Recommendations For Use Of Vaccines Research Articles

Advisory Committee on Immunization Practices Recommended Immunization Schedule for Adults Aged 19 Years or Older — United States, 2016

I October 2015, the Advisory Committee on Immunization Practices (ACIP) approved the Recommended Adult Immunization Schedule: United States, 2016. This schedule summarizes ACIP recommendations for the use of vaccines routinely recommended for adults in 2 figures (Figures 1 and 2), footnotes for each vaccine (Figure 3), and a table that describes primary contraindications and precautions for commonly used vaccines for adults (Table). Details on these updates and information on other vaccines recommended for adults can be found at www.cdc.gov/vaccines/schedules. The full ACIP recommendations for each vaccine are not included in the schedule owing to space limitations but can be found at www.cdc.gov/vaccines/hcp/acip-recs /index.html. The 2016 adult immunization schedule was reviewed and approved by the American College of Physicians, American Academy of Family Physicians, American College of Obstetricians and Gynecologists, and American College of Nurse-Midwives. Changes in the 2016 adult immunization schedule from the 2015 schedule include the following new ACIP recommendations: Y Interval change for 13-valent pneumococcal conjugate vaccine (PCV13) followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) from “6 to 12 months” to “at least 1 year” for immunocompetent adults aged ≥65 years (1). Adults aged ≥19 years with anatomical or functional asplenia, cerebrospinal fluid leak, or cochlear implant or who are immunocompromised should receive PPSV23 at least 8 weeks after PCV13. Y Serogroup B meningococcal (MenB) vaccine series should be administered to persons aged ≥10 years who are at increased risk for serogroup B meningococcal disease (2). Those at increased risk include persons with anatomical or functional asplenia or persistent complement component deficiencies, microbiologists who are routinely exposed to isolates of Neisseria meningitidis, and persons identified at increased risk because of a serogroup B meningococcal disease outbreak. MenB vaccine series may be administered to adolescents and young adults aged 16 through 23 years (preferred age is 16 through 18 years) to provide short-term protection against most strains of serogroup B meningococcal disease (3). Y Nine-valent human papillomavirus (HPV) vaccine (9vHPV) was added to the 2016 adult immunization schedule. This vaccine can be used for routine vaccination against HPV as 1 of 3 HPV vaccines (bivalent HPV vaccine [2vHPV], quadrivalent HPV vaccine [4vHPV], and 9vHPV) recommended for females and 1 of 2 HPV vaccines (4vHPV and 9vHPV) recommended for males (4). Notable changes in Figures 1 and 2 are as follows: Y The row for “Meningococcal” was retitled to “Meningococcal 4-valent conjugate (MenACWY) or polysaccharide (MPSV4)” to indicate that there are 2 types of serogroup A, C, W, and Y meningococcal vaccines available for adults. Y A new row for “Meningococcal B (MenB)” was added. Y Additional text was added in several indication bars to describe reasons for alternate dosing schedules for vaccines where such designations were appropriate; for example, in the “Measles, mumps, and rubella (MMR)” indication bar that states “1 or 2 doses,” the clause “depending on indication” was added. Y The text in the “Hepatitis A” indication bar was revised from “2 doses” to “2 or 3 doses depending on vaccine” to account for the hepatitis A and hepatitis B combination vaccine that is administered in a 3-dose series. Additional clarifying changes in Figure 2 include: Y The text in the consolidated “Influenza” indication bar was simplified to “one dose annually”; readers should refer to the footnotes for additional information regarding which influenza vaccine types are recommended for different age and risk groups. Y The text in the “Pneumococcal polysaccharide (PPSV23)” indication bar was revised from “1 or 2 doses” to “1, 2, or 3 doses depending on indication” to account for the recommendation that adults aged ≥19

Recommended Childhood and Adolescent Immunization Schedule--United States, 2016.

