TrialSite has reviewed confidential Pfizer documents that raise questions about the safety of its mRNA-based COVID-19 vaccine.
Pfizer mRNA Vaccine Trial Audit Discovers Misreported Patient Deaths
Included in the documents is an April 22, 2020 audit report that shows Pfizer’s contractor in charge of managing its COVID-19 mRNA-based vaccine’s clinical trials misreported details about at least three study patient deaths.
Nonclinical Study of Pfizer Vaccines Shows Accumulation of mRNA LNP in Rat Livers
Another Pfizer document reviewed by TrialSite is a nonclinical study, which shows that in laboratory animals (mice), Pfizer’s mRNA lipid nanoparticles concentrated in the liver to an extent previously unknown.
Audit Reveals Deaths Recorded as Adverse Events
The audit report shows that the pharmaceutical company’s clinical trials management firm, Ventavia Research Group, reported that already deceased patients had experienced adverse events caused by the vaccines.
“There cannot be a date later than the date of death,” wrote an auditor about a patient named Josee Robillard. “Please remove data from the COVID Illness visit and add COUGH and SHORTNESS OF BREATH AS AEs.”
“AE” is an abbreviation for adverse events potentially caused by Pfizer’s mRNA COVID vaccine.
Another entry for a patient named Jen Vasilio reads: “The symptoms were reported to the site after subjects death via subjects family, per medical monitor, this data is to be entered.”
And another entry for a patient named Amol Shinde reads: “Please verify subject ended study on [redacted] 2020 due to death however COVID ILL visit performed on 14DEC2020 after death details, which cannot [sic] possible. Kindly consider updating dates or else clarify. Thank you.”
Ventavia came under fire for allegedly doctoring Pfizer’s trial data, including withholding information that would raise concerns about the pharmaceutical giant’s vaccines’ safety. An ongoing federal lawsuit claims the Texas-based clinical research organization mismanaged patient data, mishandled vaccines, failed to abide by patient treatment protocols and failed to maintain “blinded study” protocols among other allegations. The British Medical Journal (The BMJ) authored an article on the Ventavia data issues which led to fact check censorship by Facebook.
Pfizer’s Nonclinical Overview Document
A separate confidential Nonclinical Overview document dated February 8, 2021, included biodistribution data that shows Pfizer’s mRNA lipid nanoparticles accumulated in rats’ livers to a higher degree than other organs.
Pfizer Biodistribution Data Shows mRNA in Rat Livers
To gain insight into the biodistribution of the actual mRNA COVID vaccine in humans, Pfizer researchers dosed a variety of animals subjects with two types of surrogate luciferase RNA – each with different excipients. One RNA surrogate was designated ALC-0315 and used an amino-lipid and the other, designated ALC-0159 used polyethylene glycol, or PEG.
“In vitro metabolism of ALC-0315 and ALC-0159 was evaluated in blood, liver microsomes, S9 fractions, and hepatocytes from mice, rats, monkeys, and humans,” the study authors wrote. “The in vivo metabolism was examined in rat plasma, urine, feces, and liver samples from the PK study.”
According to the study, as much as 60 percent of a 15.3 mg/kg analyte dose of ALC-0315 surrogate luciferase RNA was found in male rats’ livers. And as much as 20 percent of a 1.96 mg/kg analyte dose of ALC-0159 was found in male rats’ livers.
“Total recovery (% of injected dose) of LNP outside the injection site was greatest in the liver and was much less in the spleen, adrenal glands, and ovaries,” the Pfizer study authors wrote.
Elsewhere, the study explains that the surrogate luciferase RNA approximates the biodistribution of the actual mRNA antigen encoder, BNT162b2. Luciferase is used as a substitute so that the LNP is bioluminescent and can be detected on scans.
“The biodistribution of the antigen encoded by the RNA component of BNT162b2 is expected to be dependent on the LNP distribution and the results presented should be representative for the vaccine RNA platform, as the LNP-formulated luciferase-encoding modRNA had the same lipid composition,” the authors wrote.
Pfizer Researchers Say mRNA Vaccine Cause No Animal Deaths, No Adverse Events
The study goes on to describe a dosing regimen that exposes the rats to the actual mRNA-based COVID vaccine.
“In conclusion, administration of BNT162b2 (V9) at 30 μg RNA/dosing day via IM injections weekly for 3 administrations to male and female Wistar Han rats was tolerated without evidence of systemic toxicity,” the authors wrote. “Dosing of BNT162b2 (V9) produced changes consistent with an inflammatory response and immune activation. The findings in this study are consistent with those typically associated with the IM administration of LNP-encapsulated mRNA vaccines.”
The authors said that determinations of genotoxicity and carcinogenicity were beyond the scope of the study. They also claimed that, overall, there was no detectable toxicity caused by the vaccine, including no impact on fertility and no recorded deaths.
Regarding concentrations of mRNA in the liver, the authors wrote: “The liver finding was reversible, not associated with changes in markers of hepatocyte injury and not considered adverse.”
Early Biodistribution Studies Show mRNA Accumulates in Sensitive Organs
Earlier revelations of documents associated with Pfizer-submitted data to Japan revealed mRNA biodistribution in laboratory animals included substantial quantities in subjects’ ovaries, testicles, and other organs.