Safety monitoring of bivalent mRNA COVID-19 vaccine among pregnant persons in the vaccine adverse event reporting System - United States, September 1, 2022 - March 31, 2023.

BACKGROUND: Pregnant persons are at increased risk of severe COVID-19 illness. Bivalent mRNA COVID-19 vaccination is recommended for everyone, including pregnant persons. However, data are limited on the safety of bivalent mRNA COVID-19 vaccination during pregnancy. OBJECTIVE: To evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system, among pregnant persons who received bivalent mRNA COVID-19 vaccine. METHODS: VAERS U.S. reports of adverse events (AEs) in pregnant persons who received the bivalent mRNA COVID-19 vaccine from 9/1/2022-03/31/2023 were identified. Clinicians reviewed all reports and available medical records. AEs of these reports were compared with AEs reported to VAERS following monovalent mRNA COVID-19 booster vaccination in pregnancy. RESULTS: VAERS received 136 reports for pregnant persons who received bivalent mRNA COVID-19 vaccine; 87 (64 %) after BNT162b2 (Pfizer-BioNTech), and 48 (35 %) after mRNA-1273 (Moderna); 28 (20.6 %) reports were classified as serious. The most common pregnancy-specific outcomes reported included 12 (8.8 %) spontaneous abortions (<20 weeks gestation), 6 (4.4 %) episodes of preterm delivery, and 5 (3.7 %) reports of preeclampsia. One stillbirth (≥20 weeks gestation) was reported. No maternal or infant deaths were reported. There were 6 reports of AEs in infants, which included 3 reports of admissions to the neonatal intensive care unit: two infants with low birth weight, and one infant with a patent ductus arteriosus and patent foramen ovale. Non-pregnancy-specific adverse events were mostly COVID-19 infection and systemic reactions (e.g., headache, fatigue). Pregnancy-specific conditions were reported less frequently after bivalent mRNA COVID-19 vaccination compared to monovalent mRNA COVID-19 booster vaccination (3rd and 4th dose). CONCLUSIONS: Based on this review of reports to VAERS, the safety profile of bivalent mRNA COVID-19 vaccination in pregnant persons was comparable to that observed for monovalent mRNA COVID-19 booster vaccination (3rd and 4th dose) in pregnant persons.

Changes in Breastfeeding and Related Maternity Care Practices After Hurricanes Irma and Maria in Puerto Rico.

Background: Breastfeeding is recommended globally for most infants, especially during and after natural disasters when risk of adverse outcomes increases because of unsanitary conditions and lack of potable water. Materials and Methods: Using 2017-2019 data from Puerto Rico's Pregnancy Risk Assessment Monitoring System for 2,448 respondents with a recent live birth, we classified respondents into 4 hurricane exposure time periods based on infant birth month and year relative to when Hurricanes Irma and Maria occurred: (1) prehurricane; (2) acute hurricane; (3) posthurricane, early recovery; and (4) posthurricane, long-term recovery. We examined the association between maternity care practices during delivery hospitalization and exclusive breastfeeding at 3 months overall and stratified by time period. We also examined the associations between each maternity care practice and exclusive breastfeeding separately by time period. Results: Exclusive breastfeeding at 3 months was higher during the acute hurricane time period (adjusted prevalence ratio [aPR]: 1.43, 95% confidence interval: 1.09-1.87) than the prehurricane time period. Supportive maternity care practices were positively associated with exclusively breastfeeding, and practices that are risk factors for discontinuing breastfeeding were negatively associated with exclusive breastfeeding. Breastfeeding in the first hour (aPR range: 1.51-1.92) and rooming-in (aPR range: 1.50-2.58) were positively associated with exclusive breastfeeding across all time periods, except the prehurricane time period. Receipt of a gift pack with formula was negatively associated with exclusive breastfeeding (aPR range: 0.22-0.54) across all time periods. Conclusions: Maternity care practices during delivery hospitalization may influence breastfeeding behaviors and can improve breastfeeding during and after natural disasters. Strategies to maintain and improve these practices can be further supported during and after natural disasters.

CDC Division of Reproductive Health's Emergency Preparedness Resources and Activities for Radiation Emergencies: Public Health Considerations for Women's Reproductive Health.

