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Use of 21-valent pneumococcal conjugate vaccine among U.S. Adults: Recommendations of the Advisory Committee on Immunization Practices - United States, 2024
Kobayashi M , Leidner AJ , Gierke R , Farrar JL , Morgan RL , Campos-Outcalt D , Schechter R , Poehling KA , Long SS , Loehr J , Cohen AL . MMWR Morb Mortal Wkly Rep 2024 73 (36) 793-798 On June 17, 2024, the Food and Drug Administration approved 21-valent pneumococcal conjugate vaccine (PCV) (PCV21; CAPVAXIVE; Merck Sharp & Dohme, LLC) for adults aged ≥18 years. PCV21 does not contain certain serotypes that are included in other licensed pneumococcal vaccines but adds eight new serotypes. The Advisory Committee on Immunization Practices (ACIP) recommends use of a PCV for all adults aged ≥65 years, as well as adults aged 19-64 years with certain risk conditions for pneumococcal disease if they have not received a PCV or whose vaccination history is unknown. Previously, options included either 20-valent PCV (PCV20; Prevnar20; Wyeth Pharmaceuticals, Inc.) alone or a 15-valent PCV (PCV15; VAXNEUVANCE; Merck Sharp & Dohme, LLC) in series with 23-valent pneumococcal polysaccharide vaccine (PPSV23; Pneumovax23; Merck Sharp & Dohme, LLC). Additional recommendations for use of PCV20 exist for adults who started their pneumococcal vaccination series with 13-valent PCV (PCV13; Prevnar13; Wyeth Pharmaceuticals, Inc.). The ACIP Pneumococcal Vaccines Work Group employed the Evidence to Recommendations framework to guide its deliberations on PCV21 vaccination among U.S. adults. On June 27, 2024, ACIP recommended a single dose of PCV21 as an option for adults aged ≥19 years for whom PCV is currently recommended. Indications for PCV have not changed from previous recommendations. This report summarizes evidence considered for these recommendations and provides clinical guidance for use of PCV21. |
Effectiveness of 13-valent pneumococcal conjugate vaccine for prevention of invasive pneumococcal disease among children in the United States between 2010 and 2019: An indirect cohort study
Andrejko KL , Gierke R , Rowlands JV , Rosen JB , Thomas A , Landis ZQ , Rosales M , Petit S , Schaffner W , Holtzman C , Barnes M , Farley MM , Harrison LH , McGee L , Chochua S , Verani JR , Cohen AL , Pilishvili T , Kobayashi M . Vaccine 2024 BACKGROUND: A U.S. case-control study (2010-2014) demonstrated vaccine effectiveness (VE) for ≥ 1 dose of the thirteen-valent pneumococcal conjugate vaccine (PCV13) against vaccine-type (VT) invasive pneumococcal disease (IPD) at 86 %; however, it lacked statistical power to examine VE by number of doses and against individual serotypes. METHODS: We used the indirect cohort method to estimate PCV13 VE against VT-IPD among children aged < 5 years in the United States from May 1, 2010 through December 31, 2019 using cases from CDC's Active Bacterial Core surveillance, including cases enrolled in a matched case-control study (2010-2014). Cases and controls were defined as individuals with VT-IPD and non-PCV13-type-IPD (NVT-IPD), respectively. We estimated absolute VE using the adjusted odds ratio of prior PCV13 receipt (1-aOR x 100 %). RESULTS: Among 1,161 IPD cases, 223 (19.2 %) were VT cases and 938 (80.8 %) were NVT controls. Of those, 108 cases (48.4 %; 108/223) and 600 controls (64.0 %; 600/938) had received > 3 PCV13 doses; 23 cases (17.6 %) and 15 controls (2.4 %) had received no PCV doses. VE ≥ 3 PCV13 doses against VT-IPD was 90.2 % (95 % Confidence Interval75.4-96.1 %), respectively. Among the most commonly circulating VT-IPD serotypes, VE of ≥ 3 PCV13 doses was 86.8 % (73.7-93.3 %), 50.2 % (28.4-80.5 %), and 93.8 % (69.8-98.8 %) against serotypes 19A, 3, and 19F, respectively. CONCLUSIONS: At least three doses of PCV13 continue to be effective in preventing VT-IPD among children aged < 5 years in the US. PCV13 was protective against serotypes 19A and 19F IPD; protection against serotype 3 IPD did not reach statistical significance. |
Pneumococci isolated from children in community-based practice differ from isolates identified by population and laboratory-based invasive disease surveillance
Kaur R , Gierke R , McGee L , Gonzalez E , Kobayashi M , Pichichero M . J Infect Dis 2024 BACKGROUND: Characterizing strains causing noninvasive and invasive pneumococcal disease (IPD) may inform the impact of new pneumococcal conjugate vaccines (PCVs). METHODS: During 2011-2019, among children aged 6-36 months, pneumococcal serotype distribution and antibiotic non-susceptibility of nasopharyngeal and middle ear fluid (MEF) isolates collected at onset of acute otitis media (AOM) in Rochester, New York were compared with IPD isolates from Active Bacterial Core surveillance (ABCs) across 10 U.S. sites. RESULTS: From Rochester, 400 (nasopharyngeal) and 156 (MEF) pneumococcal isolates were collected from 259 children. From ABCs, 907 sterile-site isolates were collected from 896 children. Non-PCV serotypes 35B and 21 were more frequent among the Rochester AOM cases, while serotypes 3, 19A, 22F, 33F, 10A, and 12F contained in PCVs were more frequent among ABCs IPD cases. The proportion of antibiotic non-susceptible pneumococcal isolates was generally more common among IPD cases. In 2015-2019, serotype 35B emerged as the most common serotype associated with multiclass antibiotic non-susceptibility for both the Rochester AOM and ABCs IPD cases. CONCLUSIONS: Pneumococcal isolates from children in Rochester with AOM differ in serotype distribution and antibiotic susceptibility compared to IPD cases identified through U.S. surveillance. Non-PCV serotype 35B emerged as a common cause of AOM and IPD. |
Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among children aged 6-18 years with immunocompromising conditions: recommendations of the Advisory Committee on Immunization Practices (ACIP)
Centers for Disease Control and Prevention , Bennett NM , Pilishvili T , Whitney CG , Moore M , Gierke R , Harris AM . MMWR Morb Mortal Wkly Rep 2013 62 (25) 521-4 On February 20, 2013, the Advisory Committee on Immunization Practices (ACIP) recommended routine use of 13-valent pneumococcal conjugate vaccine (PCV13; Prevnar 13, Wyeth Pharmaceuticals, Inc., a subsidiary of Pfizer, Inc.) for children aged 6-18 years with immunocompromising conditions, functional or anatomic asplenia, cerebrospinal fluid (CSF) leaks, or cochlear implants who have not previously received PCV13. PCV13 should be administered to these children regardless of whether they received the 7-valent pneumococcal conjugate vaccine (PCV7) or the 23-valent pneumococcal polysaccharide vaccine (PPSV23). Recommendations for PPSV23 use for children in this age group remain unchanged. The evidence for the benefits and risks associated with PCV13 vaccination of children with immunocompromising conditions was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework. This recommendation reflects a policy change from permissive and off-label recommendation of PCV13 in the pediatric immunocompromised population to a category A recommendation. This report summarizes the evidence considered by ACIP to make this recommendation and reviews the recommendations for use of PCV13 and PPSV23 for children aged 6-18 years. |
ACIP Updates: Recommendations for Use of 20-Valent Pneumococcal Conjugate Vaccine in Children - United States, 2023
Centers for Disease Control and Prevention , Farrar J , Gierke R , Andrejko K , Ayabina D , Zielinski L , Cohen A , Kobayashi M . MMWR Morb Mortal Wkly Rep 2023 72 (39) 1072 On June 22, 2023, the Advisory Committee on Immunization Practices (ACIP) convened and approved recommendations for the use of 20-valent pneumococcal conjugate vaccine (PCV20 [Prevnar 20; Wyeth Pharmaceuticals, Inc., a subsidiary of Pfizer, Inc.]) in U.S. children. The ACIP recommendations were adopted by the CDC Director on June 27, 2023, and are official. The recommendations, underlying evidence and rationale, and clinical guidance are available (Supplementary Report, https://stacks.cdc.gov/view/cdc/133252). |
