Vaccine 33 (2015) 405–414

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Discussion

The history of the United States Advisory Committee on Immunization Practices (ACIP) L. Reed Walton a , Walter A. Orenstein b , Larry K. Pickering c,d,∗ a

Advisory Committee on Immunization Practices, Centers for Disease Control and Prevention, United States1 Emory Vaccine Center, Influenza Pathogenesis & Immunology Research, Emory University School of Medicine, United States c National Center for Immunization and Respiratory Diseases, Advisory Committee on Immunization Practices, Centers for Disease Control and Prevention, United States d Emory University School of Medicine, United States b

a r t i c l e

i n f o

Article history: Received 15 July 2014 Received in revised form 17 September 2014 Accepted 22 September 2014 Available online 25 October 2014 Keywords: Immunization Vaccination History Vaccinology Legislation Childhood immunization schedule Adult immunization schedule Harmonized schedule Biologics Recommendations Advisory Committee on Immunization Practices ACIP Measles MMR Rubella Vaccines for Children Program Patient Protection and Affordable Care Act Catch-up schedule Vaccine licensing Vaccine development Vaccine safety

a b s t r a c t 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. Published by Elsevier Ltd.

The Public Health Service Advisory Committee on Immunization Practices (ACIP) was formed and its members were appointed by the Surgeon General of the United States in the spring of 1964. The

∗ Corresponding author at: Centers for Disease Control and Prevention, 1600 Clifton Rd., NE, Mailstop A-27, Room 8236, Atlanta, GA 30333, United States. Tel.: +1 404 639 8562. E-mail address: [email protected] (L.K. Pickering). 1 Under contract with the CDC. http://dx.doi.org/10.1016/j.vaccine.2014.09.043 0264-410X/Published by Elsevier Ltd.

new committee was charged with providing regular and informed advice on the most effective application of specific immunizing agents in the control of communicable diseases in public health practice. Since its inception 50 years ago, the ACIP has continually made vaccine recommendations for the civilian population in the United States, and has simultaneously undergone notable changes in organization, operational activities, and the scope of its interaction with other organizations and professional societies. The mechanisms ACIP uses to disseminate vaccine recommendations also have undergone significant change over the past half century.

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Table 1 Major national public sector immunization initiatives. Year

Initiative

1938

•President Roosevelt founds the National Foundation for Infantile Paralysis (March of Dimes – www.marchofdimes.com) •Public Health Service Act (http://www.fda.gov/regulatoryinformation/legislation/ucm148717.htm) •Polio Vaccination Assistance Act (http://ajph.aphapublications.org/doi/pdf/10.2105/AJPH.45.10.1349) •Vaccination Assistance Act (http://www.gpo.gov/fdsys/pkg/STATUTE-76/pdf/STATUTE-76-Pg1155.pdf) •Creation of the Advisory Committee on Immunization Practices (ACIP) (http://www.cdc.gov/vaccines/acip/index.html) •Childhood Immunization Initiative I •National Childhood Vaccine Injury Act (http://www.hrsa.gov/vaccinecompensation/authorizinglegislation.pdf) •Creation of the National Vaccine Program (NVP) (http://www.hhs.gov/nvpo/) •National Vaccine Advisory Committee (NVAC) (http://www.hhs.gov/nvpo/nvac/) •Creation of National Vaccine Injury Compensation Program (NVICP) trust (http://www.hrsa.gov/vaccinecompensation/index.html) •Center for Biologics Evaluation and Research created within FDA (http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm123340.htm) •Childhood Immunization Initiative II (http://www.nap.edu/catalog.php?record id=2224) •Creation of National Immunization Program (NIP) at CDC •Vaccines for Children (VFC) program (http://www.cdc.gov/vaccines/programs/vfc/about/index.html) •National Immunization Survey (NIS) begins collecting data to measure compliance with the ACIP schedule in each state and nationally (http://www.cdc.gov/nchs/nis/about nis.htm) •FDA Modernization Act (FDAMA) (http://www.gpo.gov/fdsys/pkg/BILLS-105hr1411ih/pdf/BILLS-105hr1411ih.pdf) •Affordable Care Act (ACA) signed into law (http://www.gpo.gov/fdsys/pkg/PLAW-111publ148/pdf/PLAW-111publ148.pdf)

1944 1955 1962 1964 1977 1986

1987 1988

1993

1994

1997 2009

The purpose of this manuscript is to provide an overview of the circumstances that brought about the formation of the ACIP, to highlight the principal aim of ACIP insofar as it makes systematic recommendations for vaccination of the civilian population in the United States, and to review the accomplishments of and changes to the ACIP since 1964.

