Animal studies
Unlike Pfizer, Moderna kept its pregnant rodents alive to test the embryos. Documents accessed by Judicial Watch, showed a “statistically significant” number of rats were born with skeletal variations after being injected with Moderna’s mRNA vaccine. But Moderna concluded that the "Skeletal variations are structural changes that do not impact development or function of a developing embryo” and therefore “not considered adverse.”
Human trials
In the absence of any human data, Pfizer announced it would begin recruiting volunteers for a clinical trial to examine the safety and efficacy of its mRNA vaccine in pregnant women and their newborns. The trial, which began in Feb 2021, originally intended to enroll 4,000 women, but enrollment stopped in late 2021 with just 349 participants. It has been over a year since the last woman was enrolled in the trial, and all of them would have given birth by now. Recently, Marty Makary, a public policy researcher at Johns Hopkins University, objected to the secrecy. &# Here we are 18 months later, the results of those 349 women have never been made public,” said Makary.“They just recommended it for pregnant women with zero data.
In response to my questions, today I can reveal the reason why Pfizer hasn't published the study -- the company admitted it does not have the data. With the declining enrollment, the study had insufficient sample size to assess the primary immunogenicity objective and continuation of this placebo controlled study could no longer be justified due to global recommendations. This proposal was shared with and agreed to by FDA and EMA.Pfizer does not yet have a complete data set from the maternal immunization study, C4591015. Pfizer and BioNTech plan to complete the analysis of the clinical trial C4591015 and share it with global public health regulators and seek publication or presentation as is our standard practice. The FDA said it does not comment on ongoing studies.
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