Pneumococcal vaccine for adults aged 19 years: Recommendations of the Advisory Committee on Immunization Practices, United States, 2023
Kobayashi M , Pilishvili T , Farrar JL , Leidner AJ , Gierke R , Prasad N , Moro P , Campos-Outcalt D , Morgan RL , Long SS , Poehling KA , Cohen AL . MMWR Recomm Rep 2023 72 (3) 1-39 This report compiles and summarizes all published recommendations from CDC’s Advisory Committee on Immunization Practices (ACIP) for use of pneumococcal vaccines in adults aged ≥19 years in the United States. This report also includes updated and new clinical guidance for implementation from CDC. | | Before 2021, ACIP recommended 23-valent pneumococcal polysaccharide vaccine (PPSV23) alone (up to 2 doses), or both a single dose of 13-valent pneumococcal conjugate vaccine (PCV13) in combination with 1–3 doses of PPSV23 in series (PCV13 followed by PPSV23), for use in U.S. adults depending on age and underlying risk for pneumococcal disease. In 2021, two new pneumococcal conjugate vaccines (PCVs), a 15-valent and a 20-valent PCV (PCV15 and PCV20), were licensed for use in U.S. adults aged ≥18 years by the Food and Drug Administration. | | ACIP recommendations specify the use of either PCV20 alone or PCV15 in series with PPSV23 for all adults aged ≥65 years and for adults aged 19–64 years with certain underlying medical conditions or other risk factors who have not received a PCV or whose vaccination history is unknown. In addition, ACIP recommends use of either a single dose of PCV20 or ≥1 dose of PPSV23 for adults who have started their pneumococcal vaccine series with PCV13 but have not received all recommended PPSV23 doses. Shared clinical decision-making is recommended regarding use of a supplemental PCV20 dose for adults aged ≥65 years who have completed their recommended vaccine series with both PCV13 and PPSV23. | | Updated and new clinical guidance for implementation from CDC includes the recommendation for use of PCV15 or PCV20 for adults who have received PPSV23 but have not received any PCV dose. The report also includes clinical guidance for adults who have received 7-valent PCV (PCV7) only and adults who are hematopoietic stem cell transplant recipients. |
Problems paying medical bills among adults with diagnosed HIV in the United States
Luna-Gierke RE , Tie Y , Yuan X , Luo Q , Beer L , Dasgupta S . J Assoc Nurses AIDS Care 2023 34 (5) 432-439 Problems paying medical bills may affect HIV outcomes among people with HIV (PWH), thus limiting progress toward achieving national HIV prevention goals. We analyzed nationally representative data from CDC's Medical Monitoring Project collected during 6/2018-5/2020. Among 8,108 PWH, we reported weighted percentages of characteristics and examined associations between problems paying medical bills and clinical outcomes using prevalence ratios with predicted marginal means, adjusting for potential confounding. Nineteen percent of PWH reported problems paying medical bills. Problems paying medical bills were more prevalent among persons who experienced homelessness (26.9% vs. 18.3%). People with problems paying medical bills were more likely to have adverse HIV outcomes and were more likely to have ≥1 emergency room visit (prevalence ratio [PR]: 1.59; 95% CI [1.51-1.68]) or hospitalization (PR: 1.72; 95% CI [1.55-1.91]) in the past year. Identifying PWH experiencing financial barriers and expanding access to safety net programs could improve access to care and outcomes. |
Presence of Symptoms 6 Weeks After COVID-19 Among Vaccinated and Unvaccinated U.S. Healthcare Personnel (preprint)
Mohr NM , Plumb ID , Harland KK , Pilishvili T , Fleming-Dutra KE , Krishnadasan A , Hoth KF , Saydah SH , Mankoff Z , Haran JP , Leon ES , Talan DA , Smithline HA , Hou PC , Lee LC , Lim SC , Moran GJ , Steele MT , Beiser DG , Faine B , Nandi U , Schrading WA , Chinnock B , Chipman A , Fuentes M , LoVecchio F , Clinansmith B , Landers S , Horcher A , Wallace K , Uribe L , Pathmarajah K , Poronsky KE , Hashimoto DM , Bahamon M , Romain MSt , Kean E , Krebs E , Stubbs A , Roy S , Volturo G , Higgins A , Galbraith J , Crosby JC , Mulrow M , Gonzalez E , Gierke R , Farrar JL , Xing W , Chung Y , Yousaf A , Okaro JO , Briggs-Hagen M , Abedi GR , Nyanseor S , Watts CK . medRxiv 2022 25 Importance: Although COVID-19 vaccines protect against infection and severe disease, the role of vaccination in preventing prolonged symptoms in those with subsequent infection is unclear. Objective(s): To determine differences in symptoms stratified by prior vaccination reported by healthcare personnel (HCP) 6 weeks after onset of COVID-19, and whether there were differences in timing of return to work. Design(s): Nested cohort study within a multicenter vaccine effectiveness study. HCP with COVID-19 between December 2020 and August 2021 were followed up 6 weeks after illness onset. Setting(s): Health systems in 12 U.S. states. Participant(s): HCP participating in a vaccine effectiveness study were eligible for inclusion if they had confirmed COVID-19 with either verified mRNA vaccination (symptom onset =14 days after two doses) or no prior COVID-19 vaccination. Among 681 eligible participants, 419 (61%) completed a follow-up survey approximately 6 weeks after illness onset. Exposures: Two doses of a COVID-19 mRNA vaccine compared with no COVID-19 vaccine. Main Outcomes and Measures: Presence of symptoms 6 weeks after onset of COVID-19 illness and days to return to work after COVID-19 illness. Result(s): Among 419 HCP with confirmed COVID-19, 298 (71%) reported one or more COVID-like symptoms 6 weeks after illness onset, with a lower prevalence among vaccinated participants (60.6%) compared with unvaccinated participants (60.6% vs. 79.1%; aRR 0.70, 95% CI 0.58-0.84). Vaccinated HCP returned to work a median 2.0 days (95% CI 1.0-3.0) sooner than unvaccinated HCP (aHR 1.37; 95% CI, 1.04-1.79). Conclusion(s): A history of two doses of COVID-19 mRNA vaccine among HCP with COVID-19 illness was associated with decreased risk of COVID-like symptoms at 6 weeks and earlier to return to work. Vaccination is associated with improved recovery from COVID-19, in addition to preventing symptomatic infection. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission. |
Racial differences in social determinants of health and outcomes among Hispanic/Latino persons with HIV-United States, 2015-2020
Padilla M , Luna-Gierke RE , Carree T , Gutierrez M , Yuan X , Dasgupta S . J Racial Ethn Health Disparities 2023 BACKGROUND: Hispanic/Latino people with HIV (PWH) experience disparities in health outcomes compared with other racial and ethnic groups. Disaggregated data based on race for Hispanic/Latino PWH in the United States are rarely reported, potentially masking inequities. METHODS: The Medical Monitoring Project (MMP) is a complex sample survey of adults with diagnosed HIV. We used weighted interview and medical record data collected from June 2015-May 2021 to examine differences in social determinants of health (SDH) and health outcomes by self-reported race among Hispanic/Latino adults with diagnosed HIV. RESULTS: Compared with White Hispanic/Latino PWH, Black Hispanic/Latino PWH were more likely to be unemployed (PR, 1.4; CI, 1.2-1.8), have a disability (PR, 1.3; CI, 1.2-1.5), have experienced homelessness (PR, 1.8; CI, 1.2-2.6), and have been incarcerated (PR, 2.6; CI, 1.5-4.5). American Indian/Alaska Native (AI/AN) (PR, 1.8; CI, 1.1-2.7) and multiracial (PR, 2.0; CI, 1.4-2.9) Hispanic/Latino PWH were more likely to have experienced homelessness than White Hispanic/Latino PWH. Black (PR, 1.3; CI, 1.2-1.5) and multiracial (PR, 1.2; CI, 1.1-1.5) Hispanic/Latino PWH were more likely to be virally unsuppressed than White Hispanic/Latino PWH. CONCLUSION: Black, multiracial, and AI/AN Hispanic/Latino PWH experience disparities in SDH and HIV outcomes. Lumping Hispanic/Latino people into one racial and ethnic category obscures health disparities, which might limit our progress towards reaching national HIV goals. Future studies should consider disaggregating by other factors such as Hispanic origin, place of birth, immigration status, and primary language. Doing so recognizes the diversity of the Hispanic/Latino population. |
