Last data update: Jun 24, 2024. (Total: 47078 publications since 2009)
Records 1-30 (of 47 Records) |
Query Trace: Macneil JR [original query] |
---|
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. |
The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Adolescents Aged 12-15 Years - United States, May 2021.
Wallace M , Woodworth KR , Gargano JW , Scobie HM , Blain AE , Moulia D , Chamberland M , Reisman N , Hadler SC , MacNeil JR , Campos-Outcalt D , Morgan RL , Daley MF , Romero JR , Talbot HK , Lee GM , Bell BP , Oliver SE . MMWR Morb Mortal Wkly Rep 2021 70 (20) 749-752 The Pfizer-BioNTech COVID-19 (BNT162b2) vaccine is a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine encoding the prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. Vaccination with the Pfizer-BioNTech COVID-19 vaccine consists of 2 intramuscular doses (30 μg, 0.3 mL each) administered 3 weeks apart. On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for use of the Pfizer-BioNTech COVID-19 vaccine (Pfizer, Inc; Philadelphia, Pennsylvania) in persons aged ≥16 years (1); on December 12, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of the vaccine in the same age group (2). As of May 12, 2021, approximately 141.6 million doses of the Pfizer-BioNTech COVID-19 vaccine had been administered to persons aged ≥16 years.* On May 10, 2021, FDA expanded the EUA for the Pfizer-BioNTech COVID-19 vaccine to include adolescents aged 12-15 years (1). On May 12, 2021, ACIP issued an interim recommendation(†) for use of the Pfizer-BioNTech COVID-19 vaccine in adolescents aged 12-15 years for the prevention of COVID-19. To guide its deliberations regarding the vaccine, ACIP used the Evidence to Recommendation (EtR) Framework,(§) using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.(¶) The ACIP recommendation for the use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥12 years under an EUA is interim and will be updated as additional information becomes available. |
Updated Recommendations from the Advisory Committee on Immunization Practices for Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine After Reports of Thrombosis with Thrombocytopenia Syndrome Among Vaccine Recipients - United States, April 2021.
MacNeil JR , Su JR , Broder KR , Guh AY , Gargano JW , Wallace M , Hadler SC , Scobie HM , Blain AE , Moulia D , Daley MF , McNally VV , Romero JR , Talbot HK , Lee GM , Bell BP , Oliver SE . MMWR Morb Mortal Wkly Rep 2021 70 (17) 651-656 On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Janssen COVID-19 (Ad.26.COV2.S) vaccine (Janssen Biotech, Inc., a Janssen Pharmaceutical company, Johnson & Johnson; New Brunswick, New Jersey), and on February 28, 2021, the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for its use in persons aged ≥18 years (1,2). On April 13, 2021, CDC and FDA recommended a pause in the use of the Janssen COVID-19 vaccine after reports of six U.S. cases of cerebral venous sinus thrombosis (CVST) with thrombocytopenia, a rare thromboembolic syndrome, among Janssen COVID-19 vaccine recipients (3). Two emergency ACIP meetings were rapidly convened to review reported cases of thrombosis with thrombocytopenia syndrome (TTS) and to consider updated recommendations for use of the Janssen COVID-19 vaccine in the United States. On April 23, 2021, after a discussion of the benefits and risks of resuming vaccination, ACIP reaffirmed its interim recommendation for use of the Janssen COVID-19 vaccine in all persons aged ≥18 years under the FDA's EUA, which now includes a warning that rare clotting events might occur after vaccination, primarily among women aged 18-49 years. Patient and provider education about the risk for TTS with the Janssen COVID-19 vaccine, especially among women aged <50 years, as well as the availability of alternative COVID-19 vaccines, is required to guide vaccine decision-making and ensure early recognition and clinical management of TTS. |
Meningococcal Vaccination: Recommendations of the Advisory Committee on Immunization Practices, United States, 2020
Mbaeyi SA , Bozio CH , Duffy J , Rubin LG , Hariri S , Stephens DS , MacNeil JR . MMWR Recomm Rep 2020 69 (9) 1-41 This report compiles and summarizes all recommendations from CDC's Advisory Committee on Immunization Practices (ACIP) for use of meningococcal vaccines in the United States. As a comprehensive summary and update of previously published recommendations, it replaces all previously published reports and policy notes. This report also contains new recommendations for administration of booster doses of serogroup B meningococcal (MenB) vaccine for persons at increased risk for serogroup B meningococcal disease. These guidelines will be updated as needed on the basis of availability of new data or licensure of new meningococcal vaccines. 