Adults aged ≥65 years experience the highest risk for COVID-19-related hospitalization and death, with risk increasing with increasing age; outpatient antiviral treatment reduces the risk for these severe outcomes. Despite the proven benefit of COVID-19 antiviral treatment, information on differences in use among older adults with COVID-19 by age group is limited. Nonhospitalized patients aged ≥65 years with COVID-19 during April 2022-September 2023 were identified from the National Patient-Centered Clinical Research Network. Differences in use of antiviral treatment among patients aged 65-74, 75-89, and ≥90 years were assessed. Multivariable logistic regression was used to estimate the association between age and nonreceipt of antiviral treatment. Among 393,390 persons aged ≥65 years, 45.9% received outpatient COVID-19 antivirals, including 48.4%, 43.5%, and 35.2% among those aged 65-75, 76-89, and ≥90 years, respectively. Patients aged 75-89 and ≥90 years had 1.17 (95% CI = 1.15-1.19) and 1.54 (95% CI = 1.49-1.61) times the adjusted odds of being untreated, respectively, compared with those aged 65-74 years. Among 12,543 patients with severe outcomes, 2,648 (21.1%) had received an outpatient COVID-19 antiviral medication, compared with 177,874 (46.7%) of 380,847 patients without severe outcomes. Antiviral use is underutilized among adults ≥65 years; the oldest adults are least likely to receive treatment. To prevent COVID-19-associated morbidity and mortality, increased use of COVID-19 antiviral medications among older adults is needed.

OBJECTIVE: To examine trends, characteristics, and outcomes of donor oocyte embryo transfer cycles by original oocyte and resultant embryo state and determine whether oocyte state (fresh or frozen) is differentially associated with clinical pregnancy, live birth, and term, normal birthweight neonates among singleton live births. DESIGN: Retrospective cohort study SUBJECTS: Patients undergoing donor oocyte embryo transfer cycles in the United States reporting to National Assisted Reproductive Technology Surveillance System (NASS) from 2013-2020 EXPOSURE: Original donor oocyte and resultant embryo state (fresh or frozen) MAIN OUTCOME MEASURES: Annual numbers and proportions of total donor oocyte embryo transfer cycles stratified by oocyte and embryo state and single embryo transfer cycles resulting in live birth of term (≥37 weeks gestation), normal birthweight (≥2500g) singletons during 2013-2020. Rates of live birth and term, normal birthweight neonates among singleton live births for 2018-2020 are also reported. Relative risks (RR) examine associations between donor oocyte state and live birth and term, normal birthweight neonates among singleton live births resulting from donor oocyte embryo transfer cycles. RESULTS: From 2013-2020, there were 135,085 donor oocyte embryo transfer cycles, of which the proportions increased for frozen embryos (42.3% to 76.6%), fresh embryos using frozen donor oocytes (19.9% to 68.3%) and single embryo transfer (SET) (36.4% to 85.5%). During 2018-2020, there were 48,679 donor oocyte embryo transfer cycles. Rates of live birth were lower with frozen compared to fresh donor oocytes for both fresh (46.2%, 55.9%; aRR 0.83 [95% CI 0.79-0.87]) and frozen (41.3%, 45.8%; aRR 0.94 [95% CI 0.91-0.98]) embryo transfer cycles. Among singleton live births, rates of delivering a term, normal birthweight neonate were similar for frozen compared to fresh donor oocyte transfer cycles among fresh (77.3, 77.2%; aRR 1.01 [95% CI 0.98-1.03]) and frozen (75.6, 75.1%; aRR 1.02 [95% CI 0.99-1.04]) embryos. CONCLUSION: In this national study of donor oocyte embryo transfer cycles, frozen embryo transfers, fresh embryo transfers using frozen oocytes, and SET increased. Although frozen compared to fresh oocytes were associated with a slightly reduced rate of live birth, rates of term, normal birthweight neonates among singleton live births were comparable between donor oocyte states.

