Feb 29, 2024 ACIP Meeting - Meningococcal Vaccines

Centers for Disease Control and Prevention (CDC)

5 Mar 202439:48

EducationalLearning

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TLDRThe transcript outlines a meeting discussing meningococcal vaccines, focusing on the adolescent vaccination schedule and the introduction of GSK's pentavalent MenABCWY vaccine. The committee evaluates the current schedule, considering changes to MenACWY and MenB recommendations, and reviews the epidemiology and effectiveness of the vaccines. They also discuss the potential benefits of pentavalent vaccines in reducing injections and harmonizing schedules. The GSK vaccine, still in trials, is compared to Pfizer's PENBRAYA, with policy questions and outcomes, including gonorrhea prevention, considered.

Takeaways

📅 The meeting is resuming with a focus on meningococcal vaccines, with Dr. Loehr leading the Meningococcal Vaccines Work Group.
🧬 Two main topics are being discussed: a review of the current adolescent schedule for meningitis vaccines and informational updates on the GSK pentavalent vaccine.
🤔 The ACIP members are asked to consider if they concur with the four options for further assessment of the adolescent vaccine schedule.
📉 Coverage data for MenACWY and MenB vaccines in 2022 shows varied uptake, with MenB having lower coverage due to its recommendation based on shared clinical decision making.
📈 Incidence of meningococcal disease has been decreasing since before the introduction of MenACWY vaccine in 2005, but has seen an uptick in recent years.
🧪 Preliminary data from 2023 indicates the highest number of invasive meningococcal disease cases since 2014.
💉 The MenACWY vaccine is routinely recommended for adolescents at 11-12 and 16 years old, while MenB is recommended based on shared clinical decision making for 16-23 year olds.
🎓 College students have a higher risk of serogroup B disease, with a peak incidence at 19 years of age.
💡 The work group is considering several options for revising the adolescent schedule, including eliminating the 11-12 year old dose of MenACWY and changing MenB recommendations to routine or risk-based.
🌐 The GSK pentavalent MenABCWY vaccine is currently in clinical trials and is intended for 10-25 year olds, with a focus on its use as an option when both MenACWY and MenB are indicated.
🔄 The GSK vaccine, like the Pfizer vaccine before it, will be assessed on its effectiveness against meningococcal disease, short-term immunity, serious adverse events, and other factors.

Q & A

What is the primary focus of the Meningitis Vaccines Work Group meeting?
-The primary focus of the Meningitis Vaccines Work Group meeting is to discuss the current adolescent schedule for meningitis vaccines, review the options for changes, and consider the introduction of the GSK pentavalent MenABCWY vaccine.
What are the two main topics being discussed in the meeting?
-The two main topics being discussed are the review of the current adolescent schedule for meningitis vaccines and the informational presentation regarding the planned considerations for the GSK pentavalent vaccine.
What is the current recommendation for MenACWY and MenB vaccines for adolescents?
-The current recommendation is for adolescents to receive the MenACWY vaccine, with the first dose administered at 11 through 12 years of age and the second dose at 16 years of age. The MenB vaccine is recommended based on shared clinical decision making, typically given in a two-dose series for individuals aged 16 through 23 years, with a preferred range of 16 through 18 years.
How has the incidence of meningococcal disease changed since the introduction of the MenACWY vaccine?
-The incidence of meningococcal disease started to decline before the introduction of the MenACWY vaccine in 2005. However, there has been an uptick in disease incidence in recent years.
What is the coverage rate for the MenACWY and MenB vaccines among adolescents?
-The 2022 coverage for at least one dose of MenACWY vaccine was 84.5% for 13-year-olds and 89.8% for 16-year-olds. For 17-year-olds, coverage for at least two doses was 60.8%. The coverage for MenB vaccine was much lower, with 29.4% for at least one dose and 11.9% for at least two doses among 17-year-olds.
What are the considerations for changing the adolescent meningococcal vaccine schedule?
-Considerations for changing the schedule include optimizing protection against meningitis, taking into account ages at higher risk, recent epidemiology, duration of vaccine-induced protection, harmonization with the existing adolescent platform, and the use of pentavalent vaccines to reduce the number of injections.
What are the four proposed options for revising the adolescent meningococcal vaccine schedule?
-Option one maintains the current MenACWY recommendations and changes MenB to routine recommendations with doses administered at 16 and 17-18 years. Option two is similar to option one but with MenB recommendations based on risk. Option three eliminates the 11-12 year old dose of MenACWY. Option four changes the MenACWY schedule to 15 years for the first dose and 17-18 years for the second dose, with routine MenB vaccination at 17-18 years.
Why is the work group considering the elimination of the 11-12 year old dose of MenACWY?
-The work group is considering this due to the low incidence of disease in young adolescents and the potential for better aligning with the age of highest risk, which is during adolescence and young adulthood.
What is the role of the pentavalent MenABCWY vaccine in the discussion?
-The pentavalent MenABCWY vaccine provides an option to administer MenACWY and MenB in a single vaccine, which could reduce the number of injections and simplify the vaccination schedule, particularly when both vaccines are indicated at the same visit.
How does the GSK pentavalent MenABCWY vaccine differ from the Pfizer pentavalent vaccine?
-While both vaccines combine an existing MenACWY vaccine with an existing MenB vaccine, the specific components differ. The GSK vaccine uses Menveo for the ACWY component and BEXSERO for the B component, and it also provides some protection against gonorrhea, unlike the Pfizer vaccine.
What are the policy questions being considered for the GSK pentavalent vaccine?
-The policy questions consider whether the GSK pentavalent vaccine should be included as an option for MenACWY and MenB vaccination in people currently recommended to receive both vaccines at the same visit, for those recommended to receive MenACWY only, and for those recommended to receive MenB only during a serogroup B outbreak.

