Safe and Effective? Part 3

A closer look at the Pfizer/BioNTech SARS-COV2 vaccine trial raises questions about what investigators and the FDA knew and didn't know about the product's efficacy from the start

In Safe and Effective? And Safe and Effective? Part 2, I broke down the key findings of the initial Pfizer/BioNTech Covid-19 vaccine trial and information taken from a publicly available memorandum between Pfizer and the FDA, the published trial data in the NEJM and CDC analyses of their own Vaccine Safety Surveillance systems. This is what was shown:

• The risk/benefit ratio of the vaccine did not support Emergency Use Authorization

• There is powerful evidence of investigator unblinding in what was purportedly a double blinded, randomized, placebo control study.

• This is the key allegation raised by Brook Jackson, a whistleblower at a Clinical Research Organization hired by Pfizer

• Investigator unblinding raises the possibility that approximately 1% of vaccine recipients suffered serious adverse events that were not counted because they were pulled from the evaluable population soon after they received the second dose of the experimental vaccine

• CDC’s own analysis of V-Safe, an active surveillance system, confirms that 0.8% of bivalent booster recipients suffered a Serious adverse event within a week of inoculation. This number likely reflects the SAEs in the original vaccine.

These findings raise serious questions around the safety of the vaccine for me. The fact that the FDA and the CDC saw no concern raises serious questions around their credibility and competence in my eyes as well.

Some people may still be able to explain all this away by coincidence, but I can’t. The evidence of investigator unblinding was the “red pill" for me. The fact that the FDA didn’t pick up on it means that there wasn’t any real regulatory oversight occurring either. 

Hundreds of thousands of serious adverse events are being reported in VAERS. They are not being ignored because they are fabricated or inaccurate; they are being ignored because our health authorities have chosen not to investigate them.

This is an important distinction to make. Many people are quick to conclude that the reason why there is no investigation into these reports is because they are not credible. Yet the Pfizer trial predicted that there would be a plethora of SAEs, many more, in fact, than has been reported in VAERS. 

Why are our health authorities dismissing them all out of hand? Is it unreasonable to expect them to investigate just a small subset of the 30,000+ reported deaths after vaccination just to make sure there isn’t any harm being done? Are they afraid of what might be found?

These are the same authorities that chose not to ask Pfizer about the stunning number of vaccine participants that dropped out of the adult and pediatric trial within a week of getting their second dose.

On what grounds can we or the CDC assume that very few (or none) of the reports of vaccine injury are not credible? I can’t find any. There is no reason to believe that these products are as safe as touted. There is a very real possibility that they are responsible for untold injuries already.

But was it excusable because of the protection it offered? We have to take a  harder look at what the trial found with regard to efficacy to answer that question...

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Pfizer did NOT test everyone who got sick

The published trial results of the Pfizer/BioNTech Covid-19 vaccine indicated that:

• Vaccine Efficacy (VE) in preventing Severe Covid-19 was 90% because 9 out of approximately 20,000 placebo recipients ended up in the hospital with Covid compared to only 1 of the vaccine recipients among an equal number of people

• VE in preventing symptomatic Covid-19 was 95% because 162 placebo recipients got Covid compared to only 8 vaccine recipients

• Covid-19 infection was defined as symptomatic disease confirmed with a positive PCR test

• “Severe Covid-19” was PCR positive disease that required hospitalization

Because the FDA ignored both the safety signal and the evidence of medical fraud and instead touted the remarkable efficacy of the vaccine, the public believed that a miracle vaccine had been developed at “warp-speed” and those who eschewed the best of modern medicine were ignorant, foolhardy and a threat to public safety.

Beyond investigator unblinding, Brook Jackson had other concerns. She also reported that not every trial participant who expressed Covid symptoms was being tested.

I had the opportunity to ask her about this off the record. Loosely quoting her, “We didn’t have enough PCR tests or people to deal with all the people that got sick”. This is yet another massive allegation. If only a subset of participants who contracted Covid in the trial were included in the efficacy calculation, we cannot be certain of how good the vaccine really was in preventing infection.

This is in fact what some of her colleagues said in a report published by the British Medical Journal.

“In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. Laboratory confirmed symptomatic covid-19 was the trial’s primary endpoint, the employee noted.”

We are again faced with the biggest question, why should we trust her?

Once again, we don’t have to trust her to know she is telling the truth. The proof of her allegation also comes from the same memorandum between Pfizer and the Vaccine and Related Biologic Products Advisory Committee:

This section of the memorandum notifies the FDA that during the trial there were trial participants that were “suspected” of having Covid that were not PCR-confirmed. The first paragraph tells us that two of the cases ended up being hospitalized but never tested positive by PCR. Both occurred among the vaccinated group. Pfizer believes that these represent reactogenicity (an inflammatory response) following the vaccine. 

It is unclear how they reached their conclusion and begs further questions. So they didn’t test positive by PCR—why didn’t they do another test, specifically an antibody level to see if their immune system was exposed to the nucleocapsid portion of the virus (something that would only be positive from viral exposure and not the vaccine itself)?

