Last data update: May 13, 2024. (Total: 46773 publications since 2009)
Records 1-9 (of 9 Records) |
Query Trace: Meissner HC[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. |
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. |
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. |
Identifying gaps in respiratory syncytial virus disease epidemiology in the United States prior to the introduction of vaccines
Kim L , Rha B , Abramson JS , Anderson LJ , Byington CL , Chen GL , DeVincenzo J , Edwards KM , Englund JA , Falsey AR , Griffin MR , Karron RA , Martin KG , Meissner HC , Munoz FM , Pavia AT , Piedra PA , Schaffner W , Simoes EAF , Singleton R , Talbot HK , Walsh EE , Zucker JR , Gerber SI . Clin Infect Dis 2017 65 (6) 1020-1025 Respiratory syncytial virus (RSV) causes lower respiratory tract illness frequently. No effective antivirals or vaccines for RSV are approved for use in the United States; however, there are at least 50 vaccines and monoclonal antibody products in development, with those targeting older adults and pregnant women (to protect young infants) in phase 2 and 3 clinical trials. Unanswered questions regarding RSV epidemiology need to be identified and addressed prior to RSV vaccine introduction to guide the measurement of impact and future recommendations. The Centers for Disease Control and Prevention (CDC) convened a technical consultation to gather input from external subject matter experts on their individual perspectives regarding evidence gaps in current RSV epidemiology in the United States, potential studies and surveillance platforms needed to fill these gaps, and prioritizing efforts. Participants articulated their individual views, and CDC staff synthesized individuals' input into this report. |
Advisory Committee on Immunization Practices (ACIP) recommended immunization schedule for persons aged 0 through 18 years--United States, 2013
Akinsanya-Beysolow I , Jenkins R , Meissner HC . MMWR Suppl 2013 62 (1) 2-8 Each year, the Advisory Committee on Immunization Practices (ACIP) reviews the current recommended immunization schedules for persons aged 0 through 18 years to ensure that the schedule reflects current recommendations for licensed vaccines. In October 2012, ACIP approved the recommended immunization schedules for persons aged 0 through 18 years for 2013, which includes several changes from 2012. | | Health-care providers are advised to use both the recommended schedule and the catch-up schedule (Figures 1 and 2) in combination with their footnotes (pages 6–8) and not as stand-alones. For guidance on the use of all the vaccines in the schedules, including contraindications and precautions to use of a vaccine, providers are referred to the respective ACIP vaccine recommendations. | | Printable versions of the regular and catch-up schedules are available at http://www.cdc.gov/vaccines/schedules in various formats, including landscape and pocket-sized, in regular paper or laminated versions. A "parent friendly" regular schedule is available at http://www.cdc.gov/vaccines/schedules/easy-to-read/child.html#print. | | For 2013, several new references and links to additional information have been added, including one for travel vaccine requirements and recommendations (1). New references also are provided for vaccination of persons with primary and secondary immunodeficiencies. Changes to the previous schedules (2) include the following: | | Figure 1, "Recommended immunization schedule for persons aged 0 through 18 years" replaces "Recommended immunization schedule for persons aged 0 through 6 years" and "Recommended immunization schedule for persons aged 7 through 18 years." | — Wording was added to bars to represent the respective vaccine dose numbers in the series. | — The meningococcal conjugate vaccine (MCV4) purple bar was extended to age 6 weeks, to reflect licensure of Hib-MenCY vaccine. | — The hepatitis A (HepA) vaccine yellow bar was extended to better reflect routine age recommendations for use of HepA vaccine. New green and purple bars were added to reflect hepatitis A vaccine recommendations for older children. | — Abbreviations for influenza vaccine were updated with the anticipation of quadrivalent vaccine for the 2013–14 influenza season. | — Pneumococcal polysaccharide vaccine (PPSV23) was added to Figure 1. | Footnotes were combined and standardized formatting was used to provide recommendations for each vaccine related to routine vaccination, catch-up vaccination, and vaccination of persons with high-risk medical conditions or under special circumstances. | — Meningococcal conjugate vaccine (MCV4) footnotes were updated to reflect recent recommendations (3). | — Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine footnotes were updated to reflect recent recommendations (4). | — Influenza vaccine footnotes were updated to provide dosing guidance for children aged 6 months through 8 years for the 2012–13 and 2013–14 influenza seasons (5). | Meningococcal conjugate (MCV4) vaccine minimum ages and intervals were updated in Figure 2, "Catch-up immunization schedule for persons aged 4 months through 18 years who start late or who are more than 1 month behind—United States, 2013," to reflect licensure of Hib-MenCY vaccine. |