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 with MenACWY for persons aged ≥2 months at increased risk for meningococcal disease caused by serogroups A, C, W, or Y, including persons who have persistent complement component deficiencies; persons receiving a complement inhibitor (e.g., eculizumab [Soliris] or ravulizumab [Ultomiris]); persons who have anatomic or functional asplenia; persons with human immunodeficiency virus infection; microbiologists routinely exposed to isolates of Neisseria meningitidis; persons identified to be at increased risk because of a meningococcal disease outbreak caused by serogroups A, C, W, or Y; persons who travel to or live in areas in which meningococcal disease is hyperendemic or epidemic; unvaccinated or incompletely vaccinated first-year college students living in residence halls; and military recruits. ACIP recommends MenACWY booster doses for previously vaccinated persons who become or remain at increased risk. In addition, ACIP recommends routine use of MenB vaccine series among persons aged ≥10 years who are at increased risk for serogroup B meningococcal disease, including persons who have persistent complement component deficiencies; persons receiving a complement inhibitor; persons who have anatomic or functional asplenia; microbiologists who are routinely exposed to isolates of N. meningitidis; and persons identified to be at increased risk because of a meningococcal disease outbreak caused by serogroup B. ACIP recommends MenB booster doses for previously vaccinated persons who become or remain at increased risk. In addition, ACIP recommends a MenB series for adolescents and young adults aged 16-23 years on the basis of shared clinical decision-making to provide short-term protection against disease caused by most strains of serogroup B N. meningitidis. |
Incidence of meningococcal disease before and after implementation of quadrivalent meningococcal conjugate vaccine in the United States
Mbaeyi S , Pondo T , Blain A , Yankey D , Potts C , Cohn A , Hariri S , Shang N , MacNeil JR . JAMA Pediatr 2020 174 (9) 843-851 IMPORTANCE: In 2005, the US Advisory Committee on Immunization Practices recommended routine quadrivalent meningococcal conjugate (MenACWY) vaccine for all adolescents aged 11 to 12 years, and in 2010, a booster dose for adolescents aged 16 years. Measuring the association between MenACWY vaccination and the incidence of meningococcal disease in adolescents is critical for evaluating the adolescent vaccination program and informing future vaccine policy. OBJECTIVE: To describe the association between MenACWY vaccination and the incidence of meningococcal disease in US adolescents. DESIGN, SETTING, AND PARTICIPANTS: In this cohort study, analysis of surveillance data included all confirmed and probable cases of Neisseria meningitidis reported to the National Notifiable Diseases Surveillance System from January 1, 2000, to December 31, 2017. Statistical analysis was conducted from October 1, 2018, to August 31, 2019. EXPOSURES: Routine MenACWY vaccination among US adolescents. MAIN OUTCOMES AND MEASURES: Poisson segmented regression analysis was used to model the annual incidence of meningococcal disease among adolescents aged 11 to 15 years and 16 to 22 years before the introduction of the MenACWY vaccine (2000-2005), after the primary dose recommendation (2006-2010), and after the booster dose recommendation (2011-2017); 95% CIs were used to determine significant differences between time periods. RESULTS: The national incidence of meningococcal disease declined from 0.61 cases per 100 000 population during the prevaccine period (2000-2005) to 0.15 cases per 100 000 population during the post-booster dose period (2011-2017). The greatest percentage decline was observed for serogroup C, W, and Y combined (CWY) among adolescents aged 11 to 15 years and 16 to 22 years in the periods after vaccine introduction. Incidence of serogroup CWY meningococcal disease among adolescents aged 11 to 15 years decreased by 16.3% (95% CI, 12.1%-20.3%) annually during the prevaccine period and 27.8% (95% CI, 20.6%-34.4%) during the post-primary dose period (P = .02); among adolescents aged 16 to 22 years, the incidence decreased by 10.6% (95% CI, 6.8%-14.3%) annually in the post-primary dose period and 35.6% (95% CI, 29.3%-41.0%) annually in the post-booster dose period (P < .001). An estimated 222 cases of meningococcal disease due to serogroup CWY among adolescents were averted through vaccination during the evaluation period. CONCLUSIONS AND RELEVANCE: After introduction of a primary and booster MenACWY dose, the rates of decline in incidence of meningococcal disease due to serogroup C, W, or Y accelerated nearly 2-fold to 3-fold in vaccinated adolescent age groups. Although the MenACWY vaccine alone cannot explain the decline of meningococcal disease in the United States, these data suggest that MenACWY vaccination is associated with reduced disease rates in adolescents. |
Evaluation of meningococcal vaccination policies among colleges and universities - United States, 2017
