Pregnancy Outcomes From the Pregnancy Registry of a Human Papillomavirus Type 6/11/16/18 Vaccine
Bibliographic record
Abstract
The (human papillomavirus) HPV6/11/16/18 vaccine is effective in girls and women 9 to 26 years of age for the prevention of cervical, vulvar, and vaginal cancer, and genital warts caused by human papillomavirus types 6, 11, 16, and 18. Because animal studies showed no evidence of impaired female fertility or adverse fetal outcomes, the vaccine is labeled Food and Drug Administration Pregnancy Category B. In the absence of well-controlled studies in pregnant women, however, the vaccine is not recommended for pregnant women. In five phase III clinical trials involving pregnancies with known outcome in 2008 vaccine and 2029 placebo-recipients with a range of follow-up of 0.6 to 3.7 years, no significant differences were found in the proportions of pregnancies resulting in live birth, congenital anomalies, fetal death, or spontaneous abortion. To establish a postmarketing safety profile of this vaccine, the manufacturer established a pregnancy registry in the United States, Canada, and France that collected data on pregnancy outcomes following exposure to the vaccine. Outcomes examined included live births, abortions, fetal deaths, and congenital anomalies. The present study presents the results of first 2 years of postlicensure surveillance based on voluntary postmarketing reports. The registry enrollment criteria included an identifiable patient and medical provider, and exposure to the vaccine within 1 month before the date of onset of the last menstrual period or at any time during pregnancy. The primary study outcomes were pregnancy outcomes and birth defects. To minimize the reporting bias toward abnormal outcomes that are inherent in retrospective reports, prospective reports were analyzed separately. Of the 517 prospective-exposed pregnancies with known outcome, 451 (87.2%) were live births (including three sets of twins) and resulted in 454 neonates. Over 96% of these 454 neonates were normal. The overall rate of spontaneous abortion among these prospective cases was 6.9 per 100 outcomes with a 95% confidence interval [CI] of 4.8 to 9.6. For the prospective reports, the rate of major birth malformations in the pregnancy registry was 2.2 per 100 live-born neonates (95% CI, 1.05–4.05). Seven fetal deaths occurred among the 454 neonates, which represents a rate of fetal deaths of 1.5 per 100 outcomes (95% CI, 0.60–3.09). These findings do not support a relationship between vaccine exposure and adverse pregnancy or fetal outcomes in the first 2 years of postlicensure surveillance.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.026 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.036 | 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 teacher head, 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".