Pregnant, postpartum, and lactating people, and infants have unique needs during public health emergencies, including nuclear and radiological incidents. This report provides information on the CDC Division of Reproductive Health's emergency preparedness and response activities to address the needs of women of reproductive age (aged 15-49 years), people who are pregnant, postpartum, or lactating, and infants during a radiation emergency. Highlighted preparedness activities include: (1) development of a quick reference guide to inform key questions about pregnant, postpartum, and lactating people, and infants during radiation emergencies; and (2) exercising the role of reproductive health experts during nuclear and radiological incident preparedness activities.

Pandemic-related stressors and mental health among women with a live birth in 2020.

The objective of this analysis was to assess the associations between pandemic-related stressors and feeling more anxious/depressed, among women with a live birth. We analyzed data from the Pregnancy Risk Assessment Monitoring System (PRAMS) COVID-19 maternal experiences supplement, implemented in 29 U.S. jurisdictions from October 2020-June 2021, among women with a live birth during April-December 2020. We examined stressors by type (economic, housing, childcare, food insecurity, partner, COVID-19 illness) and score (number of stressor types experienced [none, 1-2, 3-4, or 5-6]). Outcomes were feeling 1) more anxious and 2) more depressed than usual due to the pandemic. We calculated adjusted prevalence ratios estimating associations between stressors and outcomes. Among 12,525 respondents, half reported feeling more anxious and 28% more depressed than usual. The prevalence of stressor types was 50% economic, 41% childcare, 18% partner, 17% food insecurity, 12% housing, and 10% COVID-19 illness. Respondents who experienced partner stressors (anxious aPR: 1.81, 95% CI: 1.73-1.90; depressed aPR: 3.01, 95% CI: 2.78-3.25) and food insecurity (anxious aPR: 1.79, 95% CI: 1.71-1.88; depressed aPR: 2.32, 95% CI: 2.13-2.53) had the largest associations with feeling more anxious and depressed than usual. As stressor scores increased, so did the aPRs for feeling more anxious and more depressed due to the pandemic. COVID-19 stressors, not COVID-19 illness, were found to be significantly associated with feeling more anxious and depressed. Pregnant and postpartum women might benefit from access to supports and services to address pandemic-related stressors/social-determinants and feelings of anxiety and depression.

Emergency Preparedness in Tennessee Women with a Recent Live Birth.

OBJECTIVES: To assess emergency preparedness (EP) actions in women with a recent live birth. METHODS: Weighted survey procedures were used to evaluate EP actions taken by women with a recent live birth responding to an EP question assessing eight preparedness actions as part of the 2016 Tennessee Pregnancy Risk Assessment and Monitoring System (PRAMS) survey. Factor analysis was used to group preparedness actions. RESULTS: Overall, 82.7% [95% Confidence Interval (CI) 79.3%, 86.1%] of respondents reported any preparedness actions, with 51.8% (95% CI 47.2%, 56.4%) completing 1-4 actions. The most common actions were having supplies at home (63.0%; 95% CI 58.5%, 67.4%), an evacuation plan for children (48.5%; 95% CI 43.9%, 53.2%), supplies in another location (40.2%; 95% CI 35.6%, 44.7%), and a communication plan (39.7%; 95% CI 35.1%, 44.2%). Having personal evacuation plans (31.6%; 95% CI 27.3%, 36.0%) and copies of documents in alternate locations (29.3%; 95% CI 25.0%, 33.5%) were least common. Factor analysis yielded three factors: having plans, having copies of documents, and having supplies. Specific preparedness actions varied by education and income level. CONCLUSIONS FOR PRACTICE: Most Tennessee women (about 8 in 10 women) with a recent live birth reported at least one EP action. A three-part EP question may be sufficient for assessing preparedness in this population. These findings highlight opportunities to improve public health education efforts around EP.

Association between history of SARS-CoV-2 infection and severe systemic adverse events after mRNA COVID-19 vaccination among U.S. adults.

