INTRODUCTION: E-cigarette unit sales have been estimated using the number of items typically available in a package to standardize unit sales of each product type. However, recent market changes, such as increases in e-liquid volume and nicotine concentration, challenge the validity of assessing sales according to item count without accounting for product attributes. This study measured nicotine content (mg) in e-cigarettes sold as a function of e-liquid volume (mL) and nicotine concentration (mg/mL), compared with e-cigarette unit sales standardized by item count. METHODS: U.S. e-cigarette retail sales data from Circana (February 2019 to June 2024) were analyzed. Trends in mg nicotine sold were compared with standardized unit sales. Additionally, sales-weighted average e-liquid volume, nicotine concentration, and price per milligram of nicotine were measured by product type. Trends were assessed using Joinpoint regression. Analyses were conducted in 2024. RESULTS: From February 2020 to June 2024, monthly milligrams of nicotine content sold increased by 249.2% (p<0.001)-an increase 7.2 times greater than the 34.7% increase in standardized unit sales. Disposable e-cigarettes experienced the greatest increase in mg nicotine sold, which was largely driven by the rise in e-liquid volume. By June 2024, a disposable device contained 9.0 times more e-liquid than a prefilled cartridge. However, the price per milligram of nicotine in prefilled cartridges was 3.7 times greater than that of disposable devices. CONCLUSIONS: Nicotine is an addictive drug added to most e-cigarettes. Measuring e-cigarette sales in milligrams of nicotine content sold could better account for rapid changes in product attributes and inform policy strategies.

INTRODUCTION: Non-survey-based data sources (e.g. electronic health records, administrative claims) have been used to estimate vaccination coverage among US adults. However, these data sources were not collected for research or surveillance purposes and may have substantial limitations. The objectives of this narrative review were to: 1) identify published studies that used non-survey-based data sources to estimate adult vaccination coverage for one or more routinely recommended vaccines; and 2) summarize the strengths and limitations of these data sources for coverage assessments. AREAS COVERED: Thirty-four publications derived from 9 data sources were reviewed: 16 publications were in a general population (i.e. defined by age), 12 were among pregnant women, and 6 were among individuals with chronic health conditions. While several data sources used continuous health insurance enrollment to define the study population, doing so limited generalizability to stably insured populations. Methods for obtaining race and ethnicity data were complex and potentially subject to bias. None of the reviewed studies presented any formal assessment of vaccine data validity. EXPERT OPINION: While multiple non-survey-based data sources have been used to assess adult vaccination coverage in the United States, important limitations exist, including related to generalizability, data validity, and risk of bias.

BACKGROUND: There are known disparities in U.S. COVID-19 vaccination but there is limited information on national vaccine uptake in a large, racially diverse, all-age population. Here, we describe COVID-19 vaccination coverage in a large U.S. population accessing care in OCHIN (not an acronym), a national network of community-based healthcare organizations. METHODS: Within OCHIN, we identified patients aged 6 months and older with ≥1 completed clinical encounter since becoming age-eligible for the COVID-19 vaccine between December 13, 2020 and December 31, 2022. Patients' COVID-19 vaccination status was assessed from OCHIN's Epic® electronic health record which includes data from state immunization information systems. Patients were considered vaccinated if they received ≥1 dose of a monovalent vaccine product; coverage was categorized by age groups (6 months-4 years; 5-11 years, 12-15 years, 16+ years). Multivariate analyses assessed factors associated with COVID-19 vaccination across age groups. RESULTS: The cohort included 3.3 million Hispanic (37 %), non-Hispanic (NH) White (31 %), NH Black (15 %), and NH Asian (7 %) patients; 45 % of whom were Medicaid-enrolled, 19 % uninsured, and 53 % with a household income below 100 % of the federal poverty level. The proportion with ≥1 COVID-19 vaccine dose increased with age, from 11.7 % (6 months through 4 years) to 72.3 % (65 years and older). The only factors associated with significantly higher COVID-19 vaccine coverage across age groups were prior receipt of an influenza vaccine and having private insurance. In adjusted modeling, when compared to NH whites, COVID-19 vaccine coverage was significantly higher among Hispanic, NH Asian, and NH multiple-race patients aged ≥5 years and significantly lower among NH Black and NH Native Hawaiian/Other Pacific Islander patients aged 6 months-4 years old. CONCLUSIONS: We identified disparities in primary series COVID-19 vaccine coverage by age, race and ethnicity, household income, insurance status, and prior influenza vaccination within this large, diverse population accessing care in community-based healthcare organizations.

INTRODUCTION: Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a chronic illness characterized by marked functional limitations and fatigue. Electronic health records can be used to estimate incidence of ME/CFS but may have limitations. METHODS: The authors used International Classification of Diseases (ICD) diagnosis codes to identify all presumptive cases of ME/CFS among 9- to 39-year-olds from 2006 to 2017. The authors randomly selected 200 cases for medical record review to classify cases as confirmed, probable, or possible, based on which and how many current clinical criteria they met, and to further characterize their illness. The authors calculated crude annual rates of ME/CFS coding stratified by age and sex using only those ICD codes that had identified confirmed, probable, or possible ME/CFS cases in the medical record review. RESULTS: The authors identified 522 individuals with presumptive ME/CFS based on having ≥ 1 ICD codes for ME/CFS in their electronic medical record. Of the 200 cases selected, records were available and reviewed for 188. Thirty (15%) were confirmed or probable ME/CFS cases, 39 (19%) were possible cases, 119 (60%) were not cases, and 12 (6%) had no medical record available. Confirmed/probable cases commonly had chronic pain (80%) or anxiety/depression (70%), and only 13 (43%) had completed a sleep study. Overall, 37 per 100,000 had ICD codes that identified confirmed, probable, or possible ME/CFS. Rates increased between 2006 and 2017, with the largest absolute increase among those 30-39 years old. CONCLUSIONS: Using ICD diagnosis codes alone inaccurately estimates ME/CFS incidence.

