Cheryl Isenhour’s research while affiliated with The Children's Hospital of Philadelphia and other places

Two meningococcal serogroup B vaccines are licensed for use in the United States. In August 2024, the Food and Drug Administration (FDA) changed the label for the meningococcal serogroup B MenB-4C vaccine (Bexsero) from a 2-dose schedule (intervals of 0 and ≥1 month) to a 2-dose schedule (0 and 6 months) and added a 3-dose schedule (0, 1-2, and 6 months), based on new immunogenicity data. On October 24, 2024, the Advisory Committee on Immunization Practices (ACIP) voted to update its recommendations for the MenB-4C dosing interval and schedule to align with the new FDA label. ACIP recommends extending the interval for the 2-dose series of MenB-4C from 0 and ≥1 month to 0 and 6 months for healthy adolescents and young adults aged 16-23 years based on shared clinical decision-making and has added a recommendation for a 3-dose series with doses administered at 0, 1-2, and 6 months for persons aged ≥10 years at increased risk. The updated ACIP recommendations for MenB-4C align with existing ACIP recommendations for the other FDA-licensed meningococcal serogroup B vaccine, MenB-FHbp (Trumenba).

Meningococcal disease is a serious but rare disease in the United States. Prior publications suggest incidence differs among privately vs publicly-insured persons, and that incidence is higher among persons experiencing homelessness (PEH) than persons not known to be experiencing homelessness (non-PEH). Using insurance claims data for persons aged <1 to 64 years, we calculated meningococcal disease incidence among a population with employer-sponsored commercial insurance and persons enrolled in state Medicaid programs nationwide. We also examined meningococcal disease incidence by PEH status in Medicaid data. From 2016 through 2019, persons who met our study inclusion criteria contributed a total of 84,460,548 person-years (PYs) to our analysis of commercial insurance data and 253,496,622 PYs to our analysis of Medicaid data. Incidence was higher among persons enrolled in Medicaid (0.12 cases per 100,000 PYs) than persons with commercial insurance (0.06 cases per 100,000 PYs). Incidence was 3.17 cases per 100,000 PYs among PEH in Medicaid, 27 times higher than among non-PEH in Medicaid. Understanding the underlying drivers of the higher meningococcal disease incidence among PEH and persons enrolled in Medicaid may inform prevention strategies for populations experiencing a higher burden of disease.

Introduction Vaccination with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) during pregnancy is highly effective against Bordetella pertussis in young infants. We aimed to evaluate uptake of maternal Tdap vaccination during the recommended gestation period of 27 through 36 weeks among women enrolled in a public medical insurance plan in the United States. Methods In this analysis using Centers for Medicare and Medicaid Services insurance claims data, we identified women aged 15 through 49 years who delivered a liveborn infant from 2016 through 2019. We identified claims for Tdap vaccination to calculate the proportion of women who were vaccinated during weeks 27 through 36 of gestation in each calendar year. We also assessed average annual maternal Tdap coverage by age group, race and ethnicity, U.S. Census region of residence, and plan type. Data were analyzed in 2021. Results Among 4,318,823 deliveries, the four-year national average for Tdap vaccination was 26%, improving from 22% in 2016 to 31% in 2019 (p<0.001). Within subgroups, the lowest four-year average coverage was among women aged 15 through 18 years (22%), black, non-Hispanic (23%) and Hispanic women (24%), those residing in the South (18%), enrolled in a Children's Health Insurance Program plan (22%), and covered by a fee-for-service plan (19%). Coverage increased across all subgroups from 2016 through 2019. Conclusion Although maternal Tdap coverage among publicly insured women in the United States increased from 2016 through 2019, it remained considerably lower than estimated national coverage, with notable differences by race and ethnicity.

Background The Coronavirus Disease 2019 (COVID-19) pandemic, caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), evolved rapidly in the United States. This report describes the demographic, clinical, and epidemiologic characteristics of 544 U.S. persons under investigation (PUI) for COVID-19 with complete SARS-CoV-2 testing in the beginning stages of the pandemic from January 17 through February 29, 2020. Methods In this surveillance cohort, the U.S. Centers for Disease Control and Prevention (CDC) provided consultation to public health and healthcare professionals to identify PUI for SARS-CoV-2 testing by quantitative real-time reverse-transcription PCR. Demographic, clinical, and epidemiologic characteristics of PUI were reported by public health and healthcare professionals during consultation with on-call CDC clinicians and subsequent submission of a CDC PUI Report Form. Characteristics of laboratory-negative and laboratory-positive persons were summarized as proportions for the period of January 17−February 29, and characteristics of all PUI were compared before and after February 12 using prevalence ratios. Results A total of 36 PUI tested positive for SARS-CoV-2 and were classified as confirmed cases. Confirmed cases and PUI testing negative for SARS-CoV-2 had similar demographic, clinical, and epidemiologic characteristics. Consistent with changes in PUI evaluation criteria, 88% (13/15) of confirmed cases detected before February 12, 2020, reported travel from China. After February 12, 57% (12/21) of confirmed cases reported no known travel- or contact-related exposures. Conclusions These findings can inform preparedness for future pandemics, including capacity for rapid expansion of novel diagnostic tests to accommodate broad surveillance strategies to assess community transmission, including potential contributions from asymptomatic and presymptomatic infections.

