Tennessee Lawmakers Pass Bill Targeting mRNA Vaccines In Food
Following concerns over research to embed vaccines in produce, the Tennessee Senate has passed a bill which would require any food containing vaccines or vaccine materials to be labeled as pharmaceutical drugs.
Lettuce grows under artificial lights on an automated growing rack at a farm in Nottingham, Maryland, on April 14, 2023.
The bill, HB 1894, was passed by the Senate in a 23-6 vote on March 28 after the state House passed it 73-22 on March 4. It awaits the governor’s signature.
The bill comes in response to a University of California-Riverside research project looking into whether mRNA which targets pathogens could be implanted into edible plants, which would then be consumed. The research was funded by a $500,000 grant from the National Science Foundation.
“You would have to get a prescription for that to make sure that we know how much of the lettuce you have to eat based off of your body type so we don’t under-vaccinate you, which leads to the possibility of the efficacy of the drug being compromised, or we overdose you based off how much lettuce is [eaten],” said Republican state Rep. Scott Cepicky during a House committee meeting in February, WKRN-TV reports.
Cepicky said that the bill, which local media described as a move targeting “vaccine lettuce,” would classify foods modified to act as vaccines, as pharmaceuticals.
“So if you want to consume them you would go to your doctor and get a prescription,” he said.
In a 2021 press release, UC Riverside associate professor of Botany and Plant Sciences, Juan Pablo, said “We are testing this approach with spinach and lettuce and have long-term goals of people growing it in their own gardens,” adding “Farmers could also eventually grow entire fields of it.”
According to Pablo, “Ideally, a single plant would produce enough mRNA to vaccinate a single person.”
Another researcher, Nicole Steinmetz, said in the same release that they planned to use nanoparticles or “plant viruses, for gene delivery to plants.”
When asked by WKRN-TV about the status of the research, a UC Riverside spokesperson said that the project is not yet complete.
“Research into the process of having plant chloroplasts express vaccine chemistry is ongoing. There are no definitive results to report,” said Jules Berinstein after the Tennessee bill was passed.
Democrat Senators oppose
During the debate on the Tennessee Senate Floor, some lawmakers questioned the need for the bill.
“Does the sponsor know of any instances of there being food offered in the state of Tennessee that contains vaccines in some kind of a retail or public forum?” asked state Sen. Heidi Campbell.
Rep. Cepicky hit back, highlighting in February that a Kentucky company has already been “infecting growing tobacco plants with a genetically modified coronavirus” to see if it can produce antibodies for a potential vaccine, adding that the company “can already do this right now.”
Massie sounds the alarm
In 2023, US Rep. Thomas Massie (R-KY) raised concerns over the use of federal money to create “transgenic edible vaccines,” which would transform edible plants such as spinach and lettuce into mRNA vaccine delivery vehicles.
In September 2023 during a debate over an appropriations bill, Massie highlighted an incident in which an edible vaccine was introduced into a corn crop used to feed pigs in order to mitigate diarrhea. The corn crop, however, became commingled with a soybean crop – contaminating 500,000 bushels that had to be recalled.
“Do we want humans eating vaccines that were grown in corn meant to stop pigs from getting diarrhea? I don’t think we want that to happen. Yet that almost happened, and it could happen,” said Massie. “There is another case where the pollen cross-contaminated another crop of corn, and 155 acres of corn had to be burned. What are the cases where we’re not discovering this? I think it’s dangerous to play God with our food.”
The Department of Health and Human Services (HHS) was paying OB-GYN doctors millions of dollars to lie to mothers that COVID mRNA injections are safe. Naomi Wolf said that if the doctors tell the truth about the dangers of COVID injections, they will have to repay the money that they received. She said that they are criminals. She said that Pfizer is aware that babies died after their mothers received COVID jabs. She asserted that babies and unborn babies have been murdered.
Naomi Wolf, a researcher and the CEO of Daily Clout, said that the Department of Health and Human Services (HHS) was paying OB-GYN doctors millions of dollars to ‘stick to the script’ and to lie to mothers that COVID mRNA injections are safe. She said that if the doctors tell the truth about the dangers of COVID injections, they will have to repay the money that they received. Wolf called these doctors criminals.
She said that the American College of Obstetrics and Gynecology, a large lobbying group, had a portal where OB-GYN doctors could register to receive money directly fro HHS in 2020 if they attested that their patients had COVID as a primary diagnosis, or, if they were pregnant, COVID could be used as a secondary diagnosis. OB-GYN doctors were incentivized in 2020 to inflate COVID diagnosis numbers.
Wolf reported that maternal deaths are up 40% after COVID injections. She said that a doctor and midwives have told her that babies are being born prematurely, they are being born with fetal malformations, chromosomal malformations and breathing problems.
She said that babies and unborn have been murdered.
Wolf said that Pfizer documents reveal that they knew that two babies died in-utero and the vaccine manufacturer stated that the deaths were due to “trans-placental exposure” to the vaccine and then they sent that report to the CDC in April 10, 2021. Three days later, CDC head Rochelle Walensky gave a press conference from the White House stating that pregnant women should take the mRNA vaccines and that it was safe and effective at any time, before, during, or after pregnancy. Wolf said that Walensky knew that two babies had died from trans-placental exposure and another baby died from poisoned breast milk when she advised the women to take the COVID shots.
A new bill has been introduced in Idaho that would make the administration of experimental mRNA COVID-19 vaccines illegal.
Representative Judy Boyle (R-Midvale) and Senator Tammy Nichols (R-Middleton) sponsored House Bill 154.
Sen. Nichols introduced the new bill on the 15th of February before the House Health and Welfare Committee, according to KTVB.
According to the bill text, “A person may not provide or administer a vaccine developed using messenger ribonucleic acid technology for use in an individual or any other mammal in this state.”
Nichols said during her presentation to the committee, “We have issues this was fast tracked.”
Nichols said there is no liability, informed consent or data on mRNA vaccines. She later clarified she was referring to the two COVID-19 vaccines, Pfizer and Moderna.
“I think there is a lot of information that comes out with concerns to blood clots and heart issues,” Nichols said.
Rep. Ilana Rubel, D-Boise, questioned Nichols’ statement that the vaccines were fast-tracked. She said her understanding was that the vaccines were approved and survived the testing, later approved by the FDA.
Nichols said she is finding it “may not have been done like we thought it should’ve been done.”
“There are other shots we could utilize that don’t have mRNA in it,” Nichols said.
More and more medical experts, scientists, and right group advocates all over the world are now demanding that the government should stop its COVID-19 vaccination campaign due to its devastating side effects among patients.
And yet governments still turn a blind eye to one of the most atrocious crimes against humanity.
CDC’s VAERS safety signal analysis based on reports from Dec. 14, 2020 – July 29, 2022 for mRNA COVID-19 vaccines shows clear safety signals for death and a range of highly concerning thrombo-embolic, cardiac, neurological, hemorrhagic, hematological, immune-system and menstrual adverse events (AEs) among U.S. adults.
There were 770 different types of adverse events that showed safety signals in ages 18+, of which over 500 (or 2/3) had a larger safety signal than myocarditis/pericarditis.
