Principles of Vaccine Licensure, Approval, and Recommendations for Use

THEMATIC REVIEW ON VACCINES

Principles of Vaccine Licensure, Approval, and Recommendations for Use Larry K. Pickering, MD; H. Cody Meissner, MD; Walter A. Orenstein, MD; and Amanda C. Cohn, MD Abstract 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. ª 2019 Mayo Foundation for Medical Education and Research

From the Division of Pediatric Infectious Diseases, Department of Pediatrics (L.K.P.), and Division of Infectious Diseases, Department of Medicine (W.A.O.), Emory University School of Medicine, Atlanta, GA; Department of Pediatrics, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (H.C.M.); Emory Vaccine Center, Emory University, Atlanta, GA (W.A.O.); Immunization Services, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA (A.C.C.).

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mmunization is one of the most effective means of preventing illness, disability, and death from infectious diseases. In 1796 Jenner reported that milkmaids who had contracted vaccinia (cowpox) were immune to smallpox.1 After this observation, Jenner inoculated vesicular fluid from cowpox lesions into the skin of susceptible people and induced protection against smallpox. This action began the remarkable era of immunization, by which artificially inducing immunity provided protection from disease.2,3 The process of immunization can be active or passive. Active immunization follows administration of vaccines or toxoids that stimulate the body’s immune system to produce antibodies or cell-mediated immunity or both. Viral or bacterial vaccines can be live attenuated or inactivated microorganisms

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or parts of an organism, plain polysaccharide or polysaccharide conjugated to a protein, modified toxins produced by bacteria, or genetically engineered. Passive immunization provides temporary protection with exogenously produced antibody administered for protection against a specific disease or by transplacental transfer of maternal antibodies to a fetus. General categories of immunizing agents include vaccines, toxoids, antibody containing standard or hyperimmune preparations, and monoclonal antibodies. Standard immune globulins can be derived from human or animal donors (polyclonal preparation) and provide broader protection than do diseasespecific monoclonal antibody preparations. Other constituents of various immunizing agents may include media or suspending fluid, preservatives, stabilizers,

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THEMATIC REVIEW ON VACCINES

Vaccine development and testing

Submission to FDA for a Biologics License Application

Vaccines and related biological products advisory committee Advisory Committee on Immunization Practices

Advises

FDA licensure

Advises

CDC consideration

Recommendations for use published in MMWR

Insurance or Medicare coverage

ACP’s Board of Regents consideration

Advises

ACP’s Adult Immunization Initiative Physician Advisory Board

Recommendations for use published in Annals

Uptake and financing

Public sector

Private sector

FIGURE 1. Development and dissemination of vaccine recommendations and policies. ACP ¼ American College of Physicians; Annals ¼ Annals of Internal Medicine; CDC ¼ Centers for Disease Control and Prevention; FDA ¼ Food and Drug Administration; MMWR ¼ Morbidity and Mortality Weekly Report. From Ann Intern Med.7 Copyright ª 2019 American College of Physicians. Used with permission.

conjugating agents, antimicrobial agents, and immunomodulators or adjuvants. Adjuvants enhance the immune response and initially consisted mainly of various aluminum salts. However, other adjuvants have been developed and are included in some licensed vaccines (eg, hepatitis B, human papillomavirus, 2-dose zoster, and some influenza vaccines). Before a candidate vaccine is considered for routine use, it must be licensed by the Food and Drug Administration (FDA) and recommended by the Advisory Committee on Immunization Practices (ACIP). Both programs are described in this article.4-25 PROCESS DEVELOPMENT Vaccine Licensure by the FDA The Center for Biologics Evaluation and Research is the center within the FDA that is Mayo Clin Proc. n XXX 2020;nn(n):600-608 www.mayoclinicproceedings.org

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responsible for regulatory oversight of biologic products for human use including vaccine development as well as licensure of new vaccines in the United States.18,19,22 The mission of this center is to protect and enhance public health through regulation of biologic and related products including vaccines, blood, allergenics, tissues, and cellular and gene therapies. To obtain a US license, the product must be shown to be safe, pure, effective, and manufactured in a consistent manner. The Biologics License Application submitted to the FDA by a vaccine manufacturer must contain a full risk-benefit analysis. The licensure process includes approval of the prescribing information, also known as the package insert, which describes indications and populations in which the vaccine has been reported to be safe and effective on the basis of pivotal clinical trials. Vaccines may be licensed on the basis of display of a clinical

