Meningococcal vaccine to teenagers in the national immunization program
Health technology assessment
|Published
The purpose of this health technology assessment is to assess effect and safety of vaccination, cost-effectiveness and budget consequences when implementing one dose of meningococcal ACWY vaccine to adolescents in the childhood immunization program in Norway.
Key message
This HTA on meningococcal vaccine for young people does not include an assessment of the use of meningococcal B vaccines. The reason for this is that none of the cases among young people since 2014 have been caused by serogroup B. With the current epidemiology, the ACWY vaccine will provide the widest coverage in this age group. The epidemiological situation can change, and the changes in the occurrence of the various serogroups can be difficult to predict. The Norwegian Institute of Public Health is following developments closely and, in the event of significant changes, the vaccination recommendations will be reassessed, and there may be a need for a revision of the HTA.
Introducing one dose of meningococcal ACWY vaccine to adolescents in the national immunization program provides individual and societal benefit. The measure is cost-effective and cost-saving for the health service and will reduce social inequalities in health.
- Meningococcal ACWY vaccine induces high levels of protective antibodies (serum bactericidal antibodies, SBA) which is the measure used by regulatory authorities to assess the efficacy of meningococcal vaccines. The findings are supported by real-world data from countries that have included the vaccine in the national immunization program which show that vaccination reduces the incidence of meningococcal disease among vaccinated individuals.
- Meningococcal ACWY vaccine reduces meningococcal carriage among those vaccinated and contributes to indirect protection of unvaccinated individuals (herd protection).
- Meningococcal ACWY vaccines have a good safety
- Providing one dose of meningococcal ACWY vaccine to 15- or 18- year-olds in a program is cost-effective compared to vaccination of 18-year-olds outside the program and at self-cost.
- Both vaccination of 15-year-olds and 18-year-olds in a program was cost-saving (dominant), given 50% discount on vaccine price and 90% vaccination coverage. The price and vaccination coverage can affect the cost-effectiveness.
- Vaccination of 15-year-olds in the program was more cost-effective and cost-saving than vaccination of 18-year-olds.
- The incidence of meningococcal disease has decreased in Norway in recent years among Nevertheless, deaths occur every 1-2 years in this group and many survivors suffer life-long sequelae. The decrease in the number of cases is partly due to many adolescents following the vaccine recommendation.
There are large geographical differences in vaccination coverage for meningococcal ACWY vaccine among adolescents, partly due to geographical differences in organization of vaccination and whether the vaccine is reimbursed or not. Adolescents and school health nurses perceive the current system as unfair and that it contributes to differences in the possibility to be protected against a severe disease due to socio-economic conditions.
Summary
Introduction
Invasive meningococcal disease is a rare but very serious disease. One in ten dies from the disease, and among those who survive, the incidence of serious, life-long sequelae is high. Adolescents are at higher risk of invasive meningococcal disease than the general population. In Norway, 16-19-year-olds have been recommended to consider getting vaccinated against meningococcal disease since 2011. Meningococcal vaccines are not included in the national immunization program and is therefore not funded by the government. Uptake of the meningococcal ACWY vaccine among 18-year-olds is high, but with large geographical differences which can partly be explained by different reimbursement agreements and that vaccination is organized differently in the municipalities/counties. In Norway, there have been few cases of meningococcal disease among adolescents in the last 20 years, especially after the recommendation for vaccination came in 2011. The decrease in the number of cases is partly due to many adolescents following the recommendation to get vaccinated. Nevertheless, deaths occur every 1-2 years among the unvaccinated in this age group and many survivors suffer life-long sequelae. If the adolescents, their guardians, or municipalities/counties had not prioritized paying for the vaccination, the incidence of invasive meningococcal disease, deaths and life-long sequelae among healthy adolescents in Norway would probably have been even higher, in addition to the fact that there would have been a higher risk of meningococcal outbreaks.
Aim
The purpose of this health technology assessment is to assess effect and safety of vaccination, cost-effectiveness and budget consequences when implementing one dose of meningococcal ACWY vaccine to adolescents in the childhood immunization program in Norway.