1. Vaccine recommendations pre-ACIP (1938–1963) For more than 25 years before the ACIP came into existence, the main body that made recommendations on vaccine use in the United States was the American Academy of Pediatrics’ (AAP) Committee on Infectious Diseases (COID)—called the Committee on Immunization Procedures at the time of its inception [1]. The committee’s first publication in 1938, an eight-page pamphlet whose red cover gave rise to the publication’s official nickname “Red Book,” informed physicians on treatment and prevention of eighteen diseases of both children and adults. The diseases were listed in alphabetical order rather than according to any schedule or prevailing order of treatment. At the time of publication of the first Red Book, there were suggested immunization recommendations for only a handful of the diseases—most of these recommendations were not of proven value. Guidance regarding the appropriate age for administration of vaccines to children, if warranted, was provided only in the case of six vaccine-preventable diseases: diphtheria, pertussis, tuberculosis, typhoid fever, varicella, and smallpox (variola) [2]. Immunization against scarlet fever due to Group A streptococcus also was discussed [2]. The Red Book was and continues to be a major resource both for physicians and for government committees such as ACIP. One of the items on the agenda of the first meeting of the ACIP in 1964 was “Relationship to the ‘Red Book’ Committee.” Vaccine development came into its “golden age” during the second half of the 20th century, when the first viruses grown in tissue

culture led to rapid proliferation of new vaccines. Around this time the first nationally driven efforts to increase availability of vaccines to the public—especially children—were made in the United States. In 1955, the Polio Vaccination Assistance Act was passed by the last session of Congress that year and was signed by President Dwight Eisenhower on August 15. The act allowed Congress to appropriate funds to what was then known as the Communicable Diseases Center (changed in 1970 to the Centers for Disease Control and Prevention [CDC] [3]) to help states purchase poliomyelitis vaccines and to provide for the costs of planning and conducting vaccination programs [4]. Prior to 1964, there was no formal mechanism for establishing national immunization policy, and federal involvement in establishing immunization recommendations for civilians was limited. The U.S. Surgeon General would recommend vaccines for licensure, making them commercially available as per the terms of the Public Health Service Act of 1944 [5]. Though the federal government was involved extensively in tracking pandemics and measuring vaccine efficacy for the armed forces [6], efforts toward civilian vaccination extended only to ad hoc groups formed to address individual issues and to work with professional organizations, including the AAP and the American Public Health Association [7]. For instance, prior to the formation of ACIP, the Public Health Service issued recommendations on the oral poliovirus vaccine (OPV) and influenza vaccine usage in 1960 [8,9]. An Advisory Committee on Poliomyelitis Vaccine was commissioned and issued recommendations in 1962 [10,11] and 1964, and an Advisory Committee on Measles Control issued measles vaccination recommendations in 1963 [12].

2. Laying the groundwork: vaccine development and the CDC (1964–1977) The 1960s bore witness to the licensure of vaccines against three diseases that strike primarily in childhood: measles (1963), mumps

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Table 2 Year of first ACIP recommendation of each vaccine on past and present routine immunization schedules, 1965 to present. Vaccine

Year first recommended by ACIP

Year of most recent recommendation

Measles vaccine (live attenuated and inactivated) Smallpox vaccine Influenza vaccine Poliovirus vaccine (oral [OPV] and inactivated poliovirus [IPV]) Mumps vaccine Rubella vaccine Measles–rubella and measles–mumps–rubella (MMR) vaccine Diphtheria–Tetanus–Pertussis (DTP) vaccine Tuberculosis (Bacille Calmette-Guérin) vaccine Meningococcal polysaccharide vaccine Pneumococcal polysaccharide vaccine Hepatitis B vaccine (plasma) Haemophilus influenzae type B Hepatitis B recombinant vaccine Diphtheria–tetanus–pertussis–Haemophilus influenzae type B combination vaccine Varicella vaccine Hepatitis A vaccine Acellular pertussis Rotavirus vaccine Meningococcal conjugate Quadrivalent Human papillomavirus vaccine Herpes zoster vaccine Bivalent human papillomavirus vaccine Measles–mumps–rubella–varicella (MMRV) vaccine Quadrivalent meningococcal conjugate vaccine 13-valent pneumococcal conjugate vaccine

1965 1965 1965 1967 1968 1969 1971 1971 1975 1975 1978 1982 1985 1987 1993 1996 1996 1997 1999 1999 2007 2007 2010 2010 2011 2012

2013 2003 2014 2009 2013 2013 2013 2000 1996 2013 2014 (adults) 2005 (children), 2006 (adults routine) 2014 2005 (children), 2006 (adults routine) 1993 2007 2006 2013 2009 2014 2014 2014 2014 2010 2014 2014 (adults)