In 2011, the Division of Cancer Prevention and Control (DCPC), at the United States Centers for Disease Control and Prevention (CDC), released a three-year funding opportunity announcement (FOA) for a competitive, non-research cooperative agreement. The agreement enhanced the capacities of state health departments to promote the application of best practices for evidence-based breast cancer genomics through education, surveillance, and policy activities. The FOA required that applicants focus on activities related to hereditary breast and ovarian cancer (HBOC). The DCPC funded three states: Georgia, Michigan, and Oregon. Georgia was a first-time recipient of cancer genomics funding, whereas Michigan and Oregon had long standing activities in cancer genomics and had received CDC funding in the past. By the end of the funding period, each state had well-functioning and impactful state-based programs in breast cancer genomics. This article highlights the impact of a few key state activities by using CDC's Science Impact Framework. There were challenges to implementing public health genomics programs, including the need to develop relevant partnerships, the highly technical nature of the subject matter, a lack of genetic services in certain areas, and the difficulty in funding genetic services. Georgia, Michigan, and Oregon have served as models for others interested in initiating or expanding cancer genomics programs, and they helped to determine what works well for promoting and integrating public health genomics into existing systems.

BACKGROUND: Understanding the long-term impact of the COVID-19 pandemic on health care utilization is important to health care organizations and policy makers for strategic planning, as well as to researchers when designing studies that use observational electronic health record data during the pandemic period. OBJECTIVE: To evaluate changes in health care utilization across all care settings among a large diverse insured population in the United States during the COVID-19 pandemic. METHODS: We conducted a retrospective cohort study within 8 health care organizations participating in the Vaccine Safety Datalink Project using electronic health record data from members of all ages during January 1, 2017 - December 31, 2021. The visit rates per person-year were calculated monthly during the study period for four health care settings combined as well as by inpatient, emergency department (ED), outpatient, and telehealth settings, both among all members and members without COVID-19. Difference-in-difference analysis and interrupted time series analysis were performed to assess the changes in visit rates from the pre-pandemic period (January 2017 to February 2020) to the early pandemic period (April 2020 to December 2020) and the later pandemic period (July 2021 to December 2021), respectively. An exploratory analysis was also conducted to assess trends through June 2023 at one of the largest sites, Kaiser Permanente Southern California (KPSC). RESULTS: The study included more than 11 million members from 2017 to 2021. Compared with the pre-pandemic period, we found reductions in visit rates during the early pandemic period for all in-person care settings. During the later pandemic period, overall utilization reached 8.36 visits per person-year, exceeding the pre-pandemic level of 7.49 visits per person-year in 2019 (adjusted percent change = 5.1%; 95% CI 0.6% to 9.9%); inpatient and ED visits returned to pre-pandemic levels, 0.103 and 0.275 visits per person-year respectively among all members, although they remained 7.5% and 8.0% lower than pre-pandemic levels among members without a documented history of COVID-19. Telehealth visits, which were approximately 42% of the volume of outpatient visits during the later pandemic period, were increased by 97.5% (95% CI 86.0% to 109.7%) from 0.865 visits per person-year in 2019 to 2.35 visits per person-year in the later pandemic period. The trends in KPSC were like those of the entire study population. Visit rates from January 2022 to June 2023 were stable and appeared to be a continuation of the utilization levels observed at the end of 2021. CONCLUSIONS: Telehealth services became a mainstay of the health care system during the late COVID-19 pandemic period. Inpatient and ED visits returned to pre-pandemic levels, although they remained low among members without evidence of COVID-19. Our findings provide valuable information for longer-term strategic resource allocation for patient care in the post-pandemic period and for designing observational studies involving the pandemic period.

BACKGROUND: In the United States, annual vaccination against seasonal influenza is recommended for all people ages ≥ 6 months. Vaccination coverage assessments can identify populations less protected from influenza morbidity and mortality and help to tailor vaccination efforts. Within the Vaccine Safety Datalink population ages ≥ 6 months, we report influenza vaccination coverage for the 2017-18 through 2022-23 seasons. METHODS: Across eight health systems, we identified influenza vaccines administered from August 1 through March 31 for each season using electronic health records linked to immunization registries. Crude vaccination coverage was described for each season, overall and by self-reported sex; age group; self-reported race and ethnicity; and number of separate categories of diagnoses associated with increased risk of severe illness and complications from influenza (hereafter referred to as high-risk conditions). High-risk conditions were assessed using ICD-10-CM diagnosis codes assigned in the year preceding each influenza season. RESULTS: Among individual cohorts of more than 12 million individuals each season, overall influenza vaccination coverage increased from 41.9 % in the 2017-18 season to a peak of 46.2 % in 2019-20, prior to declaration of the COVID-19 pandemic. Coverage declined over the next three seasons, coincident with widespread SARS-CoV-2 circulation, to a low of 40.3 % in the 2022-23 season. In each of the six seasons, coverage was lowest among males, 18-49-year-olds, non-Hispanic Black people, and those with no high-risk conditions. While decreases in coverage were present in all age groups, the declines were most substantial among children: 2022-23 season coverage for children ages six months through 8 years and 9-17 years was 24.5 % and 22.4 % (14 and 10 absolute percentage points), respectively, less than peak coverage achieved in the 2019-20 season. CONCLUSIONS: Crude influenza vaccination coverage increased from 2017 to 18 through 2019-20, then decreased to the lowest level in the 2022-23 season. In this insured population, we identified persistent disparities in influenza vaccination coverage by sex, age, and race and ethnicity. The overall low coverage, disparities in coverage, and recent decreases in coverage are significant public health concerns.