Use of 15-valent pneumococcal conjugate vaccine among U.S. Children: Updated Recommendations of the Advisory Committee on Immunization Practices - United States, 2022
Kobayashi M , Farrar JL , Gierke R , Leidner AJ , Campos-Outcalt D , Morgan RL , Long SS , Poehling KA , Cohen AL . MMWR Morb Mortal Wkly Rep 2022 71 (37) 1174-1181 The 13-valent pneumococcal conjugate vaccine (PCV13 [Prevnar 13, Wyeth Pharmaceuticals, Inc, a subsidiary of Pfizer, Inc]) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23 [Merck Sharp & Dohme LLC]) have been recommended for U.S. children, and the recommendations vary by age group and risk group (1,2). In 2021, 15-valent pneumococcal conjugate vaccine (PCV15 [Vaxneuvance, Merck Sharp & Dohme LLC]) was licensed for use in adults aged ≥18 years (3). On June 17, 2022, the Food and Drug Administration (FDA) approved an expanded usage for PCV15 to include persons aged 6 weeks-17 years, based on studies that compared antibody responses to PCV15 with those to PCV13 (4). PCV15 contains serotypes 22F and 33F (in addition to the PCV13 serotypes) conjugated to CRM197 (genetically detoxified diphtheria toxin). On June 22, 2022, CDC's Advisory Committee on Immunization Practices (ACIP) recommended use of PCV15 as an option for pneumococcal conjugate vaccination of persons aged <19 years according to currently recommended PCV13 dosing and schedules (1,2). ACIP employed the Evidence to Recommendation (EtR) Framework,* using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE)(†) approach to guide its deliberations regarding use of these vaccines. Risk-based recommendations on use of PPSV23 for persons aged 2-18 years with certain underlying medical conditions(§) that increase the risk for pneumococcal disease have not changed. |
Impact of pneumococcal conjugate vaccines on antibiotic-nonsusceptible invasive pneumococcal disease in the United States
Bajema KL , Gierke R , Farley MM , Schaffner W , Thomas A , Reingold AL , Harrison LH , Lynfield R , Burzlaff KE , Petit S , Barnes M , Torres S , Snippes Vagnone PM , Beall B , Pilishvili T . J Infect Dis 2022 226 (2) 342-351 BACKGROUND: Antibiotic-nonsusceptible invasive pneumococcal disease (NS-IPD) incidence declined dramatically in the United States following introduction of pneumococcal conjugate vaccines (PCVs) into the infant immunization schedule (7-valent PCV7 in 2000, replaced by the 13-valent PCV13 in 2010). We evaluated the long-term impact of PCVs on NS-IPD. METHODS: We identified IPD cases through the Centers for Disease Control Active Bacterial Core surveillance during 1998-2018. Isolates intermediate or resistant to ≥1 antibiotic class were classified as nonsusceptible. We calculated annual rates of IPD (cases per 100,000 persons). RESULTS: From 1998 through 2018, NS-IPD incidence decreased from 43.9 to 3.2 among children <5 years and from 19.8 to 9.4 among adults ≥65 years. Incidence of vaccine-type NS-IPD decreased in all age groups, while incidence of NVT NS-IPD increased in all age groups; the greatest absolute increase in NVT NS-IPD occurred among adults ≥65 years (2.3 to 7.2). During 2014-18, NVTs 35B, 33F, 22F, and 15A were the most common NS-IPD serotypes. CONCLUSIONS: NS-IPD incidence decreased following PCV7 and PCV13 introduction in the United States. However, recent increases in NVT NS-IPD, most pronounced among older adults, have been observed. New higher valency PCVs containing the most common nonsusceptible serotypes, including 22F and 33F, could help further reduce NS-IPD. |
Impact of 13-valent pneumococcal conjugate vaccine on invasive pneumococcal disease among adults with HIV-United States, 2008-2018
Kobayashi M , Matanock A , Xing W , Adih WK , Li J , Gierke R , Almendares O , Reingold A , Alden N , Petit S , Farley MM , Harrison LH , Holtzman C , Baumbach J , Thomas A , Schaffner W , McGee L , Pilishvili T . J Acquir Immune Defic Syndr 2022 90 (1) 6-14 BACKGROUND: People with HIV (PWH) are at increased risk for invasive pneumococcal disease (IPD). Thirteen-valent pneumococcal conjugate vaccine (PCV13) was recommended for use in US children in 2010 and for PWH aged 19 years or older in 2012. We evaluated the population-level impact of PCV13 on IPD among PWH and non-PWH aged 19 years or older. METHODS: We identified IPD cases from 2008 to 2018 through the Active Bacterial Core surveillance platform. We estimated IPD incidence using the National HIV Surveillance System and US Census Bureau data. We measured percent changes in IPD incidence from 2008 to 2009 to 2017-2018 by HIV status, age group, and vaccine serotype group, including serotypes in recently licensed 15-valent (PCV15) and 20-valent (PCV20) PCVs. RESULTS: In 2008-2009 and 2017-2018, 8.4% (552/6548) and 8.0% (416/5169) of adult IPD cases were among PWH, respectively. Compared with non-PWH, a larger proportion of IPD cases among PWH were in adults aged 19-64 years (94.7%-97.4% vs. 56.0%-60.1%) and non-Hispanic Black people (62.5%-73.0% vs. 16.7%-19.2%). Overall and PCV13-type IPD incidence in PWH declined by 40.3% (95% confidence interval: -47.7 to -32.3) and 72.5% (95% confidence interval: -78.8 to -65.6), respectively. In 2017-2018, IPD incidence was 16.8 (overall) and 12.6 (PCV13 type) times higher in PWH compared with non-PWH; PCV13, PCV15/non-PCV13, and PCV20/non-PCV15 serotypes comprised 21.5%, 11.2%, and 16.5% of IPD in PWH, respectively. CONCLUSIONS: Despite reductions post-PCV13 introduction, IPD incidence among PWH remained substantially higher than among non-PWH. Higher-valent PCVs provide opportunities to reduce remaining IPD burden in PWH. |
Use of 15-valent pneumococcal conjugate vaccine and 20-valent pneumococcal conjugate vaccine among U.S. Adults: Updated recommendations of the Advisory Committee on Immunization Practices - United States, 2022
Kobayashi M , Farrar JL , Gierke R , Britton A , Childs L , Leidner AJ , Campos-Outcalt D , Morgan RL , Long SS , Talbot HK , Poehling KA , Pilishvili T . MMWR Morb Mortal Wkly Rep 2022 71 (4) 109-117 In 2021, 20-valent pneumococcal conjugate vaccine (PCV) (PCV20) (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.) and 15-valent PCV (PCV15) (Merck Sharp & Dohme Corp.) were licensed by the Food and Drug Administration for adults aged ≥18 years, based on studies that compared antibody responses to PCV20 and PCV15 with those to 13-valent PCV (PCV13) (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.). Antibody responses to two additional serotypes included in PCV15 were compared to corresponding responses after PCV13 vaccination, and antibody responses to seven additional serotypes included in PCV20 were compared with those to the 23-valent pneumococcal polysaccharide vaccine (PPSV23) (Merck Sharp & Dohme Corp.). On October 20, 2021, the Advisory Committee on Immunization Practices (ACIP) recommended use of either PCV20 alone or PCV15 in series with PPSV23 for all adults aged ≥65 years, and for adults aged 19-64 years with certain underlying medical conditions or other risk factors* who have not previously received a PCV or whose previous vaccination history is unknown. ACIP employed the Evidence to Recommendation (EtR) framework,(†) using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE)(§) approach to guide its deliberations regarding use of these vaccines. Before this, PCV13 and PPSV23 were recommended for use for U.S. adults and the recommendations varied by age and risk groups. This was simplified in the new recommendations. |
Effectiveness of mRNA Covid-19 Vaccine among U.S. Health Care Personnel.