Oliver SE , Patton ME , Hoban M , Leino V , Mbaeyi SA , Hariri S , MacNeil JR . J Am Coll Health 2019 69 (5) 1-6 Objective: Quadrivalent meningococcal conjugate vaccines (MenACWY) have been recommended routinely for adolescents since 2005; in 2015, serogroup B meningococcal (MenB) vaccines were recommended for persons aged 16-23 years based on individual clinical decision making. We surveyed college health providers or administrators to understand current meningococcal vaccine policies. Methods/Participants: In January 2017, we distributed a survey to 985 institutions in partnership with the American College Health Association to assess vaccination policies and outbreak response plans. Results: Overall, 352 (36%) institutions completed the survey. Most either required (N = 186, 53%) or recommended (N = 148, 42%) a meningococcal vaccine; only half (N = 167) had a policy specifically addressing MenB vaccines. Few institutions with a MenB vaccine policy required vaccination (N = 7, 4%); most recommended vaccination (N = 160, 96%). Conclusion: Most institutions have a meningococcal vaccination policy; however, there is substantial diversity in policies. Fewer schools have policies specifically addressing MenB vaccines. |
Invasive meningococcal disease due to nongroupable Neisseria meningitidis - Active Bacterial Core Surveillance Sites, 2011-2016
McNamara LA , Potts CC , Blain A , Topaz N , Apostol M , Alden NB , Petit S , Farley MM , Harrison LH , Triden L , Muse A , Poissant T , Wang X , MacNeil JR . Open Forum Infect Dis 2019 6 (5) ofz190 We characterized 22 meningococcal disease cases due to nongroupable Neisseria meningitidis, a rare cause of invasive disease. Disease presentation and severity were similar to those for serogroupable meningococcal disease. However, 7 (32%) patients had complement deficiency or abnormal complement testing results, highlighting the importance of complement testing for nongroupable cases. |
University-based outbreaks of meningococcal disease caused by serogroup B, United States, 2013-2018
Soeters HM , McNamara LA , Blain AE , Whaley M , MacNeil JR , Hariri S , Mbaeyi SA . Emerg Infect Dis 2019 25 (3) 434-440 We reviewed university-based outbreaks of meningococcal disease caused by serogroup B and vaccination responses in the United States in the years following serogroup B meningococcal (MenB) vaccine availability. Ten university-based outbreaks occurred in 7 states during 2013-2018, causing a total of 39 cases and 2 deaths. Outbreaks occurred at universities with 3,600-35,000 undergraduates. Outbreak case counts ranged from 2 to 9 cases; outbreak duration ranged from 0 to 376 days. All 10 universities implemented MenB vaccination: 3 primarily used MenB-FHbp and 7 used MenB-4C. Estimated first-dose vaccination coverage ranged from 14% to 98%. In 5 outbreaks, additional cases occurred 6-259 days following MenB vaccination initiation. Although it is difficult to predict outbreak trajectories and evaluate the effects of public health response measures, achieving high MenB vaccination coverage is crucial to help protect at-risk persons during outbreaks of meningococcal disease caused by this serogroup. |
Meningococcal Disease Among College-Aged Young Adults: 2014-2016.
Mbaeyi SA , Joseph SJ , Blain A , Wang X , Hariri S , MacNeil JR . Pediatrics 2019 143 (1) ![]() ![]() BACKGROUND: Freshman college students living in residence halls have previously been identified as being at an increased risk for meningococcal disease. In this evaluation, we assess the incidence and characteristics of meningococcal disease in college-aged young adults in the United States. METHODS: The incidence and relative risk (RR) of meningococcal disease among college students compared with noncollege students aged 18 to 24 years during 2014-2016 were calculated by using data from the National Notifiable Diseases Surveillance System and enhanced meningococcal disease surveillance. Differences in demographic characteristics and clinical features of meningococcal disease cases were assessed. Available meningococcal isolates were characterized by using slide agglutination, polymerase chain reaction, and whole genome sequencing. RESULTS: From 2014 to 2016, 166 cases of meningococcal disease occurred in persons aged 18 to 24 years, with an average annual incidence of 0.17 cases per 100 000 population. Six serogroup B outbreaks were identified on college campuses, accounting for 31.7% of serogroup B cases in college students during this period. The RR of serogroup B meningococcal (MenB) disease in college students versus noncollege students was 3.54 (95% confidence interval: 2.21-5.41), and the RR of serogroups C, W, and Y combined was 0.56 (95% confidence interval: 0.27-1.14). The most common serogroup B clonal complexes identified were CC32/ET-5 and CC41/44 lineage 3. CONCLUSIONS: Although the incidence is low, among 18- to 24-year-olds, college students are at an increased risk for sporadic and outbreak-associated MenB disease. Providers, college students, and parents should be aware of the availability of MenB vaccines. |
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. |
Whole genome sequencing for investigations of meningococcal outbreaks in the United States: a retrospective analysis.
