In the month of June alone, the FDA demonstrated its most extreme regulatory capture to date with its Vaccine and Related Biological Products Advisory Committee's (VRBPAC) approval for (1) Emergency Use Authorization (EUA) to vaccinate the final age cohort of six-month-old babies to five-year-old toddlers (6/14-15/22); and (2) Emergency Use Authorization (EUA) to reformulate Pfizer and Moderna original vaccines to accommodate current and future variants without clinical trials (6/28/22).
The medical-science world exploded both in support and opposition relative to both decisions. Several concerns relative to the first decision approving vaccinations for babies and toddlers on June 14-15, 2022, are below.
Those favoring inoculating babies and toddlers with mRNA gene therapy technology expressed relief and optimism for returning to normal activities sans fears of COVID-19 for their youngsters.
Proponents admonished the FDA for prolonging approval for immunizing children and leaving them vulnerable to the disease. Contrarily, those opposed to vaccinating children expressed exponentially greater fear and alarm due to the absurdly inconclusive data submitted on mRNA vaccines' safety and efficacy for this new cohort, who have statistical zero risk (.0027 percent) for death from COVID-19.
Data Charts, Graphs, and Tables Hold a Deeper Truth
Both Pfizer and Moderna presented their clinical trial findings to VRBPAC on June 14-15, 2022. FDA also presented its analysis of the data submitted. Various comparative visuals provide optimistic scenarios for mRNA vaccine efficacy until the underlying data is further examined in context. Whether overlooked or ignored is moot at this juncture, as the policy to inject babies and toddlers was unanimously approved 15-0.
Beginning with a clinical trial comprised of nearly 4,500 babies and toddlers, Pfizer's trial size was reduced by 3,000 to 1,500 participants (50 percent vaccinated and 50 percent given placebos), However, only 82 children ages 6-23 months and 143 children ages 2-4 years old were chosen for an “immunogenicity population” for data submission to the FDA and VRBPAC review.
Blood work was only drawn from the vaccinated group, with none from the placebo group, one month post Dose 3 and measured for antibodies against the ancestral SARS-VoV-2 strain. Not only did this disqualify the study as a random control trial; no explanation was given for selecting these particular children, a curious omission since they represented less than 5 percent of the original trial population.
During its April 6, 2022, meeting, VRBPAC concluded that, even though antibody responses can be generated, there are no known “correlates of protection” to predict immunity to SARS-CoV-2. Yet comparative analysis of antibody responses, called “immunobridging,” was the new measurement used for determining vaccine efficacy based on neutralizing titers, justifying the installation of mRNA gene therapies into babies and toddlers.
Never mind that the comparisons were to antibody levels from the six-months-to-five-years cohort and those from 170 participants in the 16-to-25-years adult cohort in a previous Pfizer study, again with no explanation as to why those specific 170 were chosen. In the end, VRBPAC acknowledged that immunobridging, comparing antibody levels, does not suffice for the purpose of determining efficacy in preventing transmission or infection of COVID-19.
PFIZER Misses Emergency Use Authorization Efficacy Requirement
It is important to note that only 375 participants (225 in the treatment group and 150 in the placebo group) had COVID-19 (positive PCR tests). This small number of infected participants is arguably reflective of the lower risk to children for symptomatic COVID-19.
Overall, the efficacy of the mRNA vaccines was approximately 20 percent. Pfizer eliminated the control group in November 2021 by vaccinating the placebo group, claiming ethics considerations that they could not withhold life-saving vaccines any longer. Pfizer further diminished its clinical trial's veracity when it stopped collecting new data on Dose 3 on April 29, 2022. The introduction of a third dose is controversial because Pfizer began administering Dose 3 in February 2022, rendering the reported efficacy as short-term, and well below the 50-percent threshold that the FDA established for Emergency Use Authorization in June of 2020. Still, the three-dose mRNA protocol for babies and toddlers was unanimously approved by VRBPAC on June 15, 2022.
One more factor unaddressed in the clinical trial for babies and toddlers is that participants were still receiving their other scheduled vaccinations during the clinical trial period, arguably compromising the entire trial. It will likely serve a future narrative to add it to the CDC's childhood-vaccination schedule, critical to Pfizer for securing indemnification from liability due to harm caused by its mRNA products.