BACKGROUND: Risk of experiencing a systemic adverse event (AE) after mRNA coronavirus disease 2019 (COVID-19) vaccination may be greater among persons with a history of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection; data on serious events are limited. We assessed if adults reporting systemic AEs resulting in emergency department visits or hospitalizations during days 0-7 after mRNA COVID-19 vaccine dose 1 were more likely to have a history of prior SARS-CoV-2 infection compared with persons who reported no or non-severe systemic AEs. METHODS: We conducted a nested case-control study using v-safe surveillance data. Participants were ≥ 18 years and received dose 1 during December 14, 2020─May 9, 2021. Cases reported severe systemic AEs 0-7 days after vaccination. Three controls were frequency matched per case by age, vaccination date, and days since vaccination. Follow-up surveys collected SARS-CoV-2 histories. RESULTS: Follow-up survey response rates were 38.6 % (potential cases) and 56.8 % (potential controls). In multivariable analyses including 3,862 case-patients and 11,586 controls, the odds of experiencing a severe systemic AE were 2.4 (Moderna, mRNA-1273; 95 % confidence interval [CI]: 1.89, 3.09) and 1.5 (Pfizer-BioNTech, BNT162b2; 95 % CI: 1.17, 2.02) times higher among participants with pre-vaccination SARS-CoV-2 histories compared with those without. Medical attention of any kind for symptoms during days 0-7 following dose 2 was not common among case-patients or controls. CONCLUSIONS: History of SARS-CoV-2 infection was significantly associated with severe systemic AEs following dose 1 of mRNA COVID-19 vaccine; the effect varied by vaccine received. Most participants who experienced severe systemic AEs following dose 1 did not require medical attention of any kind for symptoms following dose 2. Vaccine providers can use these findings to counsel patients who had pre-vaccination SARS-CoV-2 infection histories, experienced severe systemic AEs following dose 1, and are considering not receiving additional mRNA COVID-19 vaccine doses.

Epidemiologic Features of the Monkeypox Outbreak and the Public Health Response - United States, May 17-October 6, 2022.

On May 17, 2022, the Massachusetts Department of Health announced the first suspected case of monkeypox associated with the global outbreak in a U.S. resident. On May 23, 2022, CDC launched an emergency response (1,2). CDC's emergency response focused on surveillance, laboratory testing, medical countermeasures, and education. Medical countermeasures included rollout of a national JYNNEOS vaccination strategy, Food and Drug Administration (FDA) issuance of an emergency use authorization to allow for intradermal administration of JYNNEOS, and use of tecovirimat for patients with, or at risk for, severe monkeypox. During May 17-October 6, 2022, a total of 26,384 probable and confirmed* U.S. monkeypox cases were reported to CDC. Daily case counts peaked during mid-to-late August. Among 25,001 of 25,569 (98%) cases in adults with information on gender identity,† 23,683 (95%) occurred in cisgender men. Among 13,997 cisgender men with information on recent sexual or close intimate contact,§ 10,440 (75%) reported male-to-male sexual contact (MMSC) ≤21 days preceding symptom onset. Among 21,211 (80%) cases in persons with information on race and ethnicity,¶ 6,879 (32%), 6,628 (31%), and 6,330 (30%) occurred in non-Hispanic Black or African American (Black), Hispanic or Latino (Hispanic), and non-Hispanic White (White) persons, respectively. Among 5,017 (20%) cases in adults with information on HIV infection status, 2,876 (57%) had HIV infection. Prevention efforts, including vaccination, should be prioritized among persons at highest risk within groups most affected by the monkeypox outbreak, including gay, bisexual, and other men who have sex with men (MSM); transgender, nonbinary, and gender-diverse persons; racial and ethnic minority groups; and persons who are immunocompromised, including persons with advanced HIV infection or newly diagnosed HIV infection.

Menstrual irregularities and vaginal bleeding after COVID-19 vaccination reported to v-safe active surveillance, USA in December, 2020-January, 2022: an observational cohort study.

BACKGROUND: Anecdotal reports of menstrual irregularities after receiving COVID-19 vaccines have been observed in post-authorisation and post-licensure monitoring. We aimed to identify and classify reports of menstrual irregularities and vaginal bleeding after COVID-19 vaccination submitted to a voluntary active surveillance system. METHODS: This observational cohort study included recipients of a COVID-19 vaccine who were aged 18 years and older and reported their health experiences to v-safe, a voluntary smartphone-based active surveillance system for monitoring COVID-19 vaccine safety in the USA, from Dec 14, 2020, to Jan 9, 2022. Responses to survey questions on reactions after vaccination were extracted, and a pre-trained natural language inference model was used to identify and classify free-text comments related to menstruation and vaginal bleeding in response to an open-ended prompt about any symptoms at intervals after vaccination. Related responses were further categorised into themes of timing, severity, perimenopausal and postmenopausal bleeding, resumption of menses, and other responses. We examined associations between symptom theme and respondent characteristics, including vaccine type and dose number received, solicited local and systemic reactions reported, and health care sought. FINDINGS: 63 815 respondents reported on menstrual irregularities or vaginal bleeding, which included 62 679 female respondents (1·0% of 5 975 363 female respondents aged ≥18 years). Common themes identified included timing of menstruation (70 981 [83·6%] responses) and severity of menstrual symptoms (56 890 [67·0%] responses). Other themes included menopausal bleeding (3439 [4·0%] responses) and resumption of menses (2378 [2·8%] responses). Respondents submitting reports related to menopausal bleeding were more likely to seek health care than were those submitting reports related to other menstruation and vaginal bleeding themes. INTERPRETATION: Reports of heterogeneous symptoms related to menstruation or vaginal bleeding after COVID-19 vaccination are being submitted to v-safe, although this study is unable to characterise the relationship of these symptoms to COVID-19 vaccination. Methods that leverage pretrained models to interpret and classify unsolicited signs and symptoms in free-text reports offer promise in the initial evaluation of unexpected adverse events potentially associated with use of newly authorised or licensed vaccines. FUNDING: Centers for Disease Control and Prevention.