Whaley MJ , Joseph SJ , Retchless AC , Kretz CB , Blain A , Hu F , Chang HY , Mbaeyi SA , MacNeil JR , Read TD , Wang X . Sci Rep 2018 8 (1) 15803 ![]() ![]() ![]() Although rare in the U.S., outbreaks due to Neisseria meningitidis do occur. Rapid, early outbreak detection is important for timely public health response. In this study, we characterized U.S. meningococcal isolates (N = 201) from 15 epidemiologically defined outbreaks (2009-2015) along with temporally and geographically matched sporadic isolates using multilocus sequence typing, pulsed-field gel electrophoresis (PFGE), and six whole genome sequencing (WGS) based methods. Recombination-corrected maximum likelihood (ML) and Bayesian phylogenies were reconstructed to identify genetically related outbreak isolates. All WGS analysis methods showed high degree of agreement and distinguished isolates with similar or indistinguishable PFGE patterns, or the same strain genotype. Ten outbreaks were caused by a single strain; 5 were due to multiple strains. Five sporadic isolates were phylogenetically related to 2 outbreaks. Analysis of 9 outbreaks using timed phylogenies identified the possible origin and estimated the approximate time that the most recent common ancestor emerged for outbreaks analyzed. U.S. meningococcal outbreaks were caused by single- or multiple-strain introduction, with organizational outbreaks mainly caused by a clonal strain and community outbreaks by divergent strains. WGS can infer linkage of meningococcal cases when epidemiological links are uncertain. Accurate identification of outbreak-associated cases requires both WGS typing and epidemiological data. |
Adoption of serogroup B meningococcal vaccine recommendations
Kempe A , Allison MA , MacNeil JR , O'Leary ST , Crane LA , Beaty BL , Hurley LP , Brtnikova M , Lindley MC , Albert AP . Pediatrics 2018 142 (3) BACKGROUND AND OBJECTIVES: In 2015, the Advisory Committee on Immunization Practices recommended that 16- to 23-year-olds may be vaccinated with the serogroup B meningococcal (MenB) vaccine on the basis of individual clinical decision-making (Category B). We assessed the following among US pediatricians and family physicians (FPs): (1) practices regarding MenB vaccine delivery, (2) factors influencing a decision to recommend the MenB vaccine, and (3) factors associated with discussing the MenB vaccine. METHODS: We surveyed a nationally representative sample of pediatricians and FPs via e-mail and Internet from October 2016 to December 2016. RESULTS: The response rate was 72% (660 of 916). During routine visits, 51% of pediatricians and 31% of FPs reported always or often discussing MenB vaccine. Among those who discussed often or always, 91% recommended vaccination; among those who never or rarely discussed, 11% recommended. We found that 73% of pediatricians and 41% of FPs currently administered the MenB vaccine. Although many providers reported not knowing about factors influencing recommendation decisions, MenB disease outbreaks (89%), disease incidence (62%), and effectiveness (52%), safety (48%), and duration of protection of MenB vaccine (39%) increased the likelihood of recommendation, whereas the Category B recommendation (45%) decreased likelihood. Those somewhat or not at all aware of the MenB vaccine (risk ratio 0.32 [95% confidence interval 0.25-0.41]) and those practicing in a health maintenance organization (0.39 [0.18-0.87]) were less likely, whereas those aware of disease outbreaks in their state (1.25 [1.08-1.45]) were more likely to discuss MenB vaccine. CONCLUSIONS: Primary care physicians have significant gaps in knowledge about MenB disease and the MenB vaccine, and this appears to be a major driver of the decision not to discuss the vaccines. |
Emergence of Localized Serogroup W Meningococcal Disease in the United States - Georgia, 2006-2016.
Moore AE , MacNeil JR , Wang X , Joseph SJ , Lorentzson L , Thomas S , Tunali A , Parrott T , Farley MM , Tobin-D'Angelo M . MMWR Morb Mortal Wkly Rep 2018 67 (32) 894-897 ![]() ![]() Several countries in Europe and Australia are reporting an increasing incidence of Neisseria meningitidis serogroup W (NmW) as a consequence of the rapid expansion of a single NmW clone belonging to clonal complex 11 (1-5). Because this clone is reported to be associated with more severe disease, unusual clinical presentations, and a high case fatality ratio (CFR), it is considered a hypervirulent strain (1,6). In the United States, NmW accounts for approximately 5% of meningococcal disease reported each year, and this proportion has remained stable for several years (7). However, localized increases in NmW have been reported, most notably in Florida during 2008-2009 (8). In Georgia, NmW accounted for only 3% of meningococcal disease cases reported during 2006-2013; however, between January 2014 and December 2016, 42% of all reported cases were NmW. Surveillance data from Georgia were analyzed to describe the epidemiology and clinical characteristics of NmW cases, and whole-genome sequencing of NmW isolates was performed for comparison with NmW strains circulating in the United States and worldwide. These data indicate that the U.S. NmW strains might have evolved from the same ancestor as the hypervirulent strain that is circulating globally. Genetic analysis demonstrates that these strains are closely related, which would suggest that genetic variation led to the rise of different strains from the same ancestor. Given the recent global expansion of this potentially hypervirulent NmW lineage, clinicians and public health officials need to remain vigilant in obtaining isolates to monitor changes in circulating strains. |
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. |
Population structure of invasive Neisseria meningitidis in the United States, 2011-15.
