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Prevention and control of meningococcal disease: recommendations of the Advisory Committee on Immunization Practices (ACIP)
Cohn AC , MacNeil JR , Clark TA , Ortega-Sanchez IR , Briere EZ , Meissner HC , Baker CJ , Messonnier NE . MMWR Recomm Rep 2013 62 1-28 Meningococcal disease describes the spectrum of infections caused by Neisseria meningiditis, including meningitdis, bacteremia, and bacteremic pneumonia. Two quadrivalent meningococcal polysaccharide-protein conjugate vaccines that provide protection against meningococcal serogroups A, C, W, and Y (MenACWY-D [Menactra, manufactured by Sanofi Pasteur, Inc., Swiftwater, Pennsylvania] and MenACWY-CRM [Menveo, manufactured by Novartis Vaccines, Cambridge, Massachusetts]) are licensed in the United States for use among persons aged 2 through 55 years. MenACWY-D also is licensed for use among infants and toddlers aged 9 through 23 months. Quadrivalent meningococcal polysaccharide vaccine (MPSV4 [Menommune, manufactured by sanofi pasteur, Inc., Swiftwater, Pennsylvania]) is the only vaccine licensed for use among persons aged ≥56 years. A bivalent meningococcal polysaccharide protein conjugate vaccine that provides protection against meningococcal serogroups C and Y along with Haemophilus influenzae type b (Hib) (Hib-MenCY-TT [MenHibrix, manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium]) is licensed for use in children aged 6 weeks through 18 months. This report compiles and summarizes all recommendations from CDC's Advisory Committee on Immunization Practices (ACIP) regarding prevention and control of meningococcal disease in the United States, specifically the changes in the recommendations published since 2005 (CDC. Prevention and control of meningococcal disease: recommendations of the Advisory Committee on Immunization Practices [ACIP]. MMWR 2005;54 [No. RR-7]). As a comprehensive summary of previously published recommendations, this report does not contain any new recommendations; it is intended for use by clinicians as a resource. ACIP recommends routine vaccination with a quadrivalent meningococcal conjugate vaccine (MenACWY) for adolescents aged 11 or 12 years, with a booster dose at age 16 years. ACIP also recommends routine vaccination for persons at increased risk for meningococcal disease (i.e., persons who have persistent complement component deficiencies, persons who have anatomic or functional asplenia, microbiologists who routinely are exposed to isolates of N. meningitidis, military recruits, and persons who travel to or reside in areas in which meningococcal disease is hyperendemic or epidemic). Guidelines for antimicrobial chemoprophylaxis and for evaluation and management of suspected outbreaks of meningococcal disease also are provided. |
Continued progress in the development of safe and effective RSV immunizations
Cohn AC , Hall AJ . N Engl J Med 2023 389 (24) 2289-2290 Before 2023, there were no immunizing tools to protect older adults and all infants from illness and death due to respiratory syncytial virus (RSV). In 2023, two RSV vaccines for older adults, one of which is also approved for use in pregnant persons, and a long-acting monoclonal antibody to protect infants and some toddlers up to 19 months of age were approved by the Food and Drug Administration and recommended by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.1-3 These major developments occurred nearly 60 years after a formalin-inactivated RSV vaccine that had been administered to children in clinical trials resulted in enhanced respiratory disease in seronegative children who had been vaccinated, and hopes for a safe and effective RSV vaccine were dashed, or at least postponed. Investigation into why this vaccine failed ultimately led to identification of the stabilized prefusion conformation of the fusion (F) glycoprotein target, which propelled the scientific community to subsequently make remarkable progress in the development of RSV vaccines.4 | | Furthermore, the discovery of the RSV prefusion F protein as a stable antigen was foundational to the work on vaccine development for coronaviruses before the Covid-19 pandemic, and researchers were able to quickly pivot to targeting SARS-CoV-2 spike protein when it emerged.5 In December 2020, the first mRNA vaccines against SARS-CoV-2 were authorized, 1 year after the disease and causative virus were first recognized. The development of these vaccines benefited from the head start provided by previous research on RSV vaccines and the mRNA platform that allows for fast production of large quantities of vaccine. Both factors were critical in controlling the Covid-19 pandemic, but they also show the immense potential for the rapid introduction of new vaccines worldwide. |
Estimated effectiveness of JYNNEOS vaccine in preventing Mpox: A Multijurisdictional Case-Control Study - United States, August 19, 2022-March 31, 2023
Dalton AF , Diallo AO , Chard AN , Moulia DL , Deputy NP , Fothergill A , Kracalik I , Wegner CW , Markus TM , Pathela P , Still WL , Hawkins S , Mangla AT , Ravi N , Licherdell E , Britton A , Lynfield R , Sutton M , Hansen AP , Betancourt GS , Rowlands JV , Chai SJ , Fisher R , Danza P , Farley M , Zipprich J , Prahl G , Wendel KA , Niccolai L , Castilho JL , Payne DC , Cohn AC , Feldstein LR . MMWR Morb Mortal Wkly Rep 2023 72 (20) 553-558 As of March 31, 2023, more than 30,000 monkeypox (mpox) cases had been reported in the United States in an outbreak that has disproportionately affected gay, bisexual, and other men who have sex with men (MSM) and transgender persons (1). JYNNEOS vaccine (Modified Vaccinia Ankara vaccine, Bavarian Nordic) was approved by the Food and Drug Administration (FDA) in 2019 for the prevention of smallpox and mpox via subcutaneous injection as a 2-dose series (0.5 mL per dose, administered 4 weeks apart) (2). To expand vaccine access, an Emergency Use Authorization was issued by FDA on August 9, 2022, for dose-sparing intradermal injection of JYNNEOS as a 2-dose series (0.1 mL per dose, administered 4 weeks apart) (3). Vaccination was available to persons with known or presumed exposure to a person with mpox (postexposure prophylaxis [PEP]), as well as persons at increased risk for mpox or who might benefit from vaccination (preexposure mpox prophylaxis [PrEP]) (4). Because information on JYNNEOS vaccine effectiveness (VE) is limited, a matched case-control study was conducted in 12 U.S. jurisdictions,(†) including nine Emerging Infections Program sites and three Epidemiology and Laboratory Capacity sites,(§) to evaluate VE against mpox among MSM and transgender adults aged 18-49 years. During August 19, 2022-March 31, 2023, a total of 309 case-patients were matched to 608 control patients. Adjusted VE was 75.2% (95% CI = 61.2% to 84.2%) for partial vaccination (1 dose) and 85.9% (95% CI = 73.8% to 92.4%) for full vaccination (2 doses). Adjusted VE for full vaccination by subcutaneous, intradermal, and heterologous routes of administration was 88.9% (95% CI = 56.0% to 97.2%), 80.3% (95% CI = 22.9% to 95.0%), and 86.9% (95% CI = 69.1% to 94.5%), respectively. Adjusted VE for full vaccination among immunocompromised participants was 70.2% (95% CI = -37.9% to 93.6%) and among immunocompetent participants was 87.8% (95% CI = 57.5% to 96.5%). JYNNEOS is effective at reducing the risk for mpox. Because duration of protection of 1 versus 2 doses remains unknown, persons at increased risk for mpox exposure should receive the 2-dose series as recommended by the Advisory Committee on Immunization Practices (ACIP),(¶) regardless of administration route or immunocompromise status. |
