The Advisory Committee on Immunization Practices (ACIP), the group that advises the Centers for Disease Control and Prevention (CDC) regarding immunizations, was formalized in 1964. At that time, the committee was tasked with “advising the Surgeon General regarding the most effective application in public health practice of specific preventive agents which may be applied in communicable disease control. Included among the agents to be considered by the Committee are inactivated and live-attenuated bacterial, rickettsial and viral agents; toxoids; anti-toxins; chemoprophylactic agents; and immune globulins. The Committee shall concern itself with immunization schedules, dosages and routes of administration and indications and contraindications for the use of these agents. The Committee shall also provide advice as to the relative priority of various population groups to whom the agents should be made available and shall advise regarding the relative merits and methods for conducting mass immunization programs. It shall also advise appropriately regarding needed programs in research" as reprinted in a recent MMWR celebrating the 50th anniversary of the committee.1
Generally speaking, the ACIP’s responsibilities have not changed; however, the charter of the committee is updated biannually.2 Over the years, changes to the Charter have solidified the requirements for the number and qualifications of committee members as well as allowed for the ACIP to determine which vaccines are included in the Vaccines for Children (VFC) program.3 More recently, two major changes have impacted the work of the ACIP. Specifically, in 2004, the Charter was updated to include a formal reference to economic analyses4, and in 2010, the committee began using the Grading of Recommendations Assessment, Development, and Evolution process, referred to as GRADE.5 This process requires that the committee “systematically assess the type or quality of evidence about a certain vaccine’s projected health impact and the balance of health benefits and risks.”6 While the latter makes sense from the perspective of ensuring “best health,” the former moves the decision away from the “first do no harm” category and toward systems that historically were considered to be more so based on economic and political reasoning, such as state mandates.
While economic considerations are essential, especially as the country struggles to control waste in the healthcare system, it may be time for brainstorming solutions that will balance the economic and health issues that may at times work against each other. Newer vaccines may employ more expensive technologies or be limited in the number of deaths they prevent or both. The result may be weak or limited recommendations as evidenced at the most recent ACIP meeting in February 2015, when two new vaccines were put forward for votes related to recommendations: a meningococcal serogroup B vaccine and a 9-valent human papillomavirus (HPV) vaccine.
To better understand the significance of these two votes, this month and next month, the Vaccine Update “News and Views” articles will look at these vaccines and the votes more closely to understand not only how and why the ACIP came to the conclusions they did, but also what these votes mean for both healthcare providers and their patients.
A closer look at the meningococcal B vaccine recommendation
The current meningococcal vaccines contain four of the five serogroups of meningococcal bacteria (A, C, W, and Y). Unfortunately, a vaccine against meningococcal serogroup B has been difficult to make. The difficulties arise from the fact that the polysaccharide on the surface of serogroup B meningococcus is similar to a neural cell adhesion molecule (NCAM) in people.
Recently, two vaccines were licensed in the U.S. that have overcome the previous technical issues associated with this problem. Both are licensed for use in 10-25 year olds:
- Trumenba® – Three-dose vaccine composed of two factor H binding proteins,
- Bexsero® – Two-dose vaccine composed of an adhesion molecule, factor H binding protein, heparin binding protein and outer membrane vesicle containing a porin protein.
Rates of meningococcal serogroup B range from about 200 to 800 cases per year; however, only a fraction of these (about 50 to 160) are in the age group for which these vaccines are licensed. The greatest risk for meningococcal serogroup B infection are in children younger than 5 years of age. Unfortunately, neither vaccine is licensed for this age group. Others at risk include people with complement deficiencies or asplenia, people who work with the bacteria in a laboratory setting and those in outbreak situations, such as on college campuses.
Recommendation options based on the licensing parameters included:
- High-risk groups only
- All 11- to 12-year-olds with a likely booster dose necessary between 16-18 years of age
- All 16- to 18-year-olds
The ACIP needed to take into account the number of cases vaccination would prevent and, as part of their charter, the cost of each recommendation choice.
The resulting decision was to recommend immunization of high-risk groups as outlined above and any people involved in an outbreak, where an outbreak is defined as two to three cases depending upon the size of the population, such as on a college campus. The committee decided to wait until the June 2015 meeting to address whether or not to have a routine recommendation during adolescence or teen years.
This decision, while it may make sense for the population, is not necessarily the best choice for individuals. It is likely that individual families will be affected when their child is left disabled by, or worse, succumbs to a meningococcal serogroup B infection. For these families, they will wish they had the opportunity to choose the vaccine for their child. Indeed, parents, family members and individuals affected by this disease before a vaccine was available attended the meeting and continue to promote the importance of a strong recommendation. And while not recorded anywhere, it is likely that voting members of the committee, if approached by a family member or friend, might suggest they get the new vaccine for their adolescent or college-aged child. However, when voting within the constraints of the current ACIP charter, these trained healthcare professionals must consider factors other than best health. While the goal to make sure that a vote is fundable and to not throw limited dollars to a program that may not be economically adventitious is noble, it leaves us, as a country, in a situation in which no single entity is concerning itself with the best medical decision only. It means that healthcare providers have no group to look to as a way to understand the health consequences of these decisions, and it means parents can no longer assume that if they follow the recommended schedule, their child is most adequately protected.
Historically, only vaccines that are recommended are fueled by education campaigns, reimbursed by insurance companies and promoted regularly by providers. So, if we are entering a new era in which vaccines exist that are not fully recommended, we need to figure out how we can ensure that patients and families know this vaccine is available, determine who will give this vaccine if it is not reimbursable, and, using the current example, answer to the families of the 50-160 adolescents who could have gotten this vaccine but didn’t because they were not in a high-risk group and weren’t informed of the opportunity.
A look at the HPV-9 vaccine story
1 History and Evolution of the Advisory Committee on Immunization Practices – United States, 1964-2014. MMWR. October 24, 2014. 63(42): 955-8.
3Hinman AR, Poland GA. Celebrating the ACIP at 50. Vaccine. 2015. 33:403-4.
4History and Evolution of the Advisory Committee on Immunization Practices – United States, 1964-2014. MMWR. October 24, 2014. 63(42): 955-8.
5Walton LR, Orenstein WA, and Pickering LK. The history of the United States Advisory Committee on Immunization Practices (ACIP). Vaccine. 2015. 33:405-14.
6Ibid, p. 412.