Introduction Eculizumab is a licensed treatment for several rare, complement-mediated diseases. Eculizumab use is associated with an approximately 2,000-fold increased meningococcal disease risk. In the United States, meningococcal vaccines are recommended for eculizumab recipients but there are no recommendations on use of long-term antibiotic prophylaxis. We describe characteristics of and meningococcal vaccine and antibiotic receipt in U.S. eculizumab recipients to inform meningococcal disease prevention strategies. Methods Persons in the IBM® MarketScan® Research Databases with ≥1 claim for eculizumab injection during 2007–2017 were included. Indication for eculizumab use, meningococcal vaccine receipt, and antibiotic receipt were assessed using International Classification of Diseases-9/10 diagnosis codes, vaccine administration procedure codes, and antibiotic codes from pharmacy claims, respectively. Results Overall 696 persons met the inclusion criteria. Paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) were the most common indications for eculizumab use (41% and 37%, respectively); 20% had an undetermined indication. From June 2015 through December 2017, 28% (41/148) of continuously-enrolled patients received ≥1 serogroup B vaccine dose. For serogroup ACWY conjugate vaccine, 45% (91/201) of patients received ≥1 dose within five years of their most recent eculizumab dose, as recommended. Of eculizumab recipients with outpatient prescription data, 7% (41/579) received antibiotics for ≥50% of the period of increased risk for meningococcal disease. Conclusion Many eculizumab recipients had an undetermined indication for eculizumab use; few were up-to-date for recommended meningococcal vaccines or were prescribed antibiotics long-term. These findings can inform further investigation of how to best protect this population from meningococcal disease.

This article summarizes what is currently known about the 2019 novel coronavirus and offers interim guidance.

In December 2019, a cluster of cases of pneumonia emerged in Wuhan City in central China's Hubei Province. Genetic sequencing of isolates obtained from patients with pneumonia identified a novel coronavirus (2019-nCoV) as the etiology (1). As of February 4, 2020, approximately 20,000 confirmed cases had been identified in China and an additional 159 confirmed cases in 23 other countries, including 11 in the United States (2,3). On January 17, CDC and the U.S. Department of Homeland Security's Customs and Border Protection began health screenings at U.S. airports to identify ill travelers returning from Wuhan City (4). CDC activated its Emergency Operations Center on January 21 and formalized a process for inquiries regarding persons suspected of having 2019-nCoV infection (2). As of January 31, 2020, CDC had responded to clinical inquiries from public health officials and health care providers to assist in evaluating approximately 650 persons thought to be at risk for 2019-nCoV infection. Guided by CDC criteria for the evaluation of persons under investigation (PUIs) (5), 210 symptomatic persons were tested for 2019-nCoV; among these persons, 148 (70%) had travel-related risk only, 42 (20%) had close contact with an ill laboratory-confirmed 2019-nCoV patient or PUI, and 18 (9%) had both travel- and contact-related risks. Eleven of these persons had laboratory-confirmed 2019-nCoV infection. Recognizing persons at risk for 2019-nCoV is critical to identifying cases and preventing further transmission. Health care providers should remain vigilant and adhere to recommended infection prevention and control practices when evaluating patients for possible 2019-nCoV infection (6). Providers should consult with their local and state health departments when assessing not only ill travelers from 2019-nCoV-affected countries but also ill persons who have been in close contact with patients with laboratory-confirmed 2019-nCoV infection in the United States.