(1967), and rubella (1969) [13]. The three live-attenuated vaccines would be combined in 1971 as the measles–mumps–rubella (MMR) vaccine. In 1963, trivalent oral polio vaccine also was licensed in the United States [11]. Several steps were taken in the 1960s toward ensuring nationwide vaccine coverage. The first of these was the Vaccination Assistance Act of 1962 (Public Law 87–868). The law authorized CDC to support mass vaccination campaigns and to provide vaccines directly to state and local health departments for the purpose of protecting their populations—particularly all preschool children—against polio, diphtheria, whooping cough, and tetanus [7]. The proliferation of new vaccines made the continuation of the ad hoc committee approach to addressing nationwide immunization untenable, leading to the creation of a permanent advisory body to the federal government [14]. The ACIP was charged with “the responsibility of advising the Surgeon General regarding the most effective application of public health practice of specific preventive agents, which may be applied in communicable disease control [14].” See Table 1 for major national public sector immunization initiatives, including formation of the ACIP. The ACIP charter provides the authority for continued functioning of the committee. The charter, which must be renewed and approved every 2 years by the Department of Health and Human Services (DHHS), states that committee deliberations on use of vaccines to control disease in the United States shall include consideration of disease epidemiology and burden of disease, vaccine efficacy and effectiveness, vaccine safety, economic analyses and implementation issues [15]. The first meeting of the ACIP was held at the CDC on May 25 and 26, 1964 and was chaired by then-CDC director James L. Goddard [16]. The CDC Director chaired the committee until 1977, when the chairmanship was transferred to one of the voting members. Vaccines considered for recommendation during the initial ACIP meeting included influenza, rubella, rubeola, and smallpox [17]. Table 2 shows the year that each vaccine was first recommended by ACIP on past and present immunization schedules, as well as the year of the most recent recommendation for each vaccine. ACIP recommendations can be found

at http://www.cdc.gov/vaccines/acip/recs/index.html. In 1972, the Federal Advisory Committee Act (enacted by Public Law 92–463) designated ACIP a Federal Advisory Committee, 8 eight years after its formation [18]. The committee worked closely with the AAP from its inception. Since then, other professional organizations—including the American Academy of Family Physicians (AAFP), the American College of Obstetricians and Gynecologists (ACOG), and the American College of Physicians (ACP)—have joined ACIP as part of a group of 31 liaison organizations [22]. During the first 3 years of the ACIP’s existence, there were no formal liaison representatives, though it often had “invited participants” representing government agencies, state health departments, and even international health departments. The first official liaison representative, Dr. Margaret H.D. Smith of the AAP, joined the committee in October 1967 [19]. She was succeeded by Dr. Samuel Katz [20]. The first formally named ex officio members (two in total) took part in the proceedings in June 1971 [21]. See Table 3 for a listing of all current liaison organizations to ACIP. In 1967, then-Executive Secretary of ACIP, H. Bruce Dull, hosted a panel at the Symposium on Immunization of the Council of Environmental and Public Health, co-sponsored by the American Medical Association (AMA) and the CDC. The panel included representatives from the Armed Forces Epidemiological Board (AFEB) and civilian organizations that were current and future liaison bodies, including the AAP and the American Public Health Association (APHA) [22]. The representatives from these organizations discussed ACIP recommendations as well as recommendations made by AAP on childhood immunization. The recommendations did not diverge in any meaningful way, though in those early days there was a definite deferral to the established recommendation publication, the AAP’s Red Book. In general, vaccine recommendations made individually by the ACIP and the AAP’s Committee on Infectious Diseases mirrored one another. Initially, ACIP was focused on public health departments and AAP on physicians in practice, but the informal coordination between the two groups was achieved by having liaison representatives who served on both committees. It took the resurgence of a disease that had been proceeding toward elimination in the United

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Table 3 Listing of liaison organizations to ACIP. 1. American Academy of Family Physicians (AAFP) 2. American Academy of Pediatrics (AAP) 3. American Academy of Physician Assistants (AAPA) 4. American College Health Association (ACHA) 5. American College of Obstetricians and Gynecologists (ACOG) 6. American College of Physicians (ACP) 7. American Geriatrics Society (AGS) 8. America’s Health Insurance Plans (AHIP) 9. American Medical Association (AMA) 10. American Nurses Association (ANA) 11. American Osteopathic Association (AOA) 12. American Pharmacists Association (APhA) 13. Association of Immunization Managers (AIM) 14. Association for Prevention Teaching and Research (APTR) 15. Association of State and Territorial Health Officials (ASTHO) 16. Biotechnology Industry Organization (BIO) 17. Council of State and Territorial Epidemiologists (CSTE) 18. Canadian National Advisory Committee on Immunization (NACI) 19. Department of Health, United Kingdom 20. Healthcare Infection Control Practices Advisory Committee (HICPAC) 21. Infectious Diseases Society of America (IDSA) 22. National Association of County and City Health Officials (NACCHO) 23. National Association of Pediatric Nurse Practitioners (NAPNAP) 24. National Foundation for Infectious Diseases (NFID) 25. National Immunization Council and Child Health Program, Mexico 26. National Medical Association (NMA) 27. National Vaccine Advisory Committee (NVAC) 28. Pediatric Infectious Diseases Society (PIDS) 29. Pharmaceutical Research and Manufacturers of America (PhRMA) 30. Society for Adolescent Health and Medicine (SAHM) 31. Society for Healthcare Epidemiology of America (SHEA)

