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FDA approves Pfizer infant vaccine after data altered to portray 80% efficacy

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Eliyahu Tulshinski

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Eliyahu Tulshinski

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Thu, Jun 16, 2022

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00:41 AM

97% of COVID case data dropped from analysis

FDA approves Pfizer infant vaccine after data altered to portray 80% efficacy

Previously pulled request after disappointing trial results

Frontline News shined light on Pfizer’s highly unusual initial request for FDA approval of its mRNA vaccine for use in 6-month-old infants and small children up to 4-years-old.

The article title revealed what was so unusual:

Pfizer vaccine for infants and children under five: 5 facts you need to know - Pharma giant pushes vaccine for small children despite failure in clinical trials.

Don’t worry, it might work later

How did the pharmaceutical giant plan to push through approval of a failed vaccine?

In a level of chutzpa never before displayed by Big Pharma executives, Pfizer told the FDA essentially, “don’t worry that it hasn’t worked; approve it and then we’ll add another dose and we think that it will then start working.”

Legacy media jumped on board with America's Frontline News’ assessment, but only after Pfizer itself dropped the idea (shortly after the Frontline News report). NBC News reported:

Pfizer's request for authorization for two doses was an unusual request, given that the first two shots didn't work and there is no guarantee that adding a third dose will be sufficient.

They’re back
Pfizer reacted to the pushback against approving a drug without proven efficacy by treating it as a minor set back to their marketing plan. They moved forward, adding that third dose to their experiment on children under five and announced in May that the third shot did the trick, with an “efficacy of over 80%” and “only mild to moderate side effects.”

In the CDC’s hands

The FDA held an Advisory Committee meeting on June 15, 2022, in which the committee voted in favor of an Emergency Use Authorization for the mRNA shot (as well as Moderna’s).

The CDC still has to weigh in. If the vaccines get the final approval, they would likely become available early next week.

Is there any reason not to?

Doesn’t prevent deaths

The FDA Briefing Document reveals that, in both study groups, those who received the Pfizer jabs and those who received placebo shots, “there were no deaths reported.” (p. 41). So the jabs did not decrease (or increase) the death rate. With regards to death, the efficacy rate is therefore zero percent (neither positive nor negative).

Causes hospitalizations?

The briefing document reveals that only one child required hospitalization for COVID symptoms during the Pfizer study - and that child was in the group that received the Pfizer jab! (p. 6). Zero children in the placebo group were hospitalized for COVID! 

This is known as negative efficacy - the odds of getting hospitalized for an illness are worse if vaccinated than not (though in this case the negative efficacy is statistically insignificant since it’s just one case).

Causes severe COVID?

Similarly, severe COVID was reported in 6 children (out of 3013) who received the Pfizer jab (0.2%), but only 2 (out of 1513) who received the placebo (0.1%). (p. 6). 

Effective?

The headlines could have thus read, 

Pfizer vaccine for small children doesn’t prevent death; doubles chance of severe COVID; hospitalization more likely. No chance for approval.

So where does the claim of efficacy come from? Pfizer came up with that number by ignoring deaths, hospitalizations, and severe COVID and only looking at cases of COVID, where a case is a positive COVID test and one COVID symptom, even one as mild as increased cough, muscle pain, diarrhea, or poor eating (p. 66).

80%?

And how did Pfizer get their 80% number for preventing positive COVID cases? 

There were a total of 375 COVID cases in the trial — 225 children who received the mRNA shot and 150 in the placebo group. (p.39). Adjusting for the larger sample size of those receiving the Pfizer shot, it turns out that 9.9% of the placebo group had COVID while 7.5% of the Pfizer group had it. That would be a 24% reduction in COVID cases.

This creates a problem for Pfizer, because the FDA’s guidance for the Licensure of Vaccines to Prevent COVID-19 states,

To ensure that a widely deployed COVID-19 vaccine is effective, the primary efficacy endpoint point estimate for a placebo-controlled efficacy trial should be at least 50%.

How did Pfizer get its 24% efficacy above the FDA’s 50% threshold?

Pfizer removed 365 (97%) of the 375 COVID cases that occurred in its trial on children under 5 and analyzed only the remaining 10, claiming those to be significant cases since they occurred at least seven days after dose 3.

Of those 10 cases, 7 were in the placebo group and 3 were in the Pfizer group, leading to the 80% efficacy claim.

No long term efficacy data

The recording of cases stopped after less than 3 months - the first shots were February 1, 2022 (counting COVID cases from 7 days after the shot or February 9, 2022) and Pfizer made a “data cutoff of April 29, 2022.” (p. 36).

Statistically significant?

If you think giving an emergency use authorization to millions of babies, infants and toddlers based on 7 placebo cases versus 3 Pfizer cases seems shaky, you’re not alone. Pfizer scientists themselves called for more than twice as many cases in the trial protocol:

These descriptive efficacy data are preliminary, as the protocol specified 21 cases have not yet been achieved. (p. 39).

Pfizer planned to recalculate the efficacy after they reached 21 cases that occurred more than 7 days after the third dose. This never happened, as Toby Rogers. Ph.D., explains.

But Pfizer never reached 21 cases post dose 3 — probably because the overwhelming majority of children already have natural immunity. 

So in the press Pfizer stated that 10 cases is inadequate (it is) but then that became the final version of the application — because they do not care and they don’t think the FDA has the stones to stop them. 

Really somewhere between 14% and 97%

The FDA Briefing Document explains the statistical significance of Pfizer not meeting its own protocol.

Vaccine efficacy post Dose 3 cannot be precisely estimated due to the limited number of cases accrued during blinded follow-up, as reflected in the wide confidence intervals associated with the estimates. (p. 39).

What are those “wide confidence intervals?” The document lists them as follows:

VE was 80.4% (95% CI: 14.1%, 96.7%).  (p. 39).

VE stands for Vaccine Efficacy, which is listed as being 80.4%.

The Confidence Interval (CI) was calculated to be between 14.1% and 96.7% (with a 95% chance of accuracy).

That means that 95% of the time that numbers come out like they did in the Pfizer study, the efficacy will be at least 14.1% and not more than 96.7%. [5% of the time, it will be lower or higher than that range]. 

That’s right, the range starts as low as 14.1% efficacy! A wide range indeed, as noted by the FDA Briefing Document.

Not as good as natural immunity 

All these maneuvers to get the 80% efficacy (ignoring 365 of the 375 COVID cases while not measuring deaths, hospitalizations or severe cases at all, and using so few cases that the range starts as low as 14.1% efficacy), still do not get the efficacy up to that obtained naturally, as noted by Dr. Rogers:

About 10% of the children in the clinical trial had evidence of prior SARS-CoV-2 infection when they enrolled (“at baseline”) — and none of those kids got Covid during February 2022 through April 2022 when the Omicron variant was prevalent in the U.S. (p. 56). 

Do you know what that means? During the crucial study period that Pfizer and the FDA really want everyone to focus on — natural immunity was 100% effective.

Mild to moderate side effects?

Check back for our continued analysis of the Pfizer shot for small children as we check the veracity of the company’s other major claim: that the babies and toddlers suffered, “only mild to moderate side effects.”

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