Adoption of Serogroup B Meningococcal Vaccine Recommendations

Discussion

This is the first national US survey of which we are aware in which researchers assess reported practices related to MenB vaccine delivery since the ACIP’s Category B recommendation for its use. With our findings, we indicate that one-half of pediatricians and approximately one-third of FPs report often or always initiating a discussion about the MenB vaccine for 16- to 18-year-olds. Greater awareness about outbreaks of disease was associated with a higher likelihood of discussing the vaccine, whereas lower awareness about the vaccine and working in an HMO setting were associated with a lower likelihood. Those physicians who reported initiating a discussion almost always reported making a recommendation to vaccinate, whereas those who rarely initiated discussions were unlikely to recommend vaccination. Providers most often cited outbreaks of MenB disease, incidence of disease, and effectiveness, safety, and duration of protection of the MenB vaccine as reasons for increasing their likelihood of recommending the MenB vaccine, although many providers reported a lack of knowledge regarding these potential influences. Two factors many providers reported would make them less likely to recommend the MenB vaccine were the fact that the MenB vaccine was given a Category B recommendation and inconsistency of reimbursement.

Whether our data indicate a level of discussion regarding the MenB vaccine that is consistent with a Category B recommendation depends on one’s interpretation of how such a recommendation should be implemented. According to the original definition of a Category B recommendation based on the Grading of Recommendations Assessment, Development and Evaluation approach used by the ACIP, such recommendations are supposed to result in individual clinical decision-making “in the context of a clinician-patient interaction.”⁷ In line with this interpretation, the authors of the AAP’s policy statement, as previously discussed, encouraged pediatricians to discuss the MenB vaccine with parents and patients.⁹ Others have stressed that a Category B recommendation is different from “no recommendation at all” and should consistently result in a discussion with parents and patients because individual decision-making “cannot occur if a patient does not know about the vaccine and the disease.”¹⁵

However, physicians may interpret “individual clinical decision-making” to reflect their own decision about whether to initiate a discussion of the MenB vaccine, given their assessment of the risks and benefits of vaccinating, without involving parents or patients in decision-making. Providers may choose not to initiate a discussion with parents or patients if they do not intend to recommend the MenB vaccine because of issues such as the low burden of the MenB disease in the United States or the lack of data about the effectiveness of the MenB vaccine, its duration of protection, or its safety.⁴ In our study, the fact that those providers who reported initiating a discussion were overwhelmingly also likely to recommend the MenB vaccine, whereas those not initiating a discussion were unlikely to recommend, is consistent with this second interpretation. Providers not initiating a discussion may not think the time required to discuss the MenB vaccine is justified by the risks posed by the disease or the benefits offered by these vaccines. Alternatively, they may have a low level of awareness regarding the disease or the MenB vaccine and feel insufficiently knowledgeable to have an informed discussion about the pros and cons of vaccination. They also may have been entirely unaware of the ACIP recommendation for MenB vaccination. Why providers working in an HMO setting were less likely to initiate a discussion is unclear. This may reflect different decisions regarding the cost-benefit ratio of the MenB vaccination in an HMO as opposed to other practice settings or may reflect more centralized decision processes in HMO settings.

