ArticleAJOG global reports2024
Safety of quadrivalent recombinant influenza vaccine in pregnant persons and their infants.
Article in AJOG global reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03694392 (Examining Vaccine Effectiveness), which is not on this map. Cited by 4 papers.
What it found
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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.
Examining Vaccine Effectiveness (VE) of Flublok Relative to Standard Dose Inactivated Influenza Vaccine Among Kaiser Permanente Northern California Members Aged 18-64 Years
Who cites it
4 citing papers in PubMed.
- Influencing Factors of Pregnant Women's Willingness to Receive Influenza Vaccination in China.Vaccines · 2025Article
- Influenza Vaccination During Pregnancy and Infant Influenza in the First 6 Months of Life.Obstetrics and gynecology · 2025Article
- Review
- Preventing Influenza Virus Infection and Severe Influenza Among Pregnant People and Infants.Journal of women's health (2002) · 2024Article
Corrections and comments
- Erratum issued
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: The Advisory Committee on Immunization Practices (ACIP) and the American College of Obstetricians and Gynecologists (ACOG) recommend that all pregnant persons receive any licensed, recommended, and age-appropriate inactivated influenza vaccine (SD-IIV) or recombinant influenza vaccine (RIV) to protect against influenza and influenza-related complications. RIV was safe and efficacious in pre- and postlicensure studies, however there is limited RIV safety data in pregnant persons. Objective: To evaluate the safety of quadrivalent recombinant influenza vaccine (RIV4) versus a quadrivalent standard-dose, inactivated influenza (SD-IIV4) in a large cohort of pregnant persons and their infants. Study Design: This postlicensure observational safety study conducted at Kaiser Permanente Northern California evaluated the subset of pregnant persons vaccinated in routine care as part of a larger cluster-randomized vaccine effectiveness study comparing RIV4 vs. SD-IIV4 (ClinicalTrials.gov NCT03694392). We identified pregnancy (spontaneous abortion, preterm labor, stillbirth/fetal death, congenital/fetal anomalies detected during pregnancy, eclampsia/pre-eclampsia, placental abruption), birth (preterm birth, low birth weight, small for gestational age), and neonatal/infant outcomes (infant death, failure to thrive, congenital anomalies detected after delivery) using diagnostic codes among pregnant persons ≥18 years immunized with RIV4 or SD-IIV4 during the 2018/19 and 2019/20 influenza seasons and their infants. We used conditional logistic regression adjusted for age group, race, ethnicity, trimester of influenza vaccination, comorbidities, and BMI, stratified by gestational age to estimate the odds ratio (OR) of pregnancy outcomes following vaccination with RIV4 vs. SD-IIV4. Using logistic regression, we separately estimated the adjusted OR of birth and neonatal/infant outcomes in the first year of life (eg, death) in infants of RIV4 vs. SD-IIV4 vaccinated pregnant persons. Results: The study population included 48,781 pregnant persons (RIV4 = 14,981; SD-IIV4 = 33,800) and 47,394 live births (RIV4 = 14,538; SD-IIV4 = 32,856). There was no statistical difference in any pregnancy outcome or in birth and neonatal/infant outcome between RIV4 vs. SD-IIV4 vaccinated pregnant persons and their infants. Conclusion: Compared with receipt of a SD-IIV4 during pregnancy, this large study did not identify any pregnancy, birth, or neonatal/infant safety concerns following receipt of a RIV4 during pregnancy and demonstrates that the safety of RIV4 in pregnancy was similar to SD-IIV4. This study provides additional evidence regarding the safety of influenza vaccination in pregnant persons and further supports ACIP and ACOG recommendations that all pregnant persons receive an inactivated or recombinant influenza vaccine.
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