States to spur a concerted public–private sector effort toward a systematically harmonized vaccine schedule. 3. The measles outbreaks and the contested second dose (1977–1989) For a while in the 1970s and again in the 1980s, it looked as if the optimistic goal that Alexander Langmuir, former chief epidemiologist at the CDC, set out in his 1962 manuscript, would be achievable: elimination of the measles virus across North America and many other parts of the industrialized world [23]. Due to high immunization coverage of the population with measles vaccines—both live and inactivated—the incidence of measles had fallen by 1968 to 5% of pre-vaccine levels. Measles disease incidence was further reduced throughout the next decade and a half [24]. Two outbreaks, however, served to demonstrate to public health officials that incidence of the disease waxed and waned. In the U.S., measles cases had reached a low of 22,000 cases per year across the country in 1974, but the number ballooned to 57,000 cases in 1977 [25]. The majority of cases occurred among school-age children, kindergarten through high school. On the federal level, the response to the outbreak was twofold. President Carter in 1977 launched the National Childhood Immunization Initiative (Table 1), aimed at attaining 90% measles immunization coverage levels by 1979 among all children with a major focus on assuring that all states put in place school attendance requirements for vaccination and increasing funding for measles surveillance. The hope was this effort would lead to elimination of indigenous measles transmission within the United States. Measles surveillance also improved dramatically between 1978 and 1988, and again infection rates declined [26,27]. In the mid-1980s, a trend in measles outbreaks was observed by CDC epidemiologists, showing that infections were occurring within two population groups: (1) preschool children in whom cases occurred predominantly in unvaccinated children less than 5 years of age, and (2) school-age children affecting primarily

children who previously had been appropriately vaccinated with a single dose of a measles containing vaccine. The preschool outbreaks were a result of failure to vaccinate and the school-age outbreaks were the result of vaccine failures due to insufficient protection induced by a single dose of measles-containing vaccine [24,25]. Toward the end of the 1980s, the question of whether or not to implement a second dose had been debated for many years but was generally rejected because of the marginal improvements in population immunity induced by a second dose, since the vast majority (95–98%) of children was protected by a single dose. Hence, there was argument that resources should be focused on enhanced implementation of the one-dose strategy rather than on the costs of implementing a second dose. In April 1989, a small meeting of national public health officials and infectious disease specialists in New York met at the state’s health department, which was led by then-Health Commissioner David Axelrod. Commissioner Axelrod vowed to implement a routine two-dose schedule across the state in an effort to prevent outbreaks, whether or not the routine second dose was adopted nationwide [25]. That meeting served as a catalyst for change, and in 1989 both the ACIP and the AAP recommended a second dose of MMR for all children [25]. This policy change coincided with a major measles resurgence beginning in 1989. Between 1989 and 1991, more than 55,000 cases of the disease were reported. The number of cases per year was lower than the number reported in the 1977 outbreak, but the effects were much more severe, with more than 10,000 hospitalizations and more than 100 deaths. Although the major cause of the resurgence was failure to vaccinate preschool-age children with a single dose of measles containing vaccine, the epidemic was characterized by college outbreaks affecting students who had received a single dose of vaccine as well as outbreaks in high schools and middle schools. These outbreaks resulted in emergency revaccination efforts among affected populations [24].

4. Harmonization of immunization schedules (1989–2014) Several factors finally led to a standardized immunization schedule across the public and private sectors [28]. For many years prior to the 1995 publication of the Recommended Child/Adolescent Immunization Schedule, the ACIP and the AAP worked together to develop respective schedules for routine child/adolescent immunization that were as similar to one another as possible. However, differences persisted, increasing the potential for future discrepancies as new vaccines—including additional combination products—were licensed by the FDA and recommended by ACIP for use. The difference that served as the largest driving force behind harmonization was a disagreement over timing of the second dose of MMR. In a supplement to MMWR, published in December 1989, the ACIP announced the official revision to the child/adolescent immunization schedule [29]. Clinicians were advised according to the CDC schedule to give the first dose of measles vaccine at 12–15 months of age, and the second dose prior to a child’s entrance into kindergarten or first grade—at 4–6 years of age. This took advantage of the existing immunization infrastructure which included a visit at 4–6 years of age for administration of other vaccines such as DTP. The same year, the AAP released its reassessment of MMR vaccination, but recommended that the second dose be given in pre-adolescence, at approximately 11–12 years of age [30]. The ACIP approach—vaccination at the preschool visit—streamlined the delivery process, which was understandable from a public health perspective. The AAP approach—vaccination in early adolescence—was backed by the scientific and epidemiologicallybased idea of creating a two-dose cohort, which would more

