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3.
JAMA ; 327(15): 1478-1487, 2022 04 19.
Article in English | MEDLINE | ID: covidwho-1756509

ABSTRACT

Importance: There is limited comparative epidemiological evidence on outcomes associated with COVID-19 vaccination during pregnancy; monitoring pregnancy outcomes in large populations is required. Objective: To evaluate peripartum outcomes following COVID-19 vaccination during pregnancy. Design, Setting, and Participants: Population-based retrospective cohort study in Ontario, Canada, using a birth registry linked with the provincial COVID-19 immunization database. All births between December 14, 2020, and September 30, 2021, were included. Exposures: COVID-19 vaccination during pregnancy, COVID-19 vaccination after pregnancy, and no vaccination. Main Outcomes and Measures: Postpartum hemorrhage, chorioamnionitis, cesarean delivery (overall and emergency cesarean delivery), admission to neonatal intensive care unit (NICU), and low newborn 5-minute Apgar score (<7). Linear and robust Poisson regression was used to generate adjusted risk differences (aRDs) and risk ratios (aRRs), respectively, comparing cumulative incidence of outcomes in those who received COVID-19 vaccination during pregnancy with those vaccinated after pregnancy and those with no record of COVID-19 vaccination at any point. Inverse probability of treatment weights were used to adjust for confounding. Results: Among 97 590 individuals (mean [SD] age, 31.9 [4.9] years), 22 660 (23%) received at least 1 dose of COVID-19 vaccine during pregnancy (63.6% received dose 1 in the third trimester; 99.8% received an mRNA vaccine). Comparing those vaccinated during vs after pregnancy (n = 44 815), there were no significantly increased risks of postpartum hemorrhage (incidence: 3.0% vs 3.0%; aRD, -0.28 per 100 individuals [95% CI, -0.59 to 0.03]; aRR, 0.91 [95% CI, 0.82-1.02]), chorioamnionitis (0.5% vs 0.5%; aRD, -0.04 per 100 individuals [95% CI, -0.17 to 0.09]; aRR, 0.92 [95% CI, 0.70-1.21]), cesarean delivery (30.8% vs 32.2%; aRD, -2.73 per 100 individuals [95% CI, -3.59 to -1.88]; aRR, 0.92 [95% CI, 0.89-0.95]), NICU admission (11.0% vs 13.3%; aRD, -1.89 per 100 newborns [95% CI, -2.49 to -1.30]; aRR, 0.85 [95% CI, 0.80-0.90]), or low Apgar score (1.8% vs 2.0%; aRD, -0.31 per 100 newborns [95% CI, -0.56 to -0.06]; aRR, 0.84 [95% CI, 0.73-0.97]). Findings were qualitatively similar when compared with individuals who did not receive COVID-19 vaccination at any point (n = 30 115). Conclusions and Relevance: In this population-based cohort study in Ontario, Canada, COVID-19 vaccination during pregnancy, compared with vaccination after pregnancy and with no vaccination, was not significantly associated with increased risk of adverse peripartum outcomes. Study interpretation should consider that the vaccinations received during pregnancy were primarily mRNA vaccines administered in the second and third trimester.


Subject(s)
COVID-19 Vaccines , COVID-19 , Chorioamnionitis , Infant, Newborn, Diseases , Postpartum Hemorrhage , Adult , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Chorioamnionitis/epidemiology , Chorioamnionitis/etiology , Cohort Studies , Female , Humans , Infant, Newborn , Infant, Newborn, Diseases/epidemiology , Ontario/epidemiology , Peripartum Period , Postpartum Hemorrhage/epidemiology , Postpartum Hemorrhage/etiology , Pregnancy , Pregnancy Outcome/epidemiology , Retrospective Studies , Vaccination/adverse effects , Vaccines, Synthetic
4.
Paediatr Perinat Epidemiol ; 36(4): 508-517, 2022 07.
Article in English | MEDLINE | ID: covidwho-1650172