The CDC analysis shows that the number of serious adverse events reported in less than two years for mRNA COVID-19 vaccines is 5.5 times larger than all serious reports for vaccines given to adults in the US since 2009 (~73,000 vs. ~13,000).
Twice as many mRNA COVID-19 vaccine reports were classified as serious compared to all other vaccines given to adults (11% vs. 5.5%). This meets the CDC definition of a safety signal.
There are 96 safety signals for 12-17 year-olds, which include: myocarditis, pericarditis, Bell’s Palsy, genital ulcerations, high blood pressure and heartrate, menstrual irregularities, cardiac valve incompetencies, pulmonary embolism, cardiac arrhythmias, thromboses, pericardial and pleural effusion, appendicitis and perforated appendix, immune thrombocytopenia, chest pain, increased troponin levels, being in intensive care, and having anticoagulant therapy.
There are 66 safety signals for 5-11 year-olds, which include: myocarditis, pericarditis, ventricular dysfunction and cardiac valve incompetencies, pericardial and pleural effusion, chest pain, appendicitis & appendectomies, Kawasaki’s disease, menstrual irregularities, vitiligo, and vaccine breakthrough infection.
The safety signals cannot be dismissed as due to “stimulated,” exaggerated, fraudulent or otherwise artificially inflated reporting, nor can they be dismissed due to the huge number of COVID vaccines administered. There are several reasons why, but the simplest one is this: the safety signal analysis does not depend on the number of reports, but whether or not some AEs are reported at a higher rate for these vaccines than for other non-COVID vaccines. Other reasons are discussed in the full post below.
In August, 2022, the CDC told the Epoch Times that the results of their safety signal analysis “were generally consistent with EB [Empirical Bayesian] data mining [conducted by the FDA], revealing no additional unexpected safety signals.” So either the FDA’s data mining was consistent with the CDC’s method—meaning they “generally” found the same large number of highly alarming safety signals—or the signals they did find were expected. Or they were lying. We may never know because the FDA has refused to release their data mining results.
INTRODUCTION
Finally! Zachary Stieber at the Epoch Times managed to get the CDC to release the results of its VAERS safety signal monitoring for COVID-19 vaccines, and they paint a very alarming picture (see his reporting and the data files here, or if that is behind a paywall then here). The analyses cover VAERS reports for mRNA COVID vaccines from the period from the vaccine rollout on December 14, 2020 through to the end of July, 2022. The CDC admitted to only having started its safety signal analysis on March 25, 2022 (coincidentally 3 days after a lawyer at Children’s Health Defense wrote to them reminding them about our FOIA request for it).
[UPDATE: T Coddington left a link in comments to a website where he made the data in the Excel files more accessible.]
Like me, you might be wondering why the CDC waited over 15 months before doing its first safety signal analysis of VAERS, despite having said in a document posted to its website that it would begin in early 2021—especially since VAERS is touted as our early warning vaccine safety system. You might also wonder how they could insist all the while that the COVID-19 vaccines are being subjected to the most rigorous safety monitoring the world has ever known. I’ll come back to that later. First I’m going to give a little background information on the analysis they did (which you can skip if you’re up to speed) and then describe what they found.
BACKGROUND ON SAFETY SIGNAL ANALYSIS
Back in June 2022, the CDC replied to a Freedom of Information Act (FOIA) request for the safety signal monitoring of the Vaccine Adverse Events Reporting System (VAERS)—the one it had said it was going to do weekly beginning in early 2021. Their response was: we never did it. Then a little later they said they had been doing it from early on. But by August, 2022, they had finally gotten their story straight, saying that they actually did do it, but only from March 25, 2022 through end of July. You can get up to speed on that here.
The analysis they were supposed to do uses what’s called proportional reporting ratios (PRRs). This is a type of disproportionality analysis commonly used in pharmacovigilance (meaning the monitoring of adverse events after drugs/vaccines go to market). The basic idea of disproportionality analysis is to take a new drug and compare it to one or more existing drugs generally considered safe. We look for disproportionality in the number of adverse events (AEs) reported for a specific AE out of the total number of AEs reported (since we generally don’t know how many people take a given drug). We then compare to existing drugs considered safe to see if there is a higher proportion of particular adverse events reported for the new drug compared to existing ones. (In this case they are looking at vaccines, but they still use PRR even though they generally have a much better sense of how many vaccines were administered.)
There are many ways to do disproportionality analysis. The PRR is one of the oldest. Empirical Bayesian data mining, which was supposed to be done on VAERS by the FDA, is another. The PRR is calculated by taking the number of reports for a given adverse event divided by the total number of events reported for the new vaccine or the total number of reports. It then divides that by the same ratio for one or more existing drugs/vaccines considered safe. Here is a simple formula:
So for example, if half of all adverse events reported for COVID-19 vaccines and the comparator vaccine(s) are for myocarditis, then the PRR is 0.5/0.5 = 1. If one quarter of all AEs for the comparator vaccine are for myocarditis, then the PRR is 0.5/0.25 = 2.
Traditionally, for a PRR to count as a safety signal, the PRR has to be 2 or greater, have a Chi-square value of 4 or greater (meaning it is statistically significant) and there has to be at least 3 events reported for a given AE. (This also means that if there are tons of different AEs reported for COVID vaccines that have never been reported for any other vaccine, it will not count as a safety signal. I found over 6,000 of those in my safety signal analysis from 2021.
Ah yes, shared with the public — after first refusing to share the results and months of foot-dragging following repeated FOIA requests! We will see that the CDC has not done a more focused study on almost any of adverse events with “new patterns” (AKA safety signals).
SO WHAT DID THE CDC ACTUALLY DO?
The Epoch Times obtained 3 weeks of safety signal analyses from the CDC for VAERS data updated on July 15, 22 and 29, 2022. Here I will focus on the last one, since there is very little difference between them and it is more complete. The safety signal analysis compares adverse events1 reported to VAERS for mRNA COVID-19 vaccines from Dec. 14, 2020 through July 29, 2022 to reports for all non-COVID vaccines from Jan 1, 2009 through July 29, 2022.
PRRs are calculated separately for 5-11 year-olds, 12-15 year-olds and 18+ separately. For each age group, there are separate tables for AEs from all reports, AEs from reports marked serious and AEs from reports not marked as serious.2 Recall that a serious report is one that involves death, a life-threatening event, new or prolonged hospitalization, disability or permanent damage, or a congenital anomaly. I will focus on the reports for all AE’s.
They also have a table that calculates PRRs by comparing reports for the Pfizer COVID-19 vaccine to reports for the Moderna vaccine and vice versa, again for all reports, serious reports only and non-serious reports. There were no remarkable findings in those tables, so I will not discuss them. [Edit: I forgot what Norman Fenton noted in his analysis: the overall proportion of reports with serious adverse events is 9.6% for Modern compared to 12.6% for Pfizer.] This isn’t that surprising since both vaccines are very similar and so should present relatively similar adverse events when compared to each other, and any differences are likely not large enough to be picked up by a PRR analysis. [Though the difference in the overall rate of serious adverse events, which are not specific to a particular type of event only how serious it is, was significant.]