Background: Missing race/ethnicity data are common in many surveillance systems and registries, which may limit complete and accurate assessments of racial and ethnic disparities. Centers for Disease Control and Prevention's National Assisted Reproductive Technology (ART) Surveillance System (NASS) has a congressional mandate to collect data on all ART cycles performed by fertility clinics in the United States and provides valuable information on ART utilization and treatment outcomes. However, race/ethnicity data are missing for many ART cycles in NASS. Materials and Methods: We multiply imputed missing race/ethnicity data using variables from NASS and additional zip code-level race/ethnicity information in U.S. Census data. To evaluate imputed data quality, we generated training data by imposing missing values on known race/ethnicity under missing at random assumption, imputed, and examined the relationship between race/ethnicity and the rate of stillbirth per pregnancy. Results: The distribution of imputed race/ethnicity was comparable to the reported one with the largest difference of 0.53% for non-Hispanic Asian. Our imputation procedure was well calibrated and correctly identified that 89.91% (standard error = 0.18) of known race/ethnicity values on average in training data. Compared to complete-case analysis, using multiply imputed data reduced bias of parameter estimates (the range of bias for stillbirth per pregnancy across race/ethnicity groups is 0.02%-0.18% for imputed data analysis, versus 0.04%-0.66% for complete-case analysis) and yielded narrower confidence intervals. Conclusions: Our results underscore the importance of collecting complete race/ethnicity information for ART surveillance. However, when the missingness exists, multiply imputed race/ethnicity can improve the accuracy and precision of health outcomes estimated across racial/ethnic groups.

OBJECTIVE: To examine whether the (1) scope of state-mandated insurance coverage for assisted reproductive technology (ART), and (2) proportion of the population eligible for this coverage, are associated with reductions in racial/ethnic inequities in ART utilization. DESIGN: National cross-sectional, ecologic study. SUBJECTS: We employed estimates from the U.S. Census Bureau of all women 20-44 years of age living in the U.S. in 2018. The number of women who initiated an ART cycle during that year that was reported to the U.S. Centers for Disease Control and Prevention (CDC) was obtained from the National ART Surveillance System (NASS). EXPOSURE: State mandates were classified by scope of required coverage for fertility services: Comprehensive, Limited, and No Mandate. MAIN OUTCOMES MEASURES: Race and ethnic-specific ART utilization rates, defined as number of women undergoing ≥1 ART cycles per 10,000 women, were the primary outcome. As state mandates do not apply to all insurance plans, Comprehensive Mandate utilization rates were recalculated using denominators corrected for the estimated proportions of populations eligible for coverage. RESULTS: Across all mandate categories, Non-Hispanic (NH) Asian and NH White populations had the highest ART utilization rates, whereas the lowest rates were among Hispanic, NH Black, and NH Other/Multiple Races populations. As compared to the NH Asian reference group, the NH Black population had smaller inequities in the Comprehensive Mandate group than the No Mandate group (Rate Ratio [RR 0.33 [0.28-0.38] versus RR 0.23 [0.22-0.24]). Using the Comprehensive Mandate group for each race/ethnicity as reference, the NH Black and NH Other/Multiple Races populations had the largest relative differences in utilization between the No Mandate and Comprehensive Mandate groups (RR 0.39 [0.37-0.41] and 0.33 [0.28-0.38], respectively). Within the Comprehensive Mandate group, the disparities in the Hispanic and NH Black populations moved towards the null after correcting for state-mandated insurance eligibility. CONCLUSIONS: Racial/ethnic inequities in ART utilization were reduced in states with comprehensive infertility coverage mandates. Inequities were further attenuated after correcting for mandate eligibility. Mandates alone, however, were not sufficient to eliminate disparities. These findings can inform future strategies aimed at improving ART access under a social justice framework.

The NVX-CoV2373 (Novavax) COVID-19 vaccine is a recombinant spike protein nanoparticle vaccine with Matrix-M adjuvant. Novavax is authorized and recommended as a primary 2-dose monovalent vaccination series in persons aged ≥12 years to prevent COVID-19 and as a monovalent booster dose in persons aged ≥18 years who are unable to or unwilling to receive an mRNA COVID-19 bivalent vaccine (1). | | Top | | Investigation and Outcomes | During July 13, 2022–March 13, 2023, a total of 69,227 Novavax doses were administered to persons aged ≥12 years in the United States, and 230 reports of adverse events (AEs) after Novavax vaccination were received by the Vaccine Adverse Event Reporting System (VAERS) (2). The median age of patients in the reports was 45 years (IQR = 31–61 years); 152 (66.1%) reports concerned females, and 104 (45.2%) concerned non-Hispanic White persons (Table). Within the study period, VAERS received no reports concerning pregnant women. Most VAERS reports (211; 91.7%) were classified as nonserious.* The most commonly reported AEs included dizziness (33; 14.3%), fatigue (26; 11.3%), and headache (25; 10.9%).

