Infectious Diseases

Adolescent Vaccinations

Advertisment

Meningococcal Vaccines: Safety, Efficacy, and Coverage Rates

expert roundtables by Robert W. Frenck Jr., MD; Gary S. Marshall, MD; Flor M. Muñoz, MD, MSc, FAAP
Overview

Meningococcal disease is extremely rare, and this makes it difficult to convince people that routine vaccination is worthwhile. Messaging for meningococcal vaccination should include reassurance about vaccine safety, evidence of efficacy, and clear but measured communication about the potentially severe impact of this disease.

QUESTION:
What are your thoughts on the safety and efficacy of meningococcal vaccines, as well as the vaccination coverage rates?
"The best approach to the prevention of meningococcal disease in the community is to improve vaccination coverage rates before an outbreak occurs because the purpose of the vaccine is precisely to prevent disease and mortality.”
— Flor M. Muñoz, MD, MSc, FAAP

Meningococcal disease is terrifying, as anyone who has had to take care of a patient with a meningococcal infection can attest. It is highly contagious and has a very high fatality rate, as approximately 1 of every 10 people with meningococcal infections has been reported to succumb to the disease. In a susceptible population, meningococcal infection can be devastating. It is easily transmitted and can result in severe consequences among survivors, including neurologic, pulmonary, and vascular long-term effects.

 

Some patients end up on dialysis for the rest of their lives because their kidneys shut down and have irreversible damage during the acute illness. Additionally, patients might suffer from the need to amputate limbs that are severely affected by shock and coagulation disorders, or they might have neurologic disabilities due to the effects of the disease on the brain. Sometimes, we do not understand the impact of meningococcal disease until we pay attention to the stories that are told by survivors and families who have been affected by it.

 

The best approach to the prevention of meningococcal disease in the community is to improve vaccination coverage rates before an outbreak occurs because the purpose of the vaccine is precisely to prevent disease and mortality. Nonetheless, when encouraging meningococcal vaccination, we do not want to scare families. Instead, we want to promote understanding about the way that this disease is transmitted, how contagious it is, and how quickly an outbreak can occur and get out of control. Vaccines work, but if you wait until an outbreak occurs to give the vaccine, there will be people who have already been negatively impacted by the time the vaccine has time to have an effect and help control the outbreak.

“To me, there is no downside to receiving the currently available meningococcal vaccines. They are safe vaccines, and they provide a good immune response. Yes, meningococcal disease is a very rare disease, but if you are the unlucky person who gets it, it is a potentially catastrophic event.”
— Robert W. Frenck Jr., MD

Yes, it can be a challenge to increase vaccination coverage rates, particularly if the disease is rare like meningococcal disease. And if you look at what we call quality-adjusted life years, the meningococcal vaccines are one of the most expensive recommended vaccines. In 2020, only 240 cases of meningococcal disease were reported in the entire United States. That is actually less than 1 case for every 1 million persons in the US population, and, if you are looking at teenagers, it is probably even a bit less than 1 in 1 million persons. However, the infection can be devastating, which is what led to the recommendation of all children aged 13 to 15 years to be vaccinated against meningococcus, with a booster at 16 to 18 years of age.

 

Typically, vaccine efficacy is based on a clinical trial demonstrating a decrease in disease among vaccine recipients. However, meningococcal disease is so uncommon, and vaccine approval was based on safety and immunogenicity. It is known that people with a serum bacterial assay titer of greater than or equal to 1:8 are protected against meningococcus. So, efficacy of the meningococcal vaccine was based on the percentage of people in whom the vaccine resulted in a titer of greater than or equal to 1:8.

 

Because meningococcal disease remains a very rare disease, and the ability of the serogroup B meningococcal (MenB) vaccine to quell an outbreak was not clear, the Advisory Committee on Immunization Practices (ACIP) recommendation for the use of the MenB vaccine in the general population is as follows: “. . . for adolescents and young adults aged 16–23 years on the basis of shared clinical decision-making to provide short-term protection against disease caused by most strains of serogroup B N. meningitidis.

 

Clinically, I do not think that there is a significant difference between the available MenB vaccines, which means that the big issue is not deciding which vaccine to get. Rather, the bigger issue is the decision to get vaccinated vs to not get vaccinated. The difference between the kind of protection that you will get from one vaccine manufacturer vs another is small. To me, the most important thing is getting them into people’s arms.

 

To me, there is no downside to receiving the currently available meningococcal vaccines. They are safe vaccines, and they provide a good immune response. Yes, meningococcal disease is a very rare disease, but if you are the unlucky person who gets it, it is a potentially catastrophic event.