Safety of Booster Doses of Coronavirus Disease 2019 (COVID-19) Vaccine in Pregnancy in the Vaccine Adverse Event Reporting System.

OBJECTIVE: To evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system, in pregnant people who received a booster dose of mRNA coronavirus disease 2019 (COVID-19) vaccine. METHODS: We searched VAERS for U.S. reports of adverse events in pregnant people who received a booster dose of an mRNA COVID-19 vaccine from September 22, 2021, to March 24, 2022. Clinicians reviewed reports and available medical records. RESULTS: The Vaccine Adverse Event Reporting System received 323 reports of adverse events in pregnant people who received a booster dose of COVID-19 vaccine; 178 (55.1%) after BNT162b2 from Pfizer-BioNTech and 145 (44.9%) after mRNA-1273 from Moderna. Seventy-two (22.3%) reports were coded as serious. One neonatal death was reported, but no maternal deaths occurred. Pregnancy-specific outcomes included 56 (17.3%) spontaneous abortions (before 20 weeks of gestation), eight (2.5%) episodes of vaginal bleeding, five (1.5%) stillbirths (at or after 20 weeks of gestation), four (1.2%) episodes of preeclampsia, and two (0.6%) preterm deliveries. Reporting rates for stillbirth and preterm delivery were below background rates. Ten instances of adverse events in neonates were reported, which included two reports of birth defects. Non-pregnancy-specific adverse events (n=207; 64.1%) were mostly systemic (eg, headache, fatigue) and local reactions and occurred in proportions comparable with those seen in pregnant people who received the primary COVID-19 vaccination series and reported to VAERS during the same period. CONCLUSION: Review of reports after a booster dose of mRNA COVID-19 vaccine in pregnant people in VAERS found their safety profile was comparable with that of published reports after primary COVID-19 vaccination in pregnant people.

Coronavirus Disease 2019 (COVID-19) Severity Among Women of Reproductive Age With Symptomatic Laboratory-Confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection by Pregnancy Status-United States, 1 January 2020-25 December 2021.

BACKGROUND: Information on the severity of coronavirus disease 2019 (COVID-19) attributable to the Delta variant in the United States among pregnant people is limited. We assessed the risk for severe COVID-19 by pregnancy status in the period of Delta variant predominance compared with the pre-Delta period. METHODS: Laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections among symptomatic women of reproductive age (WRA) were assessed. We calculated adjusted risk ratios for severe disease including intensive care unit (ICU) admission, receipt of invasive ventilation or extracorporeal membrane oxygenation (ECMO), and death comparing the pre-Delta period (1 January 2020-26 June 2021) and the Delta period (27 June 2021-25 December 2021) for pregnant and nonpregnant WRA. RESULTS: Compared with the pre-Delta period, the risk of ICU admission during the Delta period was 41% higher (adjusted risk ratio [aRR], 1.41 [95% confidence interval {CI}, 1.17-1.69]) for pregnant WRA and 9% higher (aRR, 1.09 [95% CI, 1.00-1.18]) for nonpregnant WRA. The risk of invasive ventilation or ECMO was higher for pregnant (aRR, 1.83 [95% CI, 1.26-2.65]) and nonpregnant (aRR, 1.34 [95% CI, 1.17-1.54]) WRA in the Delta period. During the Delta period, the risk of death was 3.33 (95% CI, 2.48-4.46) times the risk in the pre-Delta period among pregnant WRA and 1.62 (95% CI, 1.49-1.77) among nonpregnant WRA. CONCLUSIONS: Compared with the pre-Delta period, pregnant and nonpregnant WRA were at increased risk for severe COVID-19 in the Delta period.

