Recently surfaced communications and regulatory documents show that senior US health officials and Pfizer were aware of potential pregnancy-related risks before Covid-19 vaccines were widely recommended for pregnant women.
Speaking to RCR, investigative journalist Sonia Elijah said Fauci had acknowledged in a January 2021 text exchange a theoretical risk that fever and immune reactions following a second mRNA vaccine dose could be associated with miscarriage during the first trimester.
Elijah said this was significant because Covid-19 vaccination was subsequently strongly promoted for pregnant women in the US and globally.
Elijah has been digging through those records, including previously private messages involving former US health official Anthony Fauci and Pfizer’s own pregnancy safety data.
A March diary entry also records discussions about animal research examining the immune response in amniotic fluid. Elijah says the entry shows officials discussing how the FDA could publicly emphasise reproductive toxicology studies described as “clean” to counter the findings. “This is a big thing of managing the optics,” she said.
Elijah was one of the first journalists to break the story on Pfizer’s Pregnancy and Lactation Cumulative Review report submitted to the FDA, having discovered it amongst hundreds of other documents released in an April 2023 data dump of the Pfizer papers.
Elijah has also examined Pfizer’s early post-authorisation pregnancy data. It recorded 270 pregnancy cases, but outcomes were unknown for 238. Of the 32 known outcomes, 23 were reported as spontaneous abortions. Those figures cannot be used to calculate a miscarriage rate because most pregnancy outcomes were unknown.
She also points to later Pfizer safety reports containing thousands of adverse-event reports involving pregnancy, including miscarriages, fetal deaths and congenital anomalies. The reports noted that limited medical and obstetric information often prevented an assessment of whether vaccination caused the reported outcomes.
Elijah argues that the documents reveal a stark difference between private discussions and the public messaging at the time. “We’ve got now Fauci on record being very aware of these harms,” Elijah said, while “in public, a completely different message” was being given.
Elijah’s work reported extensively on other Pfizer documents that raised questions about what the company and regulators knew as the vaccine rollout expanded.
A Pfizer Pregnancy and Lactation Community Review recorded 458 pregnancy exposure cases, with more than half involving adverse events. Reports included spontaneous abortions, and cases of transplacental exposure involving premature deliveries and neonatal deaths.
Elijah said the review was signed off in April 2021, just days before the CDC began recommending Covid vaccination for pregnant women. She also noted that pregnant women were supposed to have been excluded from Pfizer’s clinical trials, raising questions about how much pregnancy-specific evidence was available when recommendations were provided.
The review, which also covered breastfeeding, showed that around 20% of the lactation cases reported adverse events in breastfed infants through what Pfizer termed the “trans mammary route”, Elijah said. She noted that subsequent scientific papers reported detecting vaccine mRNA in breast milk.
Separate animal biodistribution studies have also raised concerns about where vaccine material travelled in the body, she said. “It went everywhere. To the ovaries, to the testes, across the placenta, to the unborn child”.
She cited an analysis of 220,000 pregnancies using Israeli health data, which she said found excess fetal losses following vaccination. “That accounted for at least 4 additional losses per 100 pregnancies, which is a very strong signal going off.”
Elijah argued that the emerging safety signals were not adequately investigated or communicated when health authorities were encouraging pregnant women to be vaccinated. They knew of these harms early on; I just want to really stress that,” she said.
She contrasted the usual caution around pregnancy with what she described as a strong push to vaccinate despite the absence of long-term safety data. “We were all lab rats. Particularly pregnant women were used as lab rats”.
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