BACKGROUND: The epidemiology of COVID-19 continues to develop with emerging variants, expanding population-level immunity, and advances in clinical care. We describe changes in the clinical epidemiology of hospitalized COVID-19 and risk factors for critical outcomes over time. METHODS: We included adults aged ≥18 years from 10 states hospitalized with COVID-19 June 2021-March 2023 when multiple SARS-CoV-2 variants or sub-lineages predominated. We evaluated changes in baseline demographic and clinical characteristics and critical outcomes (intensive care unit admission and/or death) and used regression models to evaluate critical outcomes risk factors (risk ratios) stratified by COVID-19 vaccination status. RESULTS: 60,488 COVID-19-associated hospitalizations were included in the analysis. Among those hospitalized, from Delta period (June-December 2021) to the Omicron post-BA.4/BA.5 period (September 2022-March 2023), median age increased from 60 to 75 years, proportion vaccinated increased from 18.2% to 70.1%, while critical outcomes declined from 24.8% to 19.4% (all p < 0.001). Compared to all hospitalization events, those with critical outcomes had a higher proportion of four or more categories of medical conditions categories assessed (32.8% critical versus 23.0% all hospitalized). Critical outcome risk factors were similar for unvaccinated and vaccinated populations; presence of ≥4 medical condition categories was most strongly associated with risk of critical outcomes regardless of vaccine status (unvaccinated aRR 2.27 [95% CI: 2.14-2.41]; vaccinated aRR 1.73 [95% CI: 1.56-1.92]) across periods. CONCLUSION: The proportion of adults hospitalized with COVID-19 who experienced critical outcomes decreased with time and median patient age increased with time. Multimorbidity was mostly strongly associated with critical outcomes.

In April 2023, following the annual International Committee on Taxonomy of Viruses (ICTV) ratification vote on newly proposed taxa, the phylum Negarnaviricota was amended and emended. The phylum was expanded by one new family, 14 new genera, and 140 new species. Two genera and 538 species were renamed. One species was moved, and four were abolished. This article presents the updated taxonomy of Negarnaviricota as now accepted by the ICTV.

There are limited data on influenza vaccination coverage among pregnant people in the United States during the coronavirus disease 2019 (COVID-19) pandemic. Within the Vaccine Safety Datalink, we conducted a retrospective cohort study to examine influenza vaccination coverage during the 2016-2017 through the 2021-2022 influenza seasons among pregnant people aged 18-49 years. Using influenza vaccines administered through March each season, we assessed crude coverage by demographic and clinical characteristics. Annual influenza vaccination coverage increased from the 2016-2017 season (63.0%) to a high of 71.0% in the 2019-2020 season. After the start of the COVID-19 pandemic, it decreased to a low of 56.4% (2021-2022). In each of the six seasons, coverage was lowest among pregnant people aged 18-24 years and among non-Hispanic Black pregnant people. The 2021-2022 season had the lowest coverage across all age and race and ethnicity groups. The recent decreases highlight the need for continued efforts to improve coverage among pregnant people.

The U.S. Food and Drug Administration authorized use of mRNA COVID-19 bivalent booster vaccines on August 31, 2022. Currently, CDC's clinical guidance states that COVID-19 and other vaccines may be administered simultaneously. At time of authorization and recommendations, limited data existed describing simultaneous administration of COVID-19 bivalent booster and other vaccines. We describe simultaneous influenza and mRNA COVID-19 bivalent booster vaccine administration between August 31-December 31, 2022, among persons aged ≥6 months in the Vaccine Safety Datalink (VSD) by COVID-19 bivalent booster vaccine type, influenza vaccine type, age group, sex, and race and ethnicity. Of 2,301,876 persons who received a COVID-19 bivalent booster vaccine, 737,992 (32.1%) received simultaneous influenza vaccine, majority were female (53.1%), aged ≥18 years (91.4%), and non-Hispanic White (55.7%). These findings can inform future VSD studies on simultaneous influenza and COVID-19 bivalent booster vaccine safety and coverage, which may have implications for immunization service delivery.