Fertility and contraception among women of reproductive age following a disaster: a scoping review.

BACKGROUND: The prevalence and severity of disasters triggered by natural hazards has increased over the last 20 years. Women of reproductive age may encounter unique reproductive health challenges following a disaster. In this scoping review we identify gaps in literature to inform future research and search for potential associations between disasters by natural hazards and post-disaster fertility and contraception among women of reproductive age. METHODS: Medline (OVID), Embase (OVID), PsycInfo (OVID), CINAHL (Ebsco), Scopus, Environmental Science Collection (ProQuest Central), and Sociological Abstracts (ProQuest Central) were searched for articles published from 1980 through March 3, 2022 in English or Spanish language. Search terms were related to fertility, contraception, and disasters. We included original research that described a discrete natural hazard exposure, a population of women of reproductive age (15-49 years), and outcomes of fertility or contraception use or access, with pre- and post-disaster measures. RESULTS: Among 9788 citations, after initial exclusion 5121 remained for title and abstract review. One hundred and eighteen citations underwent full-text review and 26 articles met the inclusion criteria. Following critical appraisal, 20 articles were included in this review. Eighteen articles described outcomes related to fertility, five articles described contraception access, and three articles described contraception use. CONCLUSIONS: Clearly defined exposure measures, robust analyses, and methodical post-disaster assessment periods, may address the current gaps within disaster research on fertility and contraception among women of reproductive age. Consistent patterns in fertility following a disaster triggered by natural hazards were not identified between or within disaster types. Studies that assessed contraception found no change in use, while some studies found a decrease in contraceptive access overall.

Post-authorization surveillance of adverse events following COVID-19 vaccines in pregnant persons in the vaccine adverse event reporting system (VAERS), December 2020 - October 2021.

BACKGROUND: Pregnant persons are at increased risk of severe illness from COVID-19 infection, including intensive care unit admission, mechanical ventilation, and death compared with non-pregnant persons of reproductive age. Limited data are available on the safety of COVID-19 vaccines administered during and around the time of pregnancy. OBJECTIVE: To evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system, in pregnant persons who received a COVID-19 vaccine to assess for potential vaccine safety problems. METHODS: We searched VAERS for US reports of adverse events (AEs) in pregnant persons who received a COVID-19 vaccine from 12/14/2020-10/31/2021. Clinicians reviewed reports and available medical records. Crude reporting rates for selected AEs were calculated, and disproportional reporting was assessed using data mining methods. RESULTS: VAERS received 3,462 reports of AEs in pregnant persons who received a COVID-19 vaccine; 1,831 (52.9%) after BNT162b2, 1,350 (38.9%) after mRNA-1273, and 275 (7.9%) after Ad26.COV2.S. Eight maternal deaths and 12 neonatal deaths were reported. Six-hundred twenty-one (17.9%) reports were serious. Pregnancy-specific outcomes included: 878 spontaneous abortions (<20 weeks), 101 episodes of vaginal bleeding, 76 preterm deliveries (<37 weeks), 62 stillbirths (≥20 weeks), and 33 outcomes with birth defects. Crude reporting rates for preterm deliveries and stillbirths, as well as maternal and neonatal mortality rates were below background rates from published sources. No disproportional reporting for any AE was observed. CONCLUSIONS: Review of reports to VAERS following COVID-19 vaccines in pregnant persons did not identify any concerning patterns of maternal or infant-fetal outcomes.

Safety of mRNA vaccines administered during the initial 6 months of the US COVID-19 vaccination programme: an observational study of reports to the Vaccine Adverse Event Reporting System and v-safe.

