James Lyons-Weiler – 1/12/2021
SECOND UPDATE: 1/15/2021 – As a result of a groundswell of people hammering AFP “Fact Check”, the non-peer-reviewed web site has now updated the title to their article. The article now reads “Researcher’s speech used to mislead about COVID-19 vaccine safety”.
The text of the AFP article is also now updated – the quote from the cited XXX professor stating that he did not know where the 21% was coming from has also been deleted. (I have deleted that professor’s name and affiliation as a professional courtesy).
The lesson here, of course is that fact checking is unscientific. It is not based on peer reivew, and people establish websites and proclaim themselves keepers of the truth often do not have sufficient checks and balances built into their determination of “facts”. When that happens, they confuse their opinion with facts.
My original article, below, is now updated to exclude the name of the XXX (affiliation blocked as a professional courtesy) professor who no longer does not know where the 21% was coming from.
UPDATE – 1/13/2021 – As a result of a colleague sending this article to AFP.com, they have updated their article to include information on the results I cited in October. AFP.com has not otherwise edited their article, including their title (US researcher exaggerated adverse reactions to Moderna Covid-19 vaccine). This is now a gross misrepresentation of fact and the article should be taken down. Please email Factcheck@afp.com and demand they remove the misinformation present in their article.
I stand by the alarm I sounded in October. FDA, AFP.com, and XXX need to up their game in translational research science and start thinking about the consequences of their recklessness on public health. AFP.com should retract their so-called “Fact Check” article immediately. Also: FDA Missed Serious Problems with Moderna and Pfizer Animal Disease Enhancement Trials
I am stunned.
In a so-called “Fact Check” article, AFP.com has revealed that XXXXXX XXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX, told them in an email, “This is false. I do not know where the 21 percent number for serious adverse events come from.” See: US researcher exaggerated adverse reactions to Moderna Covid-19 vaccine | Fact Check (afp.com) (original title, this notation added 1/15/2021)
This stunning admission of ignorance comes at a time when the US and World turns, on a regular basis, to XXX for information on rates of infection and deaths associated with COVID19.
The “21 percent number” that XXXX is referring to, and which I was referencing, came from Moderna’s safety report – published in the New England Journal of Medicine.
This finding had been mentioned also by Politifact in their attempt to “Fact Check” my mention during my speech at that PA State Capitol.
“We did find reference to 21% in a preliminary safety assessment of the Moderna vaccine in November that included a higher dose (250 micrograms) than is used today (100 micrograms). Only 14 people received two doses at the higher level, and three of them — 21% — had a systemic reaction that was judged to be serious. ”
That preliminary safety assessment was a New England Journal of Medicine report by Jackson et al., published in November. (https://www.nejm.org/doi/full/10.1056/nejmoa2022483).
The fact is that AFP.Com utterly failed in their attempt to “Fact-Check” my reference to the safety study and should have determined where the 21% came from. They could have contacted me.
Evidently, social media companies that rely on so-called “Fact-Checkers” must now hire fact checker-checkers.
Why 21% Still Matters
In their blog article (which is not peer-reviewed), AFP.com boldly claimed: “A speech by a biomedical researcher claiming that 21 percent of patients from the Moderna vaccine trial have experienced severe adverse events has been shared thousands of times on social media since December 11. This claim is false…”
Clearly, it matters that AFP.com and XXX were not aware of the 21% rate of serious adverse events that I cited.
In his statement to AFP, XXX claimed that Prior to authorization, Moderna submitted a document to the FDA, the federal agency responsible for approving vaccines, showing that only 82 people, or 0.5 percent of trial patients out of 15,184, experienced adverse effects, with only five, or less than 0.1 percent, linked to the vaccine (see the “Safety” section starting page 31 of the document). That much is also true – looking only at the numbers. However, looking at the process, those numbers are patently unreliable. We should all wonder, as I wondered in October and November, and I still wonder now – why the safety signal of 21% did not trip a flag of caution from the US FDA, which, in spite of the 21% number, allowed the combined Phase 2/3 trials to continue.