On September 1, 2022, CDC recommended an updated (bivalent) COVID-19 vaccine booster to help restore waning protection conferred by previous vaccination and broaden protection against emerging variants for persons aged ≥12 years (subsequently extended to persons aged ≥6 months).* To assess the impact of original (monovalent) COVID-19 vaccines and bivalent boosters, case and mortality rate ratios (RRs) were estimated comparing unvaccinated and vaccinated persons aged ≥12 years by overall receipt of and by time since booster vaccination (monovalent or bivalent) during Delta variant and Omicron sublineage (BA.1, BA.2, early BA.4/BA.5, and late BA.4/BA.5) predominance.(†) During the late BA.4/BA.5 period, unvaccinated persons had higher COVID-19 mortality and infection rates than persons receiving bivalent doses (mortality RR = 14.1 and infection RR = 2.8) and to a lesser extent persons vaccinated with only monovalent doses (mortality RR = 5.4 and infection RR = 2.5). Among older adults, mortality rates among unvaccinated persons were significantly higher than among those who had received a bivalent booster (65-79 years; RR = 23.7 and ≥80 years; 10.3) or a monovalent booster (65-79 years; 8.3 and ≥80 years; 4.2). In a second analysis stratified by time since booster vaccination, there was a progressive decline from the Delta period (RR = 50.7) to the early BA.4/BA.5 period (7.4) in relative COVID-19 mortality rates among unvaccinated persons compared with persons receiving who had received a monovalent booster within 2 weeks-2 months. During the early BA.4/BA.5 period, declines in relative mortality rates were observed at 6-8 (RR = 4.6), 9-11 (4.5), and ≥12 (2.5) months after receiving a monovalent booster. In contrast, bivalent boosters received during the preceding 2 weeks-2 months improved protection against death (RR = 15.2) during the late BA.4/BA.5 period. In both analyses, when compared with unvaccinated persons, persons who had received bivalent boosters were provided additional protection against death over monovalent doses or monovalent boosters. Restored protection was highest in older adults. All persons should stay up to date with COVID-19 vaccination, including receipt of a bivalent booster by eligible persons, to reduce the risk for severe COVID-19.

IMPORTANCE: Because of historical associations between vaccines and Guillain-Barré syndrome (GBS), the condition was a prespecified adverse event of special interest for COVID-19 vaccine monitoring. OBJECTIVE: To evaluate GBS reports to the Vaccine Adverse Event Reporting System (VAERS) and compare reporting patterns within 21 and 42 days after vaccination with Ad26.COV2.S (Janssen), BNT162b2 (Pfizer-BioNTech), and mRNA-1273 (Moderna) COVID-19 vaccines. DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study was conducted using US VAERS reports submitted during December 2020 to January 2022. GBS case reports verified as meeting the Brighton Collaboration case definition for GBS in US adults after COVID-19 vaccination were included. EXPOSURES: Receipt of the Ad26.COV2.S, BNT162b2, or mRNA-1273 COVID-19 vaccine. MAIN OUTCOMES AND MEASURES: Descriptive analyses of GBS case were conducted. GBS reporting rates within 21 and 42 days after Ad26.COV2.S, BNT162b2, or mRNA-1273 vaccination based on doses administered were calculated. Reporting rate ratios (RRRs) after receipt of Ad26.COV2.S vs BNT162b2 or mRNA-1273 within 21- and 42-day postvaccination intervals were calculated. Observed-to-expected (OE) ratios were estimated using published GBS background rates. RESULTS: Among 4 651 785 COVID-19 vaccine doses, 17 944 515 doses (3.7%) were Ad26.COV2.S, 266 859 784 doses (54.7%) were BNT162b2, and 202 847 486 doses (41.6%) were mRNA-1273. Of 295 verified reports of individuals with GBS identified after COVID-19 vaccination (12 Asian [4.1%], 18 Black [6.1%], and 193 White [65.4%]; 17 Hispanic [5.8%]; 169 males [57.3%]; median [IQR] age, 59.0 [46.0-68.0] years), 275 reports (93.2%) documented hospitalization. There were 209 and 253 reports of GBS that occurred within 21 days and 42 days of vaccination, respectively. Within 21 days of vaccination, GBS reporting rates per 1 000 000 doses were 3.29 for Ad26.COV.2, 0.29 for BNT162b2, and 0.35 for mRNA-1273 administered; within 42 days of vaccination, they were 4.07 for Ad26.COV.2, 0.34 for BNT162b2, and 0.44 for mRNA-1273. GBS was more frequently reported within 21 days after Ad26.COV2.S than after BNT162b2 (RRR = 11.40; 95% CI, 8.11-15.99) or mRNA-1273 (RRR = 9.26; 95% CI, 6.57-13.07) vaccination; similar findings were observed within 42 days after vaccination (BNT162b2: RRR = 12.06; 95% CI, 8.86-16.43; mRNA-1273: RRR = 9.27; 95% CI, 6.80-12.63). OE ratios were 3.79 (95% CI, 2.88-4.88) for 21-day and 2.34 (95% CI, 1.83-2.94) for 42-day intervals after Ad26.COV2.S vaccination and less than 1 (not significant) after BNT162b2 and mRNA-1273 vaccination within both postvaccination periods. CONCLUSIONS AND RELEVANCE: This study found disproportionate reporting and imbalances after Ad26.COV2.S vaccination, suggesting that Ad26.COV2.S vaccination was associated with increased risk for GBS. No associations between mRNA COVID-19 vaccines and risk of GBS were observed.