Vaccine effectiveness of JYNNEOS against mpox disease in the United States
Deputy NP , Deckert J , Chard AN , Sandberg N , Moulia DL , Barkley E , Dalton AF , Sweet C , Cohn AC , Little DR , Cohen AL , Sandmann D , Payne DC , Gerhart JL , Feldstein LR . N Engl J Med 2023 388 (26) 2434-2443 BACKGROUND: In the United States, more than 30,000 cases of mpox (formerly known as monkeypox) had occurred as of March 1, 2023, in an outbreak disproportionately affecting transgender persons and gay, bisexual, and other men who have sex with men. In 2019, the JYNNEOS vaccine was approved for subcutaneous administration (0.5 ml per dose) to prevent mpox infection. On August 9, 2022, an emergency use authorization was issued for intradermal administration (0.1 ml per dose); however, real-world effectiveness data are limited for either route. METHODS: We conducted a case-control study based on data from Cosmos, a nationwide Epic electronic health record (EHR) database, to assess the effectiveness of JYNNEOS vaccination in preventing medically attended mpox disease among adults. Case patients had an mpox diagnosis code or positive orthopoxvirus or mpox virus laboratory result, and control patients had an incident diagnosis of human immunodeficiency virus (HIV) infection or a new or refill order for preexposure prophylaxis against HIV infection between August 15, 2022, and November 19, 2022. Odds ratios and 95% confidence intervals were estimated from conditional logistic-regression models, adjusted for confounders; vaccine effectiveness was calculated as (1 - odds ratio for vaccination in case patients vs. controls) × 100. RESULTS: Among 2193 case patients and 8319 control patients, 25 case patients and 335 control patients received two doses (full vaccination), among whom the estimated adjusted vaccine effectiveness was 66.0% (95% confidence interval [CI], 47.4 to 78.1), and 146 case patients and 1000 control patients received one dose (partial vaccination), among whom the estimated adjusted vaccine effectiveness was 35.8% (95% CI, 22.1 to 47.1). CONCLUSIONS: In this study using nationwide EHR data, patients with mpox were less likely to have received one or two doses of JYNNEOS vaccine than control patients. The findings suggest that JYNNEOS vaccine was effective in preventing mpox disease, and a two-dose series appeared to provide better protection. (Funded by the Centers for Disease Control and Prevention and Epic Research.). |
Incidence of monkeypox among unvaccinated persons compared with persons receiving 1 JYNNEOS vaccine vose - 32 U.S. jurisdictions, July 31-September 3, 2022
Payne AB , Ray LC , Kugeler KJ , Fothergill A , White EB , Canning M , Farrar JL , Feldstein LR , Gundlapalli AV , Houck K , Kriss JL , Lewis NM , Sims E , Smith DK , Spicknall IH , Nakazawa Y , Damon IK , Cohn AC , Payne DC . MMWR Morb Mortal Wkly Rep 2022 71 (40) 1278-1282 Human monkeypox is caused by Monkeypox virus (MPXV), an Orthopoxvirus, previously rare in the United States (1). The first U.S. case of monkeypox during the current outbreak was identified on May 17, 2022 (2). As of September 28, 2022, a total of 25,341 monkeypox cases have been reported in the United States.* The outbreak has disproportionately affected gay, bisexual, and other men who have sex with men (MSM) (3). JYNNEOS vaccine (Modified Vaccinia Ankara vaccine, Bavarian Nordic), administered subcutaneously as a 2-dose (0.5 mL per dose) series with doses administered 4 weeks apart, was approved by the Food and Drug Administration (FDA) in 2019 to prevent smallpox and monkeypox infection (4). U.S. distribution of JYNNEOS vaccine as postexposure prophylaxis (PEP) for persons with known exposures to MPXV began in May 2022. A U.S. national vaccination strategy(†) for expanded PEP, announced on June 28, 2022, recommended subcutaneous vaccination of persons with known or presumed exposure to MPXV, broadening vaccination eligibility. FDA emergency use authorization (EUA) of intradermal administration of 0.1 mL of JYNNEOS on August 9, 2022, increased vaccine supply (5). As of September 28, 2022, most vaccine has been administered as PEP or expanded PEP. Because of the limited amount of time that has elapsed since administration of initial vaccine doses, as of September 28, 2022, relatively few persons in the current outbreak have completed the recommended 2-dose series.(§) To examine the incidence of monkeypox among persons who were unvaccinated and those who had received ≥1 JYNNEOS vaccine dose, 5,402 reported monkeypox cases occurring among males(¶) aged 18-49 years during July 31-September 3, 2022, were analyzed by vaccination status across 32 U.S. jurisdictions.** Average monkeypox incidence (cases per 100,000) among unvaccinated persons was 14.3 (95% CI = 5.0-41.0) times that among persons who received 1 dose of JYNNEOS vaccine ≥14 days earlier. Monitoring monkeypox incidence by vaccination status in timely surveillance data might provide early indications of vaccine-related protection that can be confirmed through other well-controlled vaccine effectiveness studies. This early finding suggests that a single dose of JYNNEOS vaccine provides some protection against monkeypox infection. The degree and durability of such protection is unknown, and it is recommended that people who are eligible for monkeypox vaccination receive the complete 2-dose series. |
COVID-19 vaccines in children and adolescents
Maldonado YA , O'Leary ST , Ardura MI , Banerjee R , Bryant KA , Campbell JD , Caserta MT , John CC , Gerber JS , Kourtis AP , Ratner AJ , Romero JR , Shah SS , Zangwill KM , Kimberlin DW , Barnett ED , Lynfield R , Sawyer MH , Bernstein HH , Cohn AC , Farizo KM , Halasa NB , Kafer LM , Kim D , LpezMedina E , Moore D , Panagiotakopoulos L , Sauv L , Silverman NS , Starke JR , Tomashek KM , Frantz JM , CommitteeonInfectious Diseases . Pediatrics 2022 149 (1) Vaccines are safe and effective in protecting individuals and populations against infectious diseases. New vaccines are evaluated by a long-standing, rigorous, and transparent process through the US Food and Drug Administration and the Centers for Disease Control and Prevention (CDC), by which safety and efficacy data are reviewed before authorization and recommendation. |
One Year of COVID-19 Vaccines: A Shot of Hope, a Dose of Reality.