Pilishvili T , Gierke R , Fleming-Dutra KE , Farrar JL , Mohr NM , Talan DA , Krishnadasan A , Harland KK , Smithline HA , Hou PC , Lee LC , Lim SC , Moran GJ , Krebs E , Steele MT , Beiser DG , Faine B , Haran JP , Nandi U , Schrading WA , Chinnock B , Henning DJ , Lovecchio F , Lee J , Barter D , Brackney M , Fridkin SK , Marceaux-Galli K , Lim S , Phipps EC , Dumyati G , Pierce R , Markus TM , Anderson DJ , Debes AK , Lin MY , Mayer J , Kwon JH , Safdar N , Fischer M , Singleton R , Chea N , Magill SS , Verani JR , Schrag SJ . N Engl J Med 2021 385 (25) e90 BACKGROUND: The prioritization of U.S. health care personnel for early receipt of messenger RNA (mRNA) vaccines against severe acute respiratory disease coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (Covid-19), allowed for the evaluation of the effectiveness of these new vaccines in a real-world setting. METHODS: We conducted a test-negative case-control study involving health care personnel across 25 U.S. states. Cases were defined on the basis of a positive polymerase-chain-reaction (PCR) or antigen-based test for SARS-CoV-2 and at least one Covid-19-like symptom. Controls were defined on the basis of a negative PCR test for SARS-CoV-2, regardless of symptoms, and were matched to cases according to the week of the test date and site. Using conditional logistic regression with adjustment for age, race and ethnic group, underlying conditions, and exposures to persons with Covid-19, we estimated vaccine effectiveness for partial vaccination (assessed 14 days after receipt of the first dose through 6 days after receipt of the second dose) and complete vaccination (assessed ≥7 days after receipt of the second dose). RESULTS: The study included 1482 case participants and 3449 control participants. Vaccine effectiveness for partial vaccination was 77.6% (95% confidence interval [CI], 70.9 to 82.7) with the BNT162b2 vaccine (Pfizer-BioNTech) and 88.9% (95% CI, 78.7 to 94.2) with the mRNA-1273 vaccine (Moderna); for complete vaccination, vaccine effectiveness was 88.8% (95% CI, 84.6 to 91.8) and 96.3% (95% CI, 91.3 to 98.4), respectively. Vaccine effectiveness was similar in subgroups defined according to age (<50 years or ≥50 years), race and ethnic group, presence of underlying conditions, and level of patient contact. Estimates of vaccine effectiveness were lower during weeks 9 through 14 than during weeks 3 through 8 after receipt of the second dose, but confidence intervals overlapped widely. CONCLUSIONS: The BNT162b2 and mRNA-1273 vaccines were highly effective under real-world conditions in preventing symptomatic Covid-19 in health care personnel, including those at risk for severe Covid-19 and those in racial and ethnic groups that have been disproportionately affected by the pandemic. (Funded by the Centers for Disease Control and Prevention.). |
Interim Estimates of Vaccine Effectiveness of Pfizer-BioNTech and Moderna COVID-19 Vaccines Among Health Care Personnel - 33 U.S. Sites, January-March 2021.
Pilishvili T , Fleming-Dutra KE , Farrar JL , Gierke R , Mohr NM , Talan DA , Krishnadasan A , Harland KK , Smithline HA , Hou PC , Lee LC , Lim SC , Moran GJ , Krebs E , Steele M , Beiser DG , Faine B , Haran JP , Nandi U , Schrading WA , Chinnock B , Henning DJ , LoVecchio F , Nadle J , Barter D , Brackney M , Britton A , Marceaux-Galli K , Lim S , Phipps EC , Dumyati G , Pierce R , Markus TM , Anderson DJ , Debes AK , Lin M , Mayer J , Babcock HM , Safdar N , Fischer M , Singleton R , Chea N , Magill SS , Verani J , Schrag S . MMWR Morb Mortal Wkly Rep 2021 70 (20) 753-758 Throughout the COVID-19 pandemic, health care personnel (HCP) have been at high risk for exposure to SARS-CoV-2, the virus that causes COVID-19, through patient interactions and community exposure (1). The Advisory Committee on Immunization Practices recommended prioritization of HCP for COVID-19 vaccination to maintain provision of critical services and reduce spread of infection in health care settings (2). Early distribution of two mRNA COVID-19 vaccines (Pfizer-BioNTech and Moderna) to HCP allowed assessment of the effectiveness of these vaccines in a real-world setting. A test-negative case-control study is underway to evaluate mRNA COVID-19 vaccine effectiveness (VE) against symptomatic illness among HCP at 33 U.S. sites across 25 U.S. states. Interim analyses indicated that the VE of a single dose (measured 14 days after the first dose through 6 days after the second dose) was 82% (95% confidence interval [CI] = 74%-87%), adjusted for age, race/ethnicity, and underlying medical conditions. The adjusted VE of 2 doses (measured ≥7 days after the second dose) was 94% (95% CI = 87%-97%). VE of partial (1-dose) and complete (2-dose) vaccination in this population is comparable to that reported from clinical trials and recent observational studies, supporting the effectiveness of mRNA COVID-19 vaccines against symptomatic disease in adults, with strong 2-dose protection. |
Serotype distribution of remaining pneumococcal meningitis in the mature PCV10/13 period: Findings from the PSERENADE Project
Garcia Quesada M , Yang Y , Bennett JC , Hayford K , Zeger SL , Feikin DR , Peterson ME , Cohen AL , Almeida SCG , Ampofo K , Ang M , Bar-Zeev N , Bruce MG , Camilli R , Chacón GC , Ciruela P , Cohen C , Corcoran M , Dagan R , De Wals P , Desmet S , Diawara I , Gierke R , Guevara M , Hammitt LL , Hilty M , Ho PL , Jayasinghe S , Kleynhans J , Kristinsson KG , Ladhani SN , McGeer A , Mwenda JM , Pekka Nuorti J , Oishi K , Ricketson LJ , Sanz JC , Savrasova L , Setchanova LP , Smith A , Valentiner-Branth P , Valenzuela MT , van der Linden M , van Sorge NM , Varon E , Winje BA , Yildirim I , Zintgraff J , Knoll MD . Microorganisms 2021 9 (4) Pneumococcal conjugate vaccine (PCV) introduction has reduced pneumococcal meningitis incidence. The Pneumococcal Serotype Replacement and Distribution Estimation (PSERENADE) project described the serotype distribution of remaining pneumococcal meningitis in countries using PCV10/13 for least 5-7 years with primary series uptake above 70%. The distribution was estimated using a multinomial Dirichlet regression model, stratified by PCV product and age. In PCV10-using sites (N = 8; cases = 1141), PCV10 types caused 5% of cases <5 years of age and 15% among ≥5 years; the top serotypes were 19A, 6C, and 3, together causing 42% of cases <5 years and 37% ≥5 years. In PCV13-using sites (N = 32; cases = 4503), PCV13 types caused 14% in <5 and 26% in ≥5 years; 4% and 13%, respectively, were serotype 3. Among the top serotypes are five (15BC, 8, 12F, 10A, and 22F) included in higher-valency PCVs under evaluation. Other top serotypes (24F, 23B, and 23A) are not in any known investigational product. In countries with mature vaccination programs, the proportion of pneumococcal meningitis caused by vaccine-in-use serotypes is lower (≤26% across all ages) than pre-PCV (≥70% in children). Higher-valency PCVs under evaluation target over half of remaining pneumococcal meningitis cases, but questions remain regarding generalizability to the African meningitis belt where additional data are needed. |