E-cigarette products, related policies, and use patterns change rapidly. In the United States, the prevalence of e-cigarette use is markedly higher among youths and young adults than it is among adults overall. In 2021, 4.5% of all adults aged ≥18 years (an estimated 11.1 million) and 11.0% of young adults aged 18-24 years (an estimated 3.1 million) currently (≥1 day during the previous 30 days) used e-cigarettes; during 2022, 14.1% of high school students (an estimated 2.14 million) currently used e-cigarettes (1,2). E-cigarettes often contain high concentrations of nicotine. Nicotine is highly addictive and can harm the adolescent brain, which continues to develop through approximately age 25 years (3). Since 2020, the availability of e-cigarette products has changed in response to multiple factors, including local and state policies to address flavored e-cigarette sales, actions undertaken by the Food and Drug Administration (FDA), COVID-19-related closures, and global supply chain disruptions. To assess trends in unit sales of e-cigarettes in the United States, by product and flavor, and top-selling brands, the CDC Foundation, Truth Initiative,* and CDC analyzed retail scanner data during January 26, 2020-December 25, 2022, from Information Resources, Inc. (IRI), a U.S. data analytics and market research company. Overall, unit sales increased by 46.6% during the study period. The unit share of menthol-flavored product sales remained relatively stable during this period, whereas nonmenthol flavor unit shares changed. During January 26, 2020-December 25, 2022, unit shares of tobacco-flavored and mint-flavored products decreased (from 28.4% to 20.1% and from 10.1% to 5.9%, respectively), whereas shares of other flavor sales increased (from 29.2% to 41.3%). In addition, during January 2020-December 2022, unit shares of prefilled cartridges decreased from 75.2% to 48.0%, and disposable e-cigarette unit share increased from 24.7% to 51.8% of total unit sales. The five top-selling e-cigarette brands for the 4-week period ending December 25, 2022, were Vuse, JUUL, Elf Bar, NJOY, and Breeze Smoke. Analysis of information on e-cigarette retail sales can guide strategies to prevent youth access to and use of e-cigarettes, including restrictions on flavored tobacco products (4).

Introduction This paper describes the epidemiology and clinical presentation of complex regional pain syndrome (CRPS) in a large, integrated health care delivery system; and CRPS incidence rates (IRs) over a time period spanning human papillomavirus (HPV) vaccine licensure and published case reports of CRPS following HPV vaccination. Methods The authors examined CRPS diagnoses in patients aged 9-30 years between January 2002 and December 2017 using electronic medical records, excluding patients with lower limb diagnoses only. Medical record abstraction and adjudication were conducted to verify diagnoses and describe clinical characteristics. CRPS IRs were calculated for 3 periods: Period 1 (2002-2006: before HPV vaccine licensure), Period 2 (2007-2012: after licensure but before published case reports), and Period 3 (2013-2017: after published case reports). Results A total of 231 individuals received an upper limb or unspecified CRPS diagnosis code during the study period; 113 cases were verified through abstraction and adjudication. Most verified cases (73%) were associated with a clear precipitating event (eg, non-vaccine-related injury, surgical procedure). The authors identified only 1 case in which a practitioner attributed CRPS onset to HPV vaccination. Twenty-five incident cases occurred in Period 1 (IR = 4.35/100,000 person-years (PY), 95% confidence interval (CI) = 2.94-6.44), 42 in Period 2 (IR = 5.94/100,000 PY, 95% CI = 4.39-8.04), and 29 in Period 3 (IR = 4.53/100,000 PY, 95% CI = 3.15-6.52); differences between periods were not statistically significant. Conclusion These data provide a comprehensive assessment of the epidemiology and characteristics of CRPS in children and young adults and provide further reassurance about the safety of HPV vaccination.

AIMS: To evaluate statewide policies restricting e-cigarette nicotine strength. DESIGN: A difference-in-difference regression analysis was used to compare e-cigarette sales in states that restrict nicotine strength with states with no restrictions. Since flavor restrictions might affect sales and nicotine strength, states with flavor restrictions were also assessed. SETTING AND CASES: United States e-cigarette retail sales data during January 2017-March 2022 were licensed from Information Resources Incorporated. States with restrictions included Massachusetts (restricted maximum nicotine strength to 3.5% and non-tobacco flavored e-cigarette sales in December 2019); Utah (restricted nicotine strength to 3.6% in September 2021); and Rhode Island, New York, and Washington (restricted non-tobacco flavor sales in October 2019, May 2020, and October 2019-January 2020 respectively). These were compared with data from 34 states with no e-cigarette nicotine strength or flavor restrictions MEASUREMENTS: Weighted mean nicotine strength and total unit sales. Total unit sales per 1,000 state population were summed into 4-week periods by state. Models controlled for emergency responses, state demographics, tobacco control policies, time, and state fixed effects. FINDINGS: Restricting both nicotine strength and flavors in Massachusetts was associated with a 2.04 percentage point (pp) reduction in mean nicotine strength and 86.76-unit reduction in monthly unit sales per 1,000 persons compared with states with no restrictions (all p<0.01). Restricting nicotine strength only in Utah was associated with a 1.77 pp (p<0.01) reduction in mean nicotine strength; however, there was no impact on unit sales. Restricting non-tobacco flavor sales only in Rhode Island, New York, and Washington slightly reduced mean nicotine strength (0.21, 0.62, and 0.19 pp, respectively) and sales (36.66, 34.51, and 16.37 units, respectively) (all p<0.01). CONCLUSIONS: US statewide policies restricting e-cigarette nicotine strength appear to be associated with reductions in average nicotine strength in sales within that state; however, there appears to be no impact on unit sales. When these policies are implemented along with flavor restrictions; reductions in average nicotine strength occur in addition to reduced unit sales.