Method
The assessment covers publications on efficacy and safety of meningococcal ACWY vaccine from randomized controlled trials and observational studies published from January 2020 to January 2023. Results include the outcomes protection against invasive meningococcal disease or meningococcal carriage, and safety of the vaccines. Confidence in the documentation was assessed using the GRADE system (Grading of Recommendations Assessment, Development and Evaluation) where possible. To evaluate the cost-effectiveness of offering the meningococcal ACWY vaccine to adolescents, we used a health economic analysis carried out by the Norwegian Institute of Public Health in 2018. The cost-effectiveness analysis was done from a healthcare perspective and evaluated expected costs expressed in Norwegian kroner (NOK) and health effects measured in quality-adjusted life years (QALYs) with the program. The results were expressed as incremental cost-effectiveness ratio (ICER), i.e. expected costs (NOK) per unit of health gain (QALY).
Result
A total of 11 publications were included from searches for studies that have investigated the efficacy or safety of meningococcal ACWY vaccines.
Effect was assessed based on three systematic reviews and six observational studies that were not mentioned in the systematic reviews. The results of the assessment show that meningococcal ACWY vaccines produce high levels of protective antibodies suggesting that they are highly effective in preventing invasive meningococcal disease caused by serogroups A, C, W and Y. The studies from countries offering meningococcal ACWY vaccines to adolescents in the national immunization program show that the incidence of invasive meningococcal disease is decreasing in vaccinated and non-vaccinated individuals. Studies from these countries also show that the meningococcal ACWY vaccines reduce carriage of meningococci. Reduced carriage leads to reduced infection in society and thus means that the vaccine will also be able to protect unvaccinated people in all age groups and provide so-called herd protection.
The assessment of safety is based on information from three systematic reviews and one primary study, which are follow-up studies after approval of the vaccines. The results from the assessment show that the side effect profile for the meningococcal ACWY vaccines corresponds to what is known for other non-live vaccines with short-term local and systemic symptoms such as pain, swelling and redness around the injection site, muscle pain, fever, headache, nausea and fatigue. There are no indications that the vaccines cause serious or long-term side effects.
The health economic analysis shows that offering one dose of meningococcal ACWY vaccine in the national immunization program to 15- or 18-year-olds is cost-effective compared to the current recommendation where vaccine is given at 18 years age and without reimbursement (ICER NOK 30,000/QALY when offered to 15-year-olds and NOK 23,000/QALY when offered to 18-year-olds). Both strategies are also cost-saving. Vaccination of 15-year-olds in the program is more cost-effective and cost-saving than vaccination of 18-year-olds in the program. Introduction into the national immunization program is estimated to prevent three cases of meningococcal disease annually, one death every two years and permanent sequelae in one person every five years. The results are robust in sensitivity analyses and the variables that most affect the cost per QALY were vaccine price and vaccination coverage.
Discussion
The literature review shows that the meningococcal ACWY vaccines are effective in preventing invasive meningococcal disease caused by the serogroups included in the vaccines. Newer data show that the vaccines also have an effect against carriage of meningococci, which means that they will also provide herd protection. The meningococcal ACWY vaccines thus provide both individual and societal benefit. Meningococcal ACWY vaccines have been used for adolescent vaccination for more than 10 years and have been distributed in several millions of doses globally. The vaccines have a good safety profile. No previously unknown side effects or serious vaccine-related reactions have been uncovered in the clinical studies prior to approval, in follow-up studies from countries that have adopted the vaccines or through adverse events monitoring by regulatory authorities in various countries. The health economic analysis shows that introducing one dose of meningococcal ACWY vaccine to adolescents in the national immunization program will be cost-effective and cost-saving compared to the current recommendation. Adolescents and school health nurses believe that the current system,
where the organization of meningococcal vaccination varies geographically, is unfair and contributes to social inequalities in health. They believe that there is a need for meningococcal vaccine to be included in the national immunization program to ensure equal access to information about the risk of meningococcal disease, the benefits of vaccination in preventing disease and that the prerequisite for being able to accept the offer of a vaccine is independent of conditions such as ability to pay, place of residence and socio-economic conditions.
Conclusion
Meningococcal disease is a rare but very serious and unpredictable disease that affects previously healthy adolescents. The disease can be prevented through vaccination. The health technology assessment shows that the benefit of the meningococcal ACWY vaccine clearly outweighs the risk. Vaccination of adolescents provides both individual and societal benefit and will reduce the incidence of meningococcal disease in the population. A universal immunization program for adolescents against meningococcal disease will be cost-effective and cost-saving in a Norwegian setting. In addition, the inclusion of the meningococcal ACWY vaccine for adolescents in the national immunization program will help to reduce inequality in health and ensure equal provision throughout the country.