However the bigger questions are raised in the second paragraph. There were 3,410 cases of suspected but unconfirmed Covid-19 in the study.

Unconfirmed.

What does that mean?

In the first paragraph, where Pfizer describes what happened to two participants that were hospitalized with Covid symptoms, “unconfirmed” meant that they tested negative for Covid-19 by PCR. Are they implying that all of the other 3,412 people who were suspected of having Covid-19 also tested negative? If so, why didn’t they say so?

According to the study protocol, Covid-19 infections had to be symptomatic and confirmed with a positive PCR test. “Unconfirmed” can mean only one of two things:

1. They all tested negative by PCR or

2. They weren’t tested

If they all tested negative, why would Pfizer choose to mention these participants in the first place? If they didn’t have Covid, they didn’t have Covid. Their outcomes should not be included in the determination of Vaccine Efficacy.

So why did they let the FDA know about these “suspected” cases but not mention them in their published and widely cited trial results in the NEJM? We cannot know the answer. To me, this is probably a gesture of “transparency”. Pfizer was letting the FDA know up front, prior to the hearing on Emergency Use Authorization, that there were thousands of participants who may have contracted Covid during the surveillance period but were not tested. In other words, if a VE of 95% as calculated from 170 outcomes turns out to be accurate when given to the public, great! If it doesn’t, oh well, we let you know that there was some uncertainty around the data from the beginning.

We can only speculate what Pfizer’s intention behind this disclosure was. Nevertheless, it’s certain that if Pfizer was ever brought to task around their efficacy claims, this disclosure shifts blame from the manufacturer to the regulators.

Note that if every one of the 3,412 tested negative this would mean that less than 5% of all the people who had symptoms of Covid-19 in the trial actually had a positive PCR test (recall that there were 170 participants that came down with symptomatic, PCR positive Covid). Is it reasonable that only 1 in 20 people expressing Covid-19 symptoms during a Covid-19 pandemic would test positive by PCR?

I don’t think so. It’s my opinion. This is another reason why I think it is more likely that Pfizer didn’t test any of them. This is what Brook and her associates are reporting.

This is another stunning revelation. The investigators should have treated those participants with Covid-19 symptoms with great attention. These were the outcomes they were waiting for. Although over 40 thousand people were recruited to participate in this trial, it was only those who succumbed to the disease that contributed to the calculation of vaccine efficacy.

Why didn’t they test them? Pfizer couldn’t provide enough PCR tests or testers? If they didn’t have enough PCR tests, why didn’t they run an antibody test to see if they were recently exposed to SARS-COV2?

The fact that this many participants may have had Covid-19 but were not included in the vaccine efficacy calculations raises questions about how good the vaccine really was. Not only is the vaccine’s safety in question, its efficacy is too.

The problem is, we don’t know how many of those “suspected cases" really were cases and how they may have been distributed among the vaccine vs. placebo recipients. Although the placebo recipients with confirmed Covid outnumbered the vaccine recipients by 20:1, they only comprised a modest majority among this “suspected” group (about 9:8).

We are forced to examine the implications of these numbers. None of them are included in the final determination of vaccine efficacy. This means that the investigators assumed that none of them had Covid-19 even though they clinically looked like they did.

For the purposes of illustration, let us assume that every single one of the placebo recipients (1,816 of them) in this large “suspected” group actually did have Covid-19. If so, how would the VE change as a function of the percentage of vaccinated recipients who may have Covid-19 too?

The graph above demonstrates how drastically VE would have changed if just a portion of the 1,594 vaccine recipients who were “suspected” of having Covid-19 actually did have Covid-19. Note that even if we assumed that all 1,816 placebo recipients in the suspected group had Covid-19, it would only take about 5% of the vaccine recipients to be PCR positive to confirm that VE, as reported to the public, was accurate. Any more than 5% would render the reported VE of 95% an exaggeration.

The graph also demonstrates that if 100% of the placebo recipients in this group had Covid and only 60% of the vaccinees also had Covid, the calculated VE would hover around 50%, the minimum efficacy required for Emergency Use Authorization.

On the other hand, if we instead assume that all of the 1,594 vaccine recipients in the suspected group actually had Covid, how would the Vaccine Efficacy have changed as a function of placebo recipients that actually had Covid?

As demonstrated in this graph, even if 80% of the placebo recipients in the suspected group had Covid-19, the VE would be about 0, i.e. completely ineffective. Anything less would have resulted in a negative efficacy meaning that the vaccination would have increased the risk of getting Covid-19.

If every person in the suspected group, vaccinated AND “placeboed” actually had Covid, the VE would have been only 19%.

To be clear, nobody knows how many of those suspected of having Covid actually did have Covid, but we can see that the distribution of Covid cases in the symptomatic, suspected group could have dwarfed the contribution of the 170, PCR positives that were used to calculate VE.

The point is that this group of suspected Covid-19 cases introduces a tremendous amount of uncertainty despite the assurances that the vaccine was incredibly effective.

At this point we have allegations that the trial sites were not equipped or staffed to test all the participants who were coming down with symptoms. We also know that Pfizer themselves reported a large number of “unconfirmed” Covid-19 cases.

