The documents total 700 pages and contain a portion of the formal biologics license application (BLA) package that Moderna had submitted to the Food and Drug Administration (FDA) for approval of its SpikeVax mRNA vaccine.
The documents, which were obtained via a Freedom of Information Act request by Judicial Watch, haven’t yet been made public, but have been analyzed by former pharma executive Alexandra Latypova and reviewed by The Epoch Times.
Included in the documents are test results showing that Moderna mRNA shots caused statistically significant skeletal malformations in the offspring of rats that received doses of mRNA-1273 (SpikeVax mRNA) vaccine.
“[The] 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. 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,” the documents read.
“F1” refers to the rat offspring. “Wavy ribs” refers to ribs not properly shaped.
“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 (Gestation Days 14 to 17),” the documents state.
Six out of about 149 baby rats had wavy ribs, and five of those also had rib nodules.
According to Latypova’s analysis, only female rats were studied (male rats weren’t treated with the Moderna vaccine).
The females received a human dose of 100mcg SpikeVax mRNA, 28 days and 14 days prior to mating and at gestation days 1 and 13.
“[Half of the] rats [were] euthanized before delivery to examine [their] fetuses. The rest [were] followed to 21 days after delivery,” Latypova stated. “No numbers are provided for the study size.”
There is no study report in the documents, but rather only Moderna’s own interpretation of the outcomes.
The results were part of reproductive toxicology testing done by Moderna, which is the only reproductive toxicology testing that was conducted for the product, according to Latypova.
It isn’t known how the dose translates from humans to rats.
“Neither Moderna nor Pfizer provided any dose calculations or justification information for dose selection in animal studies,” Latypova told The Epoch Times.
“Doses of drugs, or especially biologics, do not necessarily have linear relationships with toxicity or efficacy. It is likely a much more complex relationship and unfortunately not known at all.”
“Reproductive toxicology is the study of adverse effects of medicinal products on reproduction. The FDA requires reproductive toxicity testing for any NME [new molecular entity] to be used in women of childbearing potential,” added Latypova, who has worked in more than 60 pharmaceutical companies, mainly focusing on creating and reviewing clinical trials, many of which have been submitted to the FDA.
Despite the lab results, the FDA issued a statement on Jan. 30 stating that there were no adverse effects on postnatal developments.
“No vaccine-related fetal malformations or variations and no adverse effect on postnatal development were observed in the study,” the statement reads.
“In a developmental toxicity study, 0.2 mL of a vaccine formulation containing nucleoside-modified mRNA (100 mcg) and other ingredients that are included in a 0.5-mL single human dose of SPIKEVAX was administered IM to female rats on four occasions: 28 and 14 days prior to mating, and on gestation days 1 and 13.”
Pfizer Vaccine Also Caused Abnormal Ribs in Rats
In August 2021, Elsevier published a peer-reviewed study (pdf) titled “Lack of Effects on Female Fertility and Prenatal and Postnatal Offspring Development in Rats with BNT162b2, a mRNA-Based COVID-19 Vaccine.”
BNT162b2 is the Pfizer vaccine product.
All the authors of the publication were employed by Pfizer, BioNTech, or Charles River, a Pfizer contractor.
This publication suggests that there was a “lack of effects” in postnatal offspring development, but the study shows that there was a 295 percent increase (8.3 percent, compared to 2.1 percent in the control group) in abnormal ribs in vaccinated rat offspring. A huge increase was reported in what is described as the “supernumerary lumbar.”
‘An Extremely Dangerous Warning Signal’
“Skeletal abnormalities in the bony rib cages are absolutely important and were statistically increased in the rat offspring of the experimental group compared with the placebo group,” Dr. James Thorp, who is board-certified in obstetrics and gynecology, as well as maternal-fetal medicine, told The Epoch Times after reviewing Latypova’s analysis of Moderna’s BLA package.
“In clinical obstetrics and maternal-fetal medicine, we see similar findings in skeletal abnormalities prior to birth that are extremely serious and often lethal.
“This was an extremely dangerous warning signal in reproductive toxicology studies and was never brought to the light of day to protect our global citizens.
“The CDC, Pfizer, Moderna, and the flagship medical journals of the medical industrial complex lied to the American public and should be held accountable.”
Thorp recently analyzed and verified the most recent Vaccine Adverse Event Reporting System data related to COVID-19 vaccines and compared them to the influenza vaccines, finding numerous abnormalities.
The CDC website recommends that pregnant women receive COVID=19 vaccines in order to “prevent severe illness and death.”
The American College of Obstetricians and Gynecologists also “strongly recommends that pregnant individuals be vaccinated against COVID-19,” adding that pregnant women’s complete vaccination should be a “priority.”
Moderna, Pfizer, the CDC, and the FDA didn’t respond to requests for comment.