all COVID vaccines, after a public and thorough review of the VAERS report of deaths.

In order to convince the public of the safety of vaccines, each step of this process would have to be transparent and subject to public comment. You know what they say about light being the best disinfectant, and let the chips fall where they may.

This is something that many groups could adopt. It could become a national thing. It is likely to be something that could enlarge the base. It involves tactics that are relatively known and simple, i.e., contacting your federal legislators and maybe some direct campaigning of the FDA. If you think this has any merit, share this post or at least this last part, and let’s see if it gets any traction.

Having a black box or another type of labeled warning of death from the COVID vaccines could do all kinds of interesting things to the COVID mandatory vaccine debate, and even the public discussion of this technical regulatory issue would be enlightening and worthwhile (and hint, that would be an understatement).

#covidvaccineblackboxwarning

Rick Jaffe, Esq.