Please Don’t Call This ‘Science’: How FDA, CDC Justified Approval of Moderna’s Spikevax
The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) did it again.
The FDA last week granted its seal of approval for a ghost vaccine that is unavailable in the United States — and it did so using a preordained process that made a mockery of “science” and of “regulation.”
Days later, the CDC backed the FDA’s decision, using similarly flawed data and reasoning.
The approval of Moderna’s Spikevax COVID-19 vaccine was an even greater travesty than the FDA’s approval last August of Pfizer’s Comirnaty shot.
That’s because Moderna has been even more secretive than Pfizer about its trial data, and because Moderna’s shot is linked to an even higher rate of heart disease than Pfizer’s.
The FDA’s approval of the Pfizer Comirnaty vaccine led people to believe they would get a fully licensed, FDA-approved vaccine — when in fact they were still getting the Pfizer-BioNTech vaccine distributed under Emergency Use Authorization (EUA).
People can ask for the Comirnaty vaccine as often as they like — but it is not being distributed in the U.S. The Comirnaty vaccine is supposed to be the same formulation as the old Pfizer-BioNTech vaccine, but the vials labeled “Comirnaty” are in a legal class of their own.
Why this Kabuki theater?
Because any adult who is harmed or killed as a side effect of an “FDA-approved” vaccine can sue the manufacturer. But if you are harmed in exactly the same way by an EUA vaccine, you are out of luck — the manufacturer and everyone in the chain of delivery has full immunity from lawsuits. The law depends on the label.
Now Moderna has the same legal advantage as Pfizer. Its “Spikevax” is the same formula as the old Moderna vaccine, but only if you are dosed with a vial bearing the “Spikevax” label can you sue for bodily harm. So, of course, the Moderna vaccine continues to be distributed, but Spikevax is not available in the U.S.
The approval of Spikevax is not just a legal sham. It’s also a scientific sham. FDA approval is supposed to include long-term safety testing, but there is no long-term data available for a product that has been in existence less than a year.
The FDA hearings on the licensing of Spikevax were one-sided and dominated by self-congratulatory rhetoric. They also raised more questions than answers.
Questions for the FDA
- Besides offering publicity to the manufacturer and sowing confusion in the public mind, why would the manufacturers want FDA approval for a vaccine that is not available in the U.S.?
- Neither Pfizer nor Moderna explicitly specified the content of their placebos, but a published review claims they were simple saline. If this is the case, why is the rate of medical problems following injection with a “placebo” so much higher with Moderna’s placebo compared to Pfizer’s placebo?
For example, 18 people out of 15,000 in the Moderna placebo group died before the start of the trial (2 weeks from the second vaccination), while only 4 people out of 22,000 who received Pfizer’s placebo dose died in a comparable period. There were 31 “severe adverse events” in the placebo group of the Moderna trial, and zero in the (larger) Pfizer placebo group. What was in that “placebo” that killed 18 people and sent 31 to the hospital?
- The FDA relies on the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to help assess the safety of vaccines before approval. There was an animated debate at the VRBPAC meeting for the Pfizer vaccine. Why was VRBPAC not invited to convene for the Moderna vaccine? The answer is given in this letter of approval from the FDA to Moderna (January 31, 2022):
“We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your BLA [Biologics License Application], including the clinical study design and trial results, did not raise concerns or controversial issues that would have benefited from an advisory committee discussion.”
- The FDA plainly states that it limited the scope of its analysis to the trial data alone. Why isn’t the FDA interested in the enormous amount of data that has become available in the last year?
Safety: Did FDA cook the books?
Deaths and disabilities associated with the mRNA “vaccines” have occurred with shocking frequency, 90 times as many as the worst vaccine in the past. There have been more than 1 million COVID vaccine reactions reported to the Vaccine Adverse Event Reporting System (VAERS), compared to 11,000 for the worst vaccine in 2020 (Shingrix).
There were more than twice as many deaths related to the COVID vaccines this year as the sum total of all vaccine deaths in the 30-year history of VAERS.
To rig the approval process in favor of such a product, the FDA needed to rewrite the rule book. The agency did this with a new statistical criterion, masking murder with mathematics. I am grateful to Matthew Crawford for having decoded the algebra and sounded the alarm.
The safety criterion chosen by the FDA is an obscure computation called PRR, which stands for Proportional Reporting Ratio. As the name implies, it is based on RATIOS of different event types and is utterly blind to the ABSOLUTE RATE of such events.