INTRODUCTION: The e-cigarette market has expanded considerably in recent years, resulting in changes in availability and use of e-cigarettes with varying characteristics. AIMS AND METHODS: This study assessed trends in sales and prices of e-cigarettes by nicotine strength level, including by product type and flavor, during January 2017-March 2022. US e-cigarette retail sales data were licensed from IRI company. Nicotine strength was categorized as: <1%; 1% to <2%; 2% to <3%; 3% to <4%; 4% to <5%; ≥5%. E-cigarette flavors were categorized as tobacco, menthol, mint, or other flavors. Product type was categorized as prefilled cartridge devices, disposable devices, or e-liquid bottles. Trend analyses were performed using Joinpoint Regression. RESULTS: During January 2017-March 2022, the unit share of products containing ≥5% nicotine strength increased by 1486.3%, while the dollar share increased by 1345.5%. By March 2022, 80.9% of total unit sales were composed of products containing ≥5% nicotine strength. By flavor, the percentage of units sold with ≥5% nicotine strength was 61.3% of tobacco-flavor sales, 79.3% of menthol sales, 87.4% of mint sales, and 96.1% of other flavor sales. By product type, the percentage of units sold with ≥5% nicotine strength was 90.6% of disposable e-cigarette sales and 74.2% of prefilled cartridge sales. During January 2017-March 2022, the price of low-nicotine strength e-cigarettes increased, while the price of high-nicotine products either decreased or did not change. CONCLUSIONS: Sales of high nicotine-strength e-cigarettes have dominated the US e-cigarette market. Limiting the nicotine strength of e-cigarettes could be considered as part of a comprehensive tobacco control strategy to reduce youth access to and use of these products. IMPLICATIONS: The findings from this study indicate that previously reported increases in e-cigarette nicotine strength during 2013-2018 have continued through 2022. The US e-cigarette market sales continue to be dominated by relatively high-nicotine products. Strategies to address factors that make these products, particularly appealing to youth, including flavors and product innovations, are critical. Such strategies are important-as part of a comprehensive approach alongside other evidence-based population-level actions-to address youth e-cigarette use. Importantly, actions to reduce e-cigarette use among youth are not mutually exclusive from actions to maximize the potential benefits of e-cigarettes for increasing smoking cessation among adults.

In March 2022, following the annual International Committee on Taxonomy of Viruses (ICTV) ratification vote on newly proposed taxa, the phylum Negarnaviricota was amended and emended. The phylum was expanded by two new families (bunyaviral Discoviridae and Tulasviridae), 41 new genera, and 98 new species. Three hundred forty-nine species were renamed and/or moved. The accidentally misspelled names of seven species were corrected. This article presents the updated taxonomy of Negarnaviricota as now accepted by the ICTV.

BACKGROUND: In 2012, the US Department of Health and Human Services updated their HIV treatment guidelines to recommend antiretroviral therapy (ART) for all people with HIV (PWH) regardless of CD4 count. We investigated recent trends and disparities in early receipt of ART prescription and subsequent viral suppression (VS). METHODS: We examined data from ART-naïve PWH newly presenting to HIV care at 13 North American AIDS Cohort Collaboration on Research and Design clinical cohorts in the United States during 2012-2018. We calculated the cumulative incidence of early ART (within 30 days of entry into care) and early VS (within 6 months of ART initiation) using the Kaplan-Meier survival function. Discrete time-to-event models were fit to estimate unadjusted and adjusted associations of early ART and VS with sociodemographic and clinical factors. RESULTS: Among 11 853 eligible ART-naïve PWH, the cumulative incidence of early ART increased from 42% in 2012 to 82% in 2018. The cumulative incidence of early VS among the 8613 PWH who initiated ART increased from 83% in 2012 to 93% in 2018. In multivariable models, factors independently associated with delayed ART and VS included non-Hispanic/Latino Black race, residence in the South census region, being a male with injection drug use acquisition risk, and history of substance use disorder (SUD; all P ≤ .05). CONCLUSIONS: Early ART initiation and VS have substantially improved in the United States since the release of universal treatment guidelines. Disparities by factors related to social determinants of health and SUD demand focused attention on and services for some subpopulations.

OBJECTIVE: Describe engagement in HIV care over time after initial engagement in HIV care, by gender identity. DESIGN: Observational, clinical cohort study of people with HIV engaged in routine HIV care across the United States. METHODS: We followed people with HIV who linked to and engaged in clinical care (attending ≥2 visits in 12 months) in cohorts in the North American Transgender Cohort Collaboration, 2000-2018. Within strata of gender identity, we estimated the 7-year (84-month) restricted mean time spent: lost-to-clinic (stratified by pre-/post-antiretroviral therapy (ART) initiation); in care prior to ART initiation; on ART but not virally suppressed; virally suppressed (≤200 copies/mL); or dead (pre-/post-ART initiation). RESULTS: Transgender women (N = 482/101,841) spent an average of 35.5 out of 84 months virally suppressed (this was 30.5 months for cisgender women and 34.4 months for cisgender men). After adjustment for age, race, ethnicity, history of injection drug use, cohort, and calendar year, transgender women were significantly less likely to die than cisgender people. Cisgender women spent more time in care not yet on ART, and less time on ART and virally suppressed, but were less likely to die compared with cisgender men. Other differences were not clinically meaningful. CONCLUSIONS: In this sample, transgender women and cisgender people spent similar amounts of time in care and virally suppressed. Additional efforts to improve retention in care and viral suppression are needed for all people with HIV, regardless of gender identity.