The CDC seems to have calculated PRRs for every different type of adverse event reported for all the COVID vaccines examined – though it’s possible they only analyzed a subset. What seems clear is that, among the AEs they examined, the only ones included in the tables satisfy at least one of two conditions: a PRR value of at least 2 and a Chi-square value of at least 4 (Chi is the Greek letter χ and is pronounced like ‘kai’). When both conditions were met, they highlighted the adverse event in yellow, which appears to indicate a safety signal. There were no COVID vaccine AEs listed with fewer than 3 reported events, though for non-COVID vaccines there were many AEs listed that had only 1 or 2 reported since 2009. The CDC tables still include these and highlight them in yellow when the PRR is greater than 2 and the Chi-square value is great than 4, indicating these events are counted as safety signals.
WHAT SAFETY SIGNALS DID THE CDC FIND?
I’m going to divide this up by age groups and the Pfizer v. Moderna comparison. Let’s start with the 18+ group.
There are 772 AEs that appear on the list. Of these, 770 are marked in yellow and have PRR and Chi-square values that qualify them as safety signals. Some of these are new COVID-19 related codes, and we would expect those to trigger a signal since they didn’t exist in prior years to be reported by other vaccines. So if we take those off, we are left with 758 different types of non-COVID adverse events that showed safety signals.
I grouped these 758 safety signals into different categories. The figure below shows the total number of AEs reported for each of the major categories of safety signals:
Let’s dig into some of these categories to look at what types of AEs generated the most number of reports:3
Let’s dig into some of these categories to look at what types of AEs generated the most number of reports:3
You can peruse the adverse events using the Excel tables provided by the CDC, which were posted by The Epoch Times and Children’s Health Defense at the links at the top of this post.
What about The Children?
If there is anything that looks remotely like a bright spot in all of this is that the list of safety signals for 12-17 and 5-11 year-olds is much shorter than for 18+. There are 96 AEs that qualify as a safety signal for the 12-17 group and 67 for the 5-11. When we take out the new COVID-era AEs, there are 92 safety signals for 12-17 year-olds and 65 for 5-11 year-olds. Here are the most alarming ones:
I don’t know why the list of AE’s is so much shorter for these age groups. It could be that the list of AE’s for other vaccines for these age groups is much shorter, so in a case where AEs have been reported for the mRNA COVID vaccines but not for other vaccines, it will not be counted as a safety signal by definition.
COMPARISONS TO MYOCARDITIS & PERICARDITIS
We are told that the existence of a safety signal doesn’t necessarily mean the AE is caused by the vaccine, and I accept that premise. But the current practice seems to be to ignore safety signals, dismiss them as noise without any evidence, and stall any investigation into them as long as possible. The precautionary principle, however, dictates we should presume that a safety signal indicates causality, until proven otherwise. Since, it has been acknowledged that the mRNA COVID vaccines can cause myocarditis and pericarditis (often referred to as myo-pericarditis), we can take those AEs as a kind of benchmark, and propose that, at minimum, any AE with a signal of equal or greater size should be considered potentially causal and investigated more thoroughly.4
After dropping the new COVID-era AEs, there are 503 AEs with PRRs larger than myocarditis (PRR=3.09) and 552 with PRRs larger than pericarditis (PRR=2.82).5This means that 66.4% of the AEs had a bigger safety signal than myocarditis and 77.3% were larger than pericarditis. You can see what those were by use this Excel file provided by the CDC and sorting the 18+ tab by the 12/14-07/29 PRR column (Column E). Then just look at which AEs have PRRs larger than the ones for pericarditis and myocarditis.
For 12-17 year-olds, there is 1 safety signal larger than myocarditis (it’s ‘troponin increased’) and 14 safety signals larger than pericarditis (excluding myocarditis), which include: mitral valve incompetence, bell’s palsy, heavy menstrual bleeding, genital ulceration, vaccine breakthrough infection, and a range of indicators of cardiac abnormalities.
For 5-11 year-olds, the comparison to myo/pericarditis is less germane, as they seem to suffer less from this side effect. But we can still make the comparison: there are 7 safety signals larger than pericarditis, including bell’s palsy, left ventricular dysfunction, mitral valve incompetence, and ‘drug ineffective’ (presumably meaning they still got COVID). There are 16 safety signals larger than myocarditis (excluding pericarditis), which in addition to those listed above also include: pericardial effusion, diastolic blood pressure increase, tricuspid valve incompetence, and vitiligo. Sinus tachycardia (high heart rate), appendicitis, and menstrual disorder come in just below myocarditis.
Now if we think of a safety signal as having both strength and clarity, then the PRR can be thought of as an indicator of how strong the signal is, while the Chi-square is a measure of how clear or unambiguous the signal is, because it gives us a sense of how likely the signal is due to chance alone: the larger the Chi-square value, the less likely the signal is due to chance. A Chi-square of 4 means there is only a 5% chance the observed signal is due to chance. A Chi-square of 8 means there is only a 0.5% chance of it being due to chance.6
For the 18+ group, there are 57 AEs with a Chi-square larger than myocarditis (Chi-square=303.8) and 68 with a Chi-square larger than pericarditis (Chi-square=229.5). Again, you can see what these are by going the Excel file linked above and sorting on Column D.
For the 12-17 group, there are 4 AEs with a larger Chi-square than myocarditis (Chi-square=681.5) and 6 larger than pericarditis (Chi-square=175.4).
For the 5-11 group, there are 22 AEs with a Chi-square larger than myocarditis (Chi-square=30.42) and 34 AEs with a Chi-square larger than pericarditis (Chi-square=18.86).
RESPONDING TO OBJECTIONS
Let’s dispense with some of the criticisms used to dismiss VAERS data, which will undoubtedly be raised if you try to bring the CDC’s analysis to people’s attention.
Objection: Anybody can report to VAERS. The reports are unreliable. Anti-vaxxers made lots of fraudulent reports. Nobody was aware of VAERS in the past, but now they are. So many people were afraid of the vaccine so they blamed all their health problems on it. Health workers were required by law to report certain adverse events, like deaths and anaphylaxis. Etc. Etc.
All of these objections ultimately rely on the notion that VAERS reports for COVID-19 vaccines have been artificially inflated over previous years for one reason or another. The thing of it is, though, that the CDC has a method for distinguishing between artificial inflation and real signal. The idea is simple: if adverse events are artificially inflated, they should be artificially inflated to the same degree. Meaning, the PRRs for all of these safety signals should be about the same. But even a casual glance at the PRRs in the Excel file show they vary widely, from as low at 2 to as high as 105 for vaccine breakthrough infection or 74 for cerebral thrombosis. This method does not on the number of reports, but the rate of reporting for certain events out of all events reported. If anything, this method would tend to hide safety signals in a situation where a new vaccine generates a very large number of reports.
The CDC has even done us the favor of calculating upper and lower confidence intervals, meaning that we can be at least 95% confident that two PRRs are truly different if their confidence intervals don’t overlap. So for example the lower confidence interval for pulmonary thrombosis is 19.7, which is higher than the upper confidence interval for 543 other signals. Artificially inflated reporting cannot explain why so many different adverse events have large PRRs that are statistically distinct from one another.