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Fig. 1. The first harmonized vaccine schedule (1995). For the current childhood (birth through 18 years of age) immunization schedule, visit: http://www.cdc.gov/vaccines/ schedules/hcp/child-adolescent.html. For the current adult immunization schedule, visit: http://www.cdc.gov/vaccines/schedules/hcp/adult.html.

quickly enhance protection of children transitioning to high school since most of the outbreaks in school-aged children were taking place in middle and high schools. Differences in these approaches caused confusion for both public health personnel and pediatricians and family physicians in the states, leading to concerns about the divergent recommendations. In December 1993, CDC convened a meeting of representatives from the AAP and other professional organizations to develop strategies to control or eliminate vaccine-preventable diseases by vaccinating at least 90% of U.S. children by their second birthday [26]. One of the results of this summit was the resolution by AAP and ACIP to develop a single, easy-to-understand schedule and format for routine childhood vaccines [31]. The AAP and ACIP, along with representatives from the AAFP, the U.S. Food and Drug Administration (FDA) and the National Institutes of Health formed the core of a work group dedicated to the task. The first harmonized immunization schedule, published in 1995, offered health care providers the option of administering the second dose of MMR at either the preschool or the adolescent visit. According to the 1997 edition of the Red Book, administration of the second dose at the preschool visit was preferable, but also that it could be given at 11–12 years of age. It was not until publication of the 2000 edition of the Red Book that complete harmonization between ACIP and AAP occurred with regard to published recommendations on timing of the second dose of MMR at 4–6 years of age. The AAP requires approval by its board of directors for vaccine recommendations made by its Committee on Infectious Diseases (COID). AAFP, ACP, and ACOG require less formal levels of organizational concurrence. The primary reason to harmonize vaccine recommendations was to develop a single, evidence-based schedule presented in a comprehensive format that accommodated the recommendations

of both the ACIP and AAP. Harmonization would ensure timely vaccination of young children following a schedule that identifies a specific age range for each vaccine. Considerations would include the number of vaccines to be administered at each visit, and the capacity of the schedule to accommodate other newly licensed vaccines. Since the turn of the century, ACIP has been faced with public concern over cumulative exposure to vaccine components, additives, and excipients (e.g., thimerosal) [32], as well as issues dealing with vaccine hesitancy [33]. The Vaccines for Children Program (VFC) is a federally funded program that was established by the Omnibus Budget Reconciliation Act of 1993. The program was signed into law in August 1993 and implemented beginning in October 1994 [34]. The aim of VFC is to provide vaccines at no cost to children who might not otherwise be vaccinated because of inability to pay [35]. Under the program, federally purchased vaccines are made available to children from birth through 18 years of age who meet one of several requirements. VFC-eligible children must be: eligible for Medicaid, without health insurance, or of American Indian or Alaskan native descent. Inclusion of specific vaccines in the VFC program is determined by a vote from the ACIP. More information about VFC can be found at: http://www.cdc.gov/vaccines/programs/vfc/index.html. The Patient Protection and Affordable Care Act (ACA) was signed into law in 2010. Among the law’s provisions is a requirement for coverage by an in-network provider for vaccines for routine use in children, adolescents, and adults that have been recommended by ACIP and adopted by CDC. An ACIP recommendation is considered to be issued on the date on which it is adopted by the Director of the CDC—meaning it is either the earlier of: the recommendation’s date of publication in MMWR or when the recommendation is incorporated into one of the recommended immunization schedules [36,37].

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Number of Published ACIP Vaccine Recommendaons, by Year, Since 1965*

16 14 12 10 8 6 4

0

1965 1966 1967 1968 1969 1970 1971 1972 1973 1974 1975 1976 1977 1978 1979 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

2

Fig. 2. Number of ACIP vaccine recommendations, by year, since 1965. *This chart takes into account General Recommendations on Immunization, recommendations for health care professionals, the annual recommended routine childhood immunization schedules (January 1995–July 2014), the annual recommended routine adult immunization schedules, and recommendations pertaining to vaccines such as those for rabies, yellow fever, smallpox, cholera, and Japanese encephalitis that are not part of any routine immunization schedule in the United States.

