COVID-19 Surveillance After Expiration of the Public Health Emergency Declaration - United States, May 11, 2023.

On January 31, 2020, the U.S. Department of Health and Human Services (HHS) declared, under Section 319 of the Public Health Service Act, a U.S. public health emergency because of the emergence of a novel virus, SARS-CoV-2.* After 13 renewals, the public health emergency will expire on May 11, 2023. Authorizations to collect certain public health data will expire on that date as well. Monitoring the impact of COVID-19 and the effectiveness of prevention and control strategies remains a public health priority, and a number of surveillance indicators have been identified to facilitate ongoing monitoring. After expiration of the public health emergency, COVID-19-associated hospital admission levels will be the primary indicator of COVID-19 trends to help guide community and personal decisions related to risk and prevention behaviors; the percentage of COVID-19-associated deaths among all reported deaths, based on provisional death certificate data, will be the primary indicator used to monitor COVID-19 mortality. Emergency department (ED) visits with a COVID-19 diagnosis and the percentage of positive SARS-CoV-2 test results, derived from an established sentinel network, will help detect early changes in trends. National genomic surveillance will continue to be used to estimate SARS-CoV-2 variant proportions; wastewater surveillance and traveler-based genomic surveillance will also continue to be used to monitor SARS-CoV-2 variants. Disease severity and hospitalization-related outcomes are monitored via sentinel surveillance and large health care databases. Monitoring of COVID-19 vaccination coverage, vaccine effectiveness (VE), and vaccine safety will also continue. Integrated strategies for surveillance of COVID-19 and other respiratory viruses can further guide prevention efforts. COVID-19-associated hospitalizations and deaths are largely preventable through receipt of updated vaccines and timely administration of therapeutics (1-4).

"We will need to build up the atmosphere of trust again": Service providers' perceptions of experiences of COVID-19 amongst resettled refugee adolescents.

Adolescent resettled refugees across the United States have been significantly impacted by the COVID-19 pandemic, through socio-economic stressors in households, disproportionate morbidity and mortality in immigrant communities, and social isolation and loss of learning due to school closures and the shift to online learning. The Study of Adolescent Lives after Migration to America [SALaMA] investigates the mental health and wellbeing of adolescents who come from-or who have parents who came from-the Middle East and North Africa [MENA] region and settled in the U.S. There is a gap in understanding of the experiences during the pandemic of MENA-background adolescents in the U.S. The objective of this study was to describe the perspective of educators and other school-affiliated service providers on the impact of the COVID-19 pandemic on mental health and wellbeing of adolescent resettled refugees and access to and quality of education and support services for adolescent resettled refugees. The researchers collected data using in-depth interviews with key informants in Chicago, Illinois; Harrisonburg, Virginia; and Detroit Metropolitan Area [DMA], Michigan, Key informants were school administrators, managers of English language learning services and programs, teachers, therapists, staff of non-governmental organizations and/ or community-based organizations, and case workers. Data analysis was conducted utilizing directed content analysis to develop an initial codebook and identify key themes in the data. Findings revealed a number of pathways through which the pandemic impacted adolescent refugees and immigrants' mental health and wellbeing, with online programming impacting students' engagement, motivation and social isolation in terms of peer and provider relationships. Specific dynamics in refugee adolescents' households increased stressors and reduced engagement through online learning, and access to space and resources needed to support learning during school closures were limited. Service providers emphasized multiple and overlapping impacts on service quality and access, resulting in reduced social supports and mental health prevention and response approaches. Due to the long-term impacts of school closures in the first two years of the pandemic, and ongoing disruption, these data both provide a snapshot of the impacts of the pandemic at a specific moment, as well as insights into ways forward in terms of adapting services and engaging students within restrictions and limitations due to the pandemic. These findings emphasize the need for educators and mental health service providers to rebuild and strengthen relationships with students and families. These findings indicate the need to consider, support and expand social support and mental health services, specifically for refugee adolescent students, in the context of learning and well-being during the COVID-19 pandemic.

Interim Recommendations from the Advisory Committee on Immunization Practices for the Use of Bivalent Booster Doses of COVID-19 Vaccines - United States, October 2022.