Potts CC , Joseph SJ , Chang HY , Chen A , Vuong J , Hu F , Jenkins LT , Schmink S , Blain A , MacNeil JR , Harrison LH , Wang X . J Infect 2018 77 (5) 427-434 ![]() ![]() OBJECTIVES: Meningococcal conjugate vaccines (MenACWY) were licensed in the United States in 2005. We assessed the population structure of invasive Neisseria meningitidis (Nm) ten years after recommended use of MenACWY among adolescents. METHODS: Meningococcal isolates obtained through Active Bacterial Core surveillance (ABCs) from 2000-05, 2006-10, and 2011-15 underwent whole genome or Sanger sequencing. Genome phylogenies were completed using maximum likelihood methods; and distribution of multilocus sequence typing (MLST) sequence type (ST) and clonal complex (CC), and PorA and FetA types were assessed. RESULTS: Prevalent serogroups (B, C, Y and W), CCs, and PorA and FetA types were detected in all three time periods, but dynamic changes were observed. The proportion of serogroup W CC11 isolates increased in 2011-15 and were most related to South American strains. Changes in CC distribution were also observed in serogroup C and serogroup Y. Phylogenetic analysis showed that U.S. serogroup W CC11s are closely related to a subset of U.S. serogroup C isolates; combined global analysis demonstrated that some CCs, including CC11, exhibit regional clustering. CONCLUSIONS: Overall, the Nm population structure has remained stable after MenACWY introduction. Dynamic changes in genotypes, unlikely related to vaccination, also occurred, highlighting the need for continued whole genome-based surveillance. |
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. |
Knowledge and attitudes regarding category B ACIP recommendations among primary care providers for children
Kempe A , Allison MA , MacNeil JR , O'Leary ST , Crane LA , Beaty BL , Hurley LP , Brtnikova M , Lindley MC , Liang JL , Albert AP , Smith JC . Acad Pediatr 2018 18 (7) 763-768 OBJECTIVE: In 2015, the Advisory Committee on Immunization Practices (ACIP) made a category B recommendation for use of serogroup B meningococcal (MenB) vaccines, meaning individual clinical decision-making should guide recommendations. This was the first use of a category B recommendation pertaining to a large population and the first such recommendation for adolescents. As part of a survey regarding MenB vaccine, our objectives were to assess among pediatricians (Peds) and family physicians (FPs) nationally: 1) knowledge of the meaning of category A versus B recommendations and insurance coverage implications; and 2) attitudes about category A and B recommendations. DESIGN/METHODS: We surveyed a nationally representative sample of Peds and FPs by e-mail and mail from 10-12/2016. RESULTS: The response rate was 72% (660/916). Although >80% correctly identified the definition of a category A recommendation, only 24% were correct about the definition for category B. Fifty-five percent didn't know that private insurance would pay for vaccines recommended as category B, and 51% didn't know that category B-recommended vaccines would be covered by the Vaccines for Children program. Fifty-nine percent found it difficult to explain category B recommendations to patients; 22% thought ACIP should not make category B recommendations; and 39% were in favor of category B recommendations because they provide leeway in decision-making. CONCLUSIONS: For category B recommendations to be useful in guiding practice, primary care clinicians will need to have a better understanding of their meaning, their implications for insurance payment and guidance on how to discuss them with parents and patients. |
Expansion of a urethritis-associated Neisseria meningitidis clade in the United States with concurrent acquisition of N. gonorrhoeae alleles.
Retchless AC , Kretz CB , Chang HY , Bazan JA , Abrams AJ , Norris Turner A , Jenkins LT , Trees DL , Tzeng YL , Stephens DS , MacNeil JR , Wang X . BMC Genomics 2018 19 (1) 176 ![]() ![]() BACKGROUND: Increased reports of Neisseria meningitidis urethritis in multiple U.S. cities during 2015 have been attributed to the emergence of a novel clade of nongroupable N. meningitidis within the ST-11 clonal complex, the "U.S. NmNG urethritis clade". Genetic recombination with N. gonorrhoeae has been proposed to enable efficient sexual transmission by this clade. To understand the evolutionary origin and diversification of the U.S. NmNG urethritis clade, whole-genome phylogenetic analysis was performed to identify its members among the N. meningitidis strain collection from the Centers for Disease Control and Prevention, including 209 urogenital and rectal N. meningitidis isolates submitted by U.S. public health departments in eleven states starting in 2015. RESULTS: The earliest representatives of the U.S. NmNG urethritis clade were identified from cases of invasive disease that occurred in 2013. Among 209 urogenital and rectal isolates submitted from January 2015 to September 2016, the clade accounted for 189/198 male urogenital isolates, 3/4 female urogenital isolates, and 1/7 rectal isolates. In total, members of the clade were isolated in thirteen states between 2013 and 2016, which evolved from a common ancestor that likely existed during 2011. The ancestor contained N. gonorrhoeae-like alleles in three regions of its genome, two of which may facilitate nitrite-dependent anaerobic growth during colonization of urogenital sites. Additional gonococcal-like alleles were acquired as the clade diversified. Notably, one isolate contained a sequence associated with azithromycin resistance in N. gonorrhoeae, but no other gonococcal antimicrobial resistance determinants were detected. CONCLUSIONS: Interspecies genetic recombination contributed to the early evolution and subsequent diversification of the U.S. NmNG urethritis clade. Ongoing acquisition of N. gonorrhoeae alleles by the U.S. NmNG urethritis clade may facilitate the expansion of its ecological niche while also increasing the frequency with which it causes urethritis. |
Meningococcal carriage among a university student population - United States, 2015.