BACKGROUND: In 2016, the US Food and Drug Administration amended existing regulations to increase access to donated embryos for reproductive use. Current information regarding the characteristics and outcomes of embryo donation cycles could benefit patients and providers during counseling and decision making. OBJECTIVE: This study aimed to examine the trends in the utilization of embryo donation, pregnancy rates, and live birth rates per transfer between 2004 and 2019 and to describe the recipients of donated embryos and outcomes of frozen donated embryo transfer cycles during the most recent time period, that is, 2016 to 2019. STUDY DESIGN: We conducted a retrospective, population-based cohort study of frozen donated embryo transfer cycles in United States fertility clinics reporting to the National Assisted Reproductive Technology Surveillance System during 2004 to 2019. The trends in the annual number and proportion of frozen donated embryo transfers, pregnancy rates, and live birth rates from 2004 to 2019 were described. During 2016 to 2019, the rates of cycle cancellation, pregnancy, miscarriage, live birth, singleton birth, and good perinatal outcome (delivery ≥37 weeks, birthweight ≥2500 g) of frozen donated embryo transfers were also calculated. Transfer and pregnancy outcomes stratified by oocyte source age at the time of oocyte retrieval were also described. RESULTS: From 2004 to 2019, there were 21,060 frozen donated embryo transfers in the United States, resulting in 8457 live births. During this period, the annual number and proportion of frozen donated embryo transfers with respect to all transfers increased, as did the pregnancy rate and live birth rate. Among all initiated cycles during 2016 to 2019, the cancellation rate was 8.2%. Among 8773 transfers with known outcomes, 4685 (53.4%) resulted in pregnancy and 3820 (43.5%) in live birth. Among all pregnancies, 814 (17.4%) resulted in miscarriage. Among all live births, 3223 (84.4%) delivered a singleton, of which 2474 (76.8%) had a good perinatal outcome. The clinical pregnancy rate and live birth rate per frozen donated embryo transfer decreased with increasing age of oocyte source. CONCLUSION: The outcomes of embryo donation cycles reported in this national cohort may aid patients and providers when considering the use of donated embryos.

Objective: To examine trends of frozen embryo transfer (FET) proportions and large-for-gestational-age (LGA) incidence and determine risk factors for LGA infants after FET. Design: Retrospective cohort study. Setting: Not applicable. Patient(s): Frozen embryo transfer cycles. Intervention(s): None. Main Outcome Measure(s): Singleton LGA infant. Result(s): The percentage of FETs increased from 20%–74% of transfers, whereas the rate of LGA among FET singleton births decreased from 18%–12% during 2004–2018. In a subanalysis of 127,525 FET-associated singleton live births during 2016–2018, patient factors associated with LGA were higher-than-normal maternal body mass index (body mass index [BMI], 25.0–29.9 kg/m2; adjusted relative risk [aRR], 1.31; 95% confidence interval [CI], 1.26–1.36; BMI, 30.0–34.9 kg/m2; aRR, 1.48; 95% CI, 1.41–1.55; and BMI, >35 Kg/m2; aRR, 1.68; 95% CI, 1.59–1.77) and ≥1 prior birth vs. none. Low maternal BMI (<18.5 vs. 18.5–24.9 kg/m2) and cycles involving patients who were non-Hispanic (NH) Asian/Native Hawaiian/Pacific Islander, NH Black, or Hispanic (compared with NH White) were at lower risk of LGA infants. Cycle factors associated with LGA included gestational carrier use (aRR, 1.25; 95% CI, 1.16–1.34) and donor sperm (aRR, 1.17; 95% CI, 1.10–1.25). Conclusion(s): Although the number and proportion of FET cycles increased from 2004–2018, the rate of LGA after FET decreased. Maternal BMI, parity, and race/ethnicity were the strongest risk factors for LGA infants after FET. © 2022

