Why did the ACIP decide on a Category B recommendation
BY CAROLE MOLONEY, RN, MSN, CPNP
The Advisory Committee on Immunization Practices (ACIP) develops written recommendations for the routine administration of vaccines, along with schedules regarding the appropriate timing, dosage, and contraindications. The ACIP consists of 15 experts in fields associated with immunization who have been selected by the Secretary of the Department of Health & Human Services to provide advice and guidance to the Secretary, the Assistant Secretary for Health, and the Centers for Disease Control and Prevention on the control of vaccine-preventable diseases. In addition to the 15 voting members, the ACIP includes eight ex officio members who represent other federal agencies that are responsible for vaccination programs in the United States and 30 nonvoting representatives of liaison organizations who are knowledgeable about immunization.
Carole Moloney, CPNP
The ACIP provides advice to reduce vaccine-preventable diseases in the United States by increasing the safe use of vaccines and related biologic products. The committee writes recommendations for the routine use of vaccines in children and adults – these include the age for the vaccines’ administration, the number of doses and intervals at which doses are administered, and precautions and contraindications.1
In 2010, the ACIP started using the modified GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. In this process, the evidence pertinent to a particular disease and vaccine is ranked according to type and quality. Key factors – the balance between benefits and harm, the evidence type or quality, values and preferences, and health economic analyses – are used to refine the recommendation and to determine what category of recommendation is made, either Category A or Category B.2
Category A. Previously known as universal, these recommendations apply to all persons in an age- or risk-based group.
Category B. Previously known as permissive, these recommendations require individual clinician decision making. During a clinician-patient interaction, the discussion needs to focus on determining whether vaccination may be appropriate for that patient.
The ACIP Meningococcal Vaccines Work Group “reviewed all of the available published and unpublished data and evidence regarding meningococcal disease epidemiology in the United States, carriage, as well as cost effectiveness, immunogenicity, and safety of the MenB vaccines.” The group’s discussions and recommendations were presented to the ACIP.3
Based on this information, at its June 2015 meeting, the ACIP recommended that “adolescents and young adults aged 16-23 years may be vaccinated with a serogroup B (MenB) vaccine to provide short-term protection against most strains for serogroup B meningococcal disease.” Preferred age of administration is 16-18 years of age.3
MenB vaccines were assigned to Category B because there was not enough evidence to recommend that all patients aged 16-18 years receive the vaccine based on current low prevalence of disease, high cost of quality-adjusted life-years saved by a universal program, and lack of information about duration of protection, effects on carriage, herd immunity, and strain coverage.
All patients aged 16-18 years should be considered for MenB vaccine, unless there is a specific contraindication. Of 1,178 cases of meningococcal disease reported during 2014-2016, 166 cases (14%) were in persons aged 18-24 years. Of those, about 51% were seen in college students and 48% in noncollege students. Although the incidence of serogroup B meningococcal disease in college students is low, with a mean 20 cases and 2-4 outbreaks reported each year, college students aged 18-21 years still are at a higher risk than are noncollege students. Although outbreaks have been a leading factor, it seems risk remains higher among college students even when outbreaks are ruled out.4
Not every teen is headed to college, but every teen should be advised on meningococcal disease and vaccine availability.
The Category B recommendation requires health care providers to initiate conversations with their teen patients about meningococcal disease, the available vaccines, and the risks versus benefits of MenB vaccination. Those conversations can prove challenging, but not having them should not be an option. Patients and families need to be educated about the disease. They need the guidance, expertise, and support of their health care provider to make an informed decision. Each patient-provider encounter is an opportunity to have this important conversation about MenB vaccines.
Ms. Moloney is a certified pediatric nurse practitioner in the division of pediatric infectious diseases at Boston Medical Center.