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TABLE 1. FDA Approval and ACIP Recommendation for Vaccines Organization

Pathways for approval or recommendation

FDA

Traditional approval

Description Must show safety in the indicated population Pivotal trials report prevention of clinical disease (effectiveness) or achievement of protective level (immunogenicity) of an accepted correlate of protection Usual pathway for new vaccines, but may not be feasible for all vaccines

Accelerated approval

Must show safety in the indicated population Targeted disease is considered serious or life-threatening Pivotal trials use a surrogate marker (immune response) reasonably likely to predict clinical benefit as an end point Adequate and well-controlled postmarketing trial is required to verify the clinical benefit

Animal Rule

Must show safety in the indicated population Targeted condition is considered serious or life-threatening Use only if Traditional or Accelerated pathways are not feasible and ethical Pivotal studies in relevant animal models to provide substantial evidence of effectiveness in humans Postmarketing human study is required to verify the clinical benefit when the study becomes feasible, as during an urgent need

ACIP

Recommendation

Vaccine is recommended for all people in an age- or risk-based group without contraindications Recommendations made for selected subpopulations and is based on individual clinical decision making

ACIP ¼ Advisory Committee on Immunization Practices; FDA ¼ Food and Drug Administration.

end point or a well-established surrogate of immunity. Figure 1 illustrates the development and dissemination of vaccine recommendations and policies for adults. Food and Drug Administration package inserts do not include recommendations for use made by the ACIP. The 3 available pathways for vaccine licensure by the FDA are Traditional, Accelerated, and Animal Rule (Table 1). After vaccine licensure, the FDA continues to play a critical role in monitoring the safety of vaccines, including post-licensure studies, safety monitoring, and production quality assurance. Vaccine Recommendations from the ACIP Until 1964, immunization recommendations for children and adolescents were developed primarily by the American Academy of Pediatrics. The ACIP was formed, and its members were appointed by the Surgeon General of the United States Public Health Service as a technical advisory committee (Figure 1).8,10 The committee initially comprised 8 members and met 2 to 3 times a year at the Centers for Disease Control and Prevention (CDC). The charge to the committee was to develop 602

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recommendations for use of vaccines licensed by the FDA for the civilian and military populations in the United States by using a systematic, science-based, formal mechanism.4,5,8,11,14,16,17,20,23,24 After licensure by the FDA, the ACIP develops and disseminates vaccine recommendations and policies for use of vaccines and related agents. An important change in committee procedures occurred in 1972 when the ACIP was designated a federal advisory committee and therefore required to follow the Federal Advisory Committee Act (https:// www.gsa.gov/policy-regulations/policy/federal -advisory-committee-management/legislationand-regulations/the-federal-advisory-commit tee-act),26 which defines procedures for creation and operation of federal advisory committees, including emphasis on open meetings, chartering, public involvement, and reporting. Other changes included increasing the number of voting members over time from 8 to 15; the chair became a member of the committee, replacing the CDC director to whom the ACIP would report. Advisory Committee on Immunization Practices members follow strict guidelines to ensure they do not have conflicts

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TABLE 2. Criteria for Each Key Factor in the Evidence to Recommendations Framework Key factor

Criteria

Problem

Is the problem of public health importance?

Benefits and harms

How substantial are the desirable anticipated effects? How substantial are the undesirable anticipated effects? Do the desirable effects outweigh the undesirable effects? What is the overall certainty of this evidence for the critical outcomes?

Values

Does the target population feel that the desirable effects are large relative to undesirable effects? Is there important uncertainty about or variability in how much people value the main outcomes?

Acceptability

Is the intervention acceptable to key stakeholders?

Resource use

Is the intervention a reasonable and efficient allocation of resources?

Feasibility

Is the intervention feasible to implement?

Adapted from MMWR Morb Mortal Wkly Rep.