BACKGROUND: In December, 2020, two mRNA-based COVID-19 vaccines were authorised for use in the USA. We aimed to describe US surveillance data collected through the Vaccine Adverse Event Reporting System (VAERS), a passive system, and v-safe, a new active system, during the first 6 months of the US COVID-19 vaccination programme. METHODS: In this observational study, we analysed data reported to VAERS and v-safe during Dec 14, 2020, to June 14, 2021. VAERS reports were categorised as non-serious, serious, or death. Reporting rates were calculated using numbers of COVID-19 doses administered as the denominator. We analysed v-safe survey reports from days 0-7 after vaccination for reactogenicity, severity (mild, moderate, or severe), and health impacts (ie, unable to perform normal daily activities, unable to work, or received care from a medical professional). FINDINGS: During the study period, 298 792 852 doses of mRNA vaccines were administered in the USA. VAERS processed 340 522 reports: 313 499 (92·1%) were non-serious, 22 527 (6·6%) were serious (non-death), and 4496 (1·3%) were deaths. Over half of 7 914 583 v-safe participants self-reported local and systemic reactogenicity, more frequently after dose two (4 068 447 [71·7%] of 5 674 420 participants for local reactogenicity and 4 018 920 [70·8%] for systemic) than after dose one (4 644 989 [68·6%] of 6 775 515 participants for local reactogenicity and 3 573 429 [52·7%] for systemic). Injection-site pain (4 488 402 [66·2%] of 6 775 515 participants after dose one and 3 890 848 [68·6%] of 5 674 420 participants after dose two), fatigue (2 295 205 [33·9%] participants after dose one and 3 158 299 participants [55·7%] after dose two), and headache (1 831 471 [27·0%] participants after dose one and 2 623 721 [46·2%] participants after dose two) were commonly reported during days 0-7 following vaccination. Reactogenicity was reported most frequently the day after vaccination; most reactions were mild. More reports of being unable to work, do normal activities, or of seeking medical care occurred after dose two (1 821 421 [32·1%]) than after dose one (808 963 [11·9%]); less than 1% of participants reported seeking medical care after vaccination (56 647 [0·8%] after dose one and 53 077 [0·9%] after dose two). INTERPRETATION: Safety data from more than 298 million doses of mRNA COVID-19 vaccine administered in the first 6 months of the US vaccination programme show that most reported adverse events were mild and short in duration. FUNDING: US Centers for Disease Control and Prevention.

Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021.

Importance: Vaccination against COVID-19 provides clear public health benefits, but vaccination also carries potential risks. The risks and outcomes of myocarditis after COVID-19 vaccination are unclear. Objective: To describe reports of myocarditis and the reporting rates after mRNA-based COVID-19 vaccination in the US. Design, Setting, and Participants: Descriptive study of reports of myocarditis to the Vaccine Adverse Event Reporting System (VAERS) that occurred after mRNA-based COVID-19 vaccine administration between December 2020 and August 2021 in 192 405 448 individuals older than 12 years of age in the US; data were processed by VAERS as of September 30, 2021. Exposures: Vaccination with BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna). Main Outcomes and Measures: Reports of myocarditis to VAERS were adjudicated and summarized for all age groups. Crude reporting rates were calculated across age and sex strata. Expected rates of myocarditis by age and sex were calculated using 2017-2019 claims data. For persons younger than 30 years of age, medical record reviews and clinician interviews were conducted to describe clinical presentation, diagnostic test results, treatment, and early outcomes. Results: Among 192 405 448 persons receiving a total of 354 100 845 mRNA-based COVID-19 vaccines during the study period, there were 1991 reports of myocarditis to VAERS and 1626 of these reports met the case definition of myocarditis. Of those with myocarditis, the median age was 21 years (IQR, 16-31 years) and the median time to symptom onset was 2 days (IQR, 1-3 days). Males comprised 82% of the myocarditis cases for whom sex was reported. The crude reporting rates for cases of myocarditis within 7 days after COVID-19 vaccination exceeded the expected rates of myocarditis across multiple age and sex strata. The rates of myocarditis were highest after the second vaccination dose in adolescent males aged 12 to 15 years (70.7 per million doses of the BNT162b2 vaccine), in adolescent males aged 16 to 17 years (105.9 per million doses of the BNT162b2 vaccine), and in young men aged 18 to 24 years (52.4 and 56.3 per million doses of the BNT162b2 vaccine and the mRNA-1273 vaccine, respectively). There were 826 cases of myocarditis among those younger than 30 years of age who had detailed clinical information available; of these cases, 792 of 809 (98%) had elevated troponin levels, 569 of 794 (72%) had abnormal electrocardiogram results, and 223 of 312 (72%) had abnormal cardiac magnetic resonance imaging results. Approximately 96% of persons (784/813) were hospitalized and 87% (577/661) of these had resolution of presenting symptoms by hospital discharge. The most common treatment was nonsteroidal anti-inflammatory drugs (589/676; 87%). Conclusions and Relevance: Based on passive surveillance reporting in the US, the risk of myocarditis after receiving mRNA-based COVID-19 vaccines was increased across multiple age and sex strata and was highest after the second vaccination dose in adolescent males and young men. This risk should be considered in the context of the benefits of COVID-19 vaccination.

