Expert Perspectives on the Vaccination of Individuals Who Are at Increased Risk of Meningococcal Disease Due to Medical Conditions: A Podcast (MP4 490702 kb)

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Introduction

Oscar Herrera-Restrepo

Hello everyone, and welcome to our podcast with Infectious Diseases and Therapy entitled “Expert Perspectives on Vaccination in Individuals Who Are at Increased Risk for Meningococcal Disease.” My name is Oscar Herrera-Restrepo, US Health Outcomes Director at GSK. Today, I am delighted to be joined by Dr. Gary Marshall, Chief of the Division of Pediatric Infectious Diseases at Norton Children’s and Professor of Pediatrics at the University of Louisville School of Medicine in Kentucky, and my colleagues Dr. Diana Clements, US Medical Affairs Director for Meningococcal Disease, and Wanda Conley, US Medical Communications and Scientific Training Director, both at GSK.

In this podcast, we will start with a brief recap of meningococcal disease, who is at increased risk for this disease, and available vaccines. We will then do a deep dive into the state of vaccination coverage in these populations, focusing on challenges for implementing vaccine recommendations for groups at increased risk, and discuss strategies to reach out to these vulnerable populations.

Discussion

Oscar Herrera-Restrepo

Alright, let’s start with some background about meningococcal disease and who is at increased risk for this condition. Gary, what can you tell us about this?

Gary Marshall

Well, Oscar it is good to be with you. Invasive meningococcal disease, or IMD, is very rare but very serious. It is an infection caused by the bacterium Neisseria meningitidis [1] and it can manifest as sepsis or meningitis, and even when treated appropriately with antibiotics and supportive measures it can lead to death in 10–15 out of every 100 cases [2]. Up to 40% of survivors can have permanent sequelae, including things like hearing loss, seizures, kidney damage, skin scarring, and even loss of limbs and digits [3].

People with functional or anatomic asplenia, including sickle cell anemia; complement component deficiency; and HIV infection have a significantly increased risk of developing IMD [4]. Other groups that are at risk include people who take complement inhibitors; microbiologists who are routinely exposed to N. meningitidis; individuals exposed during outbreak; individuals who travel to or live in countries where meningococcal disease is hyperendemic or epidemic; and also first-year college students living in residence halls and military recruits, that is because of their close contact with each other [4].

So going back to individuals with medical conditions, the risk of IMD may be as much as 10,000-fold higher among people with persistent complement component deficiencies as compared to healthy individuals [4, 5]. Likewise, the risk of IMD among people with HIV has been reported to be 10–13 times higher than the risk in individuals without HIV [6, 7], and in those with functional or anatomic asplenia they have a 40–70% higher mortality rate due to meningococcal disease, compared to healthy people [4, 8,9,10,11].

Oscar Herrera-Restrepo

Thank you, Gary. Diana, a follow-up question then is, what vaccines are currently available in the US for prevention of meningococcal disease?

Diana Clements

Thank you, Oscar. It’s great to be here also with Dr. Marshall and Dr. Conley.

In summary, to help protect against the serogroups that most commonly cause disease, two vaccine types are currently recommended by the Advisory Committee on Immunization Practices, or ACIP, of the Centers for Disease Control and Prevention: one type protects against serogroups A, C, W, and Y, known as MenACWY vaccines, and one protects against serogroup B, known as MenB vaccines [4, 12].

Vaccination recommendations vary between vaccine types. For instance, MenACWY vaccines are routinely recommended for individuals 2 months of age or older who are diagnosed with functional or anatomic asplenia, complement component deficiencies (including use of complement inhibitors), or HIV [4]. The ACIP-recommended vaccination schedule consists of 2–4 doses, depending on the age when the first dose is received and the vaccine type. Booster doses are recommended for individuals who remain at increased risk 3 years after the primary vaccination and every 5 years thereafter for individuals 2–7 years of age, and 5 years after the primary vaccination and every 5 years thereafter for individuals 7 years of age or older [4].

