From individual to herd protection with pneumococcal vaccines: the contribution of the Cuban pneumococcal conjugate vaccine implementation strategy

Abstract

A new pneumococcal conjugate vaccine is currently undergoing advanced clinical evaluation prior to its planned introduction in Cuba. The implementation of the pneumococcal vaccination strategy has been designed with consideration of the need to maximize both its direct and indirect effects. A novel approach is suggested, which addresses preschool children as the first-line target group to generate herd immunity in infants and to have an impact on transmission at the community level. The clinical evaluation pipeline is described herein, including evaluations of effectiveness, cost-effectiveness, and impact. The scientific contribution of the Cuban strategy could support a paradigm shift from individual protection to a population effect based on a rigorous body of scientific evidence.

Cost-effectiveness of introducing a domestic pneumococcal conjugate vaccine (PCV7-TT) into the Cuban national immunization programme

“…The main purpose of the Cuban heptavalent vaccine is the national market based on the principle of "vaccine for all, all the time". This vaccine, PCV7-TT, includes a 2.2 mg capsular polysaccharide of serotypes 1, 5, 14, 18C, 19F and 23F, and 4.4 mg of serotype 6B, conjugated with tetanus toxoid as a carrier protein and adsorbed in aluminum phosphate as an adjuvant (Linares-Pérez et al, 2017). The seven serotypes contained in the new vaccine candidate represent 42.3% of total IPD in Cuba in 2014 (Organización Panamericana de la Salud, 2015) and account for over 60% of isolated serotypes worldwide (International Vaccine Access, 2017).…”

Burden of pneumococcal disease in children in Cuba before the introduction of a novel pneumococcal conjugate vaccine

“…Pending positive clinical results, the Cuban government is planning to introduce the novel heptavalent PCV product in its national immunization program in 2019 using a 2+1 schedule. 9 In the meantime, a randomized clinical trial enrolling infants 2-6 months of age is being conducted to assess the efficacy of this vaccine for use in this age group (RPCEC00000243). Estimates of pneumococcal disease burden are needed to inform the use of this PCV product and to assess the potential impact of the new vaccine.…”

Safety and immunogenicity of the Cuban heptavalent pneumococcal conjugate vaccine in healthy infants. Results from a double-blind randomized control trial Phase I

“…The study protocol was reviewed and approved by the Ethics Committee of the Children University Hospital "Juan Manuel Márquez" in Havana, Cuba. The clinical trial was authorized by the Cuban National Regulatory Agency according the Good Clinical Practice (GCP) Cuban guidance (12), and published in the Cuban Public Register of Clinical Trials with the code RPCEC00000173 (a protocol summary is available at http://registroclinico.sld.cu). It was conducted in accordance with the code of Ethic of the World Medical Association for experiments in human beings (13).…”