Disaster Preparedness Among Women With a Recent Live Birth in Hawaii - Results From the Pregnancy Risk Assessment Monitoring System (PRAMS), 2016.

OBJECTIVE: The aim of this study was to examine emergency preparedness behaviors among women with a recent live birth in Hawaii. METHODS: Using the 2016 Hawaii Pregnancy Risk Assessment Monitoring System, we estimated weighted prevalence of 8 preparedness behaviors. RESULTS: Among 1010 respondents (weighted response rate, 56.3%), 79.3% reported at least 1 preparedness behavior, and 11.2% performed all 8 behaviors. The prevalence of women with a recent live birth in Hawaii reporting preparedness behaviors includes: 63.0% (95% CI: 58.7-67.1%) having enough supplies at home for at least 7 days, 41.3% (95% CI: 37.1-45.6%) having an evacuation plan for their child(ren), 38.7% (95% CI: 34.5-43.0%) having methods to keep in touch, 37.8% (95% CI: 33.7-42.1%) having an emergency meeting place, 36.6% (95% CI: 32.6-40.9%) having an evacuation plan to leave home, 34.9% (95% CI: 30.9-39.2%) having emergency supplies to take with them if they have to leave quickly, 31.8% (95% CI: 27.9-36.0%) having copies of important documents, and 31.6% (95% CI: 27.7-35.8%) having practiced what to do during a disaster. CONCLUSIONS: One in 10 women practiced all 8 behaviors, indicating more awareness efforts are needed among this population in Hawaii. The impact of preparedness interventions implemented in Hawaii can be tracked with this question over time.

Emergency Preparedness and Response: Highlights from the Division of Reproductive Health, 2011-2021.

This report provides historical context and rationale for coordinated, systematic, and evidence-based public health emergency preparedness and response (EPR) activities to address the needs of women of reproductive age. Needs of pregnant and postpartum women, and infants-before, during, and after public health emergencies-are highlighted. Four focus areas and related activities are described: (1) public health science; (2) clinical guidance; (3) partnerships, communication, and outreach; and (4) workforce development. Finally, the report summarizes major activities of the Division of Reproductive Health's EPR Team at the Centers for Disease Control and Prevention.

Update: Characteristics of Symptomatic Women of Reproductive Age with Laboratory-Confirmed SARS-CoV-2 Infection by Pregnancy Status - United States, January 22-October 3, 2020.

Studies suggest that pregnant women might be at increased risk for severe illness associated with coronavirus disease 2019 (COVID-19) (1,2). This report provides updated information about symptomatic women of reproductive age (15-44 years) with laboratory-confirmed infection with SARS-CoV-2, the virus that causes COVID-19. During January 22-October 3, CDC received reports through national COVID-19 case surveillance or through the National Notifiable Diseases Surveillance System (NNDSS) of 1,300,938 women aged 15-44 years with laboratory results indicative of acute infection with SARS-CoV-2. Data on pregnancy status were available for 461,825 (35.5%) women with laboratory-confirmed infection, 409,462 (88.7%) of whom were symptomatic. Among symptomatic women, 23,434 (5.7%) were reported to be pregnant. After adjusting for age, race/ethnicity, and underlying medical conditions, pregnant women were significantly more likely than were nonpregnant women to be admitted to an intensive care unit (ICU) (10.5 versus 3.9 per 1,000 cases; adjusted risk ratio [aRR] = 3.0; 95% confidence interval [CI] = 2.6-3.4), receive invasive ventilation (2.9 versus 1.1 per 1,000 cases; aRR = 2.9; 95% CI = 2.2-3.8), receive extracorporeal membrane oxygenation (ECMO) (0.7 versus 0.3 per 1,000 cases; aRR = 2.4; 95% CI = 1.5-4.0), and die (1.5 versus 1.2 per 1,000 cases; aRR = 1.7; 95% CI = 1.2-2.4). Stratifying these analyses by age and race/ethnicity highlighted disparities in risk by subgroup. Although the absolute risks for severe outcomes for women were low, pregnant women were at increased risk for severe COVID-19-associated illness. To reduce the risk for severe illness and death from COVID-19, pregnant women should be counseled about the importance of seeking prompt medical care if they have symptoms and measures to prevent SARS-CoV-2 infection should be strongly emphasized for pregnant women and their families during all medical encounters, including prenatal care visits. Understanding COVID-19-associated risks among pregnant women is important for prevention counseling and clinical care and treatment.