Epidemiology and diagnosis of health care-associated infections in the NICU
Polin RA , Denson S , Brady MT , Papile LA , Baley JE , Carlo WA , Cummings JJ , Kumar P , Tan RC , Watterberg KL , Barfield WD , Jefferies AL , Macones GA , Mainous RO , Raju TNK , Wang KS , Couto J , Byington CL , Davies HD , Edwards KM , Glode MP , Jackson MA , Keyserling HL , Maldonado YA , Murray DL , Orenstein WA , Schutze GE , Willoughby RE , Zaoutis TE , Fischer MA , Gellin B , Gorman RL , Lee L , Pratt RD , Read JS , Robinson J , Safadi MAP , Seward J , Starke JR , Simon G , Tan TQ , Baker CJ , Bernstein HH , Kimberlin DW , Long SS , Meissner HC , Pickering LK , Rubin LG , Frantz J . Pediatrics 2012 129 (4) e1104-e1109 Health care-associated infections in the NICU are a major clinical problem resulting in increased morbidity and mortality, prolonged length of hospital stays, and increased medical costs. Neonates are at high risk for health care-associated infections because of impaired host defense mechanisms, limited amounts of protective endogenous flora on skin and mucosal surfaces at time of birth, reduced barrier function of neonatal skin, the use of invasive procedures and devices, and frequent exposure to broad-spectrum antibiotics. This statement will review the epidemiology and diagnosis of health care-associated infections in newborn infants. (Copyright 2012 by the American Academy of Pediatrics.) |
Policy statement--Recommended childhood and adolescent immunization schedules--United States, 2010
Bocchini JA Jr , Bradley JS , Brady MT , Bernstein HH , Byington CL , Fisher MC , Glode MP , Jackson MA , Keyserling HL , Kimberlin DW , Orenstein WA , Schutze GE , Willoughby RE Jr , Bell BP , Bortolussi R , Clover RD , Fischer MA , Gorman RL , Lee L , Pratt RD , Read JS , Gellin BG , Starke JR , Swanson J , Meissner HC , Rubin LG , Pickering LK , Baker CJ , Long SS , Frantz J , Committee on Infectious Diseases . Pediatrics 2010 125 (1) 195-6 The 2010 recommended childhood and adolescent immunization schedules have been approved by the American Academy of Pediatrics, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention, and the American Academy of Family Physicians. There are 3 schedules: one for children 0 through 6 years of age, one for people 7 through 18 years of age, and a catch-up immunization schedule for children and adolescents who start late or fall behind. These schedules reflect current recommendations for the use of vaccines licensed by the US Food and Drug Administration and include the following changes from last year: | Reference to the recommendations of the Advisory Committee on Immunization Practices for use of influenza A (H1N1) 2009 monovalent vaccine1 is included in a footnote. | Revaccination with meningococcal conjugate vaccine (MCV4) is recommended for children who remain at increased risk for meningococcal disease. A dose of MCV4 should be administered after 3 years in children who received the initial MCV4 dose at ages 2 through 6 years and after 5 years if the first dose was given at age 7 years or older. Additional doses of MCV4 are then given every 5 years.2 | Recommendations on use of combination vaccines have been updated (the use of a combination vaccine generally is preferred over separate injections of its equivalent component vaccines). The final dose in the inactivated poliovirus vaccine series should be administered on or after the 4th birthday and at least 6 months following the previous dose. If 4 doses are administered before age 4 years, an additional (fifth) dose should be administered at age 4 through 6 years.3 | Recommendations for use of the recently licensed bivalent human papillomavirus vaccine in females and the quadrivalent human papillomavirus vaccine in males are included. | Most of the footnotes for the individual vaccines have been revised to provide additional information and to clarify recommendations provided in the schedules. |
The role of immunoprophylaxis in the reduction of disease attributable to respiratory syncytial virus