Cohn AC , Mahon BE , Walensky RP . JAMA 2021 327 (2) 119-120 One year after the first authorized COVID-19 vaccine was administered in the US, the nation celebrates a historic achievement in vaccine development and delivery. In 12 months, more than an estimated 200 million people in the US have completed their primary vaccine series. Vaccination has prevented millions of COVID-19 cases and hospitalizations and saved hundreds of thousands of lives. A report released in December 2021 by the Office of the Assistant Secretary of Planning and Evaluation highlights the large effects of vaccine on health, and also the estimated social value of avoiding COVID-19 hospitalizations and deaths.1 |
Principles of vaccine licensure, approval, and recommendations for use
Pickering LK , Meissner HC , Orenstein WA , Cohn AC . Mayo Clin Proc 2020 95 (3) 600-608 The licensure and recommendation processes for vaccines are complex. In the United States, vaccines are licensed for the civilian and military populations on the basis of review of Biologics License Applications submitted to the Food and Drug Administration (FDA) by vaccine manufacturers. For FDA-licensed vaccines, the product label includes indications, contraindications, and precautions for each vaccine. Package inserts do not include recommendations for vaccine use from the Advisory Committee on Immunization Practices (ACIP). The ACIP is chartered as a federal advisory committee to provide expert external advice and guidance to the director of the Centers for Disease Control and Prevention on the use of vaccines and related agents for control of vaccine preventable diseases in the civilian and military populations of the United States. As an external advisory committee to the Centers for Disease Control and Prevention, the ACIP has no regulatory authority but the committee does have responsibility for approving vaccines to be covered under the Vaccines for Children program. To implement ACIP vaccine recommendations in the public and private sectors, a collaboration of federal, state, and local governments as well as private organizations dealing with public health, vaccine supply, vaccine administration, vaccine finance, outcomes monitoring, public perception, and public trust and support must work together. Issues including vaccine misinformation, declining community immunity (herd protection), and need for risk communication add stress to this complex and fragile system. This study describes the functions of and interactions between FDA and ACIP. |
Increase in measles cases - United States, January 1-April 26, 2019
Patel M , Lee AD , Redd SB , Clemmons NS , McNall RJ , Cohn AC , Gastanaduy PA . MMWR Morb Mortal Wkly Rep 2019 68 (17) 402-404 As of April 26, 2019, CDC had reported 704 cases of measles in the United States since the beginning of 2019, representing the largest number of cases reported in the country in a single year since 1994, when 963 cases occurred, and since measles was declared eliminated* in 2000 (1,2). Measles is a highly contagious, acute viral illness characterized by fever and a maculopapular rash; complications include pneumonia, encephalitis, and death. Among the 704 cases, 503 (71%) were in unvaccinated persons and 689 (98%) occurred in U.S. residents. Overall, 66 (9%) patients were hospitalized. Thirteen outbreaks have been reported in 2019, accounting for 663 cases, 94% of all reported cases. Six of the 13 outbreaks were associated with underimmunized close-knit communities and accounted for 88% of all cases. High 2-dose measles vaccination coverage in the United States has been critical to limiting transmission (3). However, increased global measles activity poses a risk to U.S. elimination, particularly when unvaccinated travelers acquire measles abroad and return to communities with low vaccination rates (4). Health care providers should ensure persons are up to date with measles, mumps, rubella (MMR) vaccine, including before international travel, and rapidly report all suspected cases of measles to public health authorities. |
Review of the economic evidence presented to the United States Advisory Committee on Immunization Practices, 2012-2016
Pike J , Leidner AJ , MacNeil JR , Cohn AC . Vaccine 2018 37 (1) 7-10 We identified 16 Advisory Committee on Immunization Practices (ACIP) presentations from 2012 to 2016 that indicated 'cost' or 'economic' content. Characteristics were reviewed, abstracted, and tabulated to quantify and assess the transparency and consistency of economic evidence presented to ACIP. To assess transparency, we documented if each study identified author affiliation, conflicts of interest, study limitations, a clearly described model structure and other model attributes. To assess consistency, we identified the frequency of specific modeling choices, including the perspective, types of health outcomes considered, inclusion of specific types of costs, discount rate, and use of sensitivity analyses. Our results indicate that the content in these presentations appear to be transparent overall and consistent in several important areas, such as study perspective and health outcomes. However, we find the inclusion of particular types of direct costs, indirect costs, program costs, and sensitivity analyses are areas that could improve consistency. |
Understanding FDA-approved labeling and CDC recommendations for use of vaccines
Meissner HC , Farizo K , Pratt D , Pickering LK , Cohn AC . Pediatrics 2018 142 (3) Adherence to recommendations for the use of licensed vaccines ensures maximum individual and societal benefits from the national immunization program. The US Food and Drug Administration (FDA) licenses a vaccine once it determines that data submitted by the manufacturer reveal that the vaccine is safe and effective for its intended use. For each US-licensed vaccine, the FDA-approved prescribing information contains detailed information for health care providers to ensure safe and effective use. Centers for Disease Control and Prevention recommendations for the use of a licensed vaccine often are based on additional considerations, such as disease epidemiology, public acceptance, vaccine supply, and cost. Our objective in this article is to explain the reasons for the differences between FDA-approved prescribing information and Centers for Disease Control and Prevention recommendations for vaccine use. |
Epidemiology of meningococcal disease outbreaks in the United States, 2009-2013
