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Effectiveness of a Meningococcal Group B Vaccine (4CMenB) in Children
Jesús Castilla1, Manuel García Cenoz1, Raquel Abad1
1From Instituto de Salud Pública de Navarra, Instituto de Investigación Sanitaria de Navarra, Pamplona (J.C., M.G.C., A.B.), Consorcio de Investigación Biomédica en Red de Epidemiología y Salud Pública (J.C., M.G.C., C.I., A.M., R.G.P., E.B., A.B.), Ministerio de Sanidad (L.S.-C., A.L., J.A.N.-A.), and Dirección General de Salud Pública, Comunidad de Madrid (S.C.L., A.S.-G.), Madrid, National Center for Microbiology, Instituto de Salud Carlos III, Majadahonda (R.A., J.A.V.), Dirección General de Salud Pública y Ordenación Farmacéutica de Andalucía, Sevilla (N.L., D.M.P.), Agència de Salut Pública de Catalunya, Barcelona (C.I., A.M., E.B.), Dirección General de Salud Pública y Adicciones de la Comunidad Valenciana, Valencia (J.R., E.P.), Dirección Xeral da Saúde Pública da Galícia, Santiago de Compostela (A.M., V.N.), Dirección de Salud Pública y Adicciones del Gobierno Vasco, Vitoria (F.G.C., J.M.A.), Servicio de Vigilancia Epidemiológica de Asturias, Oviedo (A.L.D.B., B.A.-F.), Dirección General de Salud Pública y Adicciones, Instituto Murciano de Investigación Biosanitaria-Arrixaca, Murcia (J.P.M., R.G.P.), Servicio de Epidemiología de Castilla y León, Valladolid (M.J.R.R., S.F.A.), Direcció General de Salut Pública i Participació, Illes Balears, Palma de Mallorca (A.G., J.V.), Servicio Epidemiología de Castilla-La Mancha, Toledo (A.C., S.G.H.), Dirección General de Salud Pública de Canarias, Santa Cruz de Tenerife (A.G.R., R.M.M.), Dirección General de Salud Pública de Aragón, Zaragoza (F.J., M.M.), Dirección General de Salud Pública de Extremadura, Mérida (M.N., M.M.L.-T.), Dirección General de Salud Pública de Cantabria, Santander (L.J.V.R., A.F.-R.), Dirección General de Salud Pública, Consumo y Cuidados de La Rioja, Logroño (E.M.O., A.B.), Consejería de Sanidad, Consumo y Gobernación, Ceuta (A.I.R., F.J.C.A.), Dirección General de Salud Pública y Consumo, Melilla (D.C., J.R.O.), and Instituto Maimónides de Investigación Biomédica de Córdoba, Reina Sofia University Hospital, University of Cordoba, Cordoba (R.R.-M.) - all in Spain.
Background:
In September 2015, the four-component, protein-based meningococcal serogroup B vaccine (4CMenB; Bexsero) became available for private purchase in Spain.
Methods:
We conducted a nationwide matched case-control study to assess the effectiveness of 4CMenB in preventing invasive meningococcal disease in children. The study included all laboratory-confirmed cases of invasive meningococcal disease in children younger than 60 months of age between October 5, 2015, and October 6, 2019, in Spain. Each case patient was matched with four controls according to date of birth and province. 4CMenB vaccination status of the case patients and controls was compared with the use of multivariate conditional logistic regression.
Results:
We compared 306 case patients (243 [79.4%] with serogroup B disease) with 1224 controls. A total of 35 case patients (11.4%) and 298 controls (24.3%) had received at least one dose of 4CMenB. The effectiveness of complete vaccination with 4CMenB (defined as receipt of at least 2 doses, administered in accordance with the manufacturer's recommendations) was 76% (95% confidence interval [CI], 57 to 87) against invasive meningococcal disease caused by any serogroup, and partial vaccination was 54% (95% CI, 18 to 74) effective. Complete vaccination resulted in an effectiveness of 71% (95% CI, 45 to 85) against meningococcal serogroup B disease. Vaccine effectiveness with at least one dose of 4CMenB was 64% (95% CI, 41 to 78) against serogroup B disease and 82% (95% CI, 21 to 96) against non-serogroup B disease. With the use of the genetic Meningococcal Antigen Typing System, serogroup B strains that were expected to be covered by 4CMenB were detected in 44 case patients, none of whom had been vaccinated.
Conclusions:
Complete vaccination with 4CMenB was found to be effective in preventing invasive disease by serogroup B and non-serogroup B meningococci in children younger than 5 years of age.