Objection: The safety signals are due to the huge number of COVID vaccines given out. Never before have we given out so many vaccine doses. By the end of July, the US had administered something like 600 million vaccine doses to people aged 18+. But the CDC analysis compares VAERS reports for these doses to all doses for all other vaccines for this age group since Jan. 1, 2009. But from 2015-2020 there were over 100 million flu doses administered annually to this age group alone. In previous work, I estimated 538 million doses of flu given to people 18+ from July 2015-June 2020. The number of flu and other non-COVID vaccines for this age group administered from Jan 1., 2009 through July 29, 2022 must be well over double this number, meaning VAERS reports for COVID vaccines are being compared to reports for at least double the number of doses for other vaccines. In addition to this, as already noted, the PRR methodology does not depend, strictly speaking, on the number of doses, but rather the rate of reporting of a specific AE out of all AEs for that vaccine.
Objection: the vaccines are mainly being given to older people who tend to have health problems, whereas other vaccines are given to younger people. This objection is dealt with, since the analyses are stratified by age groups. It might be still be somewhat valid for the 18+ group, except that in the safety signal analysis I did in the fall of 2021, I stratified by smaller age bands and still found safety signals. In any case, this objection is not enough to dismiss the safety signal analysis out of hand, but rather calls for better and more refined research.
Objection: The VAERS data is not verified and cannot be trusted. I’ll be the first person to agree that VAERS is not high quality data, but if it is completely untrustworthy, then how is it that the CDC uses these data to publish in the best medical journals such as JAMA and The Lancet? If the data were worthless, then these journals shouldn’t accept these papers. In that JAMA paper, they reported that 80% of the myocarditis reports met their definition of myocarditis and were included in the analysis. Many other reports simply needed more details for validation. Furthermore, the CDC has the ability and budget to follow-up on every report VAERS receives to get more details and even medical records to verify the report.
So if myocarditis shows a clear signal in the CDC’s analysis, and 80% of those reports were apparently high quality enough to be included in a paper published in one of the world’s top medical journals, how is it possible that all the rest of the reports are junk? That all of the other safety signals are meaningless? Answer: it isn’t.
And since we’re on the topic of safety signals that turned out to be real, it’s instructive to find appendicitis turn up as a safety signal in all 3 age groups, since a study published in NEJM based on medical records of over a million adult Israelis found an increased risk of appendicitis in the 42 days following Pfizer vaccination (but not following a positive SARS-CoV-2 PCR test). That study also found an increase in lymphadenopathy (swollen lymph nodes) after vaccination, but not after positive COVID test. Lymphadenopathy was another safety signal.
And that brings us to our last objection to be dispensed with: all of these AEs were due to COVID. There was an epidemic and so people were falling ill due to COVID and having all of these problems that were then blamed on the vaccine. Well to begin with, as we just saw, at least two of them (appendicitis and lymphadenopathy) do not appear to have increased risk ratios following a positive SARS-CoV-2 test, and we know that the mRNA vaccines increase risk of myo/pericarditis independent of infections. So how can we assume the rest of these are and dismiss them with the wave of a hand? We can’t. At minimum, they need further investigation. Furthermore, in the safety signal analysis I did in 2021, I dropped all VAERS reports where any sign of a SARS-CoV-2 exposure or infection was indicated on the report, and I still found large, significant safety signals.
PUTTING IT ALL INTO PERSPECTIVE
The Epoch Times article quotes my esteemed colleague and friend, Norman Fenton, Professor of Risk Management and an world renowned expert in Bayesian statistical analysis: “from a Bayesian perspective, the probability that the true rate of the AE of the COVID-19 vaccines is not higher than that of the non-COVID-19 vaccines is essentially zero…. The onus is on the regulators to come up with some other causal explanation for this difference if they wish to claim that the probability a COVID vaccine AE results in death is not significantly higher than that of other vaccines.” (See his post on the CDC analysis here.) The same is true for all the safety signals they found.
The CDC’s VAERS SOP analysis document lists 18 Adverse Events of Special Interest says they are going to pay close attention to. In their 2021 JAMA paper (and similar presentations to ACIP), the researchers responsible for analyzing the millions of medical records in the CDC’s Vaccine Safety Datalink (VSD) using the ‘Rapid Cycle Analysis’ only studied 23 outcomes. A Similar analysis in NEJM from Israeli researchers focused on only 25 outcomes. Compare this to over 700 safety signals found by the CDC when they finally decided to look—and that’s not even counting all the adverse events that have never been reported for other vaccines so cannot ever show a safety signal by definition. How can the CDC say that these safety signals are meaningless if almost none of them have been studied any further? And yet we are assured that these vaccines have undergone the most intensive safety monitoring effort in history. It’s complete and utter hogwash!
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Josh Guetzkow is a senior lecturer at The Hebrew University of Jerusalem. Subscribe to his Substack here.
1) To be precise, the ‘adverse events’ are for ‘preferred terms’ (PTs) which is a type/level of classification used in the Medical Dictionary for Regulatory Activities (MedDRA), which is the classification system used by VAERS and in other pharmacovigilance systems and clinical research for coding reported adverse events. Not all preferred terms are a symptom or adverse event per se. Some refer to a specific diagnostic test that was done or a treatment that was given.
2) It’s not entirely clear how they divided these up, since there are clearly AEs that should be considered serious that don’t show up in the serious Excel table — though maybe they don’t come up simply because they are looking within serious reports. I believe that they just filtered the reports to include only serious reports or non-serious reports, then did the safety signal analysis on all the AE’s coded in those reports. The reason I think this is that I used the MedAlerts Wayback Machine, selected just the serious COVID-19 vaccine reports, and the numbers of total reports was very close to the one in the table provided by the CDC (MedAlerts actually had a bit less). The files obtained by the Epoch Times do not include much in the way of a description as to how the analyses were done, so I had to infer some details, which might be incorrect. I will try to note when I am drawing an inference about how the analysis was done.
3) Generally speaking, these figures show the top ten AEs in each category. In some cases I combined AEs that indicated the same thing, such as combining ‘heart rate irregular’ with ‘arrythmia.’ [UPDATE: Note that the charts of all categories, cardiac and thrombo-embolic events were updated on Jan 7, 2023. The reason is that I had previously categorized acute myocardial infarction as a cardiac issue and myocardial infarction as thrombo-embolic. To be consistent, I have now combined myocardial infarction and acute myocardial infarction into one AE category in the thrombo-embolic events (which made the total AEs reported for that category larger than for pulmonary ones) and then added a different cardiac AE to the cardiovascular AE category, ventricular extrasystoles, AKA premature ventricular contraction (PVC), which dependent on frequency and the presence of other cardiomyopathies is associated with sudden cardiac arrest.]
4) Note that using the myo-pericarditis signal as a yardstick doesn’t mean that these are the only signals that matter. To give one example, anaphylactic reactions don’t even show up in the list of safety signals, even though that was one of the very first risk of the vaccine that became apparent from day one of the vaccine rollout.
One potential objection to this benchmark is that it is too low of a bar, since myo-pericarditis appears to disproportionately affect younger men and so a proper safety signal should be stratified by age and gender then compared with myocarditis similarly stratified. I agree, and it is the CDC’s job to do that. But the fact is that any adverse reaction might disproportionately affect some subgroup of people, in which case the safety signal for that group would be similarly faint or diluted when we look at everyone together. So objection overruled.
5) In their Standard Operation Procedures document, the CDC said they would combine these and related codes together to assess a safety signal, but never mind – at least they finally got around to doing something.