Mbaeyi SA , Blain A , Whaley MJ , Wang X , Cohn AC , MacNeil JR . Clin Infect Dis 2018 68 (4) 580-585 Background: Although incidence of meningococcal disease is low in the United States, outbreaks remain a serious public health concern. In this evaluation, we identify and describe outbreaks of meningococcal disease. Methods: A retrospective review of all meningococcal disease cases reported from January 1, 2009 to December 31, 2013 was performed by state health departments and CDC to identify meningococcal disease outbreaks. An outbreak was defined as 2 or more primary cases of the same serogroup in less than three months in an organization, or an at-least two-fold increase in disease rates in a community. Results: From 2009 to 2013, 3,686 cases of meningococcal disease were reported in the United States. Among these, 180 primary cases (4.9%) occurred as part of 36 outbreaks (17 organization-based and 19 community-based). Serogroup B accounted for 8 (47.1%) organization-based outbreaks, including 6 of 8 university outbreaks. Serogroup C accounted for 10 (52.6%) community-based outbreaks, including both of the 2 outbreaks identified among men who have sex with men. Organization- and community-based outbreaks differed in predominant serogroup, age distribution of cases, and clinical syndrome. Among 33 outbreaks with known information, a vaccination and/or expanded chemoprophylaxis campaign were conducted in 16 (48.5%). Conclusions: Outbreak-associated cases account for approximately 5% of all meningococcal disease cases in the United States. Serogroup B is the primary cause of organization-based outbreaks, with the majority of university outbreaks due to serogroup B, while serogroup C is the primary cause of community-based outbreaks. |
Mass chemoprophylaxis for control of outbreaks of meningococcal disease
McNamara LA , MacNeil JR , Cohn AC , Stephens DS . Lancet Infect Dis 2018 18 (9) e272-e281 Although vaccination is the main strategy used to control meningococcal disease outbreaks, mass chemoprophylaxis has also been used as an immediate response to outbreaks, either to supplement vaccination or when vaccination is not possible. However, public health guidelines regarding the use of mass chemoprophylaxis for outbreak control vary by country, partly because the impact of mass chemoprophylaxis on the course of an individual outbreak is difficult to assess. We have reviewed data for the use of mass chemoprophylaxis during 33 outbreaks that occurred both in military populations and in communities and non-military organisations. In most outbreaks, no additional cases of meningococcal disease occurred after mass chemoprophylaxis, or cases occurred only in individuals who had not received prophylaxis. A delay of several weeks was common before cases occurred among prophylaxis recipients. Overall, the outbreak reports that we reviewed suggest that mass chemoprophylaxis might provide temporary protection to chemoprophylaxis recipients during outbreaks. |
Current epidemiology and trends in meningococcal disease - United States, 1996-2015
MacNeil JR , Blain AE , Wang X , Cohn AC . Clin Infect Dis 2017 66 (8) 1276-1281 Background: In 2005, meningococcal conjugate vaccine (MenACWY) was recommended for routine use among adolescents aged 11-18 years. This report describes the epidemiologic features of meningococcal disease and trends in meningococcal disease incidence following MenACWY introduction in the United States. Methods: Incidence rates and case-fatality ratios by age group and serogroup during 2006-2015 were calculated using data from the National Notifiable Diseases Surveillance System (NNDSS); changes in incidence during this time were evaluated. Additionally, 20-year trends (1996-2015) in age- and race-standardized incidence were examined using data from Active Bacterial Core surveillance (ABCs). Results: During the years 2006-2015, 7,924 cases of meningococcal disease were reported to NNDSS, resulting in an average annual incidence of 0.26 cases per 100,000 population; 14.9% of cases were fatal. Among cases with serogroup information, 2,290 (35.8%) were serogroup B, 1,827 (28.5%) were serogroup Y, 1,457 (22.8%) were serogroup C, 436 (6.8%) were serogroup W, and 392 (6.1%) were other serogroups. The incidence of serogroups A, C, W, and Y combined declined 76% among persons aged 11-20 years from 2006-2010 to 2011-2015 (p<.0001). From 1996-2015, the incidence of meningococcal disease declined among all age groups and predominant serogroups. Conclusions: Declines in meningococcal disease incidence in the United States have been observed among all age groups and predominant serogroups (B, C, and Y). Reductions in the incidence of meningococcal disease due to serogroups A, C, W, and Y among adolescents suggest an impact of the MenACWY vaccine program in this age group. |
Effectiveness and duration of protection of one dose of a meningococcal conjugate vaccine
Cohn AC , MacNeil JR , Harrison LH , Lynfield R , Reingold A , Schaffner W , Zell ER , Plikaytis B , Wang X , Messonnier NE . Pediatrics 2017 139 (2) BACKGROUND: Meningococcal conjugate vaccines were licensed beginning in 2005 on the basis of serologic end points and recommended for use in adolescents. A single dose at age 11 to 12 years was expected to provide protection through late adolescence. We conducted a case-control evaluation of vaccine effectiveness (VE) and duration of protection of a meningococcal (groups A, C, W, and Y) polysaccharide diphtheria toxoid conjugate vaccine (MenACWY-D). METHODS: Cases of culture- or polymerase chain reaction-confirmed serogroup A, C, W, and Y meningococcal disease among adolescents were identified through meningococcal disease surveillance sites in the United States from January 1, 2006, through August 31, 2013. Attempts were made to enroll 4 friend and school controls per case. VE was calculated using the generalized estimating equation, controlling for underlying medical conditions and smoking. RESULTS: Serogroup C accounted for 88 (49%), serogroup Y 80 (44%), and serogroup W 13 (7%) of enrolled cases. Thirty-six (20%) cases and 87 (44%) controls received MenACWY-D. The overall VE estimate 0 to 8 years postvaccination was 69% (51% to 80%); VE was 79% (49% to 91%) at <1 year, 69% (44% to 83%) at 1 to <3 years, and 61% (25% to 79%) at 3 to <8 years. VE was 77% (57% to 88%) against serogroup C and 51% (1% to 76%) against serogroup Y. CONCLUSIONS: MenACWY-D was effective in the first year after vaccination but effectiveness waned 3 to <8 years postvaccination. The estimates of VE from this evaluation informed the Advisory Committee on Immunization Practices in its decision to add a booster dose of MenACWY. |