“. . . previously, the low-hanging fruit for vaccination were very common diseases such as chickenpox, measles, mumps, and polio. We have done a good job of vaccinating against those diseases and are now dealing with diseases that have a 1 in a million incidence rate. And yet, that does not mean that we should have no interest in preventing them.”
— Gary S. Marshall, MD

I am glad that Dr Frenck brought up the absolute numbers of cases, because that is what this all comes down to. If you assume a 10% or 15% mortality rate, given the low number of cases reported annually, there may be a total of only 15 or 20 deaths per year among adolescents in the United States. This is far less than the number of children who die from influenza every year, and the number of those who have died from COVID-19. In terms of bang for your buck, you would probably be better off getting influenza and COVID-19 vaccine coverage to nearly 100% rather than getting meningococcal vaccine coverage to that level.

 

That does not mean that protection is not warranted—invasive meningococcal disease is serious and can be prevented. I just think that the strategy for meningococcal vaccines has to be a little different than it is for the influenza or COVID-19 vaccines. Instead of emphasizing that this potentially life-threatening bacteria is out there and that they really need to be protected against it, we can say something like, “Look, this disease is very, very rare, but it is unpredictable, rapidly progressive, and extremely serious. There is really no reason not to be vaccinated. Your arm may hurt a little, and you may have minor side effects, but then you will be fine—and protected.”

 

It is important to point out that, with MenB, there are many strains that differ from one another only slightly. Both of the available MenB vaccines protect against the strains that are circulating, but the spectrum of activity is measured in different ways. That is part of the problem. There is no standard way to assess efficacy against all those strains. In the eyes of the ACIP and the US Food and Drug Administration (FDA), there is no clinically meaningful difference between the 2 available MenB vaccines.

 

We are in an interesting time now because, previously, the low-hanging fruit for vaccination were very common diseases such as chickenpox, measles, mumps, and polio. We have done a good job of vaccinating against those diseases and are now dealing with diseases that have a 1 in a million incidence rate. And yet, that does not mean that we should have no interest in preventing them.

References

Bekkat-Berkani R, Fragapane E, Preiss S, et al. Public health perspective of a pentavalent meningococcal vaccine combining antigens of MenACWY-CRM and 4CMenB. J Infect. 2022;85(5):481-491. doi:10.1016/j.jinf.2022.09.001

 

Centers for Disease Control and Prevention. Disease burden of flu. Updated October 4, 2022. Accessed December 7, 2023. https://www.cdc.gov/flu/about/burden/index.html

 

Centers for Disease Control and Prevention. Meningococcal disease surveillance. Reviewed July 10, 2023. Accessed December 7, 2023. https://www.cdc.gov/meningococcal/surveillance/index.html

 

Centers for Disease Control and Prevention. Meningococcal vaccination: what everyone should know. Reviewed November 20, 2023. Accessed December 7, 2023. https://www.cdc.gov/vaccines/vpd/mening/public/index.html

 

De Oliveira LH, Jauregui B, Flavia Carvalho A, Giglio N. Impact and effectiveness of meningococcal vaccines: a review. Rev Panam Salud Publica. 2017;41:e158. doi:10.26633/RPSP.2017.158

 

Findlow J, Lucidarme J, Taha MK, Burman C, Balmer P. Correlates of protection for meningococcal surface protein vaccines: lessons from the past. Expert Rev Vaccines. 2022;21(6):739-751. doi:10.1080/14760584.2021.1940144

 

Mbaeyi SA, Bozio CH, Duffy J, et al. Meningococcal vaccination: recommendations of the Advisory Committee on Immunization Practices, United States, 2020. MMWR Recomm Rep. 2020;69(9):1-41. doi:10.15585/mmwr.rr6909a1

 

McMillan M, Wang B, Koehler AP, Sullivan TR, Marshall HS. Impact of meningococcal B vaccine on invasive meningococcal disease in adolescents. Clin Infect Dis. 2021;73(1):e233-e237. doi:10.1093/cid/ciaa1636

 

Ortega-Sanchez IR, Lee GM, Jacobs RJ, et al. Projected cost-effectiveness of new vaccines for adolescents in the United States. Pediatrics. 2008;121(suppl 1):S63-S78. doi:10.1542/peds.2007-1115H

 

Pingali C, Yankey D, Elam-Evans LD, et al. National, regional, state, and selected local area vaccination coverage among adolescents aged 13-17 years – United States, 2020. MMWR Morb Mortal Wkly Rep. 2021;70(35):1183-1190. doi:10.15585/mmwr.mm7035a1

 

Robert W. Frenck Jr., MD

Professor of Pediatrics
Director, Center for Vaccine Research
Division of Infectious Diseases
Cincinnati Children’s Hospital
Cincinnati, OH

Gary S. Marshall, MD

Professor of Pediatrics
Chief, Division of Pediatric Infectious Diseases
Norton Children's and the University of Louisville School of Medicine
Louisville, KY

Flor M. Muñoz, MD, MSc, FAAP

Associate Professor of Pediatrics and Infectious Diseases
Texas Children’s Hospital
Baylor College of Medicine
Houston, TX 

Advertisment