MenACWY vaccines are also recommended for other groups at increased risk, including microbiologists routinely exposed to N. meningitidis; individuals identified to be at increased risk during an outbreak caused by serogroups A, C, W, or Y; individuals who travel to or live in countries where meningococcal disease is hyperendemic or epidemic; and first-year college students living in residence halls; and military recruits. These individuals also receive periodic booster doses in some cases [4].

MenB vaccines, on the other hand, are routinely recommended for individuals 10 years of age or older who are diagnosed with functional or anatomic asplenia, or complement component deficiencies (including use of complement inhibitors) [4]. The vaccination schedules of the two MenB vaccines that are currently available in the US are different: one is 2 doses at least 1 month apart, the other is 3 doses, at 0, 1–2, and 6 months. For both vaccines, the ACIP recommends booster doses be administered to individuals who remain at increased risk 1 year after completion of primary vaccination and every 2–3 years thereafter [4]. Note that HIV per se is not an indication for MenB vaccination, but individuals living with HIV may qualify for MenB vaccination if otherwise indicated [4].

MenB vaccines are also recommended for other groups at increased risk, including microbiologists routinely exposed to N. meningitidis; and individuals identified to be at increased risk during an outbreak caused by serogroup B. These individuals also receive periodic booster doses in some cases [4].

I should also mention that MenACWY vaccines are also routinely recommended for all adolescents and MenB vaccines are recommended for adolescents under shared clinical decision-making [4].

Oscar Herrera-Restrepo

Thanks Gary and Diana for that thorough overview. It’s clear that individuals who are at increased risk for meningococcal disease due to medical conditions should be routinely vaccinated. I’d like to review what the available data tell us about the state of vaccination coverage in these high-risk groups.

A retrospective study looking at US commercial claims showed that 28.1% of individuals newly diagnosed with asplenia, excluding sickle cell disease, received a MenACWY vaccine, and 9.7% received a MenB vaccine, in the first 3 years after diagnosis [13]. Vaccine series completion was 11.6% for MenACWY and 51.3% for MenB within 2 years of the first dose among individuals with at least 1 year of continuous enrollment after the first dose [13].

A similar retrospective study of US commercial claims showed that less than 5% of individuals newly diagnosed with complement component deficiencies initiated MenACWY or MenB vaccination within 3 years of the diagnosis [14]. For individuals who received the first dose of these vaccines and had at least 1 year of continuous enrollment after the first dose, vaccine series completion within 1 year of the first dose was 4.4% for MenACWY and 83.3% for MenB [14].

For individuals newly diagnosed with HIV, in a cohort study using US commercial claims, only 16.3% of individuals eligible for vaccination received a first dose of the MenACWY vaccine in the 2 years after an HIV diagnosis [15]. Also, among those individuals who received a first dose and had at least 1 year of continuous enrollment after the first dose, only 66.2% received a second dose within 1 year of the first dose [15].

MenACWY vaccine coverage rates for individuals with increased risk due to medical conditions are much lower than those for adolescents who fall under the routine recommendations mentioned by Diana earlier. In 2021, for example, 89% of US teens 13–17 years of age had received at least one dose of the MenACWY vaccine, which is routinely recommended at 11 or 12 years of age, and 60% of 17-year-olds had received the booster dose routinely recommended at age 16 [16].

So, in addition to the data that suggest suboptimal coverage in these vulnerable populations, it’s important to consider the recent meningococcal disease outbreak in Florida, and what we can learn from it. Wanda, would you comment on this, particularly in relation to populations at increased risk for meningococcal disease?

Wanda Conley

Indeed Oscar, it is my pleasure to join the group today, thank you for having me. Since December 2021 a large group of cases of serogroup C meningococcal disease have been reported in Florida [17, 18]. According to CDC reports, this outbreak has mainly involved gay and bisexual men; half of the cases are among Hispanic men, and some of the people affected report living with HIV [17]. As of June 2022, the CDC reported at least 24 cases and 6 deaths among gay and bisexual men [19]. More recently, as of the end of November 2022, the Florida Department of Health reports 65 total confirmed cases of meningococcal disease to date in their ongoing outbreak, although granular detail of the serogroup breakdown of these cases isn’t specified [20].

