The U.S. general fertility rate fell to 53.1 births per 1,000 women in 2025, a record low (CDC provisional data). The documents below show imbalances in the manufacturers’ own pregnancy data, a pregnancy trial that stopped far short of its planned 4,000 participants, menstrual effects that regulators added to labels, and ovarian uptake of the vaccine’s lipid carrier in Pfizer’s rat study.
- 3.7% vs 1.2%
- Pre-eclampsia in vaccinated against placebo (6 of 161 and 2 of 163) in Pfizer’s pregnancy trial. In the same trial, infant adverse events of special interest to six months were 5.1% against 1.3%, and major congenital anomalies 3.8% against 1.3%.Comirnaty prescribing information, section 8.1; ClinicalTrials.gov NCT04754594
- 1.97
- Rate ratio for spontaneous abortion (95% CI 1.71–2.27) in Moderna’s first periodic safety report, if half of cases were reported. Moderna writes that the observed rate “could indicate an increase in the rate if reporting rate sensitivity is poor.”Moderna SPIKEVAX PBRER No. 1, FDA-CBER-2022-1614
- 238 of 270
- Pregnancies in Pfizer’s cumulative post-authorization report, data to 28 February 2021, with no outcome provided. Of the 32 with a known outcome, 28 ended in loss or neonatal death.Pfizer 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports, FDA-CBER-2021-5683
- 1,360 vs 71
- VAERS reports of spontaneous abortion that list a COVID-19 vaccine, against reports that list other vaccines, 2021 to 2026.VAERS data files, counted from the project archive
- 1.13 (1.05–1.22)
- Adjusted hazard ratio for gestational hypertension after vaccination around conception or in the first trimester, 80,253 pregnancies in Ontario.Regan et al., Acta Obstetricia et Gynecologica Scandinavica, 2025
- 1.90 (1.69–2.13)
- Relative risk of heavier menstrual bleeding after the first dose in 3,972 Norwegian women aged 18 to 30. A meta-analysis of 17 studies found cycle length increased by a pooled ratio of 1.19 (1.11–1.26). The European Medicines Agency added heavy menstrual bleeding to the Comirnaty and Spikevax labels in 2022 after almost 9,000 reports.Trogstad et al., Vaccine, 2023; Dorjee et al., PLoS One, 2025; EMA safety update, November 10, 2022
- 12.261 µg/g
- Lipid marker in rat ovaries 48 hours after a single dose, up from 5.240 at 24 hours and still rising (0.095% of the dose). Pfizer’s report lists the ovaries among the organs the lipid carrier reached.Pfizer biodistribution Study 185350, FDA-CBER-2021-5683-0013970
- 1 hour
- Time for mRNA-1273 to cross the placenta into the fetal circulation in pregnant mice, where fetal tissue produced spike protein. Spike protein was found in 31 of 106 human term placentas from vaccinated and/or infected women.Chen et al., Molecular Therapy Nucleic Acids, 2025; Bartmann et al., PLoS One, 2026