There has been at least one recent instance in which a recommendation was not approved or was revised by DHHS. In 2002, a recommendation concerning vaccination for smallpox prior to an event of biological terrorism was voted on by ACIP [38]. It was reported in a publication by the Institute of Medicine that several people in the administration of George W. Bush thought the scope of the planned vaccination should be broadened beyond health care workers to make vaccine available to the public at large, even though then-CDC Director Julie Gerberding stated that the CDC official position was a recommendation to wait until a newer vaccine was available [39]. The ACIP recommendation, which limited vaccination to response teams only, was published in 2003 [40]. 5. The recommended childhood immunization schedules for persons 0–18 years of age The child/adolescent immunization schedule that was approved by ACIP, AAP, and AAFP, and became effective in January 1995 (Fig. 1), included age ranges for each recommended vaccine dose. The harmonized schedule included not only an expanded age range for administering MMR vaccine, but also included diphtheria–tetanus–pertussis (DTP), the Hib booster, and the third dose of the oral polio vaccine (OPV) [25,41,42]. The annual harmonized schedules published between 1995 and 2000 featured expanded age ranges for administration at provider discretion of vaccines including hepatitis B, MMR, and varicella to previously unimmunized or underimmunized children [43]. The 2003 schedule was the first to integrate a “catch-up” schedule for all vaccines in the case that children did not receive all or some doses at the recommended ages and intervals [44]. Current changes in the recommended child/adolescent immunization schedule are updated, harmonized, and approved by ACIP and professional societies including AAP, ACOG, and AAFP. Annually, the childhood/adolescent immunization schedule is published in MMWR as well as in the journals of the AAP, ACOG, and AAFP in February each year. 6. The adult immunization schedule ACIP also makes recommendations for adult immunization. In 1984/1985, a collaboration between ACIP and the American

College of Physicians (ACP) produced a comprehensive guide on adult immunization, which included a table of four vaccines with broad age ranges (19–24 years, 25–64 years, and ≥65 years of age) in which vaccines could be administered, as well as input on vaccination in pregnancy from ACOG [45]. The purpose of the guide was to raise provider and public health awareness of the need for adult immunization as well as to address influenza deaths among adults and hepatitis B infection in men who have sex with men, as well as other topics [46]. Along with ACP, ACOG, and AAFP, ACIP in 2002 published a new harmonized schedule of routine immunizations for adults (19 years of age and older). The purpose of the schedule was to raise awareness of the substantial morbidity and mortality from vaccinepreventable diseases including hepatitis A and B, influenza, and pneumococcal disease among people 19 years of age and older [47]. The harmonized adult immunization schedule has evolved over the years since its introduction, now encompassing six routine vaccines for all included in the targeted age group and who lack documentation of vaccination or who have no evidence of previous infection, and six additional vaccines recommended for people with high-risk indications or some other risk factor based on medical, occupational, lifestyle, or other indications. The adult vaccine recommendations are presented in two tables: one by specific vaccine and age group and the other based on medical and other indications [48]. For additional information, see the 2014 Recommended Adult Immunization Schedule. Annually, the adult immunization schedule is approved by ACIP, AAFP, ACP, and the American College of Nurse Midwives (ACNM) and published in MMWR and the society journals of these professional organizations.

7. Advances in vaccine and information technology (entering the 21st century) The unified child/adolescent and adult immunization schedules came about none too soon; between 1995 and 2014—and especially since 2005—there were more changes to the immunization schedules than in any prior period (Fig. 2). During this time, new vaccines for children were recommended, and changes in existing

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Table 4 Major accomplishments of ACIP, 2004–2014. Area