Kurtosis: a new tool for noise analysis
Qiu W , Murphy WJ , Suter A . Acoust Today 2020 16 (4) 39-47 Hearing loss due to high-level noise exposure remains a significant occupational health hazard that continues to increase in prevalence in industrial and military work environments despite government-mandated hearing conservation programs. The underlying assumption in current noise standards is that hearing loss over an 8-hour A-weighted equivalent continuous exposure level (often abbreviated as LAeq,8h) can be predicted by the equal energy hypothesis. This method assumes equivalent effects on hearing for a 3 dB increase or decrease in exposure intensity with a halving or doubling of exposure duration, respectively. In other words, equal amounts of hearing loss are expected regardless of how the noise exposure levels have occurred over time. The equal energy hypothesis is the basis of most noise standards and guidelines in the United States and internationally. Although this approach is generally considered appropriate for steady-state noise, it is not adequate for complex noise (Hamernik and Qiu, 2001). Some Background: Consensus has been lacking on the use of simple energy averaging to predict the effects of noise on hearing. In the United States, some government agencies use a modification consisting of a 5 dB trading relationship, whereas others use the internationally accepted 3 dB rule. Use of the 3 dB rule has been recommended by the National Institute of Occupational Safety and Health (NIOSH) since 1998, which recommendation has been validated based on additional, more recent research (Suter, 2017). Another issue with using a simple energy metric is the inability of sound energy averaging to account for the increased hazard of noise with impulsive components. Although intermittences in noise exposures may have been considered helpful to hearing in the past, this no longer seems to be the case with complex noise exposures, which are found frequently in manufacturing industries. Because the additional hazards from impulsive noise were already recognized, the earliest version of the International Standards Organization (ISO) 1999 standard (1971) suggested a 10 dB adjustment to the average exposure level when impulsive noise is superimposed on a background of continuous noise. At a 1981 meeting of noise experts in Southampton, UK, some participants proposed keeping the 10 dB adjustment, with others wanting to change it to 5 dB, and a third group proposing just using simple energy averaging (Personal Observation, Suter, 1981). The resulting report concluded that hearing conservation programs should be initiated at a 5 dB lower level as a precautionary measure whenever there are impulsive noise conditions (von Gierke et al., 1981). Consequently, the 1990 version of the standard contained a note suggesting a 5 dB correction but even that disappeared without explanation in later iterations of the ISO 1999 standard (2013). Since then, more evidence has emerged regarding the hazard to hearing from complex noise environments relative to continuous noise environments. Complex or Non-Gaussian Noise: A steady-state, continuous noise exposure typically has a normal or Gaussian amplitude distribution (see background in Figure 1). However, the temporal pattern of noise exposures often varies significantly in work environments. A complex noise environment may be described as Gaussian background noise punctuated by a series of high-level transient noises resulting in a non-Gaussian distribution (as shown in Figure 1). These transients can be brief, high-level noise bursts, impulses, or impacts with varying interpeak intervals, peak levels, and peak durations. Industrial workers are often exposed to complex noise environments. Examples include jobs involving maintenance work, metalworking, and power tools, such as impact wrenches and nail guns. Over the past several decades, a number of studies using animal models have shown that exposure to complex noise produces more hearing damage than an equivalent energy exposure to continuous Gaussian noise, in terms of both behavioral hearing loss and sensory cell loss (e.g., Lei et al., 1994). These results, along with similar findings from human data in industrial settings, have demonstrated that although acoustic energy and exposure duration are necessary metrics, they are not sufficient to evaluate the hearing loss from complex non-Gaussian noise exposure. Because many noise environments can be characterized by the same equivalent energy and spectra, a metric that describes the temporal structure of an exposure would be a useful adjunct to the equivalent sound pressure level metric. The kurtosis of a sample distribution is such a metric. |
Upsurge of conjugate vaccine serotype 4 invasive pneumococcal disease clusters among adults experiencing homelessness in California, Colorado, and New Mexico.
Beall B , Walker H , Tran T , Li Z , Varghese J , McGee L , Li Y , Metcalf BJ , Gierke R , Mosites E , Chochua S , Pilishvili T . J Infect Dis 2020 223 (7) 1241-1249 After 7-valent pneumococcal conjugate vaccine introduction in the US in 2000, invasive pneumococcal disease (IPD) due to serotype 4 greatly decreased in children and adults. Starting in 2013, serotype 4 IPD incidence increased among adults >18 years old within three of ten Active Bacterial Core surveillance sites. Of 325 serotype 4 cases among adults in 2010-2018, 36% were from persons experiencing homelessness (PEH); incidence of serotype 4 IPD among PEH was 100-300 times higher than in the general population within these 3 areas. Genome sequencing for isolates recovered during 2015-2018 (n=246), revealed that increases in serotype 4 IPD were driven by lineages, ST10172, ST244, and ST695. Within each lineage, clusters of near-identical isolates indicated close temporal relatedness. Increases in serotype 4 IPD were limited to Colorado, California, and New Mexico, with highest increases observed among PEH, who were at increased risk for exposure to and infections caused by these strains. |
Preliminary Estimates of the Prevalence of Selected Underlying Health Conditions Among Patients with Coronavirus Disease 2019 - United States, February 12-March 28, 2020.