PRR measures the distribution of different kinds of adverse events, e.g. blood clots, heart attacks and deaths. If those ratios are severely out of line with the great variety of vaccine reactions in the past, PRR would detect that.
For example, if the new vaccines caused an extraordinary risk of myocarditis, but everything else was low, then PRR would flag that. But if myocarditis was just one risk among many that have been reported from past vaccines, then PRR would not pick that up.
The real scandal is that PRR is blind to the absolute risk numbers. PRR is defined in such a way as to look for unusual PATTERNS of adverse events, but it is completely insensitive to unusual RATES of adverse events.
Of course, it is the rates and not the patterns that are of primary concern, and the PRR is designed NOT to reflect that.
For example, suppose we have two vaccines:
- Vaccine A has 1 reported death per million vaccinations, 3 reported heart attacks per million, and 20 reported headaches per million.
- Vaccine B has 1 reported death per hundred vaccinations, 3 reported heart attacks per hundred, and 20 reported headaches per hundred.
Vaccine A is quite safe, and vaccine B is extremely dangerous. And yet the formula for PRR will produce the same result for vaccine A and B!
Clearly, PRR is not an appropriate criterion for evaluating the safety of any particular vaccine. Did the FDA use PRR in order to cook the books?
In Moderna’s own trials, 1.3% of vaccine recipients had a reaction to the vaccine that was severe enough to require medical attention. The following possible side effects were listed in information given to doctors:
“Anaphylaxis and other severe allergic reactions, myocarditis, pericarditis, and syncope have been reported following administration of the Moderna COVID-19 Vaccine during mass vaccination outside of clinical trials.”
Off with his head! — the CDC’s ACIP hearings
In Alice’s Wonderland, the Red Queen’s justice began with the execution, then there was a verdict — and finally a trial.
The FDA hearing was followed by a meeting of the Advisory Committee on Immunization Practices (ACIP), which reports to the CDC.
The committee on Feb. 4 voted to recommend the Moderna Spikevax. Only after that action step had been secured did the committee hear testimony from the Public Health Agency of Canada that Moderna’s vaccine was associated with a myocarditis risk five times higher than Pfizer’s.
Questions for the CDC
- All-cause mortality was equal in both placebo and vaccine groups (16 deaths in each). In the midst of a pandemic, Moderna’s vaccine demonstrated no survival benefit. This should have been enough to end any further consideration of approval.
- We have detailed data on myocarditis from decades of past history. One-fourth of myocarditis patients are dead within 5 years, but the same study reports that if the myocarditis is caused by human immunodeficiency virus, then three-fourths die in the same 5 years.
We have no long-term data on vaccine-induced myocarditis, but we do have some 6-month data, which show 39% of cases still had their activity restricted by their doctors, 20% were still on heart medication, 32% still reported chest pain, 22% still had shortness of breath, 22% had palpitations and 25% still reported fatigue. Thirteen vaccine recipients died. (All these numbers were presented at the ACIP hearing on Feb. 4.)
Why should we have confidence that the course of vaccine-induced myocarditis will be much less severe than other forms of the disease?
- The Moderna trial, like the Pfizer trial, was limited to healthy people, mostly young, with no pre-existing problems. Pregnant women were explicitly excluded. Why is the vaccine being approved as safe for everyone, including diabetics and immune-compromised, elderly and pregnant women?
- When mRNA vaccines were approved on an emergency basis, the FDA promised to track all safety concerns with a new cell phone app called V-Safe. Why are the results of V-Safe being withheld from the public?
- The FDA was considering approval of Moderna’s vaccine in January 2022. There was a full year’s experience with side effects reported from nearly 200 million doses of the Moderna vaccine in the U.S. alone. But the FDA limited its consideration to the 15,000 subjects who were in the Moderna trial, ending March 26, 2021. Why was this huge trove of data on vaccine safety not reviewed by the FDA?
- Yes, we understand that the vaccine doesn’t become fully effective until 2 weeks after the second shot. But is that a reason to exclude from consideration the damage that is inflicted by enhanced vulnerability to disease during those two weeks, or, for that matter, the four weeks between shots? These have been counted as diseases of the “unvaccinated,” but in fact, people in this stage of treatment are much more vulnerable than the truly unvaccinated.
- France and Germany do not recommend Moderna’s vaccination for young people, presumably because the Moderna vaccine is associated with a higher rate of myocarditis than the Pfizer vaccine. How did our FDA come to a different conclusion?
- Anaphylaxis following vaccination is an immediate, life-threatening and an undeniable consequence of the vaccine. The CDC claimed the rate of anaphylaxis is 6 per 1 million.