The PREP and CARES Acts allow for Emergency Use Authorization to provide full indemnification for any harm up until the product(s) is fully approved and licensed, at which time the protection from liability ends. However, if the licensed product is recommended for children, indemnification automatically attaches to the manufacturer and also applies for any adults who receive it, as well.
Editorial Board member Allysia Finley noted concerns over the FDA's lowering standards for approving mRNA vaccines for the youngest cohort in her recent editorial, highlighted in Children's Health Defense The Defender, “Why The Rush For Toddler Vaccines?”
“Children are at low risk of dying from COVID-19: Only 209 kids between 6 months and 4 years old have died from COVID-19 – about 0.02% of all virus deaths in the U.S. About half as many toddlers were hospitalized with COVID-19 between October 2020 and September 2021 as were hospitalized with the flu during the previous winter.
The two children in Pfizer’s trial who got sickest with COVID-19 also tested positive for other viruses. It’s possible that many hospitalizations attributed to COVID-19 this winter were instigated or exacerbated by other viruses.
The FDA authorized vaccines for toddlers based on a comparison of the antibodies they generated to the original Wuhan variant with those in young adults who had received two doses. But two doses offer little if any protection against Omicron infection in adults, and even protection against hospitalization is only around 40% to 60%.
Vaccinated toddlers in Pfizer’s trial were more likely to get severely ill with COVID-19 than those who received a placebo. Most children who developed multiple infections during the trial were vaccinated.”
The CDC Is iGnoring Its Pharmacovigilance Responsibility to Monitor COVID-19 Safety Signals in its Vaccine Adverse Event Reporting System (VAERS) as Defined in Its January 2021 Briefing Document Outlining Its Standard Operating Procedures.
Proportional Reporting Ratio (PRR) is a calculation the CDC routinely performs on its Vaccine Adverse Event Reporting System (VAERS) to identify safety signals across its platform due to adverse reactions from all vaccines, including those from COVID-19. However, in response to a FOIA request by Childrens Health Defense, the CDC in a letter to CHD, admitted it is not monitoring VAERS for COVID safety signals, nor calculating the automated weekly PRR that is done for most other vaccine data, claiming it is outside it purview.
According to CHD, “This [PRR] is a method of comparing the proportion of different types of adverse events reported for a new vaccine to the proportion of those events reported for an older, established vaccine. If the new vaccine shows a significantly higher reporting rate of a particular adverse event relative to the old one, it counts as a safety signal that should then trigger a more thorough investigation.”
If not the purview of the CDC, then whose?
“Pfizer Asks Court to Dismiss Whistleblower Lawsuit Because Government Was Aware of Fraud”
In an interview with The Defender, the lawyer representing whistleblower Brook Jackson, Robert Barnes, said Pfizer is arguing the court should dismiss Jackson’s lawsuit alleging fraud in Pfizer’s COVID-19 clinical trials, because the U.S. government knew about the wrongdoings but continued to do business with the vaccine maker.
In other words, according to Pfizer, it done it, but it isn't fraud if the government is in on it? The absurdity of Pfizer's defense would be content for a comedy, except the court is actually considering it. Pfizer is using an equally absurd precedence of “materiality,” allowing that if the government issues a check despite knowing of the fraud, the fraud is not material to the contract. If that isn't a load of hooey on toast, nothing is.
In Conclusion, a List of the Emergency Use Authorization Requirements
It is important to review the FDA's four legal requirements for granting Emergency Use Authorization for vaccines. They are as follows:
(1) Products must exceed 50-percent efficacy in prevention/transmission of disease or condition.
(2 ) Informed consent must be received by all participants who are administered an EUA vaccine or booster, including written acknowledgment of all the known risks and benefits associated with the product.
(3 ) An established risk/benefit ratio where the benefits demonstrably exceed the risks.
(4 ) No other treatment is available.
To date, there are problems with manufacturers complying with one or more of these requirements and this should greatly concern the public-health authorities and public.