Vaccine hesitancy or refusal of MenB vaccination during an outbreak
BY MICHAEL E. PICHICHERO, MD
Credit: Monkey Business/Fotolia
Neisseria meningitides infections are uncommon but they have a high mortality (10%-15%) and morbidity, loss of limbs being the most dramatic. Vaccination is the best way to protect against meningococcal disease. Currently, two doses of quadrivalent meningococcal conjugate vaccine that protects against four serogroups (A, C, W, and Y; MenACWY) are recommended for adolescents at age 11-12 years and 16 years.1,2
Serogroup B meningococcal (MenB) vaccines were licensed in the United States in 2014 and 2015 for individuals aged 1-25 years. The Centers for Disease Control and Prevention recommendation for MenB is permissive that all adolescents and young adults may be vaccinated with a MenB vaccine, preferably at 16 through 18 years of age. However, the CDC recommends that certain adolescents and young adults should be vaccinated with a MenB vaccine. They include those identified as being at increased risk because of a serogroup B meningococcal disease outbreak and people with certain medical conditions.3
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MenB vaccines are an important step forward for controlling serogroup B meningococcal disease, but they will not prevent all cases. MenB vaccines protect against most but not all serogroup B strains circulating in the United States. Additional studies assessing breadth of strain coverage are ongoing, and the CDC will review results as they become available. Immunogenicity studies predict efficacy of MenB vaccines in most individuals in the short term, but there are currently no data available on duration of effectiveness; the limited data available on antibody persistence suggest rapid waning of antibodies after vaccination.3
Both MenB vaccines licensed in the United States require more than one dose for maximum protection. The same vaccine product must be used for all doses. Bexsero (GSK Vaccines) should be administered as two doses, with a second dose 1 or more months after first dose. Trumenba (Pfizer Vaccines) should be administered as two doses, with the second dose 6 months or more after first dose. The CDC has no preference as to which MenB vaccine is used.3
Although serogroup B meningococcal disease incidence among adolescents and young adults is low, with 50-60 cases and 5-10 deaths reported per year,2 serogroup B outbreaks on college campuses have garnered much public attention. During outbreaks, a 200- to 1,400-fold increase in risk was noted for meningococcal disease among students at these colleges during the outbreak period, compared with the equivalent age group in the general population.3
This review addresses the issue of vaccine hesitancy or refusal as it relates to MenB vaccination during an outbreak. Vaccine hesitancy and refusal reflects concerns about the decision to vaccinate oneself or one’s children.4 Various factors contribute to vaccine hesitancy, including the compulsory nature of vaccines, their coincidental temporal relationships to adverse health outcomes, unfamiliarity with vaccine-preventable diseases, and lack of trust in vaccine companies and public health agencies.4 Although vaccination is a norm in the United States and most parents vaccinate their children, many do so despite concerns. Vaccine refusal has been associated with outbreaks of invasive Haemophilus influenzae type b disease, varicella, pneumococcal disease, measles, and pertussis, resulting in unnecessary suffering of young children.4
Vaccine hesitancy is an extremely important issue that compromises effective control of MenB diseases. The complex causes of hesitancy surrounding MenB vaccine require a range of approaches at the provider, health system, and national levels. The potential of MenB vaccines to prevent illness and save lives has arrived. Yet, that potential is directly dependent on acceptance of vaccines, which requires confidence in vaccines and health care providers who recommend and administer vaccines.
The data on MenB vaccine acceptance, hesitancy during outbreaks
The published data in the United States and Canada on MenB vaccine acceptance and hesitancy during an outbreak were generated in recent years during prelicensure and early postlicensure use on college campuses. Several observations are noteworthy in a study reported by Breakwell et al. on factors affecting university students’ decision to receive a serogroup B meningococcal vaccine.5 To quell an outbreak, all undergraduates were offered two doses of meningococcal B vaccine (Bexsero, GSK); 51% of undergraduates received one or more doses. A knowledge, attitudes, and practice survey was conducted to understand which factors and sources of information affected student’s decision on whether to receive the vaccine. Among vaccinated respondents, the predominant reasons for receiving vaccine were knowledge of disease severity, parental recommendation, and believing that vaccination offered the best protection. Among unvaccinated respondents, the predominant reasons for not receiving vaccine were perception of low disease risk and concern over vaccine newness and safety. Respondents’ top primary sources of information were e-mails from the university, followed by their parents. The authors concluded that reasons behind students’ decision to receive the vaccine were similar to those reported for routinely recommended vaccines.
Parents’ and adolescents’ willingness to be vaccinated against serogroup B meningococcal disease during a mass vaccination in Saguenay–Lac-St-Jean (Quebec) was described by Dubé et al.6 A mass vaccination campaign with the MenB vaccine (Bexsero; GSK) was launched in a serogroup B endemic area in Quebec. A telephone survey was conducted to assess parental and adolescent opinions about the acceptability of the vaccine. Intent to receive the vaccine or vaccine receipt was reported by the majority of parents (93%) and adolescents (75%). The majority of parents and adolescents perceived meningitis as being a serious disease and they considered the MenB vaccine to be safe and effective. The main reason for positive vaccination intention or behavior was self-protection. A negative attitude toward vaccination in general was the main reason parents advised against vaccination. Adolescents reported lack of interest, time, or information, and low perceived susceptibility and disease severity as the main reasons for not being vaccinated.
