Rachael Zimlich is a freelance writer in Cleveland, Ohio. She writes regularly for Contemporary Pediatrics, Managed Healthcare Executive, and Medical Economics.
Not every vaccine is recommended for universal application, but clinicians largely lack understanding about these conditional or permissive recommendations and don’t know how to talk to patients and families about them.
Not every adolescent or young adult needs to get vaccinated against meningococcal disease, according to the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP), but a new report reveals that clinicians don’t really understand the permissive nature of ACIP’s recommendation and how to talk to patients about it.1
Allison Kempe, MD, MPH, a professor of Pediatrics at the University of Colorado School of Medicine, Aurora, director of the Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), and lead author of the paper, says the study sought to investigate what clinicians knew about category B recommendations, specifically pertaining to the serogroup B meningococcal (MenB) vaccines.
The category B MenB recommendation was the first use of the designation by ACIP for a large group, and was issued for teenagers and young adults in 2015. Prior to this recommendation, the only other category B recommendation was made in regard to hepatitis B vaccines in a subgroup of adult patients, according to the report. A category B recommendation means that individual clinical decision-making should guide recommendations based on assessment of risk and benefit, whereas a category A recommendation means that all members of a particular group should routinely receive a vaccine.
According to the CDC, meningococcal disease is caused by the bacteria Neisseria meningitidis and can lead to meningitis and infections of the blood. The disease can occur without warning in healthy individuals, and is spread through close contact with infected individuals. Infants aged younger than 1 year, teenagers and young adults, individuals who are immune compromised, and individuals exposed to a community outbreak are at a higher risk of contracting meningococcal disease, according to the CDC. Once contracted, meningococcal disease is serious and, even with treatment, kills 10% to 15% of those infected. Another 10% to 20% of those who survive the disease may still suffer permanent damage or disability.
Vaccination can help prevent the disease, but it cannot be administered to individuals with certain allergies, or to women who are pregnant or breastfeeding.
Outbreaks of MenB are rare, but the CDC has tracked recent incidences on college campuses, including 2 ongoing outbreaks on college campuses in Massachusetts and Oregon.
In a report issued shortly after the category B recommendation was made, the reasoning behind the decision to grant a category B, or permissive, recommendation rather than a category A, or universal, recommendation was that there simply was not enough evidence to warrant an endorsement that all adolescents and young adults receive the vaccine. The low frequency of the disease and the high cost of universal vaccination along with insufficient data about duration of protection and safety of the vaccine led the ACIP to give providers and patients a choice.
“Under category B, patients should have a choice between being vaccinated or not being vaccinated, a choice that boils down to, at the individual level, the trade-off between a sore arm and continued vulnerability to a rare but potentially devastating disease, the 2017 report from Pediatrics notes. “One problem with the latter approach is that there is no way to predict, short of exposure during an outbreak, which healthy adolescents are at risk for invasive serogroup B disease-even college attendance is not a risk factor.”
Kempe’s report, however, reveals that many clinicians don’t know what to make of the recommendation.
“I hope this manuscript will both alert pediatricians to the fact that they may not understand what category B ACIP recommendations mean, as well as provide them with information about the difference between the meaning of category A and B recommendations,” Kempe says. “In addition, the manuscript provides information about insurance coverage for vaccination covered by category A and B recommendations.”
The recommendation was developed as the result of a national survey of pediatric and family practitioners via e-mail. Over the course of the study, only 24% of respondents correctly identified what a category B recommendation was, and 55% were unaware that private insurance would pay for category B vaccines. Another 51% responded that they didn’t know that category B vaccines would be covered by the Vaccines for Children program. Nearly 60% of respondents had difficulty explaining what a category B recommendation was to parents and patients; 22% believed that the ACIP should not make category B recommendations; and 39% liked the autonomy in decision-making that category B recommendations provide, according to the report.
“Providers’ lack of understanding of the difference between category A and B recommendations might result in the incorporation of a category B vaccine into a practice’s routine vaccine administration schedule via standing orders with little or no discussion of patients’ individual circumstances, which is not the intention of a category B recommendation,” the report notes.
For category B recommendations to be useful in guiding practice, clinicians need a better understanding of their meaning, implications for insurance payment, and guidance on how to communicate about the recommendation with parents and patients.
“Both the American Academy of Pediatrics and the American Academy of Family Physicians have provided guidelines either online or in publications about discussing category B ACIP recommendations,” Kempe says. “To supplement these efforts, such national organizations could be key in providing more specific talking points to help providers discuss category B vaccination recommendations with patients and families.”
Kempe says she hopes the guidelines will stimulate providers-particularly those who treat teenagers and young adults-to become better informed about the pros and cons of recommending the MenB vaccine and expand their understanding of the meaning of permissive or category B vaccine recommendations.
“There were significant differences between pediatricians and family physicians on several of the knowledge questions, although one specialty was not consistently more knowledgeable than the other,” the report says. “Given the fact that adolescents in the 16- to18-year-old age group may be roughly equally likely to see pediatricians or family physicians, both specialties need to be aware of the distinctions between types of recommendations, particularly with respect to MenB vaccine.”
1. Kempe A, Allison MA, MacNeil JR, et al. Knowledge and attitudes regarding category B ACIP recommendations among primary care providers for children. Acad Pediatr. April 17, 2018. Epub ahead of print.