COVID vaccine trials document birth defects, lost pregnancies, FOIA requests reveal
Federal inspector general faults National Institutes of Health for not consistently posting clinical trial results.
The Facts Inside Our Reporter’s Notebook
- 22 of 50 pregnant women who took Pfizer's vaccine lost their pregnancies
- compared to an iPhone by its CEO
- Moderna Spikevax approval
- granular review in TrialSiteNews
- Her bio
- Office of Inspector General faulted the National Institutes of Health
- the report said
- CDC's surreptitious removal of its claim
- HCA Healthcare
- report from its "Scholarly Commons" section
- HCA told Berenson it removed the report
- complaints by senior FDA vaccine officials
- Epoch Times
More than a year and a half after Pfizer and Moderna COVID-19 vaccines received U.S. emergency use authorization (EUA), the public is learning about negative clinical trial results related to pregnancy from Freedom of Information Act requests.
A crowdsourced review project led by deplatformed feminist Naomi Wolf discovered 22 of 50 pregnant women who took Pfizer's vaccine lost their pregnancies, which the company attributed to unnamed "other" causes than vaccination.
Meanwhile trial documents for Moderna's vaccine just obtained by Just the News reveal birth defects in some offspring of female rats given the vaccine.
"mRNA-1273-related variations in skeletal examination included statistically significant increases in the number of F1 rats with 1 or more wavy ribs and 1 or more rib nodules," says the toxicology section near the end of the 699-page FOIA production, provided to Just the News. "Wavy ribs appeared in 6 fetuses and 4 litters with a fetal prevalence of 4.03% and a litter prevalence of 18.2%. Rib nodules appeared in 5 of those 6 fetuses."
While it claimed skeletal variations are "structural changes that do not impact development or function of a developing embryo," Moderna acknowledged the connection to the vaccine. "Maternal toxicity in the form of clinical observations was observed for 5 days following the last dose ([gestation day] 13), correlating with the most sensitive period for rib development in rats (GDs 14 to 17)."
These findings directly contradict the FDA's claim in its Moderna Spikevax approval that the study found "no vaccine-related fetal malformations or variations and no adverse effect on postnatal development," according to a granular review in TrialSiteNews last month by Sasha Latypova.
Her bio says she's a former pharmaceutical executive with 25 years' experience in clinical trials and regulatory approvals who has interacted with the FDA through a consortium on "improving cardiac safety assessments in clinical trials."
The FDA has not responded to Just the News queries about the Pfizer and Moderna trial documents.
Scrutiny of clinical trials is also coming from inside the government. This week the Department of Health and Human Services Office of Inspector General faulted the National Institutes of Health for not ensuring requirements were met in federally funded trials.
In more than half of the 72 trials whose results were required to be posted on ClinicalTrials.gov in calendar year 2019 or 2020, the IG found results were either not submitted at all (25) or late (12). Half each were conducted internally and externally, with outside scientists faring worse than NIH scientists on compliance.
The agency not only "took limited enforcement action when there was noncompliance" but kept funding "new research of responsible parties that had not submitted the results of their completed clinical trials," the report said. Failure to timely post trial results deprives healthcare providers, patients and researchers of important information, "including information on adverse events."
Stanford medical professor Jay Bhattacharya, coauthor of the anti-lockdown Great Barrington Declaration, explained the importance of the database to "Just the News Not Noise." Negative trial results don't get published in journals, "so when the NIH doesn't follow the rule, essentially, it's painting an incomplete, biased picture" of what taxpayer money is supporting, he said.
Regarding the CDC's surreptitious removal of its claim that mRNA and spike proteins from COVID vaccines "do not last long in the body," Bhattacharya said the agency "has not been very good at forthrightly explaining to the American people exactly what the risks are."
The agency would face less distrust if it weren't portraying vaccines as "equally important for every single person" regardless of age or prior infection," he added.
Judicial Watch's FOIA litigation has recently revealed complaints by senior FDA vaccine officials that vaccine makers and Biden administration officials were pressuring them to authorize boosters without data and on timelines that "make no sense."
But the watchdog has yet to publish the Moderna trial documents it received from the FDA months ago. "We have at least a dozen releases in the pipeline," JW told Just the News. "We process them as we can."
Neither Epoch Times nor Latypova, the former pharma executive, posted the documents in their articles either. Just the News obtained the April 13 production from a third party after Judicial Watch's external representatives said Wednesday morning the watchdog wasn't sure which document Epoch Times was citing.
Latypova told Just the News she first reviewed the Moderna trial documents at the "informal request" of Judicial Watch but became impatient waiting for it to publish them.
"The children are now getting injected with this poison, this is being pushed on pregnant women with catastrophic consequences, so I just went ahead and published my review when the FDA was 'approving' it in babies, as I could not stand this anymore," Latypova wrote in an email, referring to the expansion of the EUA to children as young as 6 months.
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