Meningococcal disease in patients with human immunodeficiency virus infection: A review of cases reported through active surveillance in the United States, 2000-2008
Harris CM , Wu HM , Li J , Hall HI , Lee A , Zell E , Harrison LH , Petit S , Farley MM , Lynfield R , Miller L , Nichols M , Reingold A , Schaffner W , Thomas A , MacNeil JR , Clark TA , Cohn AC . Open Forum Infect Dis 2016 3 (4) ofw226 BACKGROUND: Although human immunodeficiency virus (HIV) infection is an established risk factor for several bacterial infections, the association between HIV infection and meningococcal disease remains unclear. METHODS: Expanded chart reviews were completed on persons with meningococcal disease and HIV infection reported from 2000 through 2008 from 9 US sites participating in an active population-based surveillance system for meningococcal disease. The incidence of meningococcal disease among patients meeting Centers for Disease Control and Prevention acquired immune deficiency syndrome (AIDS) surveillance criteria was estimated using data from the National HIV Surveillance System for the participating sites. RESULTS: Thirty-three cases of meningococcal disease in individuals with HIV infection were reported from participating sites, representing 2.0% of all reported meningococcal disease cases. Most (75.8%) persons with HIV infection were adult males aged 25 to 64 years old. Among all meningococcal disease cases aged 25 to 64 years old, case fatality ratios were similar among HIV-infected and HIV-uninfected persons (13.3% vs 10.6%; P = .6). The cumulative, mean incidence of meningococcal disease among patients aged 25 to 64 years old with HIV infection ever classified as AIDS was 3.5 cases per 100000 person years (95% confidence interval [CI], 2.1-5.6), compared with 0.3 cases per 100000 person years (95% CI, 0.3-0.3) for persons of the same age group not reported to have AIDS (relative risk = 12.9; 95% CI, 7.9-20.9). CONCLUSIONS: Individuals with HIV infection meeting the AIDS surveillance case definition have a higher incidence of meningococcal disease compared with the general adult population. |
Penicillin use in meningococcal disease management: Active Bacterial Core surveillance sites, 2009
Blain AE , Mandal S , Wu H , MacNeil JR , Harrison LH , Farley MM , Lynfield R , Miller L , Nichols M , Petit S , Reingold A , Schaffner W , Thomas A , Zansky SM , Anderson R , Harcourt BH , Mayer LW , Clark TA , Cohn AC . Open Forum Infect Dis 2016 3 (3) ofw152 In 2009, in the Active Bacterial Core surveillance sites, penicillin was not commonly used to treat meningococcal disease. This is likely because of inconsistent availability of antimicrobial susceptibility testing and ease of use of third-generation cephalosporins. Consideration of current practices may inform future meningococcal disease management guidelines. |
Update: interim guidance for prevention of sexual transmission of Zika virus - United States, 2016
Oster AM , Russell K , Stryker JE , Friedman A , Kachur RE , Petersen EE , Jamieson DJ , Cohn AC , Brooks JT . MMWR Morb Mortal Wkly Rep 2016 65 (12) 323-325 CDC issued interim guidance for the prevention of sexual transmission of Zika virus on February 5, 2016 (1). The following recommendations apply to men who have traveled to or reside in areas with active Zika virus transmission* and their female or male sex partners. These recommendations replace the previously issued recommendations and are updated to include time intervals after travel to areas with active Zika virus transmission or after Zika virus infection for taking precautions to reduce the risk for sexual transmission. This guidance defines potential sexual exposure to Zika virus as any person who has had sex (i.e., vaginal intercourse, anal intercourse, or fellatio) without a condom with a man who has traveled to or resides in an area with active Zika virus transmission. This guidance will be updated as more information becomes available. |
Population-Based Surveillance of Neisseria meningitidis Antimicrobial Resistance in the United States.
Harcourt BH , Anderson RD , Wu HM , Cohn AC , MacNeil JR , Taylor TH , Wang X , Clark TA , Messonnier NE , Mayer LW . Open Forum Infect Dis 2015 2 (3) ofv117 BACKGROUND: Antimicrobial treatment and chemoprophylaxis of patients and their close contacts is critical to reduce the morbidity and mortality and prevent secondary cases of meningococcal disease. Through the 1990's, the prevalence of antimicrobial resistance to commonly used antimicrobials among Neisseria meningitidis was low in the United States. Susceptibility testing was performed to ascertain whether the proportions of isolates with reduced susceptibility to antimicrobials commonly used for N meningitidis have increased since 2004 in the United States. METHODS: Antimicrobial susceptibility testing was performed by broth microdilution on 466 isolates of N meningitidis collected in 2004, 2008, 2010, and 2011 from an active, population-based surveillance system for susceptibility to ceftriaxone, ciprofloxacin, penicillin G, rifampin, and azithromycin. The molecular mechanism of reduced susceptibility was investigated for isolates with intermediate or resistant phenotypes. RESULTS: All isolates were susceptible to ceftriaxone and azithromycin, 10.3% were penicillin G intermediate (range, 8% in 2008-16.7% in 2010), and <1% were ciprofloxacin, rifampin, or penicillin G resistant. Of the penicillin G intermediate or resistant isolates, 63% contained mutations in the penA gene associated with reduced susceptibility to penicillin G. All ciprofloxacin-resistant isolates contained mutations in the gyrA gene associated with reduced susceptibility. CONCLUSIONS:. Resistance of N meningitidis to antimicrobials used for empirical treatment of meningitis in the United States has not been detected, and resistance to penicillin G and chemoprophylaxis agents remains uncommon. Therapeutic agent recommendations remain valid. Although periodic surveillance is warranted to monitor trends in susceptibility, routine clinical testing may be of little use. |
First use of a serogroup B meningococcal vaccine in the US in response to a university outbreak