On December 31, 2019, Chinese health officials reported a cluster of cases of acute respiratory illness in persons associated with the Hunan seafood and animal market in the city of Wuhan, Hubei Province, in central China. On January 7, 2020, Chinese health officials confirmed that a novel coronavirus (2019-nCoV) was associated with this initial cluster (1). As of February 4, 2020, a total of 20,471 confirmed cases, including 2,788 (13.6%) with severe illness,* and 425 deaths (2.1%) had been reported by the National Health Commission of China (2). Cases have also been reported in 26 locations outside of mainland China, including documentation of some person-to-person transmission and one death (2). As of February 4, 11 cases had been reported in the United States. On January 30, the World Health Organization (WHO) Director-General declared that the 2019-nCoV outbreak constitutes a Public Health Emergency of International Concern.† On January 31, the U.S. Department of Health and Human Services (HHS) Secretary declared a U.S. public health emergency to respond to 2019-nCoV.§ Also on January 31, the president of the United States signed a "Proclamation on Suspension of Entry as Immigrants and Nonimmigrants of Persons who Pose a Risk of Transmitting 2019 Novel Coronavirus," which limits entry into the United States of persons who traveled to mainland China to U.S. citizens and lawful permanent residents and their families (3). CDC, multiple other federal agencies, state and local health departments, and other partners are implementing aggressive measures to slow transmission of 2019-nCoV in the United States (4,5). These measures require the identification of cases and their contacts in the United States and the appropriate assessment and care of travelers arriving from mainland China to the United States. These measures are being implemented in anticipation of additional 2019-nCoV cases in the United States. Although these measures might not prevent the eventual establishment of ongoing, widespread transmission of the virus in the United States, they are being implemented to 1) slow the spread of illness; 2) provide time to better prepare health care systems and the general public to be ready if widespread transmission with substantial associated illness occurs; and 3) better characterize 2019-nCoV infection to guide public health recommendations and the development of medical countermeasures including diagnostics, therapeutics, and vaccines. Public health authorities are monitoring the situation closely. As more is learned about this novel virus and this outbreak, CDC will rapidly incorporate new knowledge into guidance for action by CDC and state and local health departments.

Objectives: With the availability of curative therapies, it is important to ensure that individuals infected with hepatitis C virus (HCV) receive recommended testing, care, and treatment. We sought to evaluate insurance claims data as a source for monitoring progression along the HCV care cascade. Study design: Longitudinal evaluation of disease progression, from diagnosis to treatment, among commercially insured enrollees with chronic HCV. Methods: We validated and used algorithms derived from standardized procedure and diagnosis codes to identify enrollees with chronic HCV in large insurance claims databases to describe the HCV care cascade, including the proportion engaged in HCV-specific care (13 possible definitions), the proportion prescribed HCV treatment, and the proportion who received an HCV RNA test 30 or more days after initiating treatment. Results: Approximately 90% of individuals with an HCV RNA test procedure code followed by either 3 or more chronic HCV diagnosis codes on different service dates or 2 or more chronic HCV diagnosis codes separated by more than 60 days truly had chronic HCV. Using these algorithms, we identified 5791 HCV cases from January 1, 2013, to June 30, 2014. Among enrollees with HCV, 95% were engaged in HCV care, but only 49% initiated treatment and 43% received a follow-up HCV RNA test 30 or more days after initiating treatment. Conclusions: With validated case-finding algorithms, insurance claims data can be used to describe and monitor portions of the HCV care cascade. Although nearly all enrollees with HCV were engaged in HCV care, only half received treatment, indicating that even commercially insured enrollees may find it challenging to access treatment.

Introduction Pregnant women should receive hepatitis B virus (HBV) testing with hepatitis B surface antigen (HBsAg), but it is unclear whether HBV-infected pregnant women are linked to care. Methods We analyzed MarketScan™ commercial insurance claims. We included pregnant women, aged 10–50 years, with 42 weeks of continuous enrollment before (predelivery) and 6 months after (postdelivery) the first delivery claim for each unique pregnancy between 1/1/2011 and 6/30/2014. We identified claims for HBsAg testing by CPT code and described the care continuum among pregnancies with an associated ICD-9 HBV diagnosis code by demographic and clinical characteristics, including HBV-directed care ([HBV DNA or hepatitis B e antigen] and ALT test codes) and antiviral treatment (claims for tenofovir, entecavir, lamivudine, adefovir, or telbivudine) pre- and postdelivery. Results There were 870,888 unique pregnancies (819,752 women) included. Before delivery, 714,830 (82%) pregnancies had HBsAg test claims, but this proportion decreased with subsequent pregnancies (p < 0.0001): second (80%), third (71%), and fourth (61%). We identified 1,190 (0.14%) pregnancies with an associated HBV diagnosis code: most were among women aged ≥ 30 years (76%) residing in the Pacific (34%) or Middle Atlantic (18%) regions. Forty-two percent of pregnancies with an HBV diagnosis received HBV-directed care (42% predelivery and 39% postdelivery). Antiviral treatment was initiated before delivery in 128 (13%) of 975 pregnancies and postdelivery in 16 (1.6%) pregnancies. Conclusions While most of these commercially insured pregnant women received predelivery HBV screening, we identified gaps in HBV testing and the HBV care continuum which highlight potential targets for public health interventions.