BACKGROUND: Herpes zoster vaccination rates remain low despite longstanding national recommendations to vaccinate immunocompetent adults aged ≥ 50 years. The Advisory Committee on Immunization Practice (ACIP) updated its recommendations for recombinant zoster vaccine (RZV) in October 2021 to include immunocompromised adults aged ≥19 years. OBJECTIVE: To assess practices, attitudes, and knowledge about RZV, barriers to recommending RZV, and likelihood of recommending RZV to patients with various immunocompromising conditions. DESIGN: Mail and internet-based survey conducted from May through July 2020. PARTICIPANTS: General internists and family physicians throughout the USA. MAIN MEASURES: Survey responses. KEY RESULTS: The response rate was 66% (632/955). Many physicians were already recommending RZV to immunocompromised populations, including adults ≥50 years with HIV (67% of respondents) and on recombinant human immune modulator therapy (56%). Forty-seven percent of respondents both stocked/administered RZV and referred patients elsewhere, frequently a pharmacy, for vaccination; 42% did not stock RZV and only referred patients. The majority agreed pharmacies do not inform them when RZV has been given (64%). Physicians were generally knowledgeable about RZV; however, 25% incorrectly thought experiencing side effects from the first dose of RZV that interfere with normal activities was a reason to not receive the second dose. The top reported barrier to recommending RZV was experience with patients declining RZV due to cost concerns (67%). Most physicians reported they would be likely to recommend RZV to immunocompromised patients. CONCLUSION: Most primary care physicians welcome updated ACIP RZV recommendations for immunocompromised adults. Knowledge gaps, communication issues, and financial barriers need to be addressed to optimize vaccination delivery.

Biological response modifiers (BRM), also known as immunomodulators or cytokine inhibitors, are immunosuppressive substances that are increasingly being used to treat various autoimmune diseases,1 including during pregnancy. Some BRM are actively transported across the placenta barrier and can remain in infants for up to 12 months after birth,2,3 raising concerns that infants exposed to BRM in utero may be at increased risk of infections and adverse events after immunization with live attenuated vaccines.

This study uses data from the Vaccine Safety Datalink on receipt of booster doses of COVID-19 vaccines among pregnant individuals aged 18 to 49 years.

BACKGROUND: The COVID-19 pandemic caused an abrupt drop in in-person health care (inpatient, Emergency Department, outpatient) and an increase in telehealth care, which poses challenges in vaccine safety studies that identify outcomes from in-person encounters. We examined the changes in incidence rates of selected encounter-based outcomes during the COVID-19 pandemic. METHODS: We assembled a cohort of members from 8 Vaccine Safety Datalink sites from January 1, 2017 through December 31, 2020. Using ICD-10 diagnosis codes or laboratory criteria, we identified 21 incident outcomes in traditional in-person settings and all settings. We defined 4 periods in 2020: January-February (pre-pandemic), April-June (early pandemic), July-September (middle pandemic), and October-December (late pandemic). We defined four corresponding periods in each year during 2017-2019. We calculated incidence rates, conducted difference in difference (DiD) analyses, and reported ratios of incidence rate ratios (RRR) to examine changes in rates from pre-pandemic to early, middle, and late pandemic in 2020, after adjusting for changes across similar periods in 2017-2019. RESULTS: Among>10 million members, regardless of setting and after adjusting for changes during 2017-2019, we found that incidence rates of acute disseminated encephalomyelitis, encephalitis/myelitis/encephalomyelitis/meningoencephalitis, and thrombotic thrombocytopenic purpura did not significantly change from the pre-pandemic to early, middle or late pandemic periods (p-values0.05). Incidence rates decreased from the pre-pandemic to early pandemic period during 2020 for acute myocardial infarction, anaphylaxis, appendicitis, Bell's palsy, convulsions/seizures, Guillain-Barr syndrome, immune thrombocytopenia (ITP), narcolepsy/cataplexy, hemorrhagic stroke, ischemic stroke, and venous thromboembolism (p-values<0.05). Incidence rates of Bell's palsy, ITP, and narcolepsy/cataplexy were higher in all settings than in traditional in-person settings during the three pandemic periods (p-values<0.05). CONCLUSION: Rates of some clinical outcomes during the pandemic changed and should not be used as historical background rates in vaccine safety studies. Inclusion of telehealth visits should be considered for vaccine studies involving Bell's palsy, ITP, and narcolepsy/cataplexy.

OBJECTIVES: Since 2006, the US human papillomavirus (HPV) vaccination program has led to decreases in HPV infections caused by high-risk vaccine-targeted HPV types (HPV 16/18). We assessed differences in high-risk HPV prevalence by cervical cytology result among 20- to 24-year-old persons participating in routine cervical cancer screening in 2015-2017 compared with 2007. MATERIALS AND METHODS: Residual routine cervical cancer screening specimens were collected from 20- to 24-year-old members of 2 integrated healthcare delivery systems as part of a cross-sectional study and were tested for 37 HPV types. Cytology results and vaccination status (1 dose) were extracted from medical records. Cytology categories were normal, atypical squamous cells of undefined significance, low-grade squamous intraepithelial lesions (SIL), or high-grade SIL/atypical squamous cells cannot exclude high-grade SIL. Prevalences of HPV categories (HPV 16/18, HPV 31/33/45/52/58, HPV 35/39/51/56/59/66/68) were estimated by cytology result for 2007 and 2015-2017. RESULTS: Specimens from 2007 (n = 4046) were from unvaccinated participants; 4574 of 8442 specimens (54.2%) from 2015-2017 were from vaccinated participants. Overall, HPV 16/18 positivity was lower in 2015-2017 compared with 2007 in all groups: high-grade SIL/atypical squamous cells cannot exclude high-grade SIL, 16.0% vs 69.2%; low-grade SIL, 5.4% vs 40.1%; atypical squamous cells of undefined significance, 5.0% vs 25.6%; and normal, 1.3% vs 8.1%. Human papillomavirus 31/33/45/52/58 prevalence was stable for all cytology groups; HPV 35/39/51/56/59/66/68 prevalence increased among low-grade SIL specimens (53.9% to 65.2%) but remained stable in other groups. CONCLUSIONS: Prevalence of vaccine-targeted high-risk HPV types 16/18 was dramatically lower in 2015-2017 than 2007 across all cytology result groups while prevalence of other high-risk HPV types was mainly stable, supporting vaccine impact with no evidence of type replacement.