6) In this context, the Chi-square is largely driven by the sheer number of adverse events: the more adverse events reported, including for the comparator vaccine, the larger the Chi-square. For example, the PRR for pericarditis and subdural haematoma is the same (2.82), but there were 1,701 incidents of pericarditis reported for mRNA COVID vaccines versus 221for the comparator vaccines, with Chi-square of 229.5. For subdural haematoma, these numbers are 162 verus 21, for a Chi-square of 21.2.
GOP Senator Demands DoD Investigate Leaked DARPA Bombshell Over Covid-19 Origins
Sen. Ron Johnson (R-WI) has requested any findings from a Department of Defense investigation into the origins of Covid-19, following the recent publication of a Defense Advanced Research Projects Agency (DARPA) report obtained by Project Veritas.
According to the leaked report written by a Marine, EcoHealth Alliance sought a contract to use controversial gain-of-function genetic manipulation techniques to study bat coronaviruses. While the proposal was rejected by DARPA, it was subsequently picked up by Anthony Fauci’s National Institute of Allergy and Infectious Disease, which funneled money to EcoHealth via a sub-grant.
Fauci has repeatedly claimed NIAID did not fund gain-of-function research into bat coronaviruses.
“It is apparent that Dr. Fauci has not been forthright with the American people regarding his involvement in funding dangerous research,” Sen. Johnson told the Daily Caller.
“According to the Major’s disclosure, EcoHealth Alliance (EcoHealth), in conjunction with the Wuhan Institute of Virology (WIV), submitted a proposal in March 2018 to the Defense Advanced Research Projects Agency (DARPA) regarding SARS-CoVs. The proposal included a program, called DEFUSE, that sought to use a novel chimeric SARS-CoV spike protein to inoculate bats against SARS-CoVs,” reads Johnson’s letter.
“Although DARPA rejected the proposal, the disclosure alleges that EcoHealth ultimately carried out the DEFUSE proposal until April 2020 through the National Institutes of Health and National Institute for Allergy and Infectious Diseases. The disclosure highlights several potential treatments, such as ivermectin, and specifically alleges that the EcoHealth DEFUSE proposal identified chloroquine phosphate (Hydroxychloriquine) and interferon as SARS-CoV inhibitors.”
The leaked documents also suggest that Covid-19 was created at the Wuhan Institute of Virology.
Johnson asks the DoD to interview the Marine who reportedly authored the report, and undertake an investigation into its claims.
If Pfizer insists that certain unvaccinated persons who come into contact with a vaccinated person creates a…
SAFETY SITUATION that must be reported to Pfizer within 24 hours…
Would you say that implies…
The transfer of vaccine components from person to person can occur?
If you answered YES, you win four tickets to Oobladee, a little-known island nation where vaccines are forbidden and the people naturally remain healthy and live to a ripe old age.
Here is a Pfizer document, admitting and warning of person-to-person transfer of dangerous vaccine components [1]: “A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS,” (see page 67).
I’m going to take this in small chunks, and translate the fake-speak clinical language as we go along.
“Exposure to the study intervention under study during pregnancy or breastfeeding and occupational exposure are reportable to Pfizer Safety within 24 hours of investigator awareness.”
The “study intervention” means the RNA COVID shot. That’s what the study is FOR—intervening with a jab. “Hi, I’m your intervener, you’re a volunteer in the clinical trial, and I’m going to hit you in the arm with this needle and inject you.”
“Exposure” to the shot doesn’t mean injection. It means somebody who hasn’t been injected gets physically close to somebody who has been injected. Or it could mean an un-injected person touches vaccine-liquid from a vial.
And that un-injected somebody would be a woman who is pregnant or breastfeeding. For example, she could be a lab worker, or a person who is giving the shots.
If THIS exposure event happens, it’s a safety situation, and it has to be reported within 24 hours.
A lab worker who is pregnant or breastfeeding gets physically close to a person who has received the vaccine and BANG, it’s serious, and it has to be reported.
Why? Because, obviously, there is a potential danger to the unborn baby. Or the mother, who is already breastfeeding her baby, could pass this danger to the baby through her breast milk.
The woman just came physically close to a person who already received the vaccine. That’s all. That’s all that happened. But it’s enough. It means THERE CAN BE A TRANSFER OF VACCINE COMPONENTS FROM PERSON TO PERSON, AND THIS IS NOT GOOD, THIS IS DANGEROUS TO PREGNANT AND BREASTFEEDING MOTHERS AND THEIR BABIES.
Here is the next piece of the Pfizer document. It’s crucial:
“An EDP [exposure to the vaccine during pregnancy] occurs if a male participant who is receiving or has discontinued study intervention exposes a female partner prior to or around the time of conception.”
This is a dangerous situation, too. A man who did get the shot then gets physically close to his female partner, who didn’t get the shot. This doesn’t necessarily mean sex. It means close physical contact. But the warning is obviously all about danger to the woman who is going to conceive a child or has just conceived, and the warning is also about a danger to that child. Some kind of severe injury. Or a miscarriage. Again, the document is obviously referring to the transfer of vaccine components from a vaccinated to unvaccinated person.
And then, in the Pfizer document, we find an example of this dangerous, immediately reportable situation: “A female family member or healthcare provider reports that she is pregnant after having been exposed to the study intervention by inhalation or skin contact….”
Here, as plain as day, we see two meanings of “come in close contact with.” Inhalation, and skin contact. Do not assume this has to mean physically rubbing up against or breathing in the liquid in the vaccine vial. Go back and read the other quotes I gave you from the Pfizer document. They are clearly talking about something much different. They’re talking about close contact between PEOPLE, one of whom has ALREADY had the shot, and one who hasn’t.
They’re talking about vaccine components passing from the inside of one person’s body to another person.
Call it shedding, call it transfer, call it transmission, call it whatever you want to. Pfizer was clearly worried about it, because they insisted that any such occurrence had to be reported to company safety personnel.
They were aware that damage could be the result. Damage to mothers conceiving, mothers pregnant, mothers who are breastfeeding, and damage to babies.
Through person to person passage of components in the vaccine.
A person might object, saying, “Well, maybe the pregnant woman had skin contact with someone who was just vaccinated, and the vaccinated person has a small amount of vaccine on his skin, because that tiny amount of liquid somehow escaped from the needle during injection.”
That’s highly doubtful. And if you go back and read the Pfizer statement about the man who received the vaccine and then had close contact with his female partner, there is no time line mentioned. A) He received the shot and then b) at some point later, he came into close contact with his female partner. It could be days later, weeks later. There would be no amount of vaccine left on his skin.
We ARE talking about the passage of vaccine components from the inside of one person’s body to another person.
Alarming Casualty Rates for mRNA Vaccines Warrant Urgent Action
By F. William Engdahl
19 May 2021 As official government data is emerging in Europe and the USA on the alarming numbers of deaths and permanent paralysis as well as other severe side effects from the experimental mRNA vaccines, it is becoming clear that we are being asked to be human guinea pigs in an experiment that could alter the human gene structure and far worse. While mainstream media ignores alarming data including death of countless healthy young victims, the politics of the corona vaccine is being advanced by Washington and Brussels along with WHO and the Vaccine Cartel with all the compassion of a mafia “offer you can’t refuse .”