The 2016 recommended childhood and adolescent immunization schedule has been approved by the American Academy of Pediatrics, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention, the American Academy of Family Physicians, and the American College of Obstetricians and Gynecologists. The 2016 format is similar to the 2015 schedule, with a single schedule for people from birth through 18 years of age. The yellow bars indicate the recommended age range for all children and contain a notation indicating the recommended dose number by age. The green bars indicate the ages for recommended catch-up. The purple bars designate the recommended ages for immunization for certain groups at high risk. A blue bar has been added for the first time and indicates the range of recommended ages for people in non–high-risk groups who may receive a vaccine, subject to individual decision-making. The combined green and purple bar indicates the recommended age when vaccine catch-up is encouraged for certain high-risk groups. The white boxes show the ages when a vaccine is not recommended routinely. The catch-up schedule offers recommendations for children and adolescents 4 months through 18 years of age who start vaccinations late or are >1 month behind.The immunization schedule will not be published in Pediatrics. Readers are referred to the American Academy of Pediatrics Web site (http://redbook.solutions.aap.org/SS/Immunization_Schedules.aspx) or the Centers for Disease Control and Prevention Web site (http://www.cdc.gov/vaccines/schedules/hcp/child-adolescent.html) for the most recent version of the immunization schedule, the full set of footnotes, and the catch-up schedule. This method will ensure that providers have the most current recommendations. In addition, the Web sites include tables (job aids) to assist in clarification of recommended use of Haemophilus influenzae type b vaccine, pneumococcal- and pertussis-containing vaccines as a function of age, the number of doses previously administered, and the time interval since the last dose.Footnotes contain recommendations for routine vaccination, for catch-up vaccination, and for vaccination of children and adolescents with high-risk conditions or in special circumstances. A parent-friendly vaccine schedule for children and adolescents is available at http://www.cdc.gov/vaccines/schedules/index.html. An adult immunization schedule is available at www.cdc.gov/vaccines.These schedules are revised annually to reflect current recommendations for use of vaccines licensed by the US Food and Drug Administration and include the following specific changes from last year:Clinically significant adverse events that follow immunization should be reported to the Vaccine Adverse Event Reporting System. Guidance about how to obtain and complete a form for this system can be obtained at www.vaers.hhs.gov or by calling 800-822-7967. Additional information can be found in the Red Book and at Red Book Online (http://aapredbook.aappublications.org/). Statements from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention that contain details of recommendations for individual vaccines, including recommendations for children with high-risk conditions, are available at www.cdc.gov/vaccines/pubs/ACIP-list.htm. Information on new vaccine releases, vaccine supplies, and interim recommendations resulting from vaccine shortages and statements on specific vaccines can be found at www.aapredbook.org/news/vaccstatus.shtml and www.cdc.gov/vaccines/pubs/ACIP-list.htm.Carrie L. Byington, MD, FAAP, ChairpersonYvonne A. Maldonado, MD, FAAP, Vice ChairpersonElizabeth D. Barnett, MD, FAAPH. Dele Davies, MD, MS, MHCM, FAAPKathryn M. Edwards, MD, FAAPRuth Lynfield, MD, FAAPFlor M. Munoz, MD, FAAPDawn Nolt, MD, MPH, FAAPAnn-Christine Nyquist, MD, MSPH, FAAPMobeen H. Rathore, MD, FAAPMark H. Sawyer, MD, FAAPWilliam J. Steinbach, MD, FAAPTina Q. Tan, MD, FAAPTheoklis E. Zaoutis, MD, MSCE, FAAPDavid W. Kimberlin, MD, FAAP – Red Book EditorMichael T. Brady, MD, FAAP – Red Book Associate EditorMary Anne Jackson, MD, FAAP – Red Book Associate EditorSarah S. Long, MD, FAAP – Red Book Associate EditorHenry H. Bernstein, DO, MHCM, FAAP – Red Book Online Associate EditorH. Cody Meissner, MD, FAAP – Visual Red Book Associate EditorDouglas Campos-Outcalt, MD, MPA – American Academy of Family PhysiciansKaren M. Farizo, MD – US Food and Drug AdministrationMarc Fischer, MD, FAAP – Centers for Disease Control and PreventionBruce G. Gellin, MD, MPH – National Vaccine Program OfficeRichard L. Gorman, MD, FAAP – National Institutes of HealthNatasha Halasa, MD, MPH, FAAP – Pediatric Infectious Diseases SocietyJoan L. Robinson, MD – Canadian Paediatric SocietyJaime Deseda-Tous, MD, FAAP – Sociedad Latinoamericana de Infectologia PediatricaJane F. Seward, MBBS, MPH, FAAP – Centers for Disease Control and PreventionGeoffrey R. Simon, MD, FAAP – Committee on Practice Ambulatory MedicineJeffrey R. Starke, MD, FAAP – American Thoracic SocietyJennifer M. Frantz, MPH

The history of the United States Advisory Committee on Immunization Practices (ACIP)

The United States Advisory Committee on Immunization Practices (ACIP) is a federal advisory committee that develops written recommendations for use of vaccines licensed by the Food and Drug Administration (FDA) for the U.S. civilian population. Vaccine development and disease outbreaks contributed to the need for a systematized, science-based, formal mechanism for establishing national immunization policy in this country. Formed in 1964, the ACIP was charged with this role. The committee has undergone significant changes in structure and operational activities during its 50-year history. The ACIP works closely with many liaison organizations to develop its immunization recommendations, which are harmonized among key professional medical societies. ACIP vaccine recommendations form two immunization schedules, which are updated annually: (1) the childhood and adolescent immunization schedule and (2) the adult immunization schedule. Today, once ACIP recommendations are adopted by the Director of the Centers for Disease Control and Prevention and the Secretary of the Department of Health and Human Services, these recommendations are published in Morbidity and Mortality Weekly Report (MMWR), become official policy, and are incorporated into the appropriate immunization schedule.