Our data reveal a lack of familiarity with many aspects of the MenB disease and the MenB vaccine among primary care providers. For example, the incidence of the MenB disease, the vaccines’ effectiveness, and the duration of protection afforded by the vaccines were among the top 5 reasons supporting a higher likelihood of provider recommendation. In truth, the low incidence of the MenB disease might be expected to be a likely reason for not recommending these vaccines. The vaccines’ effectiveness against clinical disease had not been demonstrated at the time but was inferred on the basis of an immunologic marker of protection, and the 2 licensed vaccines were not expected to provide protection against all serogroup B strains circulating.⁴ In addition, the duration of protection provided by the MenB vaccines is unknown, and studies have revealed a rather steep decline in antibodies for both vaccines, suggesting protection may in fact be short-lived.^16,17 Finally, sizable portions of respondents, especially FPs, reported they “didn’t know” how these factors influenced recommendation decisions. Providers were also more likely to recommend the MenB vaccine at precollege visits rather than routine 16- to 18-year-old health maintenance visits, as recommended by the ACIP, possibly as the result of the extensive publicity around college outbreaks of the MenB disease. They were more likely to initiate a discussion regarding the vaccine if they were aware of the MenB disease outbreaks in their state, despite the fact that most cases are not outbreak-related.⁹ Approximately 10% of pediatricians and one-third of FPs reported recommending the MenB vaccine to healthy 11- to 12-year-olds, indicating confusion with timing for the first MenACWY vaccine. In addition, 19% of pediatricians and 43% of FPs reported making no recommendation regarding the MenB vaccine for children aged ≥10 years who were at increased risk for meningococcal disease. MenB vaccination in this group is a Category A, rather than Category B recommendation; therefore, this is an important misunderstanding among primary care physicians. These findings suggest a need to develop methods of better highlighting differential recommendations for the same vaccine in different patient groups.

The rather substantial differences in awareness regarding the MenB vaccine and in delivery practices seen between pediatricians and FPs reflect previous literature. Similar to previous studies regarding childhood^{12–14,18–20} and adolescent vaccines,^21–26 FPs were much less likely to have been aware of the MenB vaccine before our survey and were less likely to report initiating a discussion or recommending the MenB vaccine or to administer the MenB vaccine in their office. The multivariable model suggests that the lack of knowledge regarding the MenB vaccine was a major contributing factor in not initiating vaccine discussions. FPs were also more likely to report they didn’t know about many of the factors queried as reasons for recommending or not recommending the MenB vaccine. As discussed in previous literature, FPs may have different attitudes and practices than pediatricians related to the fact that they may see fewer or less severe cases of certain childhood diseases, have more competing demands given their focus on both children and adults, and may face more barriers related to vaccine financing and vaccine supply.^19,27

There are strengths and limitations to our data. We surveyed large, nationally representative samples of pediatricians and FPs and achieved high response rates. The responses of our sentinel physicians may not be fully generalizable, especially because participating providers are aware they are going to be surveyed about vaccine-related issues. However, authors of previous work have demonstrated the sampling methods described yield similar responses to the most commonly employed method of sampling physicians nationally.¹⁰ Nonrespondents may have had different views than respondents, although the high response rates somewhat mitigate against this source of bias. The survey was conducted a year after the Category B recommendations were made, and results might differ if a longer time frame after the recommendations had been used. Finally, physicians’ reported frequency of initiating a discussion about the MenB vaccine or recommending it were based on self-report rather than direct observation and responses may reflect social desirability bias.

Primary care physicians are responding to the new Category B recommendation for the MenB vaccine in a variety of ways, which might be expected from this type of recommendation. Our data suggest that a lack of knowledge about MenB disease or awareness of the MenB vaccine may be a primary motivation for not initiating a discussion for many, rather than clinician or parent and patient assessment of the risk and benefit of these vaccines. Many primary care physicians do not appear to be familiar enough with the data required to have a well-informed discussion with parents and patients about the pros and cons of the MenB vaccination in healthy adolescents. In addition, sizable percentages are unaware of the routine recommendation for MenB vaccination in children aged ≥10 years at increased risk. Lack of awareness about the MenB vaccine may not be surprising given the competing demands of primary care, the low prevalence of MenB disease, and the relative newness of the recommendation. With our data, we highlight the challenges providers face with implementing recommendations for vaccination based on individual clinical decision-making when they have limited experience with a disease and limited knowledge of a new vaccine. Because category B recommendations are likely to continue to occur in certain situations, it will be key for national clinical organizations such as the AAP and AAFP to provide as specific guidance as possible about how to implement Category B recommendations for different vaccines, including talking points, to assist in the complex decision-making that such a recommendation requires.