Four COVID-19 vaccines are currently approved for primary series vaccination in the United States under a Biologics License Application or authorized under an emergency use authorization (EUA) by the Food and Drug Administration (FDA), and recommended for primary series vaccination by the Advisory Committee on Immunization Practices (ACIP): 1) the 2- or 3-dose monovalent mRNA BNT162b2 (Pfizer-BioNTech, Comirnaty) COVID-19 vaccine; 2) the 2- or 3-dose monovalent mRNA mRNA-1273 (Moderna, Spikevax) COVID-19 vaccine; 3) the single-dose adenovirus vector-based Ad26.COV.S (Janssen [Johnson & Johnson]) COVID-19 vaccine; and 4) the 2-dose adjuvanted, protein subunit-based NVX-CoV2373 (Novavax) COVID-19 vaccine. The number of doses recommended is based on recipient age and immunocompromise status (1). For additional protection, FDA has amended EUAs to allow for COVID-19 booster doses in eligible persons (1). Because COVID-19 vaccines have demonstrated decreased effectiveness during the period when the Omicron variant (B.1.1.529) of SARS-CoV-2 predominated, bivalent booster doses (i.e., vaccine with equal components from the ancestral and Omicron strains) were considered for the express purpose of improving protection conferred by COVID-19 vaccine booster doses (2). During September-October 2022, FDA authorized bivalent mRNA vaccines for use as a booster dose in persons aged ≥5 years who completed any FDA-approved or FDA-authorized primary series and removed EUAs for monovalent COVID-19 booster doses (1). Pfizer-BioNTech and Moderna bivalent booster vaccines each contain equal amounts of spike mRNA from the ancestral and Omicron BA.4/BA.5 strains. After the EUA amendments, ACIP and CDC recommended that all persons aged ≥5 years receive 1 bivalent mRNA booster dose ≥2 months after completion of any FDA-approved or FDA-authorized monovalent primary series or monovalent booster doses.

Interim Recommendation of the Advisory Committee on Immunization Practices for Use of the Novavax COVID-19 Vaccine in Persons Aged ≥18 years - United States, July 2022.

The NVX-CoV2373 (Novavax) COVID-19 vaccine is a recombinant spike (rS) protein nanoparticle vaccine with Matrix-M adjuvant to protect against infection with SARS-CoV-2, the virus that causes COVID-19. On July 13, 2022, the Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the Novavax vaccine for primary COVID-19 immunization of unvaccinated adults aged ≥18 years, administered as 2 doses (5 µg rS and 50 µg Matrix-M adjuvant in each dose) 3 weeks apart (1). On July 19, 2022, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of the Novavax vaccine in persons aged ≥18 years for the prevention of COVID-19.* In the per-protocol† efficacy analysis, vaccine efficacy (VE) against reverse transcription-polymerase chain reaction (RT-PCR)-confirmed symptomatic COVID-19 was 89.6% (95% CI = 82.4%-93.8%). The Alpha variant (B.1.1.7) of SARS-CoV-2 was the predominant circulating variant during the period of case accrual for VE assessments. Cases of myocarditis or pericarditis were reported in temporal association with vaccination, suggesting a possible causal relationship. The ACIP recommendation for the use of the Novavax COVID-19 vaccine is interim and will be updated as additional information becomes available. The adjuvanted, protein subunit-based Novavax COVID-19 vaccine provides an additional option for unvaccinated adults, increasing flexibility for the public and for vaccine providers. Vaccination is important for protection against COVID-19.

Interim Recommendations of the Advisory Committee on Immunization Practices for Use of Moderna and Pfizer-BioNTech COVID-19 Vaccines in Children Aged 6 Months-5 Years - United States, June 2022.

On June 17, 2022, the Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) amendments for the mRNA-1273 (Moderna) COVID-19 vaccine for use in children aged 6 months-5 years, administered as 2 doses (25 µg [0.25 mL] each), 4 weeks apart, and BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine for use in children aged 6 months-4 years, administered as 3 doses (3 µg [0.2 mL] each), at intervals of 3 weeks between doses 1 and 2 and ≥8 weeks between doses 2 and 3. On June 18, 2022, the Advisory Committee on Immunization Practices (ACIP) issued separate interim recommendations for use of the Moderna COVID-19 vaccine in children aged 6 months-5 years and the Pfizer-BioNTech COVID-19 vaccine in children aged 6 months-4 years for the prevention of COVID-19.* Both the Moderna and Pfizer-BioNTech COVID-19 vaccines met the criteria for immunobridging, which is the comparison of neutralizing antibody levels postvaccination in young children with those in young adults in whom efficacy had been demonstrated. Descriptive efficacy analyses were also conducted for both Moderna and Pfizer-BioNTech COVID-19 vaccines during the period when the Omicron variant of SARS-CoV-2 (the virus that causes COVID-19) predominated. No specific safety concerns were identified among recipients of either vaccine. ACIP recommendations for the use of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine in children aged 6 months-5 years and 6 months-4 years, respectively, are interim and will be updated as additional information becomes available. Vaccination is important for protecting children aged 6 months-5 years against COVID-19.