ABSTRACT

BACKGROUND: Large-scale evaluation of COVID-19 is likely to rely on the quality of ICD coding. However, little is known about the validity of ICD-coded COVID-19 diagnoses. OBJECTIVES: To evaluate the performance of diagnostic codes in detecting COVID-19 during pregnancy. METHODS: We used data from a national cohort of 78,283 individuals with a pregnancy ending between 11 March 2020 and 31 January 2021 in the OptumLabs® Data Warehouse (OLDW). OLDW is a longitudinal, real-world data asset with de-identified administrative claims and electronic health record data. We identified all services with an ICD-10-CM diagnostic code of U07.1 and all laboratory claims records for COVID-19 diagnostic testing. We compared ICD-coded diagnoses to testing results to estimate positive and negative predictive values (PPV and NPV). To evaluate impact on risk estimation, we estimated risk of adverse pregnancy outcomes by source of exposure information. RESULTS: Of 78,283 pregnancies, 5644 had a laboratory test result for COVID-19. Testing was most common among older individuals, Hispanic individuals, those with higher socioeconomic status and those with a diagnosed medical condition or pregnancy complication; 52% of COVID-19 cases was identified through ICD-coded diagnosis alone, 19% from laboratory test results alone and 29% from both sources. Agreement between ICD-coded diagnosis and laboratory testing records was high 91% (95% confidence interval [CI] 90, 92). However, the PPV of ICD-code diagnosis was low (36%; 95% CI 33, 39). We observed up to a 50% difference in risk estimates of adverse pregnancy outcomes when exposure was based on laboratory testing results or diagnostic coding alone. CONCLUSIONS: More than one-in-five COVID-19 cases would be missed by using ICD-coded diagnoses alone to identify COVID-19 during pregnancy. Epidemiological studies exclusively relying on diagnostic coding or laboratory testing results are likely to be affected by exposure misclassification. Research and surveillance should draw upon multiple sources of COVID-19 diagnostic information.


Subject(s)
COVID-19 , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19 Testing , Clinical Coding , Databases, Factual , Female , Humans , Pregnancy , Pregnancy Outcome/epidemiology
5.
Am J Epidemiol ; 191(8): 1383-1395, 2022 Jul 23.
Article in English | MEDLINE | ID: covidwho-1639032

ABSTRACT

Some reproductive-aged individuals remain unvaccinated against coronavirus disease 2019 (COVID-19) because of concerns about potential adverse effects on fertility. Using data from an internet-based preconception cohort study, we examined the associations of COVID-19 vaccination and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection with fertility among couples trying to conceive spontaneously. We enrolled 2,126 self-identified female participants aged 21-45 year residing in the United States or Canada during December 2020-September 2021 and followed them through November 2021. Participants completed questionnaires every 8 weeks on sociodemographics, lifestyle, medical factors, and partner information. We fit proportional probabilities regression models to estimate associations between self-reported COVID-19 vaccination and SARS-CoV-2 infection in both partners with fecundability (i.e., the per-cycle probability of conception), adjusting for potential confounders. COVID-19 vaccination was not appreciably associated with fecundability in either partner (female fecundability ratio (FR) = 1.08, 95% confidence interval (CI): 0.95, 1.23; male FR = 0.95, 95% CI: 0.83, 1.10). Female SARS-CoV-2 infection was not strongly associated with fecundability (FR = 1.07, 95% CI: 0.87, 1.31). Male infection was associated with a transient reduction in fecundability (for infection within 60 days, FR = 0.82, 95% CI: 0.47, 1.45; for infection after 60 days, FR = 1.16, 95% CI: 0.92, 1.47). These findings indicate that male SARS-CoV-2 infection may be associated with a short-term decline in fertility and that COVID-19 vaccination does not impair fertility in either partner.