Severe Coronavirus Infections in Pregnancy: A Systematic Review.

OBJECTIVE: To inform the current coronavirus disease 2019 (COVID-19) outbreak, we conducted a systematic literature review of case reports of Middle East respiratory syndrome coronavirus (MERS-CoV), severe acute respiratory syndrome coronavirus (SARS-CoV), and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, during pregnancy and summarized clinical presentation, course of illness, and pregnancy and neonatal outcomes. DATA SOURCES: We searched MEDLINE and ClinicalTrials.gov from inception to April 23, 2020. METHODS OF STUDY SELECTION: We included articles reporting case-level data on MERS-CoV, SARS-CoV, and SARS-CoV-2 infection in pregnant women. Course of illness, indicators of severe illness, maternal health outcomes, and pregnancy outcomes were abstracted from included articles. TABULATION, INTEGRATION, AND RESULTS: We identified 1,328 unique articles, and 1,253 articles were excluded by title and abstract review. We completed full-text review on 75, and 29 articles were excluded by full-text review. Among 46 publications reporting case-level data, eight described 12 cases of MERS-CoV infection, seven described 17 cases of SARS-CoV infection, and 31 described 98 cases of SARS-CoV-2 infection. Clinical presentation and course of illness ranged from asymptomatic to severe fatal disease, similar to the general population of patients. Severe morbidity and mortality among women with MERS-CoV, SARS-CoV, or SARS-CoV-2 infection in pregnancy and adverse pregnancy outcomes, including pregnancy loss, preterm delivery, and laboratory evidence of vertical transmission, were reported. CONCLUSION: Understanding whether pregnant women may be at risk for adverse maternal and neonatal outcomes from severe coronavirus infections is imperative. Data from case reports of SARS-CoV, MERS-CoV, and SAR-CoV-2 infections during pregnancy are limited, but they may guide early public health actions and clinical decision-making for COVID-19 until more rigorous and systematically collected data are available. The capture of critical data is needed to better define how this infection affects pregnant women and neonates. This review was not registered with PROSPERO.

Characteristics of Women of Reproductive Age with Laboratory-Confirmed SARS-CoV-2 Infection by Pregnancy Status - United States, January 22-June 7, 2020.

As of June 16, 2020, the coronavirus disease 2019 (COVID-19) pandemic has resulted in 2,104,346 cases and 116,140 deaths in the United States.* During pregnancy, women experience immunologic and physiologic changes that could increase their risk for more severe illness from respiratory infections (1,2). To date, data to assess the prevalence and severity of COVID-19 among pregnant U.S. women and determine whether signs and symptoms differ among pregnant and nonpregnant women are limited. During January 22-June 7, as part of COVID-19 surveillance, CDC received reports of 326,335 women of reproductive age (15-44 years) who had positive test results for SARS-CoV-2, the virus that causes COVID-19. Data on pregnancy status were available for 91,412 (28.0%) women with laboratory-confirmed infections; among these, 8,207 (9.0%) were pregnant. Symptomatic pregnant and nonpregnant women with COVID-19 reported similar frequencies of cough (>50%) and shortness of breath (30%), but pregnant women less frequently reported headache, muscle aches, fever, chills, and diarrhea. Chronic lung disease, diabetes mellitus, and cardiovascular disease were more commonly reported among pregnant women than among nonpregnant women. Among women with COVID-19, approximately one third (31.5%) of pregnant women were reported to have been hospitalized compared with 5.8% of nonpregnant women. After adjusting for age, presence of underlying medical conditions, and race/ethnicity, pregnant women were significantly more likely to be admitted to the intensive care unit (ICU) (aRR = 1.5, 95% confidence interval [CI] = 1.2-1.8) and receive mechanical ventilation (aRR = 1.7, 95% CI = 1.2-2.4). Sixteen (0.2%) COVID-19-related deaths were reported among pregnant women aged 15-44 years, and 208 (0.2%) such deaths were reported among nonpregnant women (aRR = 0.9, 95% CI = 0.5-1.5). These findings suggest that among women of reproductive age with COVID-19, pregnant women are more likely to be hospitalized and at increased risk for ICU admission and receipt of mechanical ventilation compared with nonpregnant women, but their risk for death is similar. To reduce occurrence of severe illness from COVID-19, pregnant women should be counseled about the potential risk for severe illness from COVID-19, and measures to prevent infection with SARS-CoV-2 should be emphasized for pregnant women and their families.