Global, regional, and national prevalence estimates of physical or sexual, or both, intimate partner violence against women in 2018.

BACKGROUND: Intimate partner violence against women is a global public health problem with many short-term and long-term effects on the physical and mental health of women and their children. The Sustainable Development Goals (SDGs) call for its elimination in target 5.2. To monitor governments' progress towards SDG target 5.2, this study aimed to provide global, regional, and country baseline estimates of physical or sexual, or both, violence against women by male intimate partners. METHODS: This study developed global, regional, and country estimates, based on data from the WHO Global Database on Prevalence of Violence Against Women. These data were identified through a systematic literature review searching MEDLINE, Global Health, Embase, Social Policy, and Web of Science, and comprehensive searches of national statistics and other websites. A country consultation process identified additional studies. Included studies were conducted between 2000 and 2018, representative at the national or sub-national level, included women aged 15 years or older, and used act-based measures of physical or sexual, or both, intimate partner violence. Non-population-based data, including administrative data, studies not generalisable to the whole population, studies with outcomes that only provided the combined prevalence of physical or sexual, or both, intimate partner violence with other forms of violence, and studies with insufficient data to allow extrapolation or imputation were excluded. We developed a Bayesian multilevel model to jointly estimate lifetime and past year intimate partner violence by age, year, and country. This framework adjusted for heterogeneous age groups and differences in outcome definition, and weighted surveys depending on whether they were nationally or sub-nationally representative. This study is registered with PROSPERO (number CRD42017054100). FINDINGS: The database comprises 366 eligible studies, capturing the responses of 2 million women. Data were obtained from 161 countries and areas, covering 90% of the global population of women and girls (15 years or older). Globally, 27% (uncertainty interval [UI] 23-31%) of ever-partnered women aged 15-49 years are estimated to have experienced physical or sexual, or both, intimate partner violence in their lifetime, with 13% (10-16%) experiencing it in the past year before they were surveyed. This violence starts early, affecting adolescent girls and young women, with 24% (UI 21-28%) of women aged 15-19 years and 26% (23-30%) of women aged 19-24 years having already experienced this violence at least once since the age of 15 years. Regional variations exist, with low-income countries reporting higher lifetime and, even more pronouncedly, higher past year prevalence compared with high-income countries. INTERPRETATION: These findings show that intimate partner violence against women was already highly prevalent across the globe before the COVID-19 pandemic. Governments are not on track to meet the SDG targets on the elimination of violence against women and girls, despite robust evidence that intimate partner violence can be prevented. There is an urgent need to invest in effective multisectoral interventions, strengthen the public health response to intimate partner violence, and ensure it is addressed in post-COVID-19 reconstruction efforts. FUNDING: UK Department for International Development through the UN Women-WHO Joint Programme on Strengthening Violence against Women Data, and UNDP-UN Population Fund-UNICEF-WHO-World Bank Special Programme of Research, Development, and Research Training in Human Reproduction, a cosponsored programme executed by WHO.

The Advisory Committee on Immunization Practices' Recommendation for Use of Moderna COVID-19 Vaccine in Adults Aged ≥18 Years and Considerations for Extended Intervals for Administration of Primary Series Doses of mRNA COVID-19 Vaccines - United States, February 2022.

The mRNA-1273 (Moderna) COVID-19 vaccine is a lipid nanoparticle-encapsulated, nucleoside-modified mRNA vaccine encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. During December 2020, the vaccine was granted Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA), and the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use among persons aged ≥18 years (1), which was adopted by CDC. During December 19, 2020-January 30, 2022, approximately 204 million doses of Moderna COVID-19 vaccine were administered in the United States (2) as a primary series of 2 intramuscular doses (100 µg [0.5 mL] each) 4 weeks apart. On January 31, 2022, FDA approved a Biologics License Application (BLA) for use of the Moderna COVID-19 vaccine (Spikevax, ModernaTX, Inc.) in persons aged ≥18 years (3). On February 4, 2022, the ACIP COVID-19 Vaccines Work Group conclusions regarding recommendations for the use of the Moderna COVID-19 vaccine were presented to ACIP at a public meeting. The Work Group's deliberations were based on the Evidence to Recommendation (EtR) Framework,* which incorporates the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach† to rank evidence quality. In addition to initial clinical trial data, ACIP considered new information gathered in the 12 months since issuance of the interim recommendations, including additional follow-up time in the clinical trial, real-world vaccine effectiveness studies, and postauthorization vaccine safety monitoring. ACIP also considered comparisons of mRNA vaccine effectiveness and safety in real-world settings when first doses were administered 8 weeks apart instead of the original intervals used in clinical trials (3 weeks for BNT162b2 [Pfizer-BioNTech] COVID-19 vaccine and 4 weeks for Moderna COVID-19 vaccine). Based on this evidence, CDC has provided guidance that an 8-week interval might be optimal for some adolescents and adults. The additional information gathered since the issuance of the interim recommendations increased certainty that the benefits of preventing symptomatic and asymptomatic SARS-CoV-2 infection, hospitalization, and death outweigh vaccine-associated risks of the Moderna COVID-19 vaccine. On February 4, 2022, ACIP modified its interim recommendation to a standard recommendation§ for use of the fully licensed Moderna COVID-19 vaccine in persons aged ≥18 years.