In a follow-up survey, Dubé et al. reported 83% of children and 59% of adolescents were completely vaccinated.7 A positive association between intention reported prior to the campaign and vaccine receipt reported after the campaign was observed for both children and adolescents. Protection against meningococcal diseases was the main reason reported for those who completed the MenB dose series. About half of the vaccinees reported an adverse event after having received a dose of MenB vaccine; pain at the injection site and fever were the most often cited. Neither negative perceptions regarding the safety of the vaccine nor report of adverse events after having received a dose of the vaccine were associated with the vaccine refusal.
During an outbreak of invasive MenB disease on a university campus in Nova Scotia, Canada, MacDougal et al. explored the knowledge, attitudes, beliefs, and behaviors of members of the university community in relation to the disease, the vaccine, and the vaccination program.8 Design: An online survey was taken, which was administered after completion of the mass clinics for the first and second doses of a MenB vaccination program. Knowledge about meningococcal disease and vaccine was generally high; more than 70% correct responses were received on each knowledge question except for one question about the different meningococcal serogroups. Female gender and higher knowledge scores were significantly associated with either being immunized or intending to be immunized. Positive attitudes about immunization, concern about meningococcal infection, a sense of community responsibility, and trust in public health advice also correlated with being vaccinated or intending to be vaccinated.
In Australia when a MenB vaccine (Bexsero, GSK) was introduced Marshall et al.9 assessed community and parental attitudes to introduction of the new vaccine to identify facilitators and barriers to vaccine implementation: 83% of parents wanted their children to receive the Men B vaccine, with 12% unsure. Main parental concerns included potential side effects, adequate vaccine testing prior to licensure, and recommendations from public health authorities. Potential for an extra injection at an immunization visit resulted in 16% of parents reporting that they were less likely to have their children immunized. Potential redness/swelling at the injection site or mild/moderate fever resulted in only 9% of parents, respectively, reporting that they were less likely to have their children immunized. Children being up to date with vaccinations and recommendations from their physicians were the strongest independent predictors of parents agreeing their children should be immunized with MenB vaccine.
Decision-making status of 4CMenB vaccine introduction in the national immunization programmes in EU/EEA countries
* Defined as ‘assessment within the next six months from March 2015’ (based on VENICE III survey, 2015)
Note: Adapted from VENICE III survey (2015), presentations from country experts and ad hoc consultation with Member States
© European Centre for Disease Prevention and Control, 2017
More on reasons for vaccine hesitancy or refusal
The accompanying table shows the most common reasons for vaccine hesitancy or refusal generally. The results of the studies described above and other studies of vaccine hesitancy point to concerns about side effects as of primary importance. Some individuals have concerns about specific side effects that have been reported in the medical literature and public press such as Guillain-Barré syndrome following influenza or meningococcal vaccine and intussusception following rotavirus vaccine. For MenB vaccines, a consistent contributor to vaccine hesitancy has been that the risk of infection is very low and/or that the infection is not that dangerous. Other concerns include: vaccines don’t work, vaccines overwhelm the immune system, they actually increase susceptibility to infection, or that contracting the infection is a better way to achieve immunity. A third group of concerns surrounds a general distrust of institutions, authority, and the profit motive of vaccine companies.
Reasons for general vaccine hesitancy or refusal
- Safety concerns
- Risk of infection is too low to be concerned
- The disease is not dangerous
- Vaccines do not work
- Too many vaccines
- Vaccines overwhelm the immune system
- Natural infection is better than vaccination
- Government-mandated actions, including vaccination, are intrusive and inappropriate
- Vaccine companies and organized medicine have primarily a profit motive
Source: Dr. Pichichero
Managing vaccine hesitancy or refusal
The management of vaccine hesitancy or refusal begins with cognizance of the reasons it occurs (Table). When confronted with such a situation during a MenB outbreak, the first step is to establish a positive dialogue with the parent and/or adolescent. Approach the encounter using a positive nonconfrontational discussion that presumes the parents/adolescent will ultimately accept the vaccination. Listen respectfully to understand key concerns, and target education to address those concerns. Provide accurate estimates of the risks of the disease and risks of adverse events from MenB vaccination. Correct misconceptions and discuss any other elements of distrust that have become insurmountable. If the encounter does not result in vaccination, document it in the medical record, have the parent/adolescent sign a copy of a statement that they are refusing, and maintain the relationship for a future opportunity to re-engage on the topic.
Dr. Pichichero is a specialist in pediatric infectious diseases and director of the Research Institute at Rochester (N.Y.) General Hospital. He reported having no conflicts of interest. Email him at firstname.lastname@example.org.