Breakwell L , Whaley M , Khan UI , Bandy U , Alexander-Scott N , Dupont L , Vanner C , Chang HY , Vuong JT , Martin S , MacNeil JR , Wang X , Meyer SA . Vaccine 2017 36 (1) 29-35 ![]() ![]() OBJECTIVES: Several outbreaks of serogroup B meningococcal disease have occurred among university students in recent years. In the setting of high coverage of the quadrivalent meningococcal conjugate vaccine and prior to widespread use of serogroup B meningococcal vaccines among adolescents, we conducted surveys to characterize the prevalence and molecular characteristics of meningococcal carriage among university students. METHODS: Two cross-sectional oropharyngeal carriage surveys were conducted among undergraduates at a Rhode Island university. Isolates were characterized using slide agglutination, real-time polymerase chain reaction (rt-PCR), and whole genome sequencing. Adjusted prevalence ratios and 95% confidence intervals were calculated using Poisson regression to determine risk factors for carriage. RESULTS: A total of 1837 oropharyngeal specimens were obtained from 1478 unique participants. Overall carriage prevalence was 12.7-14.6% during the two survey rounds, with 1.8-2.6% for capsular genotype B, 0.9-1.0% for capsular genotypes C, W, or Y, and 9.9-10.8% for nongroupable strains by rt-PCR. Meningococcal carriage was associated with being male, smoking, party or club attendance, recent antibiotic use (inverse correlation), and recent respiratory infections. CONCLUSIONS: In this university setting, the majority of meningococcal carriage was due to nongroupable strains, followed by serogroup B. Further evaluation is needed to understand the dynamics of serogroup B carriage and disease among university students. |
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. |
High risk for invasive meningococcal disease among patients receiving eculizumab (Soliris) despite receipt of meningococcal vaccine
McNamara LA , Topaz N , Wang X , Hariri S , Fox L , MacNeil JR . MMWR Morb Mortal Wkly Rep 2017 66 (27) 734-737 Use of eculizumab (Soliris, Alexion Pharmaceuticals), a terminal complement inhibitor, is associated with a 1,000-fold to 2,000-fold increased incidence of meningococcal disease (1). Administration of meningococcal vaccines is recommended for patients receiving eculizumab before beginning treatment (2,3). Sixteen cases of meningococcal disease were identified in eculizumab recipients in the United States during 2008-2016; among these, 11 were caused by nongroupable Neisseria meningitidis. Fourteen patients had documentation of receipt of at least 1 dose of meningococcal vaccine before disease onset. Because eculizumab recipients remain at risk for meningococcal disease even after receipt of meningococcal vaccines, some health care providers in the United States as well as public health agencies in other countries recommend antimicrobial prophylaxis for the duration of eculizumab treatment; a lifelong course of treatment is expected for many patients. Heightened awareness, early care seeking, and rapid treatment of any symptoms consistent with meningococcal disease are essential for all patients receiving eculizumab treatment, regardless of meningococcal vaccination or antimicrobial prophylaxis status. |
Serogroup B meningococcal disease vaccine recommendations at a university, New Jersey, USA, 2016
Soeters HM , Dinitz-Sklar J , Kulkarni PA , MacNeil JR , McNamara LA , Zaremski E , Chang HY , Lujan E , Granoff D , Lasky M , Montana B . Emerg Infect Dis 2017 23 (5) 867-869 In response to a university-based serogroup B meningococcal disease outbreak, the serogroup B meningococcal vaccine Trumenba was recommended for students, a rare instance in which a specific vaccine brand was recommended. This outbreak highlights the challenges of using molecular and immunologic data to inform real-time response. |
Updated recommendations for use of MenB-FHbp serogroup B meningococcal vaccine - Advisory Committee on Immunization Practices, 2016