BACKGROUND: The Vaccine Safety Datalink (VSD) uses vaccination data from electronic health records (EHR) at eight integrated health systems to monitor vaccine safety. Accurate capture of data from vaccines administered outside of the health system is critical for vaccine safety research, especially for COVID-19 vaccines, where many are administered in non-traditional settings. However, timely access and inclusion of data from Immunization Information Systems (IIS) into VSD safety assessments is not well understood. METHODS: We surveyed the eight data-contributing VSD sites to assess: 1) status of sending data to IIS; 2) status of receiving data from IIS; and 3) integration of IIS data into the site EHR. Sites reported separately for COVID-19 vaccination to capture any differences in capacity to receive and integrate data on COVID-19 vaccines versus other vaccines. RESULTS: All VSD sites send data to and receive data from their state IIS. All eight sites (100%) routinely integrate IIS data for COVID-19 vaccines into VSD research studies. Six sites (75%) also routinely integrate all other vaccination data; two sites integrate data from IIS following a reconciliation process, which can result in delays to integration into VSD datasets. CONCLUSIONS: COVID-19 vaccines are being administered in a variety of non-traditional settings, where IIS are commonly used as centralized reporting systems. All eight VSD sites receive and integrate COVID-19 vaccine data from IIS, which positions the VSD well for conducting quality assessments of vaccine safety. Efforts to improve the timely receipt of all vaccination data will improve capacity to conduct vaccine safety assessments within the VSD.

OBJECTIVE: To describe, among pediatricians (Peds) and family physicians (FPs), 1) changes made to routine childhood vaccination delivery as a result of the pandemic, and 2) perceived barriers to delivering vaccinations from March 2020 through the time of the survey. METHODS: A nationally representative survey among Peds and FPs was administered by mail or Internet in October-December 2020. RESULTS: Response rate was 64% (579/909). For children aged 0-2 years, among those who vaccinated that age group pre-pandemic (Peds n=265, FPs n=222), 5% of Peds and 15% of FPs reported they had stopped vaccinating these children at any time. For children aged 4-6 years (Peds n=264, FPs n=229), 19% of Peds and 17% of FPs reported they had stopped vaccinating at any time. For children aged 11-18 years (Peds n=265, FPs n=251), 24% of Peds and 19% of FPs reported they had stopped vaccinating at any time. Nearly all reported returning to pre-pandemic vaccination services at the time of the survey. Factors most frequently reported as major/moderate barriers to providing vaccinations included fewer in-person visits because patients/parents were concerned about risk of SARS-CoV-2 infection (Peds, 52%; FPs, 54%), fewer in-person visits for sports clearance (Peds, 39%; FPs, 44%), and fewer back-to-school in-person visits because some children were in virtual learning (Peds, 25%; FPs, 33%). CONCLUSIONS: Although some physicians reported interrupting vaccination services at some point during the pandemic, the majority reported continuing to provide vaccinations throughout, with essentially all returning to pre-pandemic vaccination services by end of 2020.

Although sub-Saharan Africa has the highest HIV burden globally, few studies have investigated disabilities and HIV in this region. We conducted a secondary analysis of text data from in-depth interviews (2014-2015) to describe HIV perceptions among a subsample of 73 deaf individuals participating in the Crane survey, Kampala, Uganda. Being deaf was defined as being profoundly or functionally deaf, having deafness onset 5 + years ago, and preferring sign language to communicate. Among participants ever tested for HIV (47%), most (88%) had a negative test. Thematic analysis revealed overcoming challenges/barriers followed by socioeconomic status, support systems, HIV, stigma, abuse, and health conditions as major themes. An unanticipated finding was the role of sex work to support basic living needs. The data showed related themes among participants, suggesting a complex context in which deaf participants experience HIV prevention and treatment. It is important to tailor HIV interventions for deaf and disabled persons.

