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Over the last decade, there has been controversy about the value of immunization to save lives and prevent disease. Sometimes the noise overwhelms the science, and the public and even some professionals become confused about how and why vaccines are recommended to prevent infectious diseases. The Advisory Committee on Immunization Practices (ACIP) has a critical role in ensuring the best use of vaccines in the United States.
The ACIP was established in 1964 by the Surgeon General of the United States1-3 to provide guidance to the director of the Centers for Disease Control and Prevention (CDC) and to the Office of the Secretary, Department of Health and Human Services, on the most effective means to prevent infectious diseases. At that time, 6 vaccines were recommended for children: smallpox, polio, diphtheria, pertussis, tetanus, and measles, whereas today, almost 3 times as many vaccines are recommended for children. Public health achievements such as the eradication of smallpox and near eradication of polio have occurred in the intervening years. Diseases that once caused substantial morbidity and mortality, such as Haemophilus influenzae type b, are a dim memory. Adults too have had their lives prolonged and improved by vaccines. The advancements in both basic and population sciences, which inform vaccinology, have been enormous.
The roles of the ACIP and the CDC are distinct from that of the US Food and Drug Administration (FDA) and its federal advisory committee, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), in that neither the ACIP nor the CDC license vaccines but rather make recommendations for their use. For licensure, both the VRBPAC and the FDA consider the efficacy and safety of vaccines. Since 2011, the ACIP and the CDC have used the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) process to determine the quality of evidence regarding the benefits and harms of a vaccine. The ACIP then uses a second process, the Evidence to Recommendations framework, instituted in 2018, to consider burden and public health importance of the disease, values related to the use of the vaccine, resource use, and feasibility.
Each vaccine work group completes this process and presents to the full committee, composed of 14 immunization experts and 1 consumer advocate appointed by the Secretary of Health and Human Services, for the development of a recommendation. The committee meetings are held in public, live-streamed, and recorded, with the agenda previously announced in the Congressional Record, so that the process is entirely transparent. Public comment is welcomed. All members are required to eliminate all conflicts of interest, or if they are not able to eliminate them, they must declare such conflicts publicly at each meeting, and recuse themselves from voting on any recommendation related to their conflict. All recommendations of the committee are forwarded to the director of the CDC for approval or disapproval before they become official.
The recommendations of the ACIP and the CDC are recommendations; they are not mandates. Over the last 25 years, 2 pieces of legislation, the Vaccines for Children Program and the Affordable Care Act, have mandated coverage for recommended vaccines, thereby increasing the influence of the ACIP to affect vaccine use, and adding cost-effectiveness to the considerations for recommendations.
The increasing availability of postlicensure effectiveness data, the rapid development of new vaccine technologies,4 and the narrowing of specific targets for vaccination contribute to changes in the role of the ACIP.
The pathway from FDA licensure to permanent ACIP recommendation has become more complex largely due to the availability of critical postlicensure data. The ACIP and CDC recommendations are not permanent. Large data networks such as the Emerging Infections Program, the Vaccine Safety Datalink, and the Influenza Vaccine Effectiveness Network provide real-time, actionable, postlicensure data that reveal the real-world safety and value of vaccines.
For example, data from the Emerging Infections Program have been critical to decisions regarding the use of pneumococcal conjugate vaccine (PCV) in adults older than 65 years. The Emerging Infections Program tracks pneumococcal disease at a population level across 10 US sites, and these data showed that vaccinating children with PCV led to large reductions in invasive pneumococcal disease in all age groups. When the manufacturer obtained licensure for the vaccine in adults, the rapidly diminishing burden of disease from vaccine type serotypes made it challenging to recommend the vaccine in adults. The ACIP carefully considered the residual invasive pneumococcal disease in older adults and the potential to prevent pneumonia and concluded, in 2014, that vaccinating adults older than 65 years might eliminate additional disease. Now, studies have shown that PCV13 serotypes are disappearing as the causes of pneumococcal disease, and vaccinating adults appears to have little benefit.5 The ACIP is reconsidering the recommendation to vaccinate all adults older than 65 years. This decision is complicated by the practical and ethical considerations of changing the recommendation.
Preferential recommendations will become more common as new technologies emerge. In 2006, the ACIP recommended the use of live attenuated herpes zoster vaccine for adults aged 60 years or older. However, over time, it became evident that the usefulness of the herpes zoster vaccine was limited by the poor strength and duration of immunity, especially among older patients, most at risk of zoster and postherpetic neuralgia. A second vaccine, based on a subunit, herpes zoster subunit vaccine and containing an adjuvant not previously used in human vaccines, was introduced in 2017. The herpes zoster subunit vaccine showed greater efficacy and immunity declined more slowly, but the duration beyond 4 years was unknown. Although the decision to recommend the use of this vaccine was unanimous, the question of a preference was challenging for the ACIP. In the end, in a very close vote, the ACIP did recommend that this vaccine be used preferentially over the live attenuated herpes zoster vaccine, creating a significant disadvantage for that product, and some risk because of the lack of population experience with the new adjuvant. However, the committee determined that the higher efficacy and longer duration of immunity justified the recommendation.
With the development of new vaccine technologies, the ACIP will be required to consider the harms and benefits of specific technologies rather than simply recommend any licensed product. This makes its deliberations not only more complex but also more controversial.
In addition, vaccines against widespread, deadly infections, such as smallpox, polio, and H influenzae, have already been deployed and have eliminated the most prevalent and virulent diseases. New vaccines are likely to prevent less severe (eg, varicella and shingles vaccines) or less common (eg, meningococcal and travel vaccines) diseases, and therefore, have a smaller population effect and be less cost-effective. Soon there may be vaccines developed for narrow indications, such as preoperative vaccines for health care–associated infections such as Clostridium difficile. Precision medicine may define subpopulations for whom certain vaccines are indicated or contraindicated. For example, just as congenital immunodeficiency is a contraindication for certain vaccines now, other genetic variations may eventually be identified that will affect the efficacy and safety of certain vaccines. Because of the smaller societal value of these vaccines, the ACIP will have greater difficulty making recommendations, and the recommendations will be more difficult to implement because of their specificity.
As the ACIP evaluates more knowledge and data, newer technologies, and vaccines for lower-burden diseases, it has begun to adapt to its new roles and will maintain its fairness, dedication to science, and respect for all viewpoints.
Corresponding Author: Nancy M. Bennett, MD, MS, Center for Community Health and Prevention, University of Rochester School of Medicine and Dentistry, 46 Prince St, Rochester, NY 14607 (email@example.com).
Published Online: January 4, 2019. doi:10.1001/jama.2018.20792
Conflict of Interest Disclosures: None reported.
Additional Information: Dr Bennett reported that she has served as a member of the Advisory Committee on Immunization Practices for 7 years, the last 3 years as chair.
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Bennett NM. The Role of the Advisory Committee on Immunization Practices in Ensuring Optimal Use of Vaccines. JAMA. Published online January 04, 2019. doi:10.1001/jama.2018.20792
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