What FDA Should Have Done in October/November 2020
The fact that FDA did split the Phase 2/3 trial into two separate trials based on the 21% serious adverse events now has us looking at data – cited by XXX and AFP – in which serious adverse events occurred in the single 2/3 trial that were determined – somehow, without replication – to not be caused by the Moderna vaccine.
What SHOULD have happened is that FDA should have split the combined Phase 2/3 into Phase 2 and Phase 3 so the list of solicited adverse events from the vaccine in Phase 3 could include those that emerged in a larger study – so causality assessments leading to those numbers in the more recent report could have been assessed by objective Science, not by subjective opinion.
It is widely know that the assessment of causality and non-causality in Science requires more than a single study and more than Moderna-paid medical expert opinions. It often requires dozens of studies, systematic reviews and meta-analyses. Not a single Phase 2/3 study. It is impossible to assess causality from a single study. The Moderna and Pfizer translational research trajectory have been made seriously problematic by a lack of adequate regulatory oversight on process.
So, I stand by my sounding the alarm in October. FDA, AFP.com, and XXX need to up their game in translational research science and start thinking about the consequences of their recklessness on public health. AFP should retract their so-called “Fact Check” article immediately.
FDA Missed Serious Problems with Moderna and Pfizer Animal Disease Enhancement Trials
The fact is we do not know the actual rate of serious adverse events from the 2/3 Phase trial because Phase 2 and Phase 3 were combined. This type of lack of adequate regulatory oversight by FDA can lead to serious risks to public health. Ignoring the initial safety signal of 21% serious adverse events was one error that allowed the combined Phase 2/3 trial to occur, preventing the discovery of which events are real.
Other errors include not requiring early animal trials designed to detected disease enhancement due to pathogenic priming from vaccination.
In the studies that were conducted, using non-human primates, concerns exist from both Modern and Pfizer studies:
For example, Moderna did not find renewed antibody production on viral challenge. They did not examine organ sites other than lung – such as liver, spleen, kidney, brain – for immunopathology. Surprisingly, while Moderna provided data on other interleukins, they did not report on IL-5 – a key marker indicative of disease enhancement – in the virus-challenged animals. Past studies of coronavirus pathogenic priming leading to disease enhancement found IL-5 to be a key player.
In the Pfizer study, not peer-reviewed while FDA examined their data, the control animals that did not receive the vaccine cleared the virus just as well as the vaccinated animals (see their oropharyngeal swab result Fig 4c). Pfizer also did not examine other organ sites such as liver for immunopathology, and did not report on IL-5 in the challenge animals. Further, on p30 of Pfizer’s study, they removed an “outlier” measurement. That’s a no-no.
I said what I said in October at the press conference because I knew FDA had ignored the important safety signal. Now, I’m reporting that FDA also missed serious problems with the animal studies that are supposed to inform us on vaccine-caused disease enhancement.
Now, it’s an open question on whether people who receive the second dose of these vaccines will experience more severe COVID19 and immunopathologies – and we have to rely on post-market surveillance studies on humans to find out.
It’s important that fact-checkers be held to some standard of reporting. When they get it wrong, the masses can be mislead by partial and potentially dangerous information that could lead others to bodily harm.
FDA needs to issue a caution on the Moderna and Pfizer vaccines and tell people to report their serious adverse events to them, to the vaccine manufacturer, and to the Vaccine Adverse Events System (VAERS) – link: https://vaers.hhs.gov/ The public should be made aware that reporting their adverse events or their loved one’s death to ALL three places – Moderna/Pfizer, the FDA, and to VAERS – is the only way Science will be able to detect #pathogenicpriming and prevent bodily harm from vaccines – and from partial/incomplete/missing or false information.
We now have to share this article across social media sites to counter the misinformation perpetuated by AFP.com.
Before you go, please look around jameslyonsweiler.com for more articles.
Contact AFP.com to complain: Contact | Fact Check (afp.com)