However, in March of 2021, an examination of anaphylaxis following mRNA vaccines revealed a much higher incidence of this adverse event. In fact, 9 of 38,971 Moderna vaccine recipients suffered documented anaphylaxis. This equates to 230 per million, or 38 times higher than the CDC estimate.
Efficacy — but at what cost?
The proper measure of the efficacy of any medication is how it affects all aspects of a patient’s health. But in evaluating the Moderna vaccine, the FDA looked only at its effect on COVID.
There are early but disturbing indications that vaccination worldwide has had dramatic effects on other aspects of health, unrelated to COVID. Insurance company trade journals report that they are paying life insurance claims for adults 18-64 years of age at a rate 40% higher than during any normal year.
This number from OneAmerica (Indianapolis) has been echoed by other studies in Europe. A leaked spreadsheet from the Defense Medical Epidemiological Database showed that incidences of many medical problems in the U.S. military surged in this year of vaccination. For example, heart attacks were up 343%, cancers up 218%, among many other disorders.
Could it be that the vaccines have had a small benefit for COVID severity and disastrous impact on other aspects of human health?
We now have some real-world experience with the efficacy of vaccines. For example, we know the virus mutated to a more contagious, less lethal form. Omicron is now the dominant form of the virus in the U.S. and most other parts of the world today.
The Omicron mutations are concentrated in the spike protein — the only part of the virus to which the vaccinated population has immunity. This suggests the virus is mutating in response to the vaccine, and mutations are an important factor affecting efficacy in the long run
Nevertheless, the FDA considered efficacy data predominantly from the first five months of data (through March 26, 2021) in making its decision to fully license Spikevax, with an absolute cutoff in November, before Omicron became dominant.
- Almost all subjects in the original Moderna trial who received placebo initially were subsequently given the vaccine. How will we ever know the long-term effects of the vaccine if we have no controls with which to compare?
- Why do CDC studies of death rates based on vaccination status differ so markedly from the same question asked by independent groups in other countries?
Here, for example, is a report from Public Health Scotland stating that vaccination increases vulnerability to Omicron. Here is a similar report from England. This study shows countries with higher vaccination rates tend to have higher rates of COVID, and this one confirms the same result for U.S. states.
- We are now in an era dominated by the Omicron variant, against which all the vaccines seem much less effective. But even “follow-up data” was analyzed only through March 26, 2021, nine months before Omicron took over. Why did the FDA base its decision on data only from older variants?
- The secondary efficacy endpoint was the prevention of severe COVID-19. Now that it is accepted that there is little, if any, protective effect of mRNA vaccines from infection, the prevention of severe disease should be the primary focus of approval determination.
Moderna claims its vaccine efficacy is an astonishing 98.2% in preventing severe COVID-19 (Table 8). Pfizer’s was 96.7% (Table S6).
The reason for the calculated difference in efficacy between these two products was not from a lower incidence of severe disease in the vaccine arm of Moderna’s trial (it was lower in Pfizer’s trial). It was because the incidence of severe disease in Moderna’s placebo group was much higher than in Pfizer’s.
Severe COVID-19 in Pfizer’s placebo group occurred in 30 participants out of 23,0379. In Moderna’s, severe disease occurred in 106 participants out of 14,164 that received a placebo. Why was the incidence of severe COVID-19 nearly six times higher in Moderna’s placebo group than Pfizer’s?
Postscript: Failure was never an option
In America, why are clinical trials for new drugs run by the same companies that own the drugs, and will profit from them if the trial is successful?
It’s a glaring conflict of interest, but necessary within a capitalist system. Since the trials cost, typically, hundreds of millions of dollars, only the company that will profit from the drug is motivated to invest such huge sums in testing.
In the case of the COVID vaccines, however, the development and the trials were both publicly funded. There was no excuse for contracting the same organization both to develop and test their own product.
Moderna’s development cost was funded through Operation Warp Speed in the U.S. and Pfizer through the German government. Now, the companies are reaping windfall profits, though they risked no money of their own.
This leaves us wondering, did our government ever want a fair and unbiased evaluation of the COVID vaccines? Or — after a full year of telling the public that vaccines were the only path out of the COVID crisis — did NIH feel they could not risk the possibility that the trials might fail?
There were no animal tests. There was no time to experimentally optimize dosage and delivery. They had to guess right the first time.
Maybe they thought this is what the exigency of a pandemic required — but please don’t call it “science.”