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of interest as outlined in the ACIP policy and procedures manual (https://www.cdc.gov/ vaccines/acip/committee/index.html).27 Advisory Committee on Immunization Practices Structure and Function The ACIP consists of 15 voting members who meet 3 times a year at CDC in an open public forum to review and discuss scientific data and vote on vaccine recommendations. Advisory Committee on Immunization Practices members cannot be government employees. All ACIP members are screened for and have no real or perceived conflicts of interest. Recommendations made by the ACIP in a majority vote must be approved by the director of the CDC. Recommendations become official after approval and publication in the Morbidity and Mortality Weekly Report, initially as policy notes followed by more comprehensive recommendations in a full report. Meeting minutes, including recommendations, PowerPoint presentations, and transcripts of all ACIP meetings are available at https://www.cdc.gov/vaccines/acip/index. html.28 Live ACIP meetings are available as a webcast at https://www.cdc.gov/vaccines/ acip/meetings/webcast-instructions.html.29 The ACIP charter states: “Committee deliberations on use of vaccines to control disease in the U.S. shall include consideration of disease epidemiology and burden of disease, vaccine efficacy and effectiveness, vaccine safety, the quality of evidence Mayo Clin Proc. n XXX 2020;nn(n):600-608 www.mayoclinicproceedings.org

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reviewed, economic analyses and implementation issues. The ACIP may revise or withdraw their recommendation(s) regarding a particular vaccine as new information on disease epidemiology, vaccine effectiveness or safety, economic considerations or other data become available” (https://www.cdc. gov/vaccines/acip/committee/charter.html).30 Advisory Committee on Immunization Practices Work Groups To develop recommendations, the ACIP forms subgroups of committee members known as work groups (WGs). Work groups are responsible for collection, analysis, preparation, and presentation of published and unpublished data and for preparation of evidence-based recommendation options for vaccines licensed by the FDA. Recommendations are presented for discussion, deliberation, and vote by the ACIP in an open public forum. Work group activities ensure ACIP voting members make informed decisions on the basis of the best and most current information. The goal of ACIP WGs is to increase the effectiveness of ACIP. Each WG must include at least 2 voting members of the ACIP, one of whom functions as WG Chair. A CDC subject matter expert serves as WG Lead and is generally selected by the concerned CDC program. Other WG members may include ACIP ex officio members, ACIP liaison representatives, and invited consultants. Most WGs should include a

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• Formulate questions in the PICO format

• Systematic review of the literature for each outcome • Assess quality of evidence

• Assess values, health economic data, and implementation issues

• Formulate recommendations through ACIP meetings

PICO definition: Patient, Population, or Problem; Intervention, Prognostic Factor, or Exposure; Comparison or Intervention (if appropriate); Outcome you would like to measure or achieve

FIGURE 2. Steps for the development of recommendations by the Advisory Committee on Immunization Practices (ACIP) using the Grading of Recommendations, Assessment, Development and Evaluation system. Reprinted from MMWR Morb Mortal Wkly Rep.18 Used with permission of AAP News, October 2019.

representative from CDC’s Immunization Safety Office and Immunization Services Division. Centers for Disease Control and Prevention staff may serve in a supportive or administrative function. Work groups are encouraged to invite a consumer representative to join as a consultant. The process used for WG member selection can be found at https://www.cdc.gov/vaccines/acip/applyfor-membership/index.html.31 Conflicts of interest are reviewed for all WG members. Work group discussions are confidential. There are 2 types of ACIP WGs: permanent and task oriented. 1. The 4 permanent WGs deal with the following areas: a. Schedule e Childhood and adolescent b. Schedule e Adult c. General e Best practices d. Influenza 2. Task oriented a. Developed in response to specific needs and disbanded when the task at hand has been completed. Examples include hepatitis, herpes zoster, dengue, and pneumococcal vaccines b. Formed to deal with licensure of a new vaccine or to update existing recommendations for other specific vaccines Regulatory Authority of the ACIP The Vaccines for Children (VFC) program is a federally funded program, administered through CDC, to provide vaccines free of charge to children whose parents or guardians may not be able to afford them, 604

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ensuring that all children have a better chance of receiving all recommended vaccines. Children and adolescents who are eligible for VFC vaccines are entitled to receive vaccines recommended by the ACIP. Criteria for VFC eligibility are Medicaid, uninsured, American Indian/ Alaska Native. In addition, children aged 0 to 18 years who have insurance that does not cover immunization (underinsured) can be covered by the VFC program but they can receive only VFC vaccines at federally qualified health centers. For additional information on the VFC program, go to https://www.cdc.gov/vaccines/programs/vfc/ index.html.32

