Maternal and Neonatal Outcomes After Respiratory Syncytial Virus Prefusion F Protein Vaccination During Pregnancy
Bibliographic record
Abstract
OBJECTIVE: To assess the safety of the respiratory syncytial virus prefusion F protein (RSVpreF) vaccine in pregnant women during the 2024-2025 French immunization campaign, with a particular focus on the risk of preterm birth. METHODS: Using the national health care database, which covers almost 99% of the population in France, we included all women who gave birth after 22 weeks of gestation between September 16 and December 31, 2024. Women vaccinated with RSVpreF were matched 1:1 with unvaccinated women on the basis of gestational age at vaccination, maternal age at pregnancy onset, region of residence, week of conception, history of preterm birth, influenza vaccination during the same pregnancy, and multiple pregnancy. Outcomes included preterm birth, delivery within 1 and 3 weeks after vaccination, stillbirth, small-for-gestational-age (SGA) birth weight, cesarean delivery, hemorrhage, preeclampsia, and major cardiovascular events, including maternal death. Time-to-event analyses were conducted with Poisson regression models with robust variance to estimate weighted incidence rate ratios (IRRs) and their 95% CIs for each outcome. RESULTS: Among the 29,032 women vaccinated during the study period, 24,891 (85.7%) were successfully matched to 24,891 unvaccinated women in a control group. In the matched cohort, the mean±SD maternal age was 30.9±5.0 years, 3.2% had a history of preterm birth, 0.6% had multiple pregnancies, and 21.8% had received influenza vaccination. No significant increase in the risk of the following outcomes was observed: preterm birth (weighted IRR 0.97, 95% CI, 0.89-1.06), delivery within 1 week (weighted IRR 0.81, 95% CI, 0.72-0.90) or within 3 weeks (weighted IRR 0.97, 95% CI, 0.93-1.00), stillbirth (weighted IRR 0.77, 95% CI, 0.45-1.32), cesarean delivery (weighted IRR 1.00, 95% CI, 0.96-1.03), SGA birth weight (weighted IRR 1.01, 95% CI, 0.96-1.07), postpartum hemorrhage (weighted IRR 1.03, 95% CI, 0.97-1.10), preeclampsia (weighted IRR 1.02, 95% CI, 0.85-1.22), or major adverse cardiovascular event (weighted IRR 0.60, 95% CI, 0.26-1.40) outcomes. Among women vaccinated at or before 32 weeks of gestation, no significant increase in the risk of preterm birth was observed (weighted IRR 1.13, 95% CI, 0.98-1.31). CONCLUSION: This large observational study found no major safety concerns associated with RSVpreF vaccination during pregnancy. Further research, including international comparisons and evaluations of effectiveness relative to monoclonal antibodies against RSV, will be needed to fully characterize the benefit-risk balance of RSVpreF. Ongoing surveillance remains essential, particularly to monitor rare adverse events.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.007 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".