Moms Are Not OK: COVID-19 and Maternal Mental Health.

Introduction: Depression and anxiety affect one in seven women during the perinatal period, and are associated with increased risk of preterm delivery, reduced mother-infant bonding, and delays in cognitive/emotional development of the infant. With this survey we aimed to rapidly assess the influence of the COVID-19 pandemic and subsequent physical distancing/isolation measures on the mental health and physical activity of pregnant and postpartum women. Methods: Between April 14 and May 8, 2020, we recruited women who were pregnant or within the first year after delivery to participate in an online survey. This included questionnaires on self-reported levels of depression/depressive symptoms (Edinburgh Postnatal Depression Survey; EPDS), anxiety (State-Trait Anxiety Inventory; STAI-State), and physical activity. Current and pre-pandemic values were assessed for each. Results: Of 900 eligible women, 520 (58%) were pregnant and 380 (42%) were in the first year after delivery. Sixty-four percent of women reported reduced physical activity with the onset of isolation measures, while 15% increased, and 21% had no change to their physical activity. An EPDS score >13 (indicative of depression) was self-identified in 15% of respondents pre-pandemic and in 40.7% currently (mean ± SD; 7.5 ± 4.9 vs. 11.2 ± 6.3, respectively; p < 0.01, moderate effect). Moderate to high anxiety (STAI-state score >40) was identified in 29% of women before the pandemic (mean STAI = 34.5 ± 11.4) vs. 72% of women currently (mean STAI = 48.1 ± 13.6; p < 0.01, large effect). However, women engaging in at least 150 min of moderate intensity physical activity (meeting current guidelines) during the pandemic had significantly lower scores for both anxiety and depression than those who did not (p < 0.01, large and small effect, respectively). Discussion: This rapid response survey identifies a substantial increase in the likelihood of maternal depression and anxiety during the COVID-19 pandemic. This highlights the strong need for heightened assessment and treatment of maternal mental health. However, these data also suggest that physical activity, which has previously been shown to reduce depression and depressive symptoms in pregnancy, may be associated with better mental health during the pandemic.

Performance Characteristics of a High-Throughput Automated Transcription-Mediated Amplification Test for SARS-CoV-2 Detection.

The COVID-19 pandemic caused by the new SARS-CoV-2 coronavirus has imposed severe challenges on laboratories in their effort to achieve sufficient diagnostic testing capability for identifying infected individuals. In this study, we report the analytical and clinical performance characteristics of a new, high-throughput, fully automated nucleic acid amplification test system for the detection of SARS-CoV-2. The assay utilizes target capture, transcription-mediated amplification, and acridinium ester-labeled probe chemistry on the automated Panther system to directly amplify and detect two separate target sequences in the open reading frame 1ab (ORF1ab) region of the SARS-CoV-2 RNA genome. The probit 95% limit of detection of the assay was determined to be 0.004 50% tissue culture infective dose (TCID50)/ml using inactivated virus and 25 copies/ml (c/ml) using synthetic in vitro transcript RNA targets. Analytical sensitivity (100% detection) was confirmed to be 83 to 194 c/ml using three commercially available SARS-CoV-2 nucleic acid controls. No cross-reactivity or interference was observed with testing of six related human coronaviruses, as well as 24 other viral, fungal, and bacterial pathogens, at high titers. Clinical nasopharyngeal swab specimen testing (n = 140) showed 100%, 98.7%, and 99.3% positive, negative, and overall agreement, respectively, with a validated reverse transcription-PCR nucleic acid amplification test (NAAT) for SARS-CoV-2 RNA. These results provide validation evidence for a sensitive and specific method for pandemic-scale automated molecular diagnostic testing for SARS-CoV-2.