Subject(s)
COVID-19 , Adult , COVID-19/epidemiology , COVID-19/prevention & control , Cohort Studies , Female , Fertility , Humans , Male , Prospective Studies , SARS-CoV-2 , United States/epidemiology
6.
J Infect Dis ; 225(5): 759-767, 2022 03 02.
Article in English | MEDLINE | ID: covidwho-1597371

ABSTRACT

BACKGROUND: Although severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been associated with increased risk of adverse perinatal health outcomes, few large-scale, community-based epidemiological studies have been conducted. METHODS: We conducted a national cohort study using deidentified administrative claims data for 78 283 pregnancies with estimated conception before 30 April 2020 and pregnancy end after 11 March 2020. We identified SARS-CoV-2 infections using diagnostic and laboratory testing data, and compared the risk of pregnancy outcomes using Cox proportional hazard models treating coronavirus disease 2019 (COVID-19) as a time-varying exposure and adjusting for baseline covariates. RESULTS: Of the pregnancies, 2655 (3.4%) had a documented SARS-CoV-2 infection. COVID-19 during pregnancy was not associated with risk of miscarriage, antepartum hemorrhage, or stillbirth, but was associated with 2-3 fold higher risk of induced abortion (adjusted hazard ratio [aHR], 2.60; 95% confidence interval [CI], 1.17-5.78), cesarean delivery (aHR, 1.99; 95% CI, 1.71-2.31), clinician-initiated preterm birth (aHR, 2.88; 95% CI, 1.93-4.30), spontaneous preterm birth (aHR, 1.79; 95% CI, 1.37-2.34), and fetal growth restriction (aHR, 2.04; 95% CI, 1.72-2.43). CONCLUSIONS: Prenatal SARS-CoV-2 infection was associated with increased risk of adverse pregnancy outcomes. Prevention could have fetal health benefits.


Subject(s)
COVID-19/diagnosis , Infectious Disease Transmission, Vertical , Pregnancy Complications, Infectious/virology , Pregnancy Outcome/epidemiology , Premature Birth , Adult , COVID-19/epidemiology , COVID-19/transmission , Cohort Studies , Female , Humans , Infant, Newborn , Pregnancy , Premature Birth/epidemiology , Premature Birth/virology , SARS-CoV-2
7.
Vaccine ; 39(25): 3333-3337, 2021 06 08.
Article in English | MEDLINE | ID: covidwho-1237907

ABSTRACT

In 2020, the state of Texas implemented coronavirus disease 2019 (COVID-19) social distancing guidelines in order to prevent surges at Texas hospital emergency rooms and in intensive care units. As noted in other states, an unintended consequence of these activities was significant declines in childhood immunizations. After analyzing state-wide immunization register data for Texas, we observed a 47% relative decline in immunization rates between 2019 and 2020 among 5-month-olds and a 58% decline among 16-month-olds. We observed a small decline (5%) among 24-month-olds, and no decline in vaccines received at birth (Hepatitis B). Declines were larger in rural counties compared to urban. These declines are superimposed on increases in state vaccine exemptions over the last five years due to an aggressive anti-vaccine movement in Texas. There are concerns that continued declines in childhood immunization coverage due to COVID-19 could lead to co-endemics of measles and other vaccine preventable diseases.


Subject(s)
COVID-19 , Pandemics , Humans , Immunization , Immunization Programs , Infant, Newborn , SARS-CoV-2 , Texas/epidemiology , Vaccination
8.
Vaccine ; 39(14): 1882-1886, 2021 04 01.
Article in English | MEDLINE | ID: covidwho-1117762

ABSTRACT

COVID-19 vaccines are now being deployed as essential tools in the public health response to the global SARS-CoV-2 pandemic. Pregnant individuals are a unique subgroup of the population with distinctive considerations regarding risk and benefit that extend beyond themselves to their fetus/newborn. As a complement to traditional pharmacovigilance and clinical studies, evidence to comprehensively assess COVID-19 vaccine safety in pregnancy will need to be generated through observational epidemiologic studies in large populations. However, there are several unique methodological challenges that face observational assessments of vaccination during pregnancy, some of which may be more pronounced for COVID-19 studies. In this contribution, we discuss the most critical study design, data collection, and analytical issues likely to arise. We offer brief guidance to optimize the quality of such studies to ensure their maximum value for informing public health decision-making.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Maternal Exposure , Observational Studies as Topic , Vaccination , COVID-19 Vaccines/adverse effects , Female , Fetus , Humans , Infant, Newborn , Pregnancy , Research Design , Vaccination/adverse effects
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