Grading of Recommendations, Assessment, Development and Evaluation Process In 2010, the ACIP formally adopted a framework called Grading of Recommendations, Assessment, Development and Evaluation (GRADE) for developing evidence-based recommendations.18 Using the GRADE framework, ACIP systematically assesses the type and quality of evidence about a vaccine’s expected health impacts and the expected balance of health benefits and harms. When making a decision about a vaccine, ACIP considers other key factors such as equity, values, and preferences of people affected as well as economic issues including costeffectiveness and risk benefit. One strength of the GRADE system is the requirement for an explicit judgment that is transparent to users to resolve potential disagreements. In February 2018, substantial additions were incorporated into

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TABLE 3. Liaison Organizations That Work With the ACIP to Disseminate Vaccine Information Organization

Publication

Childhood and adolescent

Adult

Websites

X

www.cdc.gov/vaccines/acip27 www.cdc.gov33

ACIP/CDC

Morbidity and Mortality Weekly Report

X

American Academy of Pediatrics

Pediatrics

X

American Academy of Family Physicians

American Family Physician

X

American College of Physicians

Annals of Internal Medicine

The American College of Obstetricians and Gynecologists

Obstetrics & Gynecology

American College of Nurse-Midwives

Journal of Midwifery and Women’s Health

X

www.aap.org34 X

www.aafp.org35

X

www.acponline.org36

X

www.acog.org37

X

www.midwife.org38

ACIP ¼ Advisory Committee on Immunization Practices; CDC ¼ Centers for Disease Control and Prevention.

the GRADE methodology, particularly use of the Evidence to Recommendations (EtR) framework to move from evidence to decision and to provide transparency regarding the impact of additional factors on deliberations when considering a recommendation.18 The EtR framework is used to summarize key factors, including balance of benefits and harms, type or quality of evidence, values and preferences of people affected, resource use, and feasibility of implementation (Table 2). This standardized and more explicit process using the EtR framework for developing ACIP recommendations enhances transparency, consistency, and communication to health care providers, partner organizations, and the public. The key steps for developing evidencebased recommendations using the EtR framework are presented in Figure 2. Advisory Committee on Immunization Practices Liaison Organizations The ACIP works closely with many liaison organizations (Table 3) to develop vaccine recommendations to ensure harmonization among leading professional medical societies. Examples include the immunization schedules for children and adolescents and for adults that are updated and published annually at the beginning of each year. Valuable sources of vaccine-related information are presented in Table 4. For example, the Vaccine Adverse Event Mayo Clin Proc. n XXX 2020;nn(n):600-608 www.mayoclinicproceedings.org

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Reporting System and Vaccine Safety Datalink detect and analyze the occurrence of adverse events after the administration of a vaccine to help determine whether an event is related to the vaccine (causal) or unrelated to the vaccine (temporal, ie, coincidental). The National Vaccine Injury Compensation Program established by the National Childhood Vaccine Injury Act of 1986 allows people who experience a serious adverse event believed to be caused by a covered vaccine to file a petition for compensation.25

Agencies and Programs That Harmonize With Vaccine Recommendations From the ACIP The ACIP, in collaboration with professional societies, issues 2 recommended immunization schedules annually in January or February, 1 for children and adolescents (through 18 years of age) and 1 for adults. Vaccine recommendations are published simultaneously in the Morbidity and Mortality Weekly Report, which is a weekly publication from the CDC, as well as in specific journals of several medical societies including the American Academy of Pediatrics, American Academy of Family Physicians, American College of Obstetricians and Gynecologists, American College of Physicians, and American College of NurseMidwives (Table 3). In 2019 the childhood/adolescent and adult immunization schedules were

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TABLE 4. Valuable Resources for Vaccine Information Descriptor

Website

Adult immunization schedule

https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf39

Armed services (military)

https://www.health.mil/Military-Health-Topics/Health-Readiness/Immunization-Healthcare/ Vaccine-Preventable-Diseases/ACIP-Guidelines40

Childhood and adolescent immunization schedule

https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf39

Clinical Immunization Safety Assessment Project

https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/index.html41

Morbidity and Mortality Weekly Report

https://www.cdc.gov/mmwr/index.html42

National Vaccine Injury Compensation Program

https://www.hrsa.gov/vaccine-compensation/index.html43

Private health insurers

www.healthinsurance.net44

State health departments

See individual state health department websites

State school entry laws

https://www.cdc.gov/vaccines/imz-managers/laws/45

Vaccine Adverse Event Reporting System

https://vaers.hhs.gov/46

Vaccine Safety Datalink

https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.html47

Vaccines for Children

https://www.cdc.gov/vaccines/programs/vfc/index.html

modified to ensure consistency in structure between the formats of the 2 schedules.