Outlines

00:00

📅 Meeting Resumption and Introduction to Meningitis Vaccines Work Group

The meeting resumes with a focus on the meningococcal vaccine section. Dr. Loehr, Chair of the Meningococcal Vaccines Work Group, introduces the group and outlines the two major topics for discussion: a review of the current adolescent schedule for meningitis vaccines and considerations for the GSK pentavalent vaccine. The work group has had extensive discussions and narrowed down options for further assessment. Dr. Loehr emphasizes the importance of ACIP's concurring with the selected options and the additional information needed for decision-making. The meeting schedule for future discussions on meningitis epidemiology, ETR analysis, cost-effectiveness analysis, and voting plans is also highlighted.

05:06

📉 Incidence and Epidemiology of Meningococcal Disease in the United States

This segment discusses the incidence of meningococcal disease in the United States from 1996 to 2022, noting a decline in incidence before the introduction of the MenACWY vaccine in 2005 and an uptick in recent years. The presentation highlights the varying proportions of disease caused by different serogroups with age, especially during the COVID pandemic, and the predominance of serogroup B among adolescents. Preliminary data for 2023 shows the highest number of cases since 2014, with a significant proportion among 11 to 23-year-olds. The effectiveness of vaccination is discussed, including the decrease in incidence among adolescents and the averted cases of serogroup C, W, and Y disease. The presentation also examines disease incidence following MenACWY vaccine implementation and the increased risk of serogroup B disease among college students.

10:07

💡 Considerations for Revising the Adolescent Meningococcal Vaccine Schedule

The discussion revolves around the considerations for revising the adolescent meningococcal vaccine schedule, focusing on disease prevention and the duration of vaccine-induced protection. The potential cross-protection of BEXSERO against gonorrhea is mentioned due to genetic similarities between Neisseria meningitidis and Neisseria gonorrhea. The work group considers optimizing protection against meningitis by looking at high-risk age groups, recent epidemiology, and the duration of vaccine protection. Harmonization with the existing adolescent vaccination platform and the use of pentavalent vaccines to reduce the number of injections are also discussed. Several options for revising the schedule are presented, with the work group expressing a preference for options one or three, which involve changes to MenB recommendations and the elimination of the 11 through 12-year-old dose of MenACWY.

15:10

🗣️ Feedback and Opinions on the Proposed Vaccine Schedule Options

This section presents feedback from various stakeholders, including the Society for Adolescent Health and Medicine, family physicians, and the American Academy of Pediatrics. Concerns are raised about eliminating the 11 to 12-year-old MenACWY vaccination, the importance of the vaccination platform, and the preference for the pentavalent vaccine. The transition of MenB recommendations to either risk-based or routine is supported, with the aim of streamlining vaccine administration. The discussion also touches on the potential impact of changes in the schedule on school requirements and the need for additional data to inform decision-making. The preference for option one is reiterated, emphasizing the importance of maintaining existing recommendations and adjusting the MenB vaccine schedule for better efficacy upon college entry.

20:13

🤔 ACIP Members' Insights and Concerns on Vaccine Schedule

ACIP members express their thoughts and concerns regarding the meningococcal vaccine schedule. Dr. Long raises questions about the effectiveness of the vaccine program and suggests that the epidemiology of the disease may be more behavior-associated. Concerns are also raised about the risk-based approach for non-college students and the potential need for cost-effectiveness analysis. Dr. Brooks supports removing the 11 to 12-year-old vaccination recommendation, while Dr. Kotton favors option one and suggests moving the second dose of MenB closer to the college age. The discussion highlights the complexity of balancing vaccine efficacy, public health, and cost considerations in making recommendations for the adolescent meningococcal vaccine schedule.

25:14

💠 Term of Reference for GSK Pentavalent MenABCWY Vaccine

The presentation shifts to discussing the term of reference for the GSK pentavalent MenABCWY vaccine, which is currently in clinical trials. The vaccine combines an existing MenACWY vaccine (Menveo) with an existing MenB vaccine (BEXSERO) and is intended for 10 to 25-year-olds. The policy questions for the GSK vaccine are outlined, including its inclusion as an option for MenACWY and MenB vaccination, as well as considerations for people recommended to receive only MenACWY or MenB. The work group's prioritization of outcomes for the GSK vaccine is discussed, with gonorrhea prevention being added as an important outcome. The presentation concludes with a call for questions and discussion on the presented information.