Meissner HC , Bocchini JA Jr , Brady MT , Hall CB , Kimberlin DW , Pickering LK . Pediatrics 2009 124 (6) 1676-9 Respiratory syncytial virus (RSV) is an RNA virus that infects human respiratory epithelial cells and causes annual outbreaks of respiratory tract disease among infants and young children, as well as recurrent infections throughout life. Annual outbreaks of RSV disease are attributable to first-time infection in susceptible infants, reinfection in children and adults with waning or incomplete immunity, and infection by viral genotypes with sufficient antigenic variation to avoid innate and acquired immunity. In industrialized countries, few infectious diseases have a greater effect on the health of young children than does lower respiratory tract disease caused by RSV. By 2 years of age, almost all children will experience an RSV infection, and ∼50% will be infected twice.1 Results from the New Vaccine Surveillance Network (a prospective, population-based surveillance program sponsored by the Centers for Disease Control and Prevention [CDC]) define the burden of RSV disease in children younger than 5 years of age.2 An estimated 2 million children require medical care because of RSV infection, and ∼57500 children younger than 5 years are hospitalized annually. The major burden of RSV disease occurs among previously healthy infants and children whose susceptibility to severe RSV illness cannot be predicted by risk factors. | Protection against RSV infection is mediated by serum antibody, secretory antibody, cytotoxic T lymphocytes, and innate immune responses. A vaccine offers the greatest promise for control of RSV disease, but vaccine development has been slowed by concerns about safety (enhancement of naturally occurring disease), the limited ability of infants to mount an immune response to RSV glycoprotein antigens, and the presence of maternal neutralizing antibody, which may attenuate an active immune response. Passive immunization with either a hyperimmune globulin or a monoclonal antibody preparation has been demonstrated in randomized, placebo-controlled trials to reduce the risk of hospitalization caused by RSV.3–7 The annual rate of hospitalization attributable to RSV infection among young infants in selected high-risk groups who do not receive immunoprophylaxis is ∼10% to 15%, which is ∼5 times higher than the hospitalization rate among infants who are not at high risk.3–7 Results from 2 randomized, placebo-controlled trials that involved 2789 infants and children with prematurity, chronic lung disease, or congenital heart disease who received palivizumab prophylaxis demonstrated a reduction in RSV hospitalization rates of between 39% and 78% in different groups.6,7 |
From the American Academy of Pediatrics: policy statements--modified recommendations for use of palivizumab for prevention of respiratory syncytial virus infections
Bocchini Jr JA , Bernstein HH , Bradley JS , Brady MT , Byington CL , Fisher MC , Glode MP , Jackson MA , Keyserling HL , Kimberlin DW , Orenstein WA , Schutze GE , Willoughby RE , Bell B , Bortolussi R , Clover RD , Fischer MA , Gellin B , Gorman RL , Pratt RD , Lee L , Read JS , Starke JR , Swanson J , Committee on Infectious Diseases . Pediatrics 2009 124 (6) 1694-701 Palivizumab was licensed in June 1998 by the US Food and Drug Administration for prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients who are at increased risk of severe disease. Safety and efficacy have been established for infants born at or before 35 weeks' gestation with or without chronic lung disease of prematurity and for infants and children with hemodynamically significant heart disease. The American Academy of Pediatrics (AAP) published a policy statement on the use of palivizumab in November 1998 (American Academy of Pediatrics, Committee on Infectious Diseases and Committee on Fetus and Newborn. Pediatrics. 1998;102[5]:1211-1216) and revised it in December 2003 (American Academy of Pediatrics, Committee on Infectious Diseases and Committee on Fetus and Newborn. Pediatrics. 2003;112[6 pt 1]:1442-1446), and an AAP technical report on palivizumab was published in 2003 (Meissner HC, Long SS; American Academy of Pediatrics, Committee on Infectious Diseases and Committee on Fetus and Newborn. Pediatrics. 2003;112[6 pt 1]:1447-1452). On the basis of the availability of additional data regarding seasonality of RSV disease as well as the limitations in available data on risk factors for identifying children who are at increased risk of serious RSV lower respiratory tract disease, AAP recommendations for immunoprophylaxis have been updated in an effort to ensure optimal balance of benefit and cost from this expensive intervention. This statement updates and replaces the 2003 AAP statement and the 2006 Red Book and is consistent with the 2009 Red Book recommendations. |
- Page last reviewed:Feb 1, 2024
- Page last updated:May 13, 2024
- Content source:
- Powered by CDC PHGKB Infrastructure