Accomplishments

Structure and function

•Ensure diversity in ACIP membership, including addition of a consumer representative as 15th voting member •Expanded number of liaison organizations to 31 and ex officio government organizations to 8 •Established a mechanism for review and acceptance of liaison organizations to ACIP •Established a mentorship program for newly appointed ACIP members •Developed and regularly update materials for orientation of new members •Implemented topic-specific work groups •Enhanced the role of the ACIP Steering Committee to nominate new ACIP members, consider liaison organization applications, develop ACIP meeting agendas, and provide advice about policy issues •Implemented structure for regular communication with ACIP members, liaison organizations and ex officio representatives •Posts data tables used for GRADE process of vaccine recommendation development to the ACIP website •Established regular review of all ACIP recommendations with a plan to renew, revise, or retire each document at an interval of 3–5 years •Created a Standard Operating Procedures document for the ACIP Secretariat •Updated the ACIP Policies and Procedures document •Standardized a procedure for review of ACIP meeting minutes by subject matter experts, in addition to the ACIP chair and executive secretary, before they are posted on the ACIP website •Post links on ACIP website to slides and meeting webcasts following each meeting •Ensure adherence to all FACA rules and regulations •Developed standard operating procedure for handling approval process by Director of CDC of ACIP recommendations, including process to be followed if an ACIP vaccine recommendation is not adopted by the Director •Developed and placed the following guidelines on the ACIP web site (http://www.cdc.gov/vaccines/recs/acip/): ◦Guidance for vaccine recommendations in pregnant and breastfeeding women www.cdc.gov/vaccines/recs/acip/rec-vac-preg.htm ◦Guidance for Health Economics Studies presented to the ACIP www.cdc.gov/vaccines/recs/acip/economic-studies.htm ◦A standardized list of acronyms for routine vaccines licensed in the United States, for use in ACIP recommendation statements and related documents. www.cdc.gov/vaccines/recs/acip/vac-abbrev.htm ◦Development and implementation of guidelines for an explicit evidence based medicine format to be applied to all ACIP recommendations http://www.cdc.gov/vaccines/recs/acip/GRADE/table-refs.htm •Implemented distribution of ACIP meeting briefing documents to the Director of CDC, other CDC leaders, and ACIP members prior to each ACIP meeting •Developed a comprehensive set of background materials, comprising key study reports, articles, and relevant documents, which are distributed to ACIP members at least 2 weeks in advance of each ACIP meeting •Provide economic analysis and GRADE education sessions for ACIP members •Worked with MMWR to establish a Policy Note format, ensuring timely publication of ACIP recommendations and decreasing time between ACIP recommendations and publication in MMWR. The Policy Note publication process meets the NVAC/NVPO vaccine finance recommendation 18 stating that CDC should substantially reduce the time from ACIP’s creation of recommendations to their publication in MMWR •Work with MMWR editors to standardize Policy Notes and Recommendations and Reports published in MMWR, including author/contributor identification •Update and maintain in real time the content and structure of the ACIP website •Simultaneous translation of proceedings of each ACIP meeting into Spanish •Ensure that meeting slides posted on the website are compliant with Section 508 •Webcast all ACIP meetings in 508-compliant format •Developed a mechanism and guidelines to minimize or eliminate conflicts of interest of ACIP members •Developed and implemented a guidance document for ACIP work groups including conflict-of-interest guidelines for work group members •By ACIP vote, immunizations for children and adolescents 0–18 years of age are added to the Vaccines for Children program •Vaccines included in the ACIP immunization schedules are covered by the Patient Protection and Affordable Care Act (ACA) with no co-pay and no deductible •Encourage visits by international dignitaries such as Ministry of Health Officials who wish to observe ACIP as a potential model for immunization policymaking in their respective countries

Guidance

Education

Communication

Conflict of interest mitigation

Outreach/implementation

recommendations were made. One example is the acellular pertussis combination vaccine (DTaP) recommended in 1997 to replace DTP as the preferred diphtheria–tetanus–pertussis vaccine for infants and young children [49], and ACIP in 2000 recommended exclusive use of the inactivated poliovirus vaccine (IPV) for infants and children [50]. Along with these developments the schedule became increasingly complex for health care professionals and parents; as many as 24 injections could be administered before a child’s second birthday [51]. In response, there has been an effort to develop combination vaccines in an attempt to reduce the number of injections and simplify the schedule. Vaccine manufacturers have developed various combination vaccines including antigens for hepatitis A, hepatitis B, Hib, poliovirus, meningococcus, DTaP, MMR, and varicella to reduce the number of injections in each visit [52]. Routine immunization for people 11–18 years of age now includes human papillomavirus vaccine [53],

meningococcal-A, C, Y, W-135 vaccine, influenza vaccine, and a tetanus–diphtheria–acellular pertussis (Tdap) booster. Other vaccines are recommended for adolescents if specific risk factors are present. Recommendations for influenza and Tdap vaccines during pregnancy also have been made by ACIP [54,55]. See Table 3 and Fig. 2 for ACIP vaccine recommendations by disease and by date, respectively. Just before the turn of the 21st century, most practitioners accessed the harmonized childhood and adult vaccine schedules in print, through the MMWR or professional society journals. However, the number of health care providers accessing the online versions of the schedules is growing. CDC began converting MMWR content to HTML in 1998 [43], and the AAP debuted Red Book Online in 2000 [56]. Both ACIP and its partners offer web-based content, and CDC has launched an immunization schedule application (“app”)—currently available in the iTunes and Android app stores—for mobile devices.

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8. Safety of the routine child/adolescent immunization schedule Assuring vaccine safety is a shared priority. The Institute of Medicine (IOM) in January 2013 published a comprehensive report detailing results of an examination of the current childhood immunization schedule. Exhaustive research into the schedule as it stands, the report states, “uncovered no evidence of major safety concerns associated with adherence to the childhood immunization schedule [57].” A systematic review of literature published before and after the IOM report supported the safety of childhood vaccines [58]. No statistically reliable causal link has been established between MMR administration and onset of any autism spectrum disorders [59]. An evidence-based meta-analysis of case control and cohort studies showed that vaccines are not associated with autism [32]. A 2004 report by the IOM favored rejection of the hypothesis that MMR as well as other vaccines containing thimerosal (a preservative) are linked to neurodevelopmental disorders [60]. The ACIP receives updates at each meeting on safety of vaccines it recommends for use. Taking into consideration biotechnology advancement and an ever-growing body of data on vaccine efficacy, effectiveness, and risk, the immunization schedules for children and adults can only become more complex. While the 1995 harmonized childhood immunization schedule featured five footnotes and five vaccines administered to prevent nine diseases [41], the 2014 recommended immunization schedule for people from birth through 18 years of age features 14 vaccines and 13 footnotes [51]. The recommended adult immunization schedule lists 11 vaccines in two tables with 15 footnotes providing specifications for both routine use and for use in people with high risk conditions [48].