Mindmap

Keywords

💡Meningococcal Vaccine

A meningococcal vaccine is a type of vaccine that protects against meningococcal bacteria, which can cause severe diseases like meningitis. In the video, the discussion revolves around the scheduling and recommendations for meningococcal vaccines, particularly for adolescents, and the introduction of a pentavalent vaccine.

💡ACIP

The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on the use of vaccines in the United States. In the video, ACIP members are engaged in a discussion about the meningococcal vaccine schedule and the introduction of new vaccines.

💡Epidemiology

Epidemiology is the study of how often diseases occur in different populations and why. In the context of the video, epidemiology is crucial for understanding the patterns of meningococcal disease and informing vaccination strategies.

💡Vaccine Schedule

A vaccine schedule outlines the recommended ages for when children and adults should receive specific vaccinations. The video focuses on revisiting the adolescent meningococcal vaccine schedule and considering changes to optimize protection against meningitis.

💡Pentavalent Vaccine

A pentavalent vaccine is a combination vaccine that protects against five different strains or serotypes of a bacteria or virus. In the video, the introduction and assessment of a pentavalent MenABCWY vaccine by GSK is discussed, which combines protection against multiple serogroups of meningococcal bacteria.

💡Vaccine Effectiveness

Vaccine effectiveness refers to how well a vaccine works in preventing disease. It is a critical factor considered when evaluating and recommending vaccination schedules, as it can influence the duration of protection and the need for booster shots.

💡Serogroup

A serogroup is a group of bacteria that share specific antigens, which are proteins or sugars on the surface of the bacteria that can trigger an immune response. In the context of the video, different serogroups of the meningococcal bacteria are discussed, with serogroup B being a significant cause of disease among adolescents.

💡Shared Clinical Decision Making

Shared clinical decision making is a process where healthcare providers discuss the risks and benefits of different treatment options with patients, allowing them to make informed decisions about their care. In the video, this concept is applied to the recommendation for MenB vaccination, where the decision to vaccinate is shared between the provider and the patient or guardian.

💡Breakthrough Disease

Breakthrough disease refers to an infection that occurs in a person who has been previously vaccinated against that disease. It indicates that the vaccine's protection was not complete or has waned over time. In the video, the discussion includes considerations about breakthrough disease in vaccinated individuals.

💡Cost-Effectiveness Analysis

A cost-effectiveness analysis is a method used to evaluate the value of interventions, such as medical treatments or public health initiatives, by comparing the costs with the benefits achieved. It helps in making decisions about resource allocation and prioritizing health interventions.

Highlights

The meeting is resuming with a focus on meningococcal vaccines, with Dr. Loehr chairing the Meningococcal Vaccines Work Group.

There are two main topics: a review of the current adolescent schedule for meningitis vaccines and an informational update on the GSK pentavalent vaccine.

The work group has narrowed down over 10 options to about four for further assessment of the adolescent vaccine schedule.

Pfizer's pentavalent vaccine was approved in October 2023 and is now being used as a framework for the GSK pentavalent vaccine.

At the June 2024 meeting, the epidemiology of meningitis disease will be reviewed, including disease burden and risk factors.

A cost-effectiveness analysis is planned for presentation in October 2024, with a potential vote in February 2025.

The MenACWY vaccine is routinely recommended for adolescents with specific dosing schedules, while MenB is recommended based on shared clinical decision making.

Coverage data for MenACWY and MenB vaccines in 2022 shows varying rates, with MenB coverage notably lower due to its recommendation style.

The incidence of meningococcal disease has been increasing slightly in recent years, with a peak in adolescence.

Vaccine effectiveness for MenACWY and MenB decreases over time, with MenB protection waning more quickly.

The work group is considering several options for revising the adolescent schedule, including eliminating the 11-12 year old dose of MenACWY and changing MenB recommendations.

The preferred options from the work group are either maintaining the current schedule or eliminating the 11-12 year old dose of MenACWY.

The use of the pentavalent vaccine is seen as an opportunity to reduce the number of injections, which is a consideration in the schedule revision.

The work group is interested in changing MenB recommendations to either risk-based or routine, with a preference for harmonization with the MenACWY schedule.

Representatives from various health organizations express their views on the proposed changes, with a general preference for maintaining or adjusting the current schedule based on various considerations.

ACIP members discuss the challenges in deciding on the schedule, considering the low incidence of disease, the behavior-associated risks, and the effectiveness of current vaccination strategies.

The presentation concludes with a discussion on the term of reference for the GSK pentavalent MenABCWY vaccine, which is in clinical trials and expected to be assessed in the coming months.

Transcripts

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Related Tags

Meningococcal Vaccines Adolescent Schedule GSK Vaccine Epidemiology Immunization Policy Pentavalent Vaccine Vaccine Recommendations Meningitis Disease Vaccine Effectiveness Public Health