CDC COVID-19 Response Team , Chow Nancy , Fleming-Dutra Katherine , Gierke Ryan , Hall Aron , Hughes Michelle , Pilishvili Tamara , Ritchey Matthew , Roguski Katherine , Skoff Tami , Ussery Emily . MMWR Morb Mortal Wkly Rep 2020 69 (13) 382-386 On March 11, 2020, the World Health Organization declared Coronavirus Disease 2019 (COVID-19) a pandemic (1). As of March 28, 2020, a total of 571,678 confirmed COVID-19 cases and 26,494 deaths have been reported worldwide (2). Reports from China and Italy suggest that risk factors for severe disease include older age and the presence of at least one of several underlying health conditions (3,4). U.S. older adults, including those aged ≥65 years and particularly those aged ≥85 years, also appear to be at higher risk for severe COVID-19-associated outcomes; however, data describing underlying health conditions among U.S. COVID-19 patients have not yet been reported (5). As of March 28, 2020, U.S. states and territories have reported 122,653 U.S. COVID-19 cases to CDC, including 7,162 (5.8%) for whom data on underlying health conditions and other known risk factors for severe outcomes from respiratory infections were reported. Among these 7,162 cases, 2,692 (37.6%) patients had one or more underlying health condition or risk factor, and 4,470 (62.4%) had none of these conditions reported. The percentage of COVID-19 patients with at least one underlying health condition or risk factor was higher among those requiring intensive care unit (ICU) admission (358 of 457, 78%) and those requiring hospitalization without ICU admission (732 of 1,037, 71%) than that among those who were not hospitalized (1,388 of 5,143, 27%). The most commonly reported conditions were diabetes mellitus, chronic lung disease, and cardiovascular disease. These preliminary findings suggest that in the United States, persons with underlying health conditions or other recognized risk factors for severe outcomes from respiratory infections appear to be at a higher risk for severe disease from COVID-19 than are persons without these conditions. |
Coronavirus Disease 2019 in Children - United States, February 12-April 2, 2020.
CDC COVID-19 Response Team , Bialek Stephanie , Gierke Ryan , Hughes Michelle , McNamara Lucy A , Pilishvili Tamara , Skoff Tami . MMWR Morb Mortal Wkly Rep 2020 69 (14) 422-426 As of April 2, 2020, the coronavirus disease 2019 (COVID-19) pandemic has resulted in >890,000 cases and >45,000 deaths worldwide, including 239,279 cases and 5,443 deaths in the United States (1,2). In the United States, 22% of the population is made up of infants, children, and adolescents aged <18 years (children) (3). Data from China suggest that pediatric COVID-19 cases might be less severe than cases in adults and that children might experience different symptoms than do adults (4,5); however, disease characteristics among pediatric patients in the United States have not been described. Data from 149,760 laboratory-confirmed COVID-19 cases in the United States occurring during February 12-April 2, 2020 were analyzed. Among 149,082 (99.6%) reported cases for which age was known, 2,572 (1.7%) were among children aged <18 years. Data were available for a small proportion of patients on many important variables, including symptoms (9.4%), underlying conditions (13%), and hospitalization status (33%). Among those with available information, 73% of pediatric patients had symptoms of fever, cough, or shortness of breath compared with 93% of adults aged 18-64 years during the same period; 5.7% of all pediatric patients, or 20% of those for whom hospitalization status was known, were hospitalized, lower than the percentages hospitalized among all adults aged 18-64 years (10%) or those with known hospitalization status (33%). Three deaths were reported among the pediatric cases included in this analysis. These data support previous findings that children with COVID-19 might not have reported fever or cough as often as do adults (4). Whereas most COVID-19 cases in children are not severe, serious COVID-19 illness resulting in hospitalization still occurs in this age group. Social distancing and everyday preventive behaviors remain important for all age groups as patients with less serious illness and those without symptoms likely play an important role in disease transmission (6,7). |
Severe Outcomes Among Patients with Coronavirus Disease 2019 (COVID-19) - United States, February 12-March 16, 2020.
CDC COVID-19 Response Team , Bialek Stephanie , Boundy Ellen , Bowen Virginia , Chow Nancy , Cohn Amanda , Dowling Nicole , Ellington Sascha , Gierke Ryan , Hall Aron , MacNeil Jessica , Patel Priti , Peacock Georgina , Pilishvili Tamara , Razzaghi Hilda , Reed Nia , Ritchey Matthew , Sauber-Schatz Erin . MMWR Morb Mortal Wkly Rep 2020 69 (12) 343-346 Globally, approximately 170,000 confirmed cases of coronavirus disease 2019 (COVID-19) caused by the 2019 novel coronavirus (SARS-CoV-2) have been reported, including an estimated 7,000 deaths in approximately 150 countries (1). On March 11, 2020, the World Health Organization declared the COVID-19 outbreak a pandemic (2). Data from China have indicated that older adults, particularly those with serious underlying health conditions, are at higher risk for severe COVID-19-associated illness and death than are younger persons (3). Although the majority of reported COVID-19 cases in China were mild (81%), approximately 80% of deaths occurred among adults aged ≥60 years; only one (0.1%) death occurred in a person aged ≤19 years (3). In this report, COVID-19 cases in the United States that occurred during February 12-March 16, 2020 and severity of disease (hospitalization, admission to intensive care unit [ICU], and death) were analyzed by age group. As of March 16, a total of 4,226 COVID-19 cases in the United States had been reported to CDC, with multiple cases reported among older adults living in long-term care facilities (4). Overall, 31% of cases, 45% of hospitalizations, 53% of ICU admissions, and 80% of deaths associated with COVID-19 were among adults aged ≥65 years with the highest percentage of severe outcomes among persons aged ≥85 years. In contrast, no ICU admissions or deaths were reported among persons aged ≤19 years. Similar to reports from other countries, this finding suggests that the risk for serious disease and death from COVID-19 is higher in older age groups. |
Geographic Differences in COVID-19 Cases, Deaths, and Incidence - United States, February 12-April 7, 2020.
CDC COVID-19 Response Team , Bialek Stephanie , Bowen Virginia , Chow Nancy , Curns Aaron , Gierke Ryan , Hall Aron , Hughes Michelle , Pilishvili Tamara , Ritchey Matthew , Roguski Katherine , Silk Benjamin , Skoff Tami , Sundararaman Preethi , Ussery Emily , Vasser Michael , Whitham Hilary , Wen John . MMWR Morb Mortal Wkly Rep 2020 69 (15) 465-471 Community transmission of coronavirus disease 2019 (COVID-19) was first detected in the United States in February 2020. By mid-March, all 50 states, the District of Columbia (DC), New York City (NYC), and four U.S. territories had reported cases of COVID-19. This report describes the geographic distribution of laboratory-confirmed COVID-19 cases and related deaths reported by each U.S. state, each territory and freely associated state,* DC, and NYC during February 12-April 7, 2020, and estimates cumulative incidence for each jurisdiction. In addition, it projects the jurisdiction-level trajectory of this pandemic by estimating case doubling times on April 7 and changes in cumulative incidence during the most recent 7-day period (March 31-April 7). As of April 7, 2020, a total of 395,926 cases of COVID-19, including 12,757 related deaths, were reported in the United States. Cumulative COVID-19 incidence varied substantially by jurisdiction, ranging from 20.6 cases per 100,000 in Minnesota to 915.3 in NYC. On April 7, national case doubling time was approximately 6.5 days, although this ranged from 5.5 to 8.0 days in the 10 jurisdictions reporting the most cases. Absolute change in cumulative incidence during March 31-April 7 also varied widely, ranging from an increase of 8.3 cases per 100,000 in Minnesota to 418.0 in NYC. Geographic differences in numbers of COVID-19 cases and deaths, cumulative incidence, and changes in incidence likely reflect a combination of jurisdiction-specific epidemiologic and population-level factors, including 1) the timing of COVID-19 introductions; 2) population density; 3) age distribution and prevalence of underlying medical conditions among COVID-19 patients (1-3); 4) the timing and extent of community mitigation measures; 5) diagnostic testing capacity; and 6) public health reporting practices. Monitoring jurisdiction-level numbers of COVID-19 cases, deaths, and changes in incidence is critical for understanding community risk and making decisions about community mitigation, including social distancing, and strategic health care resource allocation. |