Post Licensure After vaccine licensure, the Immunization Safety Office at CDC conducts 4 primary vaccine safety activities (https://www.cdc. gov/vaccinesafety/index.html).48 The public health surveillance activities include identifying potential vaccine adverse events, performing vaccine safety research, determining whether vaccines caused the adverse event in certain cases, and evaluating risk factors for causally related adverse events, which could lead to establishment of contraindications or precautions (Table 4). 1. Vaccine Adverse Event Reporting System: An early warning system that helps CDC and FDA monitor events after vaccinations. Anyone can report an event that occurs after vaccination. 2. Vaccine Safety Datalink: A collaboration between CDC and several health care organizations that allows ongoing monitoring and proactive searches of vaccinerelated data. Vaccine Safety Datalink is important for the assessment of causality among events reported to the Vaccine Adverse Event Reporting System. 3. Clinical Immunization Safety Assessment Project: A partnership between CDC and several medical centers that conduct 606

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clinical research on vaccine-associated health risks in certain groups of people. 4. Emergency Preparedness for Vaccine Safety: In the event of a disease outbreak in which a mass vaccination campaign is needed, CDC activates emergency preparedness activities to ensure that vaccines remain safe.

CONCLUSION Licensure of vaccines and implementation of recommendations that lead to vaccine uptake, community protection, and decrease in disease burden represent a complex system that requires collaboration in many areas of basic science, public health, vaccine delivery, outcomes monitoring, and public perception. ACKNOWLEDGMENTS We appreciate the time, effort, and input on this manuscript from Dianne Miller and review by Susan Goldstein, MD. This article is dedicated to Jean C. Smith, MD, who has worked tirelessly with the Advisory Committee on Immunization Practices to ensure that Food and Drug Administrationelicensed vaccines are incorporated into the childhood/adolescent and/ or adult vaccine schedules. Along the way, many of us have been educated by her thoughts and insight.

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Abbreviations and Acronyms: ACIP = Advisory Committee on Immunization Practices; CDC = Centers for Disease Control and Prevention; EtR = Evidence to Recommendations; FDA = Food and Drug Administration; GRADE = Grading of Recommendations, Assessment, Development and Evaluation; VFC = Vaccines for Children Potential Competing Interests: Dr Pickering is a board member of the Infectious Diseases Society of America (outside the submitted work). The other authors report no competing interests. Correspondence: Address to Larry K. Pickering, MD, Division of Infectious Diseases, Department of Pediatrics, Emory University School of Medicine, 2015 Uppergate Dr, Atlanta, GA 30322 ([email protected]). Individual reprints of this article and a bound reprint of the entire Thematic Review on Vaccines will be available for purchase from our website www.mayoclinicproceedings.org.

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32. Vaccines for Children Program (VCF). Centers for Disease Control and Prevention website, https://www.cdc.gov/vaccines/ programs/vfc/index.html. Accessed November 11, 2019. 33. Centers for Disease Control and Prevention website. https:// www.cdc.gov/. Accessed November 11, 2019. 34. American Academy of Pediatrics website. https://www.aap.org/ en-us/Pages/Default.aspx. Accessed November 11, 2019. 35. American Academy of Family Physicians website. https://www. aafp.org/home.html. Accessed November 11, 2019. 36. American College of Physicians website. https://www.acponline. org/. Accessed November 11, 2019. 37. The American College of Obstetricians and Gynecologists website. https://www.acog.org/. Accessed November 11, 2019. 38. American College of Nurse-Midwives website. https://www. midwife.org/default.aspx. Accessed November 11, 2019. 39. Recommended adult immunization schedule for ages 19 years and older: United States 2019. Centers for Disease Control and Prevention website, https://www.cdc.gov/vaccines/schedules/ downloads/adult/adult-combined-schedule.pdf. Accessed November 11, 2019. 40. ACIP guidelines. Health.mil: The official website of the Military Health System. https://www.health.mil/Military-Health-Topics/ Health-Readiness/Immunization-Healthcare/Vaccine-PreventableDiseases/ACIP-Guidelines. Accessed November 12, 2019.

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https://doi.org/10.1016/j.mayocp.2019.11.002 www.mayoclinicproceedings.org