Patton ME , Stephens D , Moore K , MacNeil JR . MMWR Morb Mortal Wkly Rep 2017 66 (19) 509-513 Two serogroup B meningococcal (MenB) vaccines are currently licensed for use in persons aged 10-25 years in the United States. The two vaccines are MenB-FHbp (Trumenba, Pfizer, Inc.) (1) and MenB-4C (Bexsero, GlaxoSmithKline Biologicals, Inc.) (2). In February 2015, the Advisory Committee on Immunization Practices (ACIP) recommended use of MenB vaccines among certain groups of persons aged ≥10 years who are at increased risk for serogroup B meningococcal disease* (Category A) (3), and in June 2015, ACIP recommended that adolescents and young adults aged 16-23 years may be vaccinated with MenB vaccines to provide short-term protection against most strains of serogroup B meningococcal disease (Category Bdagger) (4). Consistent with the original Food and Drug Administration (FDA) licensure for the two available MenB vaccines, ACIP recommended either a 3-dose series of MenB-FHbp or a 2-dose series of MenB-4C. Either MenB vaccine can be used when indicated; ACIP does not state a product preference. The two MenB vaccines are not interchangeable; the same vaccine product must be used for all doses in a series. In April 2016, changes to the dosage and administration of MenB-FHbp were approved by FDA to allow for both a 2-dose series (administered at 0 and 6 months) and a 3-dose series (administered at 0, 1-2, and 6 months) (5,6). In addition, the package insert now states that the choice of dosing schedule depends on the patient's risk for exposure and susceptibility to serogroup B meningococcal disease. These recommendations are regarding use of the 2- and 3-dose schedules of MenB-FHbp vaccine (Trumenba) and replace previous ACIP recommendations for use of MenB-FHbp vaccine published in 2015 (3,4). Recommendations regarding use of MenB-4C (Bexsero) are unchanged (3,4). |
Increased Risk for Meningococcal Disease among Men who have Sex with Men in the United States, 2012-2015.
Folaranmi TA , Kretz CB , Kamiya H , MacNeil JR , Whaley MJ , Blain A , Antwi M , Dorsinville M , Pacilli M , Smith S , Civen R , Ngo V , Winter K , Harriman K , Wang X , Bowen VB , Patel M , Martin S , Misegades L , Meyer SA . Clin Infect Dis 2017 65 (5) 756-763 ![]() ![]() Background: Several clusters of serogroup C meningococcal disease among men who have sex with men (MSM) have been reported in the United States in recent years. The epidemiology and risk of meningococcal disease among MSM is not well-described. Methods: All meningococcal disease cases among men aged 18-64 years reported to the National Notifiable Disease Surveillance System between January 2012 and June 2015 were reviewed. Characteristics of meningococcal disease cases among MSM and men not known to be MSM (non-MSM) were described. Annualized incidence rates among MSM and non-MSM were compared through calculation of the relative risk and 95% confidence intervals. Isolates from meningococcal disease cases among MSM were characterized using standard microbiological methods and whole genome sequencing. Results: Seventy-four cases of meningococcal disease were reported among MSM and 453 among non-MSM. Annualized incidence of meningococcal disease among MSM was 0.56 cases per 100,000 population, compared to 0.14 among non-MSM, for a relative risk of 4.0 (95% CI: 3.1-5.1). Among the 64 MSM with known status, 38 (59%) were HIV-infected. HIV-infected MSM had 10.1 times (95% CI: 6.1-16.6) the risk of HIV-uninfected MSM. All isolates from cluster-associated cases were serogroup C sequence type 11. Conclusions: MSM are at increased risk for meningococcal disease, although the incidence of disease remains low. HIV infection may be an important factor for this increased risk. Routine vaccination of HIV-infected persons with a quadrivalent meningococcal conjugate vaccine in accordance with Advisory Committee on Immunization Practices recommendations should be encouraged. |
Meningococcal carriage evaluation in response to a serogroup B meningococcal disease outbreak and mass vaccination campaign at a college - Rhode Island, 2015-2016
Soeters HM , Whaley M , Alexander-Scott N , Kanadanian KV , MacNeil JR , Martin SW , McNamara LA , Sicard K , Vanner C , Vuong J , Wang X , Bandy U , Patel M . Clin Infect Dis 2017 64 (8) 1115-1122 BACKGROUND: Serogroup B meningococcal disease caused 7 US university outbreaks during 2013-2016. Neisseria meningitidis can be transmitted via asymptomatic nasopharyngeal carriage. MenB-FHbp (factor H binding protein), a serogroup B meningococcal (MenB) vaccine, was used to control a college outbreak. We investigated MenB-FHbp impact on meningococcal carriage. METHODS: Four cross-sectional surveys were conducted in conjunction with MenB-FHbp vaccination campaigns. Questionnaires and oropharyngeal swabs were collected from students. Specimens were evaluated using culture, slide agglutination, real-time polymerase chain reaction (rt-PCR), and whole genome sequencing. Adjusted prevalence ratios (aPRs) were calculated using generalized estimating equations. RESULTS: During each survey, 20%-24% of participants carried any meningococcal bacteria and 4% carried serogroup B by rt-PCR. The outbreak strain (ST-9069) was not detected during the initial survey; 1 student