In response to this outbreak and following the ACIP vaccination guidelines for individuals identified to be at increased risk during an outbreak caused by serogroups A, C, W, or Y, [4] the CDC has encouraged gay and bisexual men to get a MenACWY vaccine if they live in Florida, and to discuss getting a MenACWY vaccine with their healthcare provider if they have plans to visit Florida [19].

In addition to groups for which MenACWY is already routinely recommended, including people living with HIV infection, immunocompromised individuals such as those with asplenia, sickle cell disease, complement component deficiencies, or those taking complement inhibitors, the Florida Department of Health has also advised individuals 18 years of age and older to consider vaccination with a MenACWY vaccine if they are men who have sex with men or members of the LGBTQ+ community; they also recommend any person in an at-risk group who received their MenACWY vaccine more than 5 years ago receive another MenACWY vaccine [18]. Health officials are continuing to monitor the outbreak in Florida, as exposures could increase as students return to college campuses for the 2022–2023 academic year [21].

Oscar Herrera-Restrepo

Thank you, Wanda. This recent outbreak highlights how important it is to improve coverage of routinely recommended vaccines among those who are at increased risk for meningococcal disease. Thinking along these lines, what do you think the main challenges are for implementing the current vaccine recommendations for groups at increased risk? Also, what strategies could be implemented to help overcome these challenges and improve vaccine coverage in these vulnerable populations? Diana?

Diana Clements

Yes, these are very important questions. Considering what Wanda has said about the recent outbreak in Florida, improved vaccination coverage could help prevent additional cases and deaths. The main challenges for implementing the current recommendations are inadequate knowledge of recommendations among healthcare providers, and difficulties identifying patients at risk, and also the lack of access to vaccination opportunities for individuals at increased risk. Healthcare providers need improved knowledge of the recommendations and awareness of the low vaccination coverage. This would help ensure awareness of the need for vaccination in vulnerable populations.

And even furthermore, even if the healthcare provider is aware of the recommendations, they may not have a system to automatically identify those who fall into the high-risk categories and remind them to consider vaccination. Therefore, I think that to bolster healthcare provider adoption of the ACIP recommendations, provider reminders or recall systems around meningococcal vaccination, especially if tied to immunization information systems, could be one mechanism, out of many others, that could be implemented.

Oscar Herrera-Restrepo

Thank you, Diana. Gary, what are your thoughts on this?

Gary Marshall

Well, I want to go back to two things that were said earlier in the podcast. One is that certain people, such as those with complement component deficiencies are at 10,000-fold increased risk of IMD. And the second thing is, as you told us Oscar, a majority of people with these high-risk conditions are not being vaccinated. So, I think that every provider needs to look at every visit as an opportunity to update and complete immunizations, and that applies to all immunizations, but particularly for populations that are at increased risk for certain diseases, and in this case, we are talking about IMD. As Diana mentioned, healthcare providers need to be aware of and understand the ACIP recommendations for MenACWY and MenB vaccines, both in healthy individuals and in those at increased risk. This has been part of the confusion, because really there are a lot of different recommendations and there are two different types of vaccines.

So, I want to boil it down to four general rules: One is, that MenACWY vaccines are recommended for all adolescents, that is a so-called strong recommendation; MenB vaccines are recommended for adolescents under shared clinical decision-making, which essentially means that the provider and the patient should have a discussion about the disease and about the availability of the vaccine; the third is that MenACWY vaccines are recommended for individuals at increased risk of IMD due to their medical conditions or in some cases their epidemiological circumstances; and then fourth, MenB vaccines are also recommended for certain individuals who are at increased risk, but it is not always exactly the same situations and individuals for which the MenACWY vaccine is recommended [4]. So those four main rules are important to keep in mind.