Statement on the Use of Conjugate Pneumococcal Vaccine - 13 Valent in Adults (Pneu-C-13): An Advisory Committee Statement (ACS) National Advisory Committee on Immunization (NACI).

This statement will supplement previous conjugate pneumococcal statements (1–3) and provide information regarding a newly authorized indication for the use of the 13-valent conjugate vaccine against pneumococcal disease, Prevnar® 13 (PNEU-C-13): As of January 2012, PNEU-C-13 has been authorized for use in adults aged 50 years and older for the prevention of invasive pneumococcal disease (IPD), including sepsis, meningitis, bacteremia, and pneumonia (with or without empyema) with bacteremia. As new data becomes available on the use of PNEU-C-13 in adults, NACI will review these data and provide new guidance as required. The 23-valent polysaccharide vaccine (PNEU-P-23) will not be discussed at length in this statement. Recommendations for its use remain unchanged. www.phac-aspc.gc.ca/publicat/cig-gci/index-eng.php This statement will: • Update the epidemiology of pneumococcal disease in Canada relevant to the introduction of PNEU-C-13; • Provide a review of the literature on the use of conjugate pneumococcal vaccines in adult populations (PNEU-C-7 and PNEU-C-13 when available); and • Provide recommendations for the use of the 13-valent conjugate vaccine in adults (PNEU-C-13), and on the use of PNEU-P-23 related to the use of PNEU-C-13. Although PNEU-C-13 was authorized for use in adults aged 50 years and over, we will be considering adults (all age groups) with high-risk conditions for IPD and the healthy 65 years and older age group because of the burden of illness that led to the recommendation of PNEU-P-23 use in this age group. II. Methods NACI reviewed (4) such considerations as the burden of disease and the target population, safety, immunogenicity, efficacy, effectiveness of the vaccine(s), vaccine schedules, and other aspects of the overall immunization strategy. Following critical appraisal of individual studies, summary tables with ratings of the quality of the evidence were prepared using NACI’s methodological hierarchy (Tables 6 and 7​7),), and proposed recommendations for vaccine use were developed. The Working Group chair presented the evidence and proposed recommendations to NACI. Following thorough review of the evidence and consultation at NACI meetings, the committee voted on specific recommendations. The description of relevant considerations, rationale for specific decisions, and knowledge gaps are described in the text of this statement. PHAC maintains documentation of these processes throughout knowledge synthesis and recommendation development.

Consultation on interactions between National Regulatory Authorities and National Immunization Technical Advisory Groups

A consultation during the Developing Country Vaccine Regulators’ Network meeting of May 2010 considered the interactions between the National Immunization Technical Advisory Group (NITAG) and the National Regulatory Authority (NRA) in various countries. This meeting was co-hosted by the WHO and the Supporting Independent Immunization and Vaccine Advisory Committees Initiative implemented by the Agence de Médecine Préventive in partnership with the International Vaccine Institute. Representatives from Developing Country Vaccine Regulators’ Network and representatives from several additional countries’ regulatory authorities met representatives from NITAGs and/or the National Immunization Program from these countries (Brazil, Canada, China, Cuba, France, Indonesia, Iran, South Africa, Thailand, Vietnam and the USA). The objectives of the workshop included a discussion on the issues of NRA–NITAG interaction, the assessment of the advantages of different models of interaction and proposals for an optimal coordination process for market authorization and recommendations for use of vaccines. It was concluded that there is need for increased and more formal interactions between NRAs and NITAGs, a clear framework establishing a formal interaction and early interactions before market authorization. NRA experts being at the same time NITAG ex officio members and vice versa are solutions which can be adopted by countries. The NRA issues the license based on the evidence submitted by the manufacturer. The NITAG makes recommendations based on scientific evidence, public health needs and policy, and consideration of the license conditions. If there is a need to make recommendations that are not covered by the license evidence then there should be interactions between NITAG, NRA and the license holder to encourage the license-holder to submit appropriate evidence, or to ensure that the justification for the off-label recommendation is communicated to the users of the medicine.