carried ST-9069 in the second and third surveys. No carriage reduction was observed over time or with more MenB-FHbp doses. In total, 615 students participated in multiple surveys: 71% remained noncarriers, 8% cleared carriage, 15% remained carriers, and 7% acquired carriage. Ten students acquired serogroup B carriage: 3 after 1 MenB-FHbp dose, 4 after 2 doses, and 3 after 3 doses. Smoking (aPR, 1.3; 95% confidence interval [CI], 1.1-1.5) and male sex (aPR, 1.3; 95% CI, 1.1-1.5) were associated with increased meningococcal carriage. CONCLUSIONS: Carriage prevalence on campus remained stable, suggesting MenB-FHbp does not rapidly reduce meningococcal carriage or prevent serogroup B carriage acquisition. This reinforces the need for high vaccination coverage to protect vaccinated individuals and chemoprophylaxis for close contacts during outbreaks. |
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. |
Recommendations for use of meningococcal conjugate vaccines in HIV-infected persons - Advisory Committee on Immunization Practices, 2016
MacNeil JR , Rubin LG , Patton M , Ortega-Sanchez IR , Martin SW . MMWR Morb Mortal Wkly Rep 2016 65 (43) 1189-1194 At its June 2016 meeting, the Advisory Committee on Immunization Practices (ACIP) recommended routine use of meningococcal conjugate vaccine (serogroups A, C, W, and Y; including MenACWY-D [Menactra, Sanofi Pasteur] or MenACWY-CRM [Menveo, GlaxoSmithKline]) for persons aged ≥2 months with human immunodeficiency virus (HIV) infection. ACIP has previously recommended routine vaccination of persons aged ≥2 months who have certain medical conditions that increase risk for meningococcal disease (1), including persons who have persistent (e.g., genetic) deficiencies in the complement pathway (e.g., C3, properdin, Factor D, Factor H, or C5-C9); persons receiving eculizumab (Soliris, Alexion Pharmaceuticals) for treatment of atypical hemolytic uremic syndrome or paroxysmal nocturnal hemoglobinuria (because the drug binds C5 and inhibits the terminal complement pathway); and persons with functional or anatomic asplenia (including persons with sickle cell disease). Routine vaccination with meningococcal conjugate vaccine is also recommended for all healthy adolescents in the United States (1). This report summarizes the evidence considered by ACIP in recommending vaccination for HIV-infected persons, and provides recommendations and guidance for use of meningococcal conjugate vaccines (serogroups A, C, W, and Y) among HIV-infected persons aged ≥2 months; the majority of meningococcal disease among HIV-infected persons is caused by these four serogroups. |
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. |
Use of serogroup B meningococcal vaccines in adolescents and young adults: recommendations of the Advisory Committee On Immunization Practices, 2015
MacNeil JR , Rubin L , Folaranmi T , Ortega-Sanchez IR , Patel M , Martin SW . MMWR Morb Mortal Wkly Rep 2015 64 (41) 1171-1176 At its June 2015 meeting, the Advisory Committee on Immunization Practices (ACIP) recommended that adolescents and young adults aged 16-23 years may be vaccinated with a serogroup B meningococcal (MenB) vaccine to provide short-term protection against most strains of serogroup B meningococcal disease. This report summarizes the deliberations of ACIP, the rationale for its decision, and recommendations for use of MenB vaccines in adolescents and young adults. Two MenB vaccines have recently been licensed by the Food and Drug Administration (FDA) for use in the United States and approved for use in persons aged 10-25 years: MenB-FHbp (Trumenba, Wyeth Pharmaceuticals, Inc.) and MenB-4C (Bexsero, Novartis Vaccines). Both MenB vaccines were licensed based on statutory regulations for accelerated approval, which enabled FDA to approve the MenB vaccines for serious or life-threatening diseases based on safety and demonstration that vaccine effectiveness, as measured by bactericidal antibody responses with assays using several MenB test strains that were representative of prevalent strains in the United States, is reasonably likely to predict clinical benefit. As a requirement for accelerated approval, confirmatory studies in the postmarketing period will be conducted to verify and further describe the effectiveness of the vaccines against an extended number of MenB strains that represent a broader diversity of endemic disease. Additional postlicensure safety data are also needed and will be reviewed by ACIP as they become available. |
- Page last reviewed:Feb 1, 2024
- Page last updated:Jun 24, 2024
- Content source:
- Powered by CDC PHGKB Infrastructure