OBJECTIVES: To assess pediatricians' mumps knowledge and testing practices, to identify physician and practice characteristics associated with mumps testing practices, and to assess reporting and outbreak response knowledge and practices. STUDY DESIGN: From January-April 2020, we surveyed a nationally representative network of pediatricians. Descriptive statistics were generated for all items. Chi-square, t-tests, and Poisson regression were used to compare physician and practice characteristics between respondents who would rarely or never vs. sometimes or often/always test for mumps in a vaccinated 17-year-old with parotitis in a non-outbreak setting. RESULTS: The response rate was 67% (297/444). For knowledge, over half of pediatricians responded incorrectly or 'Don't know' for six of nine true/false statements about mumps epidemiology, diagnosis, and prevention; and over half reported they would need additional guidance on mumps buccal swab testing. For testing practices, 59% of respondents reported they would sometimes (35%) or often/always (24%) test for mumps in a vaccinated 17-year-old with parotitis in a non-outbreak setting; older physicians, rural physicians, and physicians from the Northeast or Midwest were more likely to test for mumps. Thirty-six percent of pediatricians reported they would often/always report a patient with suspected mumps to public health authorities. CONCLUSIONS: Pediatricians report mumps knowledge gaps and practices that do not align with public health recommendations. These gaps may lead to under-diagnosis and under-reporting of mumps cases, delaying public health response measures and contributing to ongoing disease transmission.

BACKGROUND: Rotavirus vaccine (RV) coverage levels for U.S. infants are <80%. METHODS: We surveyed nationally representative networks of pediatricians by internet/mail from April-June, 2019. Multivariable regression assessed factors associated with difficulty administering the first RV dose (RV#1) by the maximum age. RESULTS: Response rate was 68% (303/448). 99% of providers reported strongly recommending RV. The most common barriers to RV delivery overall (definite/somewhat of a barrier) were: parental concerns about vaccine safety overall (27%), parents wanting to defer (25%), parents not thinking RV was necessary (12%) and parent concerns about RV safety (6%). The most commonly reported reasons for non-receipt of RV#1 by 4-5 months (often/always) were parental vaccine refusal (9%), hospitals not giving RV at discharge from nursery (7%), infants past the maximum age when discharged from NICU/nursery (6%), and infant not seen before maximum age for well care visit (3%) or seen but no vaccine given (4%). Among respondents 4% strongly agreed and 25% somewhat agreed that they sometimes have difficulty giving RV#1 before the maximum age. Higher percentage of State Child Health Insurance Program/Medicaid-insured children in the practice and reporting that recommendations for timing of RV doses are too complicated were associated with reporting difficulty delivering the RV#1 by the maximum age. CONCLUSIONS: U.S. pediatricians identified multiple, actionable issues that may contribute to suboptimal RV immunization rates including lack of vaccination prior to leaving nurseries after prolonged stays, infants not being seen for well care visits by the maximum age, missed opportunities at visits and parents refusing/deferring.

Background: Identifying pregnancy episodes and accurately estimating their beginning and end dates are imperative for observational maternal vaccine safety studies using electronic health record (EHR) data. Methods: We modified the Vaccine Safety Datalink (VSD) Pregnancy Episode Algorithm (PEA) to include both the International Classification of Disease, ninth revision (ICD-9 system) and ICD-10 diagnosis codes, incorporated additional gestational age data, and validated this enhanced algorithm with manual medical record review. We also developed the new Dynamic Pregnancy Algorithm (DPA) to identify pregnancy episodes in real time. Results: Around 75% of the pregnancy episodes identified by the enhanced VSD PEA were live births, 12% were spontaneous abortions (SABs), 10% were induced abortions (IABs), and 0.4% were stillbirths (SBs). Gestational age was identified for 99% of live births, 89% of SBs, 69% of SABs, and 42% of IABs. Agreement between the PEA-assigned and abstractor-identified pregnancy outcome and outcome date was 100% for live births, but was lower for pregnancy losses. When gestational age was available in the medical record, the agreement was higher for live births (97%), but lower for pregnancy losses (75%). The DPA demonstrated strong concordance with the PEA and identified pregnancy episodes ⩾6 months prior to the outcome date for 89% of live births. Conclusion: The enhanced VSD PEA is a useful tool for identifying pregnancy episodes in EHR databases. The DPA improves the timeliness of pregnancy identification and can be used for near real-time maternal vaccine safety studies. Plain Language Summary: Improving identification of pregnancies in the Vaccine Safety Datalink electronic medical record databases to allow for better and faster monitoring of vaccination safety during pregnancy Introduction: It is important to monitor of the safety of vaccines after they have been approved and licensed by the Food and Drug Administration, especially among women vaccinated during pregnancy. The Vaccine Safety Datalink (VSD) monitors vaccine safety through observational studies within large databases of electronic medical records. Since 2012, VSD researchers have used an algorithm called the Pregnancy Episode Algorithm (PEA) to identify the medical records of women who have been pregnant. Researchers then use these medical records to study whether receiving a particular vaccine is linked to any negative outcomes for the woman or her child. Methods: The goal of this study was to update and enhance the PEA to include the full set of medical record diagnostic codes [both from the older International Classification of Disease, ninth revision (ICD-9 system) and the newer ICD-10 system] and to incorporate additional sources of data about gestational age. To ensure the validity of the PEA following these enhancements, we manually reviewed medical records and compared the results with the algorithm. We also developed a new algorithm, the Dynamic Pregnancy Algorithm (DPA), to identify women earlier in pregnancy, allowing us to conduct more timely vaccine safety assessments. Results: The new version of the PEA identified 2,485,410 pregnancies in the VSD database. The enhanced algorithm more precisely estimated the beginning of pregnancies, especially those that did not result in live births, due to the new sources of gestational age data. Conclusion: Our new algorithm, the DPA, was successful at identifying pregnancies earlier in gestation than the PEA. The enhanced PEA and the new DPA will allow us to better evaluate the safety of current and future vaccinations administered during or around the time of pregnancy. © The Author(s), 2021.