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What the Heck is the Harvard Pilgrim Study and did it really say that about the underreporting of vaccine adverse events?

What the Heck is the Harvard Pilgrim Study and did it really say that about the underreporting of vaccine adverse events?

There has been much social media chatter about some Harvard Pilgrim study and how it found that vaccine adverse events and deaths are underreported by a factor of 100. As a litigator in the vaccine field, this is something I have come across and have used, so I thought it might be helpful to some readers to post the study, and maybe clear-up some misimpressions in circulation.  So, here is the study:  r18hs017045-lazarus-final-report-2011(6)

For those who just want the highlights (and a little more) here is what’s what:

What is a Harvard Pilgrim? It is a health insurance company in Massachusetts that has some research affiliation with Harvard (and as of 2019 it merged with the Tufts Health plan).

What did it study and why?

According to the listed purpose: “This research project was funded to improve the quality of vaccination programs by improving the quality of physician adverse vaccine event detection and reporting to the national Vaccine Adverse Event Reporting System (VAERS) . . ..”

***

“Public and professional confidence in vaccination depends on reliable postmarketing surveillance systems to ensure that rare and unexpected adverse effects are rapidly identified. The goal of this project is to improve the quality of vaccination programs by improving the quality of physician adverse vaccine event detection and reporting to the national Vaccine Adverse Event Reporting System (VAERS).”

Noble goals for sure, though most of you would take issue that AE’s from vaccines are “rare and unexpected.”

What was the universe studied?

This is from the first paragraph of the Results section.

“Preliminary data were collected from June 2006 through October 2009 on 715,000 patients, and 1.4 million doses (of 45 different vaccines) were given to 376,452 individuals. Of these doses, 35,570 possible reactions (2.6 percent of vaccinations) were identified. This is an average of 890 possible events, an average of 1.3 events per clinician, per month. These data were presented at the 2009 AMIA conference.”

So what about this thing about less than 1 percent of vaccine AE’s are reported?

Ok, now we get to the heart of it. Pay very close attention:

“Adverse events from drugs and vaccines are common, but underreported. Although 25% of ambulatory patients experience an adverse drug event, less than 0.3% of all adverse drug events and 1-13% of serious events are reported to the Food and Drug Administration (FDA).

Likewise, fewer than 1% of vaccine adverse events are reported. Low reporting rates preclude or slow the identification of “problem” drugs and vaccines that endanger public health. New surveillance methods for drug and vaccine adverse effects are needed. Barriers to reporting include a lack of clinician awareness, uncertainty about when and what to report, as well as the burdens of reporting: reporting is not part of clinicians’ usual workflow, takes time, and is duplicative. Proactive, spontaneous, automated adverse event reporting imbedded within EHRs and other information systems has the potential to speed the identification of problems with new drugs and more careful quantification of the risks of older drugs.”

That’s a mouthful, and I could spend hours and pages about what this means (and doesn’t), but what I’m not seeing here is a source for the less than 1% underreporting of vaccine AE’s, and I wish there was.

I am also not seeing any mention of deaths. While death associated with a medical intervention is surely the most extreme AE, I don’t think it is reasonable to extrapolate the less than 1% number to deaths, in terms of an extrapolation argument that the 500 (or now 1,200) deaths associated with the COVID vaccine is really 100 times that amount. And with the widespread reporting of individual COVID-associated deaths, I think we would know if there were really 50,000 to 100k deaths from the COVID vaccine in the few months in which the vaccines have been administered.  So to my mind, making the argument that COVID vaccine deaths are underreported by a factor of a hundred based on this study is both unjustified and ridiculous on its face.

Of course, the quoted language from the results about how low reporting rates slow identification of problem drugs which  “endanger[s] public health” is music to the ears of the vaccine concerned. As is the listing of all the reasons practitioners do not report AE’s.

Were there any limitations or impediments to the study?

you betcha!

“Unfortunately, there was never an opportunity to perform system performance assessments because the necessary CDC contacts were no longer available and the CDC consultants responsible for receiving data were no longer responsive to our multiple requests to proceed with testing and evaluation.”

I guess everyone just got too busy or they didn’t think it was important enough to increase the efficacy of the AE reporting system.

So there you have it

While interesting, and certainly confirmatory of what most of you believe, it seems a little thin in general.  But even beyond that, we live in pandemic times with a still (for now at least) very active social media reporting on serious adverse events from the COVID vaccines, which is unparalleled to the vaccine context a dozen or so years ago when this study was performed. Therefore, I question the soundness of the extrapolation that some are making from this study onto the COVID vaccine AE situation, and more so about extrapolating about deaths. I think the latter should stop forthwith because it shows a lack of contact with reality, and thus undercuts credibility.

BUT MORE TO THE POINT,

I think there are much better and direct data points for extrapolation for the possible underreporting of Covid vaccine-related adverse events, and it is sort of obvious, namely, the reported data from the clinical trial itself. A while back, I did a post on the phase 1 clinical trial results for the Moderna vaccine. Here is that post. http://rickjaffeesq.com/2020/07/28/digging-into-the-moderna-vaccine-clinical-trials-protocols-and-results/

The bottom line is that after the second dose, 100% of Phase 1 subjects who received the Moderna vaccine had either a mild or moderate local and a mild or moderate systemic side effect from the vaccine. That’s right, 100%.

Two related caveats: Clinical trial AE reporting involves active follow-up with test subjects, obviously.  The VAER’s system is passive and voluntary. One would certainly expect a passive system not to be nearly as robust as an active reporting system. Relatedly, common sense might tell us that a passive, voluntary reporting system might well significantly underreport localized mild symptoms, i.e., a sore arm from a needle stick.

Those two caveats aside, (and assuming half of the 42 million delivered shots were the Moderna vaccine and half the reported 5k or now 12k VAER total reported side effects were from the Moderna vaccine), how is it that the active surveillance reported AE rate of 100%  goes down to 0.0005 (math might be wrong but it’s surely a couple of zeros after the decimal point.)

Either those Moderna folk made a really big improvement to the vaccine before EUA administration (which of course they couldn’t have legally) or this is pretty good evidence of the very significant underreporting of the passive VAER reporting system for the Moderna vaccine.

And in fairness, the FDA has recently admitted that its AE reporting system for the COVID vaccines is not fully up in place yet. Ya think? And this is all when most of the 42 million vaccinated have only received one of the two doses. But based on the above, don’t expect VAER’s to capture what is really going on, at least compared to what was reported in Moderna’s Phase 1 clinical trial results. I guess my point is that to me, Moderna’s actual reported clinical trial AE data is a much better basis for extrapolation than this Harvard Pilgrim thing.

Rick Jaffe, Esq.