Pneumococcal conjugate vaccine breakthrough infections: 2001-2016
Adebanjo TA , Pondo T , Yankey D , Hill HA , Gierke R , Apostol M , Barnes M , Petit S , Farley M , Harrison LH , Holtzman C , Baumbach J , Bennett N , McGuire S , Thomas A , Schaffner W , Beall B , Whitney CG , Pilishvili T . Pediatrics 2020 145 (3) BACKGROUND: Most countries use 3-dose pneumococcal conjugate vaccine (PCV) schedules; a 4-dose (3 primary and 1 booster) schedule is licensed for US infants. We evaluated the invasive pneumococcal disease (IPD) breakthrough infection incidence in children receiving 2 vs 3 primary PCV doses with and without booster doses (2 + 1 vs 3 + 1; 2 + 0 vs 3 + 0). METHODS: We used 2001-2016 Active Bacterial Core surveillance data to identify breakthrough infections (vaccine-type IPD in children receiving >/=1 7-valent pneumococcal conjugate vaccine [PCV7] or 13-valent pneumococcal conjugate vaccine [PCV13] dose) among children aged <5 years. We estimated schedule-specific IPD incidence rates (IRs) per 100 000 person-years and compared incidence by schedule (2 + 1 vs 3 + 1; 2 + 0 vs 3 + 0) using rate differences (RDs) and incidence rate ratios. RESULTS: We identified 71 PCV7 and 49 PCV13 breakthrough infections among children receiving a schedule of interest. PCV13 breakthrough infection rates were higher in children aged <1 year receiving the 2 + 0 (IR: 7.8) vs 3 + 0 (IR: 0.6) schedule (incidence rate ratio: 12.9; 95% confidence interval: 4.1-40.4); PCV7 results were similar. Differences in PCV13 breakthrough infection rates by schedule in children aged <1 year were larger in 2010-2011 (2 + 0 IR: 18.6; 3 + 0 IR: 1.4; RD: 16.6) vs 2012-2016 (2 + 0 IR: 3.6; 3 + 0 IR: 0.2; RD: 3.4). No differences between schedules were detected in children aged >/=1 year for PCV13 breakthrough infections. CONCLUSIONS: Fewer PCV breakthrough infections occurred in the first year of life with 3 primary doses. Differences in breakthrough infection rates by schedule decreased as vaccine serotypes decreased in circulation. |
HIV care outcomes among Hispanics/Latinos with diagnosed HIV in the United States by place of birth-2015-2018, Medical Monitoring Project
Demeke HB , Luo Q , Luna-Gierke RE , Padilla M , Girona-Lozada G , Miranda-De Leon S , Weiser J , Beer L . Int J Environ Res Public Health 2019 17 (1) Relocation from one's birthplace may affect human immunodeficiency virus (HIV) outcomes, but national estimates of HIV outcomes among Hispanics/Latinos by place of birth are limited. We analyzed Medical Monitoring Project data collected in 2015-2018 from 2564 HIV-positive Hispanic/Latino adults and compared clinical outcomes between mainland US-born (referent group), Puerto Rican (PR-born), and those born outside the United States (non-US-born). We reported weighted percentages of characteristics and used logistic regression with predicted marginal means to examine differences between groups (p < 0.05). PR-born Hispanics/Latinos were more likely to be prescribed antiretroviral therapy (ART) (94%) and retained in care (94%) than mainland-US-born (79% and 77%, respectively) and non-US-born (91% and 87%, respectively) Hispanics/Latinos. PR-born Hispanics/Latinos were more likely to have sustained viral suppression (75%) than mainland-US-born Hispanics/Latinos (57%). Non-US-born Hispanics/Latinos were more likely to be prescribed ART (91% vs. 79%), retained in care (87% vs. 77%), and have sustained viral suppression (74% vs. 57%) than mainland-US-born Hispanics/Latinos. Greater Ryan White HIV/AIDS-funded facility usage among PR-born, better mental health among non-US-born, and less drug use among PR-born and non-US-born Hispanics/Latinos may have contributed to better HIV outcomes. Expanding programs with comprehensive HIV/AIDS services, including for mental health and substance use, may reduce HIV outcome disparities among Hispanics/Latinos. |
A national behavioral and clinical surveillance system of adults with diagnosed HIV (The Medical Monitoring Project): Protocol for an annual cross-sectional interview and medical record abstraction survey
Beer L , Johnson CH , Fagan JL , Frazier EL , Nyaku M , Craw JA , Sanders CC , Luna-Gierke RE , Shouse RL . JMIR Res Protoc 2019 8 (11) e15453 BACKGROUND: The Medical Monitoring Project (MMP) is a national population-based behavioral and clinical surveillance system of adults with diagnosed HIV in the United States, and it is sponsored by the Centers for Disease Control and Prevention (CDC). Its purpose is to provide locally and nationally representative estimates of factors affecting HIV transmission risk and clinical outcomes. OBJECTIVE: This study aimed to describe the rationale for and methodology of the MMP, in addition to its contribution to evaluating and monitoring HIV prevention, care, and treatment efforts in the United States. METHODS: MMP employs a stratified 2-stage sample design to select annual samples of persons living with diagnosed HIV from the National HIV Surveillance System and conducts interviews and medical record abstractions with participating persons. RESULTS: MMP data are published routinely via annual reports, conference presentations, and scientific publications. Data may be accessed upon request from the CDC, contingent on the guidelines established for the security and confidentiality of HIV surveillance data. CONCLUSIONS: MMP is the only source of annual population-based data on the behaviors and clinical care of persons with diagnosed HIV in the United States. It provides essential information for monitoring progress toward national treatment and prevention goals and guiding efforts to improve the health of persons with diagnosed HIV and prevent HIV transmission. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/15453. |
Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among adults aged 65 years: Updated recommendations of the Advisory Committee on Immunization Practices
Matanock A , Lee G , Gierke R , Kobayashi M , Leidner A , Pilishvili T . MMWR Morb Mortal Wkly Rep 2019 68 (46) 1069-1075 Two pneumococcal vaccines are currently licensed for use in adults in the United States: a 13-valent pneumococcal conjugate vaccine (PCV13 [Prevnar 13, Pfizer, Inc.]) and a 23-valent pneumococcal polysaccharide vaccine (PPSV23 [Pneumovax 23, Merck and Co., Inc.]). In 2014, the Advisory Committee on Immunization Practices (ACIP)* recommended routine use of PCV13 in series with PPSV23 for all adults aged >/=65 years based on demonstrated PCV13 safety and efficacy against PCV13-type pneumonia among adults aged >/=65 years (1). At that time, ACIP recognized that there would be a need to reevaluate this recommendation because it was anticipated that PCV13 use in children would continue to reduce disease burden among adults through reduced carriage and transmission of vaccine serotypes from vaccinated children (i.e., PCV13 indirect effects). On June 26, 2019, after having reviewed the evidence accrued during the preceding 3 years (https://www.cdc.gov/vaccines/acip/recs/grade/PCV13.html), ACIP voted to remove the recommendation for routine PCV13 use among adults aged >/=65 years and to recommend administration of PCV13 based on shared clinical decision-making for adults aged >/=65 years who do not have an immunocompromising condition,(dagger) cerebrospinal fluid (CSF) leak, or cochlear implant, and who have not previously received PCV13. ACIP recognized that some adults aged >/=65 years are potentially at increased risk for exposure to PCV13 serotypes, such as persons residing in nursing homes or other long-term care facilities and persons residing in settings with low pediatric PCV13 uptake or traveling to settings with no pediatric PCV13 program, and might attain higher than average benefit from PCV13 vaccination. When patients and vaccine providers( section sign) engage in shared clinical decision-making for PCV13 use to determine whether PCV13 is right for a particular person, considerations might include both the person's risk for exposure to PCV13 serotypes and their risk for developing pneumococcal disease as a result of underlying medical conditions. All adults aged >/=65 years should continue to receive 1 dose of PPSV23. If the decision is made to administer PCV13, it should be given at least 1 year before PPSV23. ACIP continues to recommend PCV13 in series with PPSV23 for adults aged >/=19 years with an immunocompromising condition, CSF leak, or cochlear implant (2). |