9. Structure and operational activities of ACIP ACIP continues not only to consider the safety and efficacy of available vaccines but to refine its own structure and operational activities in order to provide a more comprehensive, informed, and evidence-based approach to vaccine recommendations. During the past 10 years, ACIP has made numerous changes and advances both structural and technological (shown in Table 4), a few of which are highlighted here. The committee had eight voting members at its inception in 1964, but the number of voting members has since been expanded to 15, including a chair and vice chair. Each member serves a non-renewable four-year term. Membership is diverse and includes a consumer representative. All members undergo a rigorous screening process for conflicts of interest before their names are submitted to the Secretary of DHHS for final consideration for nomination, at the time of appointment to ACIP, and annually during committee service. In addition, members declare any conflicts at the beginning of each ACIP meeting. Voting members are required to submit an Office of Government Ethics (OGE) Form 450 during each year of their four-year term. Any changes are reported immediately to CDC’s Federal Advisory Committee Management Board. Adjunct to the voting members are 8 non-voting ex officio members from other government agencies (outside CDC) and 31 nonvoting liaison representatives from health-related professional societies. These professional organizations now extend beyond the United States to the United Kingdom, Mexico, and Canada (Table 3). Liaison members represent organizations with broad responsibility for vaccine administration. Liaison members participate in appropriate work groups and are active during discussion

periods at ACIP meetings. In addition, ACIP welcomes international visitors each meeting, including delegations from countries that are members of the Pan-American Health Organization (PAHO). In the past, delegations from countries including Japan, India, and China have attended meetings in order to observe proceedings that are open to the public. These visitors attend to observe the function of ACIP, often model the operations of their vaccine advisory committees on those of the ACIP, and uniformly comment upon the transparency associated with the process used to create ACIP recommendations. ACIP has numerous permanent and need-based work groups, which inform the ACIP voting members of information relevant to each vaccine and its safety, efficacy, and use. These groups, each of which is chaired by an ACIP voting member, work yearround to provide this information in time for each of the regularly scheduled ACIP meetings (February, June, and October of each year). In a development important to the continued scientific integrity and transparency, in 2010 ACIP began use of the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process in order to systematically assess the type or quality of evidence about a certain vaccine’s projected health impact and the balance of health benefits and risks. Evidence is grouped into four categories, with the order reflecting the level of confidence in the estimated evidence of vaccination on healthcare outcomes. This standardized and more explicit process for developing ACIP recommendations enhances transparency, consistency, and communication [61,62]. All data tables used for development of ACIP vaccine recommendations are posted on the ACIP website (http://www.cdc.gov/vaccines/acip/recs/GRADE/table-refs.html). There will likely be alterations and modifications as to how ACIP functions as well as additional licensed vaccine products to be considered by the committee in the future. Research and technologies—including genomic sequencing of microbes and studies on cellular response to adjuvants—are contributing to creation of the next generation of vaccines [63], and candidate vaccines are being designed to protect not only against infectious diseasecausing organisms such as Staphylococcus aureus and Clostridium difficile but against non-infectious conditions such as obesity and certain types of cancer [64]. The ACIP is a critical component to the network of public- and private-sector entities that is crucial to harmonization of the immunization schedules in the future as vaccines continue to proliferate.

Acknowledgements The authors express their appreciation to Anne Schuchat and Melinda Wharton for their review of the article; to James Singleton for his contribution of information on coverage of eligible children under the Vaccines for Children program; Cathy Hogan and Shilpa Kottakapu for information on the immunization schedule mobile app; Ray Strikas, Carolyn Bridges, and Walt Williams for information on past adult immunization schedules; Dale Morse for information on the 1989 measles meeting in New York State; and Kristin Pope both for reviewing the manuscript and for her referral to information on the Vaccines for Children Program and the Patient Protection and Affordable Care Act. Conflict of interest statement: Neither L. Reed Walton, Walter A. Orenstein, nor Larry K. Pickering in the past 12 months has had any relevant financial relationships with or conflicts of interest in terms of manufacturers of commercial products or providers of commercial services mentioned in this article.

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Appendix A. [{(Appendix 1)}]

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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...
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