Background: Limited surveillance of preconception care (PCC) impedes states' ability to monitor access and provision of quality PCC. In response, we describe PCC indicators and the evaluation process used to identify a set of PCC indicators for state use. Materials and Methods: The Surveillance and Research Workgroup and Clinical Workgroup of the National Preconception Health and Health Care Initiative used a systematic process to identify, evaluate, and prioritize PCC indicators from nationwide public health surveillance systems that Maternal and Child Health (MCH) programs can use for state-level surveillance using the Pregnancy Risk Assessment Monitoring System (PRAMS) and Behavioral Risk Factor Surveillance System (BRFSS). For each indicator, we assessed target population, prevalence, measurement simplicity, data availability, clinical utility, and whether it was related to the 10 prioritized preconception health indicators. We also assessed relevance to clinical recommendations, Healthy People (HP)2020 objectives, and the National Quality Forum measures. Lastly, we considered input from stakeholders and subject matter experts. Results: Eighty potential PCC indicators were initially identified. After conducting evaluations, obtaining stakeholder input, and consulting with subject matter experts, the list was narrowed to 30 PCC indicators for states to consider using in their MCH programs to inform the need for new strategies and monitor programmatic activities. PRAMS is the data source for 27 of the indicators, and BRFSS is the data source for three indicators. Conclusions: The identification and evaluation of population-based PCC indicators that are available at the state level increase opportunities for state MCH programs to document, monitor, and address PCC in their locales.

The Coronavirus Disease 2019 (COVID-19) pandemic has had a devastating impact on global health, and has resulted in an unprecedented, international collaborative effort to develop vaccines to control the outbreak, protect human lives, and avoid further social and economic disruption. Mass vaccination campaigns are underway in multiple countries and are expected worldwide once more vaccine becomes available. Some early candidate vaccines use novel platforms, such as mRNA encapsulated in lipid nanoparticles, and relatively new platforms, such as replication-deficient viral vectors. While these new vaccine platforms hold promise, limited safety data in humans are available. Serious health outcomes linked to vaccinations are rare, and some outcomes may occur incidentally in the vaccinated population. Knowledge of background incidence rates of these medical conditions is a critical component of vaccine safety monitoring to aid in the assessment of adverse events temporally associated with vaccination and to put these events into context with what would be expected due to chance alone. A list of 22 potential adverse events of special interest (AESI), including neurologic, autoimmune, and cardiovascular disorders, was compiled by subject matter experts at the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention. The most recently available U.S. background rates for these medical conditions, overall and by age, sex, and race/ethnicity (when available), were sourced from reported statistics (data published by medical panels/ associations or federal government reports), and literature reviews in PubMed. This review provides estimates of background incidence rates for medical conditions that may be monitored or studied as AESI during safety surveillance and research for COVID-19 vaccines and other new vaccines.

BACKGROUND: Many pregnant persons in the United States are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. METHODS: From December 14, 2020, to February 28, 2021, we used data from the "v-safe after vaccination health checker" surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. RESULTS: A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). CONCLUSIONS: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.