ArticleReproductive toxicology (Elmsford, N.Y.)2021
Lack of effects on female fertility and prenatal and postnatal offspring development in rats with BNT162b2, a mRNA-based COVID-19 vaccine.
Article in Reproductive toxicology (Elmsford, N.Y.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
46 citing papers in PubMed, 3 syntheses or guidelines pooled it, 79 citations in OpenAlex.
- Pooled it
- The dose- and time-dependent effectiveness and safety associated with COVID-19 vaccination during pregnancy: a systematic review and meta-analysis.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2023Pooled it
- Systematic review and meta-analysis of the effectiveness and perinatal outcomes of COVID-19 vaccination in pregnancy.Nature communications · 2022Pooled it
- MomsTalkShots, tailored educational app, improves vaccine attitudes: a randomized controlled trial.BMC public health · 2022Trial
- Exploring offspring behaviour after prenatal COVID-19 vaccination in mice.Translational psychiatry · 2026Article
- Safety and efficacy of COVID-19 vaccines in pregnant and lactating women: a comprehensive review.Inflammopharmacology · 2026Review
- COVID-19 and Pregnancy: Key Findings.Scandinavian journal of immunology · 2026Review
- Comprehensive review of preclinical evaluation strategies for COVID-19 vaccine candidates: assessing immunogenicity, toxicology, and safety profiles.Iranian journal of microbiology · 2025Review
- Ovarian function after COVID-19: long-term effects and vaccine safety in ART patients.Journal of assisted reproduction and genetics · 2025Article
- Safety and reactogenicity of the BNT162b2 COVID-19 vaccine: Development, post-marketing surveillance, and real-world data.Human vaccines & immunotherapeutics · 2024Review
- A review of the scientific literature on experimental toxicity studies of COVID-19 vaccines, with special attention to publications in toxicology journals.Archives of toxicology · 2024Review
- Effect of SpikoGen subunit vaccine administration during pregnancy on fetal development of rats.Clinical and experimental vaccine research · 2024Article
- Toxicologic Pathology Forum: mRNA Vaccine Safety-Separating Fact From Fiction.Toxicologic pathology · 2024Article
- Messenger RNA Therapy for Female Reproductive Health.Molecular pharmaceutics · 2024Review
- Article
- Assessing gut barrier integrity and reproductive performance following pre-mating oral administration of solid-lipid-nanoparticles designed for drug delivery.Frontiers in toxicology · 2024Article
- Review
- Female reproduction and abnormal uterine bleeding after COVID-19 vaccination.Clinical and experimental reproductive medicine · 2023Article
- Developmental and reproductive toxicity of a recombinant protein subunit COVID-19 vaccine (ZF2001) in rats.NPJ vaccines · 2023Article
- Effects of COVID-19 Infection and Vaccination on the Female Reproductive System: A Narrative ReviewBalkan medical journal · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BNT162b2 is a vaccine developed to prevent coronavirus disease 2019 (COVID-19). BNT162b2 is a lipid nanoparticle formulated nucleoside-modified messenger RNA (mRNA) encoding the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein locked in its prefusion conformation. A developmental and reproductive toxicity study was conducted in rats according to international regulatory guidelines. The full human BNT162b2 dose of 30 μg mRNA/dose (>300 times the human dose on a mg/kg basis) was administered intramuscularly to 44 female rats 21 and 14 days prior to mating and on gestation days 9 and 20. Half of the rats were subject to cesarean section and full fetal examination at the end of gestation, and the other half were allowed to deliver and were monitored to the end of lactation. A robust neutralizing antibody response was confirmed prior to mating and at the end of gestation and lactation. The presence of neutralizing antibodies was also confirmed in fetuses and offspring. Nonadverse effects, related to the local injection site reaction, were noted in dams as expected from other animal studies and consistent with observations in humans. There were no effects of BNT162b2 on female mating performance, fertility, or any ovarian or uterine parameters nor on embryo-fetal or postnatal survival, growth, physical development or neurofunctional development in the offspring through the end of lactation. Together with the safety profile in nonpregnant people, this ICH-compliant nonclinical safety data supports study of BNT162b2 in women of childbearing potential and pregnant and lactating women.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.