Cost effectiveness and budget impact of universal varicella vaccination in Russia.

This economic evaluation assesses the cost-effectiveness and budget impact of introducing a two-dose varicella vaccine in the Russian national immunization program. A static Markov model followed a simulated 2019 Russian cohort over its lifetime and compared outcomes and costs of three varicella vaccination strategies: strategy I (doses given at 12 and 15 months of age), strategy II (doses given at 1 year and 6 years of age), and a no vaccination scenario. Inputs on age-dependent clinical pathways, associated costs, and related health outcomes were collected from national sources and published literature. Results are presented as incremental cost-effectiveness ratio (ICER) from the healthcare payer and societal perspective over the lifetime of the birth cohort and the budget impact over a 10 years' time horizon. Vaccination strategies I and II resulted in an ICER of approximately 1.7 million rubles per quality-adjusted life years gained from the healthcare payer perspective and were cost-saving from the societal perspective. From the healthcare payer perspective, the costs per varicella case averted were 5,989 and 7,140 rubles per case for strategies I and II, respectively. However, from the societal perspective, vaccination is a dominant strategy and the budget impact analysis shows significant healthcare savings over 10 years, with strategy I realizing savings of ~2 billion rubles more than strategy II. From a public health impact perspective, varicella vaccination of children at 12 and 15 months of age through the Russian NIP is expected to be cost-effective with an affordable budget impact compared to no vaccination.

A graphical version of the plain language summary can be found here: 10.6084/m9.figshare.19291463Focus on the patientWhat is the context? Varicella, or chickenpox, is a highly contagious infection. Though mild in children, complications can occur in older individuals, increasing the economic burden for society and public health institutions.In 2019, approximately 0.6% of the Russian population was impacted by varicella, a vaccine-preventable disease.In Russia, varicella vaccination is only implemented in some regions. These regions report a decreasing trend in infection rates in the groups covered by vaccination.What is new? This study assesses the public health and economic impact of implementing varicella vaccination in Russia through its National Immunization Program.We compared two vaccination strategies to a no vaccination scenario: º Strategy I: two doses at 12 and 15 months of ageº Strategy II: two doses at 1 and 6 years of age Over a 10-year period, we found that: º Strategy I prevented 607,682 cases, 2,388,659 general practitioner visits and 10,256 hospitalizations, and saved 6.2 million rublesº Strategy II prevented 491,084 cases, 1,805,668 general practitioner visits and 10,108 hospitalizations, and saved 4.2 million rubles Strategy I saves more direct (i.e., general practitioner visits, hospitalizations and treatment) and indirect (i.e., income loss, disability payments, and caregiving) costs to society than strategy II.What is the impact? Varicella vaccination, especially when introduced at 12 and 15 months (strategy I) in the National Immunization Program, provides public health and economic benefits.From the healthcare payer perspective: this is a cost-effective intervention. From the societal perspective: the budget impact analysis shows significant savings.

A randomized trial assessing the efficacy, immunogenicity, and safety of vaccination with live attenuated varicella zoster virus-containing vaccines: ten-year follow-up in Russian children.

In Russia, a universal varicella vaccination (UVV) program has not been implemented, and varicella vaccination coverage is low. We assessed the efficacy, antibody persistence, and safety of one- and two-dose varicella vaccination schedules in Russian children with a ten-year follow-up period, as part of an international phase IIIB, observer-blind, randomized, controlled trial (NCT00226499). Children aged 12-22 months were randomized (3:3:1) to receive two doses of tetravalent measles-mumps-rubella-varicella vaccine (V2 group), one dose trivalent measles-mumps-rubella (MMR) vaccine and one dose of varicella vaccine (V1 group), or two doses of MMR vaccine (V0 [control] group), 42 days apart. Main study outcomes were: vaccine efficacy (VE) against confirmed varicella cases, anti-varicella zoster virus (VZV) seropositivity rates and geometric mean concentrations, and reporting of (serious) adverse events ([S]AEs). The total vaccinated cohort in Russia comprised 1000 children; 900 were followed up until study end (year [Y] 10). VE estimates against confirmed varicella (Y10) were 92.4% in the V2 group and 74.7% in the V1 group. Anti-VZV seropositivity rates remained ≥99.4% in the V2 group and ≥89.7% in the V1 group from day 42 post-vaccination 2 until Y10. Occurrence of (un)solicited AEs and SAEs was similar across groups and confirmed the safety profile of the vaccines. No vaccination-related SAEs or deaths were reported. These results are consistent with the global trial results, i.e., the highest VE estimates observed following the two-dose schedule compared to the one-dose schedule. These data may inform decision-making related to potential implementation of a UVV program.

What is the context?Varicella is a common childhood disease caused by the highly contagious varicella zoster virus.Varicella vaccines have been used for more than three decades.A large clinical trial conducted in ten countries assessed the efficacy and safety of one dose of monovalent varicella vaccine or two doses of combined varicella vaccine (MMRV). The enrolled children were also followed up for a ten-year period to evaluate the persistence of the immune response and the long-term efficacy of the vaccine.What is new?Here, we present the long-term efficacy, immunogenicity, and safety results in the cohort of children enrolled in Russia, as part of the global ten-year follow-up study. We found that:The monovalent and combined vaccines reduced the number of varicella cases.The MMRV two-dose regimen displayed higher efficacy in preventing varicella of all severities compared to the one-dose regimen.The immune response conferred by the vaccine persisted up to ten years post-vaccination.No vaccination-related deaths occurred, and no safety concerns were raised.What is the impact?Vaccination against varicella resulted in long-term protective efficacy and antibody persistence over ten years post-vaccination in Russian children.Although one-dose varicella vaccination was effective at protecting against varicella, a two-dose schedule provided a more complete protection. This could inform health policy decisions regarding the implementation of varicella vaccination in routine immunization program in Russia.