McNamara LA , Shumate AM , Johnsen P , MacNeil JR , Patel M , Bhavsar T , Cohn AC , Dinitz-Sklar J , Duffy J , Finnie J , Garon D , Hary R , Hu F , Kamiya H , Kim HJ , Kolligian J Jr , Neglia J , Oakley J , Wagner J , Wagner K , Wang X , Yu Y , Montana B , Tan C , Izzo R , Clark TA . Pediatrics 2015 135 (5) 798-804 BACKGROUND: In 2013-2014, an outbreak of serogroup B meningococcal disease occurred among persons linked to a New Jersey university (University A). In the absence of a licensed serogroup B meningococcal (MenB) vaccine in the United States, the Food and Drug Administration authorized use of an investigational MenB vaccine to control the outbreak. An investigation of the outbreak and response was undertaken to determine the population at risk and assess vaccination coverage. METHODS: The epidemiologic investigation relied on compilation and review of case and population data, laboratory typing of meningococcal isolates, and unstructured interviews with university staff. Vaccination coverage data were collected during the vaccination campaign held under an expanded-access Investigational New Drug protocol. RESULTS: Between March 25, 2013, and March 10, 2014, 9 cases of serogroup B meningococcal disease occurred in persons linked to University A. Laboratory typing results were identical for all 8 isolates available. Through May 14, 2014, 89.1% coverage with the 2-dose vaccination series was achieved in the target population. From the initiation of MenB vaccination through February 1, 2015, no additional cases of serogroup B meningococcal disease occurred in University A students. However, the ninth case occurred in March 2014 in an unvaccinated close contact of University A students. CONCLUSIONS: No serogroup B meningococcal disease cases occurred in persons who received 1 or more doses of 4CMenB vaccine, suggesting 4CMenB may have protected vaccinated individuals from disease. However, the ninth case demonstrates that carriage of serogroup B Neisseria meningitidis among vaccinated persons was not eliminated. |
Epidemiology of infant meningococcal disease in the United States, 2006-2012
MacNeil JR , Bennett N , Farley MM , Harrison LH , Lynfield R , Nichols M , Petit S , Reingold A , Schaffner W , Thomas A , Pondo T , Mayer LW , Clark TA , Cohn AC . Pediatrics 2015 135 (2) e305-11 BACKGROUND: The incidence of meningococcal disease is currently at historic lows in the United States; however, incidence remains highest among infants aged <1 year. With routine use of Haemophilus influenzae type b and pneumococcal vaccines in infants and children in the United States, Neisseria meningitidis remains an important cause of bacterial meningitis in young children. METHODS: Data were collected from active, population- and laboratory-based surveillance for N meningitidis conducted through Active Bacterial Core surveillance during 2006 through 2012. Expanded data collection forms were completed for infant cases identified in the surveillance area during 2006 through 2010. RESULTS: An estimated 113 cases of culture-confirmed meningococcal disease occurred annually among infants aged <1 year in the United States from 2006 through 2012, for an overall incidence of 2.74 per 100 000 infants. Among these cases, an estimated 6 deaths occurred. Serogroup B was responsible for 64%, serogroup C for 12%, and serogroup Y for 16% of infant cases. Based on the expanded data collection forms, a high proportion of infant cases (36/58, 62%) had a smoker in the household and the socioeconomic status of the census tracts where infant meningococcal cases resided was lower compared with the other Active Bacterial Core surveillance areas and the United States as a whole. CONCLUSIONS: The burden of meningococcal disease remains highest in young infants and serogroup B predominates. Vaccines that provide long-term protection early in life have the potential to reduce the burden of meningococcal disease, especially if they provide protection against serogroup B meningococcal disease. |
Use of MenACWY-CRM vaccine in children aged 2 through 23 months at increased risk for meningococcal disease: recommendations of the Advisory Committee on Immunization Practices, 2013
MacNeil JR , Rubin L , McNamara L , Briere EC , Clark TA , Cohn AC . MMWR Morb Mortal Wkly Rep 2014 63 (24) 527-30 During its October 2013 meeting, the Advisory Committee on Immunization Practices (ACIP) recommended use of a third meningococcal conjugate vaccine, MenACWY-CRM (Menveo, Novartis), as an additional option for vaccinating infants aged 2 through 23 months at increased risk for meningococcal disease. MenACWY-CRM is the first quadrivalent meningococcal conjugate vaccine licensed for use in children aged 2 through 8 months. MenACWY-D (Menactra, Sanofi Pasteur) is recommended for use in children aged 9 through 23 months who are at increased risk for meningococcal disease, and Hib-MenCY-TT (MenHibrix, GlaxoSmithKline) is recommended for use in children aged 6 weeks through 18 months at increased risk. This report summarizes information on MenACWY-CRM administration in infants and provides recommendations for vaccine use in infants aged 2 through 23 months who are at increased risk for meningococcal disease. Because the burden of meningococcal disease in infants is low in the United States and the majority of cases that do occur are caused by serogroup B, which is not included in any vaccine licensed in the United States, only those infants who are at increased risk for meningococcal disease are recommended to receive a meningococcal vaccine. |
Pediatric anthrax clinical management
Bradley JS , Peacock G , Krug SE , Bower WA , Cohn AC , Meaney-Delman D , Pavia AT . Pediatrics 2014 133 (5) e1411-36 Anthrax is a zoonotic disease caused by Bacillus anthracis, which has multiple routes of infection in humans, manifesting in different initial presentations of disease. Because B anthracis has the potential to be used as a biological weapon and can rapidly progress to systemic anthrax with high mortality in those who are exposed and untreated, clinical guidance that can be quickly implemented must be in place before any intentional release of the agent. This document provides clinical guidance for the prophylaxis and treatment of neonates, infants, children, adolescents, and young adults up to the age of 21 (referred to as "children") in the event of a deliberate B anthracis release and offers guidance in areas where the unique characteristics of children dictate a different clinical recommendation from adults. |
Persistence of serogroup C antibody responses following quadrivalent meningococcal conjugate vaccination in United States military personnel