The alarming EMA Report
On May 8 the European Medicines Agency (EMA) an agency of the European Union (EU) in charge of the evaluation and supervision of medical products, using the data base EudraVigilance which collects reports of suspected side effects of medicines including vaccines, published a report that barely warranted mention in major mainstream media. Through May 8, 2021 they had recorded 10,570 deaths and 405,259 injuries following injections of four experimental COVID-19 shots: COVID-19 mRNA VACCINE of MODERNA (CX-024414); COVID-19 mRNA VACCINE of PFIZER-BIONTECH; COVID-19 VACCINE of ASTRAZENECA (CHADOX1 NCOV-19); and Johnson & Johnson’s Janssen COVID-19 VACCINE (AD26.COV2.S).
A detailed analysis of each vaccine gives the following: The Pfizer-BioNTech mRNA gene-edited vaccine resulted in the largest fatalities– 5,368 deaths and 170,528 injuries or nearly 50% of the total for all four. The Moderna mRNA vaccine was second with 2,865 deaths and 22,985 injuries. That is to say, the only two gene manipulated mRNA experimental vaccines, Pfizer-BioNTech and Moderna, accounted for 8,233 deaths of the total registered deaths of 10,570. That’s 78% of all deaths from the four vaccines currently in use in the EU.
And among the serious side effects or injuries recorded by the EMA, for the two mRNA vaccines which we focus on in this article, for the Pfizer “experimental” vaccine, most reported injuries included blood and lymphatic system disorders including deaths; cardiac disorders including deaths; musculoskeletal and connective tissue disorders; respiratory, thoracic and mediastinal disorders, and vascular disorders. For the Moderna mRNA vaccine, most serious injuries or causes of death included blood and lymphatic system disorders; cardiac disorders; musculoskeletal and connective tissue disorders; disorders of the central nervous system.
Note that these are only the most serious injuries related to those two genetically manipulated mRNA vaccines. The EMA also notes that it is believed that only a small percent of actual vaccine deaths or serious side effects, perhaps only 1% to 10%, are reported for various reasons. Officially more than 10,000 persons have died after receiving the coronavirus vaccines since January, 2021 in the EU. That is a horrifying number of vaccine-related deaths, even if the true numbers are far greater.
CDC as well
Even the US Centers for Disease Control (CDC) a notoriously political and corrupt agency with for-profit ties to vaccine makers, in its official Vaccine Adverse Event Reporting System (VAERS), shows a total of 193,000 “adverse events” including 4,057 deaths, 2,475 permanent disabilities, 25,603 emergency room visits, and 11,572 hospitalizations following COVID-19 injections between December 14, 2020 and May 14, 2021. That included the two mRNA vaccines, Pfizer and Moderna, and the far less prevalent J&J Janssen vaccine. Of the reported deaths, 38% occurred in people who became ill within 48 hours of being vaccinated. The official US vaccine-related death toll is greater in just 5 months than all the vaccine-related deaths from the past 20 years combined. Yet the major media worldwide and the US Government virtually bury the alarming facts.
Some 96% of the fatal results were from the Pfizer and Moderna vaccines, the two variants funded and promoted by the Gates Foundation and Tony Fauci’s NIAID with the experimental mRNA genetic technology. Moreover, Dr. Tony Fauci, the US Biden Administration vaccine czar and his NIAID Vaccine Research Center co-designed the Moderna mRNA vaccine and gave Moderna and Pfizer each $6 billion to produce it. That’s also a blatant conflict of interest as Fauci and his NIAID are allowed to financially benefit from their patent earnings in the vaccine under a curious US law. The NIAID developed the coronavirus spike proteins for the development of SARS-CoV-2 mRNA vaccines using taxpayer money. They licensed it to Moderna and Pfizer.
“never seen in nature…”
In a tragic sense, the experience with reactions to the two unprecedented mRNA experimental vaccines since rollout in unprecedented speed “warp speed” as the US Government called it, is only now beginning to be seen, in real trials of human guinea pigs. Few realize that the two mRNA vaccines use genetic manipulations that never before have been used in humans. And under the cover of urgency, US and EU health authorities waived normal animal trials and did not even approve the safety, but gave an “emergency use authorization.” Moreover, the vaccine makers were made 100% exempt from damage litigation.
The general public was reassured of the vaccine safety when Pfizer and Moderna published reports of 94% and 95% “efficacy” of these vaccines. NIAID’s Fauci was quick to call it “extraordinary” in November 2020, and Warp Speed was off and running as was the stock price of Pfizer and Moderna.
Peter Doshi, Associate Editor of the British Medical Journal pointed to a huge flaw in the 90+% reports for efficacy of Moderna and Pfizer vaccines. He noted that the percentages are relative, in relation to the select small healthy young test group, and not absolute as in real life. In real life we want to know how effective the vaccine is among the large general population. Doshi points to the fact that Pfizer excluded over 3400 “suspected COVID-19 cases” that were not included in the interim analysis. Moreover individuals “in both Moderna and Pfizer trials were deemed to be SARS-CoV-1- (the 2003 Asian SARS virus) positive at baseline, despite prior infection being grounds for exclusion,” Doshi notes. Both companies refused to release their raw data. Pfizer in-house scientists did their tests. In short 95% is what Pfizer or Moderna claim. We are told, “Trust us.” A more realistic estimate of the true efficacy of the two vaccines for the general public, using data supplied by the vaccine makers to the FDA, shows the Moderna vaccine at the time of interim analysis demonstrated an absolute risk reduction of 1.1%, while the Pfizer vaccine absolute risk reduction was 0.7%. That is very poor.
Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, says, “Ideally, you want an antiviral vaccine to do two things . . . first, reduce the likelihood you will get severely ill and go to the hospital, and two, prevent infection and therefore interrupt disease transmission.” As Doshi notes, none of the trials were “designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus.” Moderna’s chief medical officer even admitted that, “Our trial will not demonstrate prevention of transmission.”
Possible effects of mRNA vaccines
In a major new study just published in the International Journal of Vaccine Theory, Practice and Research, Dr. Stephanie Seneff, senior scientist at the MIT Computer Science and Artificial Intelligence Laboratory, and Dr. Greg Nigh, Naturopathic oncology specialist, analyze in detail the possible pathways in which the experimental mRNA vaccines of Pfizer and Moderna could be causing such adverse effects in the vaccinated. First they point out that both the Pfizer and Moderna gene-edited vaccines are highly unstable: “Both are delivered through muscle injection, and both require deep-freeze storage to keep the RNA from breaking down. This is because, unlike double-stranded DNA which is very stable, single-strand RNA products are apt to be damaged or rendered powerless at warm temperatures and must be kept extremely cold to retain their potential efficacy.” Pfizer recommends minus 70’ Celsius.