Add to it Ms. Jackson’s allegations of investigator unblinding which was corroborated by the inexplicable disparity between the number of placebo and vaccinated participants that were dropped from the trial soon after the second dose. 

If the investigators were unblinded, it would be very easy to skew calculated vaccine efficacy to get the numbers you want. All you have to do is preferentially test the unvaccinated. Is this what happened?

We cannot know, but this is why unblinding in the study is so potentially damning. 

Real World Data also points to a fraudulent Vaccine Trial

Is it possible that if the trial was conducted with the rigor the public deserved it would have revealed a VE that was significantly less than reported? What would have happened if a vaccine with significantly less efficacy than 95% was unleashed upon the public? 

Would there be so-called “breakthrough infections”, i.e. vaccine failures, reported soon after the product was deployed?

Would our public health agencies start backpedaling from their initial claims of near complete protection from Covid-19 if vaccinated and focus only on the reduction of symptoms, hospitalizations and deaths?

Would there be documented “spreader events” that demonstrated the lack of effectiveness at preventing infection a few months after the vaccine campaign was launched?

Would the public be soon warned of the need for boosters because of “waning efficacy”?

Now, two years after a near world-wide vaccine campaign began, it is widely acknowledged that these vaccines do not prevent infection or transmission. However this was apparent early on, and the trials very likely predicted their own failure in this regard. The idea that a vaccine trial demonstrated a 95% efficacy in preventing symptomatic infection and then was proven to be ineffectual within months should raise questions about how rigorous and honest the investigators were to begin with.

Covid-19 vaccine proponents and pharmaceutical industry apologists would probably argue that the trial data was based on a very brief period of observation and efficacy in the medium to long term could not have been quantified. In other words, though real world outcomes eventually demonstrated that protection from the vaccine waned in a few months, that is not proof of fraud.

Yet when we look at the trial’s six month data, published in the NEJM “Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months”, we once again see remarkably high efficacy numbers in preventing infection:

How do we reconcile reported VE in excess of 90% in every subgroup in the trial after four to six months of observation while UK Heath Security Agency’s Covid-19 Surveillance data (arguably the most transparent official public data set) from September, 2021 was already reporting near zero or negative efficacy in most age groups?

The two rightmost columns in the table above compare the rates of Covid-19 cases in the fully vaccinated and unvaccinated. If you were over the age of 29 in the UK the chance that you would contract Covid if fully vaccinated was equal or greater than if unvaccinated.

Remember the large group of symptomatic trial participants that weren’t tested? This UK data would make sense if a good chunk of those “suspected” of having Covid actually did have Covid and those who were vaccinated outnumbered the placeboed by a factor of 1.2 to 1.3. This is not so unreasonable especially given Pfizer’s admission that in the seven day period after a dose of their vaccine there were more vaccinated in the suspected group than unvaccinated:

“Suspected Covid-19 cases that occurred within 7 days after any vaccination were 409 in the vaccine group vs. 284 in the placebo group.”

Pfizer attributes this to reactogenicity, or an inflammatory response that would be expected after a vaccine but not a placebo. This, of course, is a hypothesis that is not substantiated by any investigation. It could also be due to a transient period of increased susceptibility to Covid immediately after inoculation, a possibility that Pfizer chose not to acknowledge.

Nevertheless, these numbers indicate that for some periods, the vaccinated were more likely to have come down with suspected but unconfirmed Covid than those who got the placebo. To demonstrate this graphically:

The UK data shows that for most age groups, VE was 0 to modestly negative. As demonstrated above, this would have been shown in the trial if about 20 to 30% more of the vaccinated in the suspected group actually did have Covid than those who got the placebo.

The problem here is that the unvaccinated and vaccinated are not matched with regard to co-morbidities, education, wealth, behaviors and propensity to seek vaccination. Skeptics of my arguments can easily use the presence of these confounders to dismiss these findings as irrelevant.

This is the difficulty with having to rely upon observational data and not data from a trial that uses matched cohorts. But is it really possible that a vaccine that was touted as providing a 95% risk reduction in contracting Covid would, in a few months, found to provide little benefit (ages 30-39)and more risk (40 and older)? Isn’t it more likely that the VE wasn’t that good to begin with and that the public was sold a product that was not properly proven efficacious?

Of course the FDA could have put all of these questions to rest if they merely fulfilled their promises to the public and demanded that the Phase III trial continue for a full two years. Instead, Pfizer was permitted to give all placebo recipients their product within six months. We no longer have any comparative data involving matched cohorts. Was it truly because of the proven “superiority” of their product over placebo? How could they have known that the product was so good if there were so many trial participants that remained untested?

The vaccine’s benefit with regard to the degree of reduction of severe symptoms and its duration of protection it offers is debatable. The criteria for Emergency Use Authorization is not. Less than 50% efficacy would not have cut it.

Are they Safe and Effective? How do you know?

What is your intuition telling you? One may say that relying on intuition is unscientific, but where else can we turn when our agencies of public health cannot be trusted entirely, if at all?