Pediatric bacterial meningitis surveillance in the World Health Organization African Region using the Invasive Bacterial Vaccine-Preventable Disease Surveillance Network, 2011-2016
Mwenda JM , Soda E , Weldegebriel G , Katsande R , Biey JN , Traore T , de Gouveia L , du Plessis M , von Gottberg A , Antonio M , Kwambana-Adams B , Worwui A , Gierke R , Schwartz S , van Beneden C , Cohen A , Serhan F , Lessa FC . Clin Infect Dis 2019 69 S49-s57 BACKGROUND: Bacterial meningitis is a major cause of morbidity and mortality in sub-Saharan Africa. We analyzed data from the World Health Organization's (WHO) Invasive Bacterial Vaccine-preventable Diseases Surveillance Network (2011-2016) to describe the epidemiology of laboratory-confirmed Streptococcus pneumoniae (Spn), Neisseria meningitidis, and Haemophilus influenzae meningitis within the WHO African Region. We also evaluated declines in vaccine-type pneumococcal meningitis following pneumococcal conjugate vaccine (PCV) introduction. METHODS: Reports of meningitis in children <5 years old from sentinel surveillance hospitals in 26 countries were classified as suspected, probable, or confirmed. Confirmed meningitis cases were analyzed by age group and subregion (South-East and West-Central). We described case fatality ratios (CFRs), pathogen distribution, and annual changes in serotype and serogroup, including changes in vaccine-type Spn meningitis following PCV introduction. RESULTS: Among 49 844 reported meningitis cases, 1670 (3.3%) were laboratory-confirmed. Spn (1007/1670 [60.3%]) was the most commonly detected pathogen; vaccine-type Spn meningitis cases declined over time. CFR was the highest for Spn meningitis: 12.9% (46/357) in the South-East subregion and 30.9% (89/288) in the West-Central subregion. Meningitis caused by N. meningitidis was more common in West-Central than South-East Africa (321/954 [33.6%] vs 110/716 [15.4%]; P < .0001). Haemophilus influenzae (232/1670 [13.9%]) was the least prevalent organism. CONCLUSIONS: Spn was the most common cause of pediatric bacterial meningitis in the African region even after reported cases declined following PCV introduction. Sustaining robust surveillance is essential to monitor changes in pathogen distribution and to inform and guide vaccination policies. |
Informing data to care: Contacting persons sampled for the Medical Monitoring Project
Beer L , Bosh KA , Chowdhury PP , Craw J , Nyaku MA , Luna-Gierke RE , Sanders CC , Shouse RL . J Acquir Immune Defic Syndr 2019 82 Suppl 1 S6-s12 BACKGROUND: Data to care (D2C) is a public health strategy that uses HIV surveillance and other data to identify persons in need of HIV medical care. The Medical Monitoring Project (MMP), which uses similar methods to contact and recruit HIV-positive persons, may inform predictors of successful contact for D2C programs. SETTING: MMP is a Centers for Disease Control and Prevention-funded surveillance system that collects nationally representative data on adults with diagnosed HIV in the United States and Puerto Rico. METHODS: Using MMP's 2016 data collection cycle, we present contact rates (ie, proportion of HIV-positive persons successfully contacted for MMP) by the age of contact information and age of laboratory test results available from HIV surveillance data. RESULTS: Nationally, 27.6% of eligible persons did not have a recorded laboratory test performed within the past year (project area range: 10.8%-54.6%). The national contact rate among persons with laboratory tests older than 1 year was 37.0% (project area range: 16.5%-67.1%). Higher contact rates were found among persons with more recent laboratory tests. Similar results were found by the age of contact information. Nationally, the most common reason for MMP ineligibility was that the person was deceased; the most common reason for not being contacted was lack of correct contact information. CONCLUSIONS: MMP findings suggest that D2C programs would benefit from efforts to improve the quality of HIV surveillance data and local surveillance practices-in particular, death ascertainment, the completeness of laboratory reporting, and the routine updating of contact information. Strengthening collaboration and integration with existing MMP programs may be beneficial. |
Genome-wide association analyses of invasive pneumococcal isolates identify a missense bacterial mutation associated with meningitis.
Li Y , Metcalf BJ , Chochua S , Li Z , Walker H , Tran T , Hawkins PA , Gierke R , Pilishvili T , McGee L , Beall BW . Nat Commun 2019 10 (1) 178 Bacterial mutations predisposing pneumococcus to causing meningitis, a more severe form of invasive pneumococcal disease (IPD), are largely unknown. Knowledge of such mutations may improve our understanding of pathogenesis and inform preventive strategies. Here we report a pneumococcal pbp1b gene mutation (pbp1bA641C causing N214T change in PBP1b transglycosylase domain) that is associated with meningitis in an exploratory cohort of IPD patients (n = 2054, p = 6.8 x 10(-6)), in an independent confirmatory cohort (n = 2518, p = 2.3 x 10(-6)), and in a combined analysis (n = 4572, p = 3.0 x 10(-10)). Patients infected by the pbp1b641C genotype pneumococci show 2.8-fold odds (95% CI 1.7 to 4.8) of meningitis compared to those infected by non-pbp1b641C pneumococci, after controlling for pneumococcal serotype, antibiotic resistance, and patient age. The pbp1bA641C change results in longer time needed for bacterial killing by antibiotic treatment and shows evidence of being under positive selection. Thus, a pneumococcal mutation conferring increased antibiotic tolerance is associated with meningitis among IPD patients. |
Differences in characteristics and clinical outcomes among Hispanic/Latino men and women receiving HIV medical care - United States, 2013-2014
Luna-Gierke RE , Shouse RL , Luo Q , Frazier E , Chen G , Beer L . MMWR Morb Mortal Wkly Rep 2018 67 (40) 1109-1114 The prevalence of diagnosed human immunodeficiency virus (HIV) infection among Hispanics/Latinos in the United States is approximately twice that of non-Hispanic whites (1). Barriers to, and experiences with, medical care have been found to vary by sex (2). Describing characteristics of Hispanics/Latinos in care by sex can help identify disparities and inform delivery of tailored services to this underserved population. Data from the 2013 and 2014 cycles of the Medical Monitoring Project (MMP) were analyzed to describe demographic, behavioral, and clinical characteristics among Hispanics/Latinos by sex. MMP is an annual cross-sectional, nationally representative surveillance system that, during 2013-2014, collected information about behaviors, medical care, and clinical outcomes among adults receiving outpatient HIV care. Hispanic/Latina women were significantly more likely than were men to live in poverty (78% versus 54%), report not speaking English well (38% versus 21%), and receive interpreter (27% versus 16%), transportation (35% versus 21%), and meal (44% versus 26%) services. There were no significant differences between Hispanic/Latino women and men in prescription of antiretroviral therapy (ART) (95% versus 96%) or sustained viral suppression (68% versus 73%). Although women faced greater socioeconomic and language-related challenges, the clinical outcomes among Hispanic/Latina women were similar to those among men, perhaps reflecting their higher use of ancillary services. Levels of viral suppression for Hispanics/Latinos are lower than those found among non-Hispanic whites (3) and lower than the national prevention goal of at least 80% of persons with diagnosed HIV infection. Providers should be cognizant of the challenges faced by Hispanics/Latinos with HIV infection in care and provide referrals to needed ancillary services. |
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