Vaccines rank as one of the top three public health successes of the past 100 years, along with sanitation and clean water. These public health measures have saved innumerable lives and have been a major contributor to the increased longevity of the American population. More recently, an evaluation of clinical preventive services identified childhood immunization, aspirin chemoprophylaxis, and screening and brief intervention for tobacco use as the three most effective interventions, based on preventable burden and cost-effectiveness. Influenza immunization in adults 50 years and older and pneumococcal immunization in adults 65 years and older also were ranked among the top nine interventions.1
Family physicians are an important source of primary preventive medicine across the United States and a vital component of the national vaccination system. The provision of a wide spectrum of care across a widespread geographic distribution creates an ideal blueprint for adult immunization. Surveys funded by a cooperative agreement between the American Academy of Family Physicians (AAFP) and the Centers for Disease Control and Prevention (CDC) show that 98.8 percent and 95.5 percent of clinically active family physicians provide care to adults 19 to 64 years of age and 65 years and older, respectively.2 Moreover, AAFP members report high rates of administration of influenza, pneumococcal, andhepatitisBvaccinestoadultpatientsintheir practices. It should be noted that these three vaccines are the only adult vaccines covered by Medicare for prevention of illness; tetanus-diphtheria (Td) vaccine is covered only in the context of wound prophylaxis.
Because family physicians are such a major component of the nation’s vaccination system, how well we perform contributes heavily to how well protected our communities are. Performing well, however, has become increasingly difficult. There is an expanding list of vaccine-preventable conditions and vaccine products, each with recommendations on who should be immunized. The 2007 adult immunization schedule3 contains the following additions and changes:
Routine immunization of nonpregnant women 26 years and younger with human papillomavirus vaccine;
Providing a second dose of mumps-containing vaccine for persons with certain exposure factors;
Expanding the recommendation for influenza vaccination to include close contacts of children up to 59 months of age;
Providing a second dose of varicella vaccine for adults without evidence of immunity (i.e., previous diagnosis of varicella or herpes zoster, laboratory evidence of immunity or disease, or born in the United States before 1980);
Substituting tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine for one dose of the 10-year Td booster through age 64.
Using alternative vaccination strategies if needed to ensure that high-risk adults are immunized against hepatitis B.
Given the recent flourish of new vaccines, concerns about vaccine supply and distribution, and financial ramifications, family physicians must have a better understanding of the process by which new vaccines come into routine use. Following appropriate phase 3 clinical trials for evaluation of a vaccine’s safety and effectiveness, manufacturers submit a biologic license application to the U.S. Food and Drug Administration. Often during this period, a working group of the Advisory Committee on Immunization Practices (ACIP) is formed to address the underlying epidemiology and need; review the clinical data for safety, immunogenicity, effectiveness, and cost-effectiveness; and draft a recommendation for use. Following licensure, if sufficient need exists, a recommendation is typically brought to ACIP for discussion and vote at its next meeting.
Once a new recommendation has been approved by ACIP, it becomes a provisional CDC recommendation and is posted on the ACIP Web site (http://www.cdc.gov/nip/recs/provisional_recs/default.htm). At the time of ACIP approval, vaccines routinely recommended for children also receive a vote for inclusion in the Vaccines for Children program. The ACIP recommendation, however, does not become an official CDC recommendation until it has been approved by the secretary of the U.S. Department of Health and Human Services and has been published in Morbidity and Mortality Weekly Report. This step often can take months.
This complex chain of events can be a source of frustration for family physicians. Vaccine manufacturers initiate advertising campaigns targeted to physicians and consumers at the time of vaccine licensure, and the news media often report ACIP recommendations at the time they are made. However, many professional organizations do not endorse ACIP recommendations until they become official. In addition, many third-party payers will not cover vaccine-associated costs, and many practices will not order vaccine until the recommendation is official. Finally, the initial demand for new vaccines often cannot be met because of a lack of sufficient production capacity. Such situations may create frustration for physicians and patients.
The AAFP has developed several resources to assist family physicians with immunizations; these resources are available on the AAFP Web site (https://www.aafp.org/online/en/home/clinical/immunizations/immunizationrecs.html). In addition, AAFP staff members spend countless hours working collaboratively with other professional organizations, the CDC, and vaccination interest groups to monitor developments and advocate for a strong vaccination program. The AAFP sends two liaisons to each ACIP meeting and participates on 12 ACIP working groups. One result of this collaboration is the harmonized adult immunization schedule, which is reproduced in this issue of AFP (page 2115). All of these efforts are aimed at assisting family physicians in providing maximum protection against vaccine-preventable diseases for our patients and communities.