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Health Technology Assessment for Vaccines Against Rare, Severe Infections: Properly Accounting for Serogroup B Meningococcal Vaccination's Full Social and Economic Benefits.

ABSTRACT: The high price of new generations of vaccines relative to their predecessors has become an important consideration in debates over whether the benefits of the new vaccines justify their costs. An increasingly central line of inquiry in the literature on valuing vaccination surrounds accounting for the full social and economic benefits of vaccination. This paper applies this emerging perspective to the particular case of vaccination against serogroup B meningococcal disease (MenB). We explore key issues involved in health technology assessments of MenB vaccination, which have led to pronounced heterogeneity in evaluation methods and recommendation outcomes across countries such as France, Germany, the US, and the UK. Accounting for typically neglected sources of socioeconomic benefit could potentially impact recommendation and reimbursement decisions. We propose a taxonomy of such benefits built around four dimensions: (i) internalized health benefits, (ii) internalized non-health benefits, (iii) externalized health benefits, and (iv) externalized non-health benefits. This approach offers a systematic, comprehensive evaluation framework that can be used in future assessment of MenB vaccines as well as other health technologies.

SUBMITTER: Stawasz A

PROVIDER: S-EPMC7366491 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Health Technology Assessment for Vaccines Against Rare, Severe Infections: Properly Accounting for Serogroup B Meningococcal Vaccination's Full Social and Economic Benefits.

Stawasz Andrew A Huang Liping L Kirby Paige P Bloom David D

Frontiers in public health 20200710

The high price of new generations of vaccines relative to their predecessors has become an important consideration in debates over whether the benefits of the new vaccines justify their costs. An increasingly central line of inquiry in the literature on valuing vaccination surrounds accounting for the full social and economic benefits of vaccination. This paper applies this emerging perspective to the particular case of vaccination against serogroup B meningococcal disease (MenB). We explore key ...[more]

PMID: 32754566

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Project description:In countries with established programmes for vaccination of infants, toddlers and adolescents with meningococcal conjugate vaccines, serogroup B invasive meningococcal disease remains the major cause of septicaemia and meningitis in the paediatric and adolescent age groups. Novartis has developed a serogroup B meningococcal vaccine, 4CMenB, to meet this need. We reviewed all 4CMenB studies. The studies found 4CMenB to be highly immunogenic when administered in all schedules, with protective antibody levels (serum bactericidal antibody titres ?4 or ?5 with human complement, hSBA) against serogroup B strains expressing vaccine antigens in >95% of vaccinated cohorts. When antibody levels waned, all tested groups demonstrated booster responses. Although possibly an underestimation, the Meningococcal Antigen Typing System (MATS) technique predicts that global coverage of 4CMenB against all serogroup B strains is in the range 66% (Canada) to 91% (USA). The vaccine was found to be generally well tolerated, although local and systemic reactions, notably fever in infants, typical of many vaccines, were increased following concomitant administration of 4CMenB with routine vaccines. When tested, prophylactic paracetamol significantly decreased the frequency and severity of reactions in infants, with no clinically significant impact on immunogenicity of 4CMenB or concomitant routine vaccines. The vaccine is approved for use in the following age groups in the European Union (2?months+), Canada (2?months through 17 years), Australia (2?months+) and Chile (2?months+), following clinical evaluation in 4843 infants and toddlers, and 1712 adolescents and adults, in schedules including a three-dose (2, 3, 4 or 2, 4, 6 months) and a two-dose (6-11 months) infant series with a booster in the second year of life, a two-dose series in toddlers (12-23 months) and children (2-10 years) given 2 months apart (with a booster at least in the EU), and a two-dose series in adolescents (11-17 years) given 1-6 months apart. 4CMenB presents a solution to the unmet medical need of offering protection against serogroup B invasive meningococcal disease in all age groups above 2 months.

Project description:BackgroundA serogroup A meningococcal polysaccharide-tetanus toxoid conjugate vaccine (PsA-TT, MenAfriVac) was licensed in India in 2009, and pre-qualified by WHO in 2010, on the basis of its safety and immunogenicity. This vaccine is now being deployed across the African meningitis belt. We studied the effect of PsA-TT on meningococcal meningitis and carriage in Chad during a serogroup A meningococcal meningitis epidemic.MethodsWe obtained data for the incidence of meningitis before and after vaccination from national records between January, 2009, and June, 2012. In 2012, surveillance was enhanced in regions where vaccination with PsA-TT had been undertaken in 2011, and in one district where a reactive vaccination campaign in response to an outbreak of meningitis was undertaken. Meningococcal carriage was studied in an age-stratified sample of residents aged 1-29 years of a rural area roughly 13-15 and 2-4 months before and 4-6 months after vaccination. Meningococci obtained from cerebrospinal fluid or oropharyngeal swabs were characterised by conventional microbiological and molecular methods.FindingsRoughly 1·8 million individuals aged 1-29 years received one dose of PsA-TT during a vaccination campaign in three regions of Chad in and around the capital N'Djamena during 10 days in December, 2011. The incidence of meningitis during the 2012 meningitis season in these three regions was 2·48 per 100,000 (57 cases in the 2·3 million population), whereas in regions without mass vaccination, incidence was 43·8 per 100,000 (3809 cases per 8·7 million population), a 94% difference in crude incidence (p<0·0001), and an incidence rate ratio of 0·096 (95% CI 0·046-0·198). Despite enhanced surveillance, no case of serogroup A meningococcal meningitis was reported in the three vaccinated regions. 32 serogroup A carriers were identified in 4278 age-stratified individuals (0·75%) living in a rural area near the capital 2-4 months before vaccination, whereas only one serogroup A meningococcus was isolated in 5001 people living in the same community 4-6 months after vaccination (adjusted odds ratio 0·019, 95% CI 0·002-0·138; p<0·0001).InterpretationPSA-TT was highly effective at prevention of serogroup A invasive meningococcal disease and carriage in Chad. How long this protection will persist needs to be established.FundingThe Bill & Melinda Gates Foundation, the Wellcome Trust, and Médecins Sans Frontères.

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Health Technology Assessment for Vaccines Against Rare, Severe Infections: Properly Accounting for Serogroup B Meningococcal Vaccination's Full Social and Economic Benefits.

Publications

Health Technology Assessment for Vaccines Against Rare, Severe Infections: Properly Accounting for Serogroup B Meningococcal Vaccination's Full Social and Economic Benefits.

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