The authors point out that to keep the mRNA from breaking down before it could produce protein, both vaccine makers substitute methyl-pseudouridine to stabilize RNA against degradation, allowing it to survive long enough to produce adequate amounts of protein antigen. The problem they point out is that, “This form of mRNA delivered in the vaccine is never seen in nature, and therefore has the potential for unknown consequences… manipulation of the code of life could lead to completely unanticipated negative effects, potentially long term or even permanent. ”
PEG Adjuvants and Anaphylactic Shock
For various reasons to avoid using aluminum adjuvants to boost the antibody response, both mRNA vaccines use polyethylene glycol, or PEG, as adjuvant. This has consequences. The authors point out, “…both mRNA vaccines currently deployed against COVID-19 utilize lipid-based nanoparticles as delivery vehicles. The mRNA cargo is placed inside a shell composed of synthetic lipids and cholesterol, along with PEG to stabilize the mRNA molecule against degradation.”
PEG has been shown to produce anaphylactic shock or severe allergenic reactions. In studies of prior non-mRNA vaccines, anaphylactic shock reactions occurred in 2 cases per million vaccinations. With the mRNA vaccines initial monitoring revealed that, “anaphylaxis occurred at a rate of 247 per million vaccinations. This is more than 21 times as many as were initially reported by the CDC. The second injection exposure is likely to cause even larger numbers of anaphylactic reactions.” One study noted, “PEG is a high-risk ’hidden’ allergen, usually unsuspected, and can cause frequent allergic reactions due to inadvertent re-exposure.” Among such reactions are included life-threatening cardiovascular collapse.
This is far from all the undeclared risks of the experimental mRNA coronavirus vaccines.
Antibody-Dependent Enhancement
Antibody-Dependent Enhancement (ADE) is an immunological phenomenon. Seneff and Nigh note that, “ADE is a special case of what can happen when low, non-neutralizing levels of… antibodies against a virus are present at the time of infection. These antibodies might be present due to… prior vaccination against the virus…” The authors suggest that in the case of both Pfizer and Moderna mRNA vaccines, “non-neutralizing antibodies form immune complexes with viral antigens to provoke excessive secretion of pro-inflammatory cytokines, and, in the extreme case, a cytokine storm causing widespread local tissue damage.”
To be clear, normally cytokines are part of the body’s immune response to infection. But their sudden release in large quantities, a cytokine storm, can cause multisystem organ failure and death. Our innate immune system undergoes an uncontrolled and excessive release of pro-inflammatory signaling molecules called cytokines.
The authors add that pre-existing “antibodies, induced by prior vaccination, contribute to severe pulmonary damage by SARS-CoV in macaques…” Another cited study shows that the much more diverse range of prior exposures to coronaviruses such as seasonal flu experienced by the elderly might predispose them to ADE upon exposure to SARS-CoV-2.” This is a possible explanation for the high incidence of post-mRNA vaccination deaths among elderly.
The vaccine makers have a clever way of denial as to the toxicity of their mRNA vaccines. As Seneff and Nigh state, “it is not possible to distinguish an ADE manifestation of disease from a true, non-ADE viral infection.” But they make the telling point, “In this light it is important to recognize that, when diseases and deaths occur shortly after vaccination with an mRNA vaccine, it can never be definitively determined, even with a full investigation, that the vaccine reaction was not a proximal cause. “
The authors make numerous other alarming points including emergence of auto-immune diseases such as Celiac disease, a disease of the digestive system that damages the small intestine and interferes with the absorption of nutrients from food. Also Guillain-Barré syndrome (GBS) that causes progressive muscle weakness and paralysis. Additionally, Immune thrombocytopenia (ITP) in which a person has unusually low levels of platelets — the cells that help blood to clot– could occur following vaccination “through the migration of immune cells carrying a cargo of mRNA nanoparticles via the lymph system into the spleen… ITP appears initially as petechiae or purpura on the skin, and/or bleeding from mucosal surfaces. It has a high risk of fatality through haemorrhaging and stroke.”
These examples are indicative of the fact that we are literally exposing the human race via untested experimental gene edited mRNA vaccines to incalculable dangers which in the end may exceed by far any potential risk of damage from something which has been called SARS-Cov-2. Far from the much-touted miracle substance proclaimed by WHO, Gates, Fauci and others, the Pfizer, Moderna and other possible mRNA vaccines clearly hold potentially tragic and even catastrophic unforeseen consequences. Little wonder some critics believe it is a disguised vehicle for human eugenics.
F. William Engdahl is strategic risk consultant and lecturer, he holds a degree in politics from Princeton University and is a best-selling author on oil and geopolitics, exclusively for the online magazine “New Eastern Outlook”
Recently Sasha Stone hosted a 2 hour live stream event called “Focus on Fauci.” Participating in the event were Dr. Rocco Galati, Dr. David Martin, Dr. Judy Mikovits, and Robert F. Kennedy Jr.
Dr. Martin has made tidal waves in the Alternative Media since this event, by explaining that the experimental mRNA COVID vaccines are not even vaccines, and legally cannot be called “vaccines,” because they are really medical devices.
Dr. Martin should be familiar to readers of Health Impact News (as are the other participants), as he was the featured scientist in filmmaker Mikki Willis’ excellent production: Plandemic. He exposed, for example, how the U.S. Government has owned patents on coronaviruses since the 1990s.
His first invention was a laser integrated system to target and treat inoperable tumors. His mathematics helped unravel the way the human body processes hormones and led to the detection and treatment of many diseases.
His observation of human behavior led to his development of technology which deciphers the intention and motivation of communication – a technology that has impacted and saved the lives of billions.
His global business activities served to develop the world’s top-performing global equity index (including the CNBC IQ100 powered by M·CAM).
He’s brought the world’s largest white-collar criminals to justice and brought the world’s most oppressed and disenfranchised transformative ways to engage.
From the starry expanses of Mongolia to the flashing lights of New York, his work is as passion-filled whether it’s with a camel herder or a global CEO. (Source.)
“This is not a vaccine.”
Here is a partial transcript of the video below explaining that the mRNA vaccines are not really vaccines:
This is not a vaccine.
We need to be really clear. We’re using the term “vaccine” to sneak this thing under public health exemptions.
This is not a vaccine. This is an mRNA packaged in a fat envelope, that is delivered to a cell.
It is a medical device designed to stimulate the human cell into becoming a pathogen creator.
It is not a vaccine. Vaccines actually are a legally defined term, and they’re a legally defined term under public health law, they’re legally defined term under the CDC and FDA standards.
And a vaccine specifically has to stimulate both an immunity within the person who is receiving it, but it also has to disrupt transmission.
And that is not what this is. They have been abundantly clear in saying that the mRNA strand that is going into the cell, it is not to stop transmission. It is a treatment.
But if it was discussed as a treatment, it would not get the sympathetic ear of the public health authorities, because then people would say, well what other treatments are there?
Americans have been following COVID-19 vaccine trial developments for weeks, watching companies jockey for frontrunner status like contestants in a reality TV show. And though participants in some of the studies (by Moderna, Oxford, Johnson & Johnson and Pfizer) have surfaced with reactions serious enough to pause several of the trials, market analysts remain “bullish” about the near-term prospects for approval of these liability-free products by the U.S. Food and Drug Administration (FDA).
On Oct. 16, Pfizer’s CEO indicated the company would likely file for FDA Emergency Use Authorization for its experimental BNT162b2 vaccine in late November. That statement came three days after Pfizer announced that it had received FDA permission to administer the unproven vaccine to children as young as 12, becoming the first company in the U.S. to include young participants in Phase 3 trials. In the UK, Oxford and AstraZeneca gained approval to test their vaccine in children aged 5-12 back in May, a couple of months before two of their adult clinical trial participants developed transverse myelitis.