The studies mentioned earlier by Oscar showed that a well-visit or a pneumococcal vaccine were associated with receipt of the MenACWY vaccine [13, 14]. For me, this speaks to the importance of bundling preventive services together to protect vulnerable populations—co-administering vaccines, presenting the indicated vaccine as a package, and taking advantage of any visit as a natural and logical opportunity to reach out to these individuals.

Oscar Herrera-Restrepo

What about you, Wanda?

Wanda Conley

Well, building on your comments, another important challenge is how to create a sense of urgency among healthcare providers around low vaccination coverage, highlighting the critically important role they play in educating patients on available vaccines, providing strong recommendations, and prescribing and administering vaccines.

We know the majority of vaccinations occur in a medical setting, where notable differences exist between provider types regarding the frequency of immunizing individuals at increased risk [13,14,15]. Therefore, medical education for healthcare providers and patients needs to be tailored to particular provider situations. For example, infectious disease specialists are often the healthcare providers for individuals with HIV and may be more accustomed to stocking and administering meningococcal vaccines. It is also possible that individuals with HIV are more engaged with their healthcare providers and the healthcare system due to management of antiretroviral therapy regimens, resulting in more opportunities to receive recommended vaccines. However, even with this potential higher frequency of healthcare interactions, meningococcal vaccination coverage in eligible individuals with HIV is low.

Knowledge gaps among providers and patients on insurance coverage of meningococcal vaccines can also pose barriers to increasing vaccination coverage. Meningococcal vaccines are usually covered by insurance and are also covered by the Vaccines for Children Program [22, 23]. Targeted education on insurance coverage for both providers and patients across different age groups could help to minimize those barriers.

When I think about vaccination outreach strategies, two pathways come to mind. The first focuses on research exploring the impact of provider type and setting so that targeted medical education can be implemented. The second focuses on exploring vaccine administration on alternative sites of care, which can be supported through mapping vaccine supply in relation to where individuals at increased risk live. This could help increase accessibility of the vaccine for these patients. There is evidence that this approach has been successful in other diseases—previous research has shown that expanding access to the influenza and pneumococcal vaccines to a pharmacy setting has had a favorable impact on vaccine uptake [24].

Conclusion

Oscar Herrera-Restrepo

Listening to all these thought-provoking points, I think my main takeaway from today’s conversation is that more work needs to be done to improve vaccination coverage among individuals at increased risk for meningococcal disease due to medical conditions; not an easy endeavor for sure, but some of the strategies discussed here can shed light on how to put knowledge into action. Before concluding, Gary, Diana, and Wanda, any final reflections on this discussion?

Gary Marshall

Well, I’ll start. You know the ACIP recommended meningococcal vaccination for individuals at increased risk for IMD several years ago; but as you showed us, vaccination coverage remains low. I think educating healthcare providers on MenACWY and MenB vaccine recommendations and how they differ between the routine recommendations and the recommendations for at-risk patient groups could improve coverage. And I think the education should be tailored to the needs of particular provider types, for example, pediatricians versus internists versus subspecialists and nurse practitioners and the respective patient populations that they serve.

Diana Clements

I couldn’t agree more, Gary. I think it’s also particularly important to point out that, despite the past and ongoing public health efforts, meningococcal vaccination rates continue to be very low among these newly diagnosed vulnerable individuals. The current outbreak of meningococcal disease in Florida highlights the importance of expanding access and increasing meningococcal vaccine uptake across all populations, including those that are commercially, Medicaid, and Medicare insured, as well as those who are uninsured.

Wanda Conley

Those are really important points. Just a final comment, that the low uptake of vaccination suggests that we need broader interventions; this has been recognized by the CDC, which has put forth several evidence-based recommendations to increase vaccination uptake among all ages and populations [25]. It seems clear that administering vaccines in alternative healthcare settings, including pharmacies, as well as settings where individuals at increased risk gravitate to, so maybe childcare centers, schools, home visits, case management, and targeted outreach initiatives may prove beneficial in enhancing vaccine uptake.

Oscar Herrera-Restrepo

Well, this concludes our podcast. Thank you, Gary, Diana, and Wanda for your time and insights today. We hope that this has been of interest to our listeners.