Patel M , Romero-Steiner S , Broderick MP , Thomas CG , Plikaytis BD , Schmidt DS , Johnson SE , Milton AS , Carlone GM , Clark TA , Messonnier NE , Cohn AC , Faix DJ . Vaccine 2014 32 (30) 3805-9 Serogroup C meningococcal (MenC) disease accounts for one-third of all meningococcal cases and causes meningococcal outbreaks in the U.S. Quadrivalent meningococcal vaccine conjugated to diphtheria toxoid (MenACYWD) was recommended in 2005 for adolescents and high risk groups such as military recruits. We evaluated anti-MenC antibody persistence in U.S. military personnel vaccinated with either MenACYWD or meningococcal polysaccharide vaccine (MPSV4). Twelve hundred subjects vaccinated with MenACYWD from 2006 to 2008 or MPSV4 from 2002 to 2004 were randomly selected from the Defense Medical Surveillance System. Baseline serologic responses to MenC were assessed in all subjects; 100 subjects per vaccine group were tested during one of the following six post-vaccination time-points: 5-7, 11-13, 17-19, 23-25, 29-31, or 35-37 months. Anti-MenC geometric mean titers (GMT) were measured by rabbit complement serum bactericidal assay (rSBA) and geometric mean concentrations (GMC) by enzyme-linked immunosorbent assay (ELISA). Continuous variables were compared using the Wilcoxon rank sum test and the proportion of subjects with an rSBA titer ≥8 by chi-square. Pre-vaccination rSBA GMT was <8 for the MenACWYD group. rSBA GMT increased to 703 at 5-7 months post-vaccination and decreased by 94% to 43 at 3 years post-vaccination. GMT was significantly lower in the MenACWYD group at 5-7 months post-vaccination compared to the MPSV4 group. The percentage of MenACWYD recipients achieving an rSBA titer of ≥8 decreased from 87% at 5-7 months to 54% at 3 years. There were no significant differences between vaccine groups in the proportion of subjects with a titer of ≥8 at any time-point. GMC for the MenACWYD group was 0.14mug/mL at baseline, 1.07mug/mL at 5-7 months, and 0.66mug/mL at 3 years, and significantly lower than the MPSV4 group at all time-points. Anti-MenC responses wane following vaccination with MenACYWD; a booster dose is needed to maintain protective levels of circulating antibody. |
Neisseria meningitidis serogroup W, Burkina Faso, 2012
Macneil JR , Medah I , Koussoube D , Novak RT , Cohn AC , Diomande FV , Yelbeogo D , Kambou JL , Tarbangdo TF , Ouedraogo-Traore R , Sangare L , Hatcher C , Vuong J , Mayer LW , Djingarey MH , Clark TA , Messonnier NE . Emerg Infect Dis 2014 20 (3) 394-9 In 2010, Burkina Faso became the first country to introduce meningococcal serogroup A conjugate vaccine (PsA-TT). During 2012, Burkina Faso reported increases in Neisseria meningitidis serogroup W, raising questions about whether these cases were a natural increase in disease or resulted from serogroup replacement after PsA-TT introduction. We analyzed national surveillance data to describe the epidemiology of serogroup W and genotyped 61 serogroup W isolates. In 2012, a total of 5,807 meningitis cases were reported through enhanced surveillance, of which 2,353 (41%) were laboratory confirmed. The predominant organism identified was N. meningitidis serogroup W (62%), and all serogroup W isolates characterized belonged to clonal complex 11. Although additional years of data are needed before we can understand the epidemiology of serogroup W after PsA-TT introduction, these data suggest that serogroup W will remain a major cause of sporadic disease and has epidemic potential, underscoring the need to maintain high-quality case-based meningitis surveillance after PsA-TT introduction. |
Geotemporal analysis of Neisseria meningitidis clones in the United States: 2000-2005.
Wiringa AE , Shutt KA , Marsh JW , Cohn AC , Messonnier NE , Zansky SM , Petit S , Farley MM , Gershman K , Lynfield R , Reingold A , Schaffner W , Thompson J , Brown ST , Lee BY , Harrison LH . PLoS One 2013 8 (12) e82048 BACKGROUND: The detection of meningococcal outbreaks relies on serogrouping and epidemiologic definitions. Advances in molecular epidemiology have improved the ability to distinguish unique Neisseria meningitidis strains, enabling the classification of isolates into clones. Around 98% of meningococcal cases in the United States are believed to be sporadic. METHODS: Meningococcal isolates from 9 Active Bacterial Core surveillance sites throughout the United States from 2000 through 2005 were classified according to serogroup, multilocus sequence typing, and outer membrane protein (porA, porB, and fetA) genotyping. Clones were defined as isolates that were indistinguishable according to this characterization. Case data were aggregated to the census tract level and all non-singleton clones were assessed for non-random spatial and temporal clustering using retrospective space-time analyses with a discrete Poisson probability model. RESULTS: Among 1,062 geocoded cases with available isolates, 438 unique clones were identified, 78 of which had ≥2 isolates. 702 cases were attributable to non-singleton clones, accounting for 66.0% of all geocoded cases. 32 statistically significant clusters comprised of 107 cases (10.1% of all geocoded cases) were identified. Clusters had the following attributes: included 2 to 11 cases; 1 day to 33 months duration; radius of 0 to 61.7 km; and attack rate of 0.7 to 57.8 cases per 100,000 population. Serogroups represented among the clusters were: B (n = 12 clusters, 45 cases), C (n = 11 clusters, 27 cases), and Y (n = 9 clusters, 35 cases); 20 clusters (62.5%) were caused by serogroups represented in meningococcal vaccines that are commercially available in the United States. CONCLUSIONS: Around 10% of meningococcal disease cases in the U.S. could be assigned to a geotemporal cluster. Molecular characterization of isolates, combined with geotemporal analysis, is a useful tool for understanding the spread of virulent meningococcal clones and patterns of transmission in populations. |
Meningococcal vaccines: current issues and future strategies
Cohn AC , Harrison LH . Drugs 2013 73 (11) 1147-55 Since the introduction of the first meningococcal conjugate vaccines in 1999, remarkable progress has been made in reducing the morbidity and mortality caused by meningococcal disease. Currently, varying meningococcal conjugate vaccines provide protection against serogroups A, C, Y, and W meningococcal disease. A large impact has been seen after vaccine introduction, particularly in the UK after vaccinating all 1-17 year olds. The introduction of serogroup A conjugate vaccine in the meningitis belt has the potential to control epidemics of disease that disproportionately affect this area of the world. Issues remain that require continued vigilance with disease surveillance and frequent reassessment of vaccine strategies. These issues include duration of protection, potential increases in non-vaccine serogroups, and vaccine safety and potential interference with other routine vaccines. Serogroup B meningococcal vaccines are protein-based vaccines, with the first approved in early 2013. Understanding the potential impact of serogroup B vaccines is critical to developing future meningococcal vaccination strategies. |