BACKGROUND: Insurance coverage for fertility services may reduce the financial burden of high-cost fertility care such as assisted reproductive technology and improve its utilization. Patients who exit care after failing to reach their reproductive goals report higher rates of mental health problems and a lower sense of well-being. It is important to understand the relationship between state-mandated insurance coverage for fertility services and assisted reproductive technology care discontinuation. OBJECTIVE: This study aimed to assess whether state-mandated insurance coverage for fertility services is associated with lower rates of care discontinuation after an initial assisted reproductive technology cycle that did not result in a live birth. STUDY DESIGN: This is a retrospective, population-based cohort study using data from United States fertility clinics reporting to the National Assisted Reproductive Technology Surveillance System during 2016 and 2018. Patients who began their first autologous assisted reproductive technology cycle during 2016 and 2017 and did not have a live birth were included. We describe the rate of assisted reproductive technology care discontinuation (no additional cycle within 12 months of the previous cycle's date of failure). Multivariable analyses were conducted to evaluate factors independently associated with care discontinuation, including the scope of fertility services included in state coverage mandate at assisted reproductive technology cycle initiation that were as follows: comprehensive (>/=3 assisted reproductive technology cycles), limited (1, 2, or an unspecified number of assisted reproductive technology cycles), mandate not including assisted reproductive technology, and no mandate. RESULTS: Among 91,324 patients who underwent their first autologous assisted reproductive technology cycle that did not result in live birth, 24,072 (26.4%) discontinued care. Compared with patients who lived in states with mandates for comprehensive assisted reproductive technology coverage, those in states with mandates for fertility services coverage that did not include assisted reproductive technology or states with no mandate were 46% (adjusted relative risk, 1.46; 95% confidence interval, 1.31-1.63) and 26% (adjusted relative risk, 1.26; 95% confidence interval, 1.15-1.39) more likely to discontinue care, respectively, after controlling for patient and cycle characteristics. Increasing patient age, distance from clinic >/=50 miles, previous live birth, fewer oocytes retrieved, and not having embryos cryopreserved were also associated with higher rates of discontinuation. Non-Hispanic Black, non-Hispanic Asian, and Hispanic patients had higher rates of care discontinuation than non-Hispanic White patients regardless of the existence or scope of state-mandated assisted reproductive technology coverage. CONCLUSION: Comprehensive state-mandated insurance coverage for assisted reproductive technology is associated with lower rates of assisted reproductive technology care discontinuation.

Efficacious behavioral interventions developed to address the spread of HIV/STIs are currently being disseminated in the USA through a national diffusion program (DEBI) spearheaded by the Centers for Disease Control and Prevention (CDC). Understanding how interventions are translated to real world settings is necessary to further scientific knowledge of this process and to facilitate future translation efforts in public health. Prior studies have begun to elucidate how agencies translate behavioral interventions into practice, but further work is needed. Guided by the ADAPT framework, we examined agencies' assessment, preparation, and implementation of interventions. Our qualitative interview-based study focused on six community-based agencies in California (United States) funded to implement three group-level HIV interventions. Findings showed considerable variation in the extent to which agencies engaged in assessment and broad-based preparation and in the ease with which agencies implemented the interventions. The findings provide insight into the process that agencies undergo in the translation of effective behavioral interventions and illustrate how agencies can inform logic models that guide translation. We also identify relevant dimensions of existing models, including the ADAPT framework and Rogers's (1995, 2005) diffusion of innovations in organizations, that have value for agencies that are translating research to practice.