Antibody responses after inactivated influenza vaccine in young children.

The frequency and duration of antibody responses after trivalent inactivated influenza vaccine (TIV) in young children are not well defined and assume greater importance with the expanded recommendations for vaccine use in children aged 6 months-5 years. Forty-three children aged 6-23 months were vaccinated with TIV in the fall of 2002. At enrollment the majority of children were seronegative to one or more of the vaccine antigens and had no previously documented influenza. Postvaccination sera were collected in the subsequent fall and winter seasons. Acute antibody responses to TIV were determined using standardized hemagglutination inhibition (HAI) and neutralization assays. In calculating the duration of responses, sequential sera were analyzed to the last available sera, to the point at which antibody became undetectable, or to intercurrent influenza infection. Forty-three subjects contributed 121 sera that were analyzed for HAI responses to TIV. Four-fold HAI rises after 2 doses of TIV in naive individuals were seen in 13 (72%) to H3N2, 22 (92%) to H1N1, and 15 (60%) to influenza B. Fewer 4-fold rises were seen in those with preexisting antibody. The results of microneutralization assays to H3N2 correlated well with HAI results. The time for antibody to decay to one-half of the postvaccination titer (t1/2) was approximately 126 days for H1N1 and 258 days for H3N2. Although not all children responded with 4-fold rises in antibody or achieved the putative protective titer of > or =1:32, the half-life of antibody suggested that children immunized in the fall should have immune responses sustained throughout the ensuing influenza season.

The Anthrax Vaccine Program: an analysis of the CDC's recommendations for vaccine use.

The anthrax vaccine was never proved to be safe and effective. It is one cause of Gulf War illnesses, and recent vaccinees report symptoms resembling Gulf War illnesses. The vaccine's production has been substandard. Without adequate evaluation, the Food and Drug Administration recently approved (retrospectively) significant changes made to the vaccine's composition since 1990. The vaccine's mandatory use for inhalation anthrax is "off-label." A skewed review of the vaccine literature by the Centers for Disease Control and Prevention (CDC) led to remunerative collaborative research with the army, involving civilian volunteers. Despite acknowledging possible fetal harm, the CDC offered the vaccine to children and pregnant women. New trends could weaken prelicensure efficacy and safety review of medical products intended for biodefense and avoid manufacturer liability for their use.

Varicella, MMR shortages prompt schedule changes

![][1] Dr. Meissner Many pediatricians in the United States are experiencing shortages of vaccines in the recommended childhood immunization schedule. As a result, temporary changes have been made in recommendations for use of vaccines in short supply. ![Figure][2] Dr.

Recommendations for the Use of Live Attenuated Varicella Vaccine

In the American Academy of Pediatrics policy statement entitled "Recommendations for the Use of Live Attenuated Varicella Vaccine" by the Committee on Infectious Diseases that appeared in the May 1995 issue of Pediatrics, there is a typographical error. On page 793 under the heading Recommendations for Vaccine Use in the fifth line of the first paragraph the word mild should be wild.

Overview of Policies Affecting Vaccine Use in Child Day Care

Vaccination policies for preschool-age children, including those in child day care, have undergone frequent changes within the past several years in response to the development of new vaccines (DTaP, Hib conjugate vaccines), the changing epidemiology of vaccine-preventable diseases (measles), and the establishment of new objectives for the control and elimination of vaccine-preventable diseases (Hib, hepatitis B). The acquisition and spread of vaccine-preventable diseases can be minimized in child day-care settings by vaccinating all children, establishing a continuing system by which all children remain fully vaccinated on schedule, providing educational materials to parents about the recommended schedule of routine childhood vaccines, and implementing new recommendations for vaccine use.

Vaccine Requirements and Recommendations for International Travelers

The incidence of infectious diseases preventable by vaccines is generally higher in foreign countries than in the United States. Thus, an increased risk of acquiring these diseases exists for US citizens traveling abroad. In addition, the importation of these infectious disease agents into the United States from both returning citizens and other international travelers is an ever-present threat. The increasing documentation of the importations of measles into the United States (p 2129) is a reflection of these problems. Requirements and recommendations for use of vaccines for travelers leaving the United States are based in part on their increased risk to these diseases during their foreign travel, but the primary purpose of international requirements is to prevent the international spread of diseases. This is the rationale behind the formulation of the International Health Regulations (IHR) pertaining to vaccination certificate requirements. 1 Unfortunately, many countries, including some that are signatories of and