Prolonged university outbreak of meningococcal disease associated with a serogroup B strain rarely seen in the US
Mandal S , Wu HM , Macneil JR , Machesky K , Garcia J , Plikaytis BD , Quinn K , King L , Schmink SE , Wang X , Mayer LW , Clark TA , Gaskell JR , Messonnier NE , Diorio M , Cohn AC . Clin Infect Dis 2013 57 (3) 344-8 BACKGROUND: College students living in residential halls are at increased risk of meningococcal disease. Unlike for serogroups prevented by quadrivalent meningococcal vaccines, public health response to outbreaks of serogroup B meningococcal disease is limited by lack of a US licensed vaccine. METHODS: In March 2010 we investigated a prolonged outbreak of serogroup B disease associated with a university. In addition to case ascertainment, molecular typing of isolates was performed to characterize the outbreak. We conducted a matched case-control study to examine risk factors for serogroup B disease. Five controls per case, matched by college year, were randomly selected. Participants completed a risk factor questionnaire. Data were analyzed using conditional logistic regression. RESULTS: Between January 2008 and November 2010, we identified 13 meningococcal disease cases (seven confirmed, four probable, and two suspected) among university students (ten) or university-linked persons (three). One student died. Ten cases were determined to be serogroup B. Isolates from six confirmed cases had an indistinguishable pulse-field gel electrophoresis pattern and belonged to sequence type ST-269, clonal complex 269. Factors significantly associated with disease were Greek Society membership (matched odds ratio [mOR] 15.0; p=0.03), >1 kissing partner (mOR 13.7; p=0.03) and attending bars (mOR 8.1; p=0.04). CONCLUSIONS: The outbreak was associated with a novel serogroup B strain (CC269) and risk factors indicative of increased social mixing. Control measures were appropriate but limited by lack of vaccine. Understanding serogroup B transmission in college and other settings will help inform use of serogroup B vaccines currently under consideration for licensure. |
Invasive Haemophilus influenzae in the United States, 1999-2008: epidemiology and outcomes
Livorsi DJ , MacNeil JR , Cohn AC , Bareta J , Zansky S , Petit S , Gershman K , Harrison LH , Lynfield R , Reingold A , Schaffner W , Thomas A , Farley MM . J Infect 2012 65 (6) 496-504 OBJECTIVES: Introduction of the Haemophilus influenzae type b (Hib) conjugate vaccine has resulted in a dramatic reduction of Hib disease in the U.S. and an increase in the relative importance of infections caused by nontypeable strains. The current project describes the characteristics and clinical outcomes of pediatric and adult patients with invasive H. influenzae (HI) and, through multivariable analysis, identifies risk factors for in-hospital mortality. METHODS: HI cases were identified during 1999-2008 through active surveillance as part of Active Bacterial Core surveillance (ABCs). Multivariable analysis was performed with logistic regression to identify factors predictive of in-hospital death. RESULTS: 4839 cases of HI were identified from 1999-2008. Children accounted for 17.1% of cases and adults 82.9%. Underlying conditions were present in 20.7% of children and 74.8% of adults. In-hospital mortality was highest in cases ≥65 years (21.9%) and <3 months (16.2%). The risk of in-hospital death in children <1 year was higher among those who were prematurely-born (<28 weeks, OR 7.1, 95% CI 3.2-15.6; 28-36 weeks OR 2.1, 95% CI 0.9-4.8) and, among children aged 1-17 years, higher in those with healthcare-associated onset and dialysis (OR 5.66, 95% CI 1.84-17.39; OR 18.11, 95% CI 2.77-118.65). In adults, age ≥40 was associated with death in nontypeable, but not encapsulated, infections. Infections with nontypeable strains increased the risk of death in cases ≥65 years (OR 1.81, 95% CI 1.31-2.52). Healthcare-associated HI, bacteremia without identifiable focus, bacteremic pneumonia, associated cirrhosis, cerebrovascular accident, dialysis, heart failure, and non-hematologic malignancy also increased the risk of death in adults. CONCLUSION: Prematurity in infants, advanced age and certain chronic diseases in adults were associated with an increased risk of in-hospital death. Nontypeable HI was associated with higher mortality in the elderly. |
Haemophilus influenzae type B disease and vaccine booster dose deferral, United States, 1998-2009
Briere EC , Jackson M , Shah SG , Cohn AC , Anderson RD , Macneil JR , Coronado FM , Mayer LW , Clark TA , Messonnier NE . Pediatrics 2012 130 (3) 414-20 BACKGROUND: Since the introduction of effective vaccines, the incidence of invasive Haemophilus influenzae type b (Hib) disease among children <5 years of age has decreased by 99% in the United States. In response to a limited vaccine supply that began in 2007, Hib booster doses were deferred for 18 months. METHODS: We reviewed national passive and active surveillance (demographic and serotype) and vaccination status data for invasive H. influenzae disease in children aged <5 years before (1998-2007) and during (2008-2009) the vaccine shortage years to assess the impact of the vaccine deferral on Hib disease. We estimated the average annual number of Hib cases misclassified as unknown (not completed or missing) serotype. RESULTS: From 1998 to 2007 and 2008 to 2009, the annual average incidence of Hib disease per 100,000 population was 0.2 and 0.18, respectively; no significant difference in incidence was found by age group, gender, or race. Among Hib cases in both time periods, most were unvaccinated or too young to have received Hib vaccine. During 2001 to 2009, there were <53 Hib cases per year, with an estimated 6 to 12 Hib cases misclassified as unknown serotype. CONCLUSIONS: The booster deferral did not have a significant impact on the burden of invasive Hib disease in children <5 years of age. Continued surveillance and serotype data are important to monitor changes in Hib incidence, especially during vaccine deferrals. Hib booster deferral is a reasonable short-term approach to a Hib vaccine shortage. |
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