To date, Pfizer has administered two doses of vaccine to almost 35,000 adult participants in five countries. Unworried by the dramatic side effects reported by some of these adults — including high fever, pounding headaches, body aches, exhaustion and shivering intense enough to crack teeth — more than 90 parents have already expressed interest in volunteering their teenagers.
Are these parents (perhaps left unemployed by coronavirus restrictions) tempted by the financial incentives offered to clinical trial participants, reportedly anywhere from $1200 to $2000? Otherwise, their motivation for wanting to throw their children into the experimental fray is unclear; as the director of the Cincinnati Children’s Hospital stated, “most of the time, what a coronavirus causes is a cold” that does not even make children “sick enough to where a parent says they need to go to a doctor.”
The Cincinnati physician has, nonetheless, just started giving Pfizer’s shot to 16- and 17-year-olds (and soon to 12-15-year-olds). To entice additional young participants, he tells parents that the COVID-19 death rate in children is “not zero” — but declines to spell out that, according to the Centers for Disease Control and Prevention, the survival rate in those age 19 and under is 99.997%. Using similarly vague language, a Memorial Sloan-Kettering health policy expert said that a COVID-19 vaccine’s benefits for the young would likely be “secondary’ in nature” but characterized the gesture as “an act of service to help protect others.”
However, reports in Pediatrics and other journals assert that children are not a source of infection and are far more likely to acquire COVID-19 from adults “rather than transmitting it to them.” In other words, policymakers expect children to accept a risk-benefit equation heavily tilted toward risk.
Corporate bad guy
Pharmaceutical giant Pfizer — the second-largest drug and biotech company in the world and the fourth-highest earner of vaccine revenues — has seen a 7% increase in its share value this year. However, though Pfizer claims to be a standard-bearer for “quality, safety and value,” it has a corporate rap sheet a mile long. Pfizer is routinely mired in controversies involving alleged price-fixing, bribery, kickbacks, tax avoidance, regulatory misdirection and other unsavory practices and has also repeatedly paid fines for environmental violations at its research and manufacturing plants.
Critics point to decades of aggressive and questionable marketing. In 2009, this behavior earned Pfizer the dubious distinction of paying the largest-ever criminal fine at the time — $2.3 billion — for fraudulent and illegal promotion of four drugs, including a painkiller marketed at “dangerously high” doses. In 2016, a British regulator levied a $106 million fine against Pfizer for a 2600% increase in the price of a widely prescribed anti-epilepsy drug that increased the National Health Services’ expenditures from one year to the next — for a single drug—from $2.5 million to $63 million.
Perhaps to compensate for its unpleasant track record, Pfizer is the top drug company spender in state elections, even outspending the industry’s own lobbying group, Pharmaceutical Research and Manufacturers of America (PhRM). As a just-published analysis of drug company political spending by STAT and the National Institute on Money and Politics shows, Pfizer’s “prolific” state-level spending ($778,000 since January 2019) “mirrors its behavior at the federal level, where its [political action committee] was also the top political spender among drug companies” — roughly $1 million over the same time period. The report pointedly notes that while the amounts paid out to legislators represent a “pittance” for a company earning tens of billions a year, “those small chunks of corporate change can have a significant impact.”
Pfizer’s vaccines
Pfizer is responsible for two vaccines on the U.S. childhood and adolescent vaccine schedule: the pneumococcal vaccine Prevnar-13 (given to children under 5 and also to older adults) and the meningococcal vaccine Trumenba (approved for 10 – 25-year-olds). Package inserts link the two vaccines to a large number of serious adverse events, including anaphylaxis and other allergic reactions, severe headaches and chronic muscle and joint pain. Among the roughly 40 harms listed in the Prevnar-13 insert are sudden infant death syndrome (SIDS) and half a dozen other fatal outcomes.
Pfizer developed its COVID-19 vaccine — which uses experimental messenger RNA (mRNA) technology — in partnership with the German biopharma company BioNTech. Although mRNA vaccines must be stored in special ultra-low-temperature freezers that pose certain logistic obstacles, Pfizer is gung-ho on the never-before-approved approach because it bypasses the more costly and difficult methods used in traditional vaccine production. It does this by essentially turning recipients into “vaccine factories” — with long-term risks that are unknown.
Pfizer and BioNTech brought their COVID-19 vaccine candidates “from concept into clinical development” in under three months, perhaps helped along by the current Pfizer CEO’s efforts to restructure Pfizer into a more “nimble” company. At the same time, observers who now place Pfizer at the head of the pack for COVID-19 vaccines credit the company’s “well-oiled system,” remarking that “Pfizer’s incredibly organized and is always … a couple steps ahead, planning where they want to go.”
Conflicts of interest and revolving doors
In the summer of 2019, after having served as the Trump administration’s FDA commissioner for two years, Scott Gottlieb passed through the revolving door to join Pfizer’s board of directors as well as becoming a regular contributor on CNBC. For the past four decades, stepping onto pharmaceutical boards has been par for the course for departing FDA commissioners, though Gottlieb may have upped the ante by also joining the boards of the AI- and big-data-reliant genetic testing start-up, Tempus, and the biotech company Illumina.
While at the FDA, Gottlieb presided over a record number of drug approvals. According to one commentator, this “trail-blazing” FDA stint and Gottlieb’s focus on “hustling up the [drug approval] process … helped endear him to the industry, making him one of the most popular commissioners in FDA history.” As the director of a consumer watchdog group put it, “He’s basically been a shill for pharmaceutical corporations for much of his career.” Two months before stepping down from the agency, Gottlieb attracted notice when he strongly denied any link between vaccines and autism while publicly threatening that the federal government might be “forced” to intervene in states with vaccine exemptions to make vaccines mandatory across the board.
Gottlieb’s affiliation with CNBC may explain why he has been a frequent public face during the coronavirus pandemic, promoting the U.S. as a world leader in the vaccine race but also vocally endorsing measures like universal masking, universal testing and restaurant and school shutdowns. On October 19, Gottlieb dourly told Americans that the U.S. is “entering a pretty difficult period” and that “the hardest part is probably [still] ahead.” Ironically, around the same time that Gottlieb was using positive test results to hype ongoing restrictive measures, a former Pfizer vice-president and chief science officer in the UK characterized mass testing as “inappropriate,” asserting that “it is impossible for the positives to be much other than false.” Discussing the harsh policies that have been particularly disastrous for children, the former Pfizer executive agreed that they have essentially been based on “completely fake data.”
Kids at risk
Reporter Whitney Webb recently outlined how Operation Warp Speed is awarding contracts to vaccine companies through a nongovernmental defense contractor intermediary, a tactic that shields the contracts from oversight and federal regulation. Meanwhile, Moncef Slaoui — who heads up the Operation Warp Speed initiative — stated that after a round of testing in adolescents, he expects the leading coronavirus vaccines to also be tested in toddlers and babies. Parents would do well to keep their children on the sidelines of these experiments. If vaccine clinical trials, including Pfizer’s, are already generating concerning results in adults capable of describing their symptoms, what will happen when preverbal babies experience similar adverse outcomes?
