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.

Issues in pediatric vaccine-preventable diseases in low- to middle-income countries.

The highest burden of pediatric vaccine-preventable disease is found in developing nations where resource constraints pose the greatest challenge, impacting disease diagnosis and surveillance as well as the implementation of large scale vaccination programmes. In November 2012, a Working Group Meeting convened in Casablanca to describe and discuss the status with respect to 8 vaccine-preventable diseases (pertussis, pneumococcal disease, measles-mumps-rubella-varicella (MMRV), rotavirus and meningococcal meningitis) to identify and consider ways of overcoming obstacles to pediatric vaccine implementation. Experts from Europe, Russia, the Commonwealth of Independent States, the Middle East, Africa and South East Asia participated in the meeting. A range of region-specific needs and barriers to uptake were discussed. The aim of this article is to provide a summary of the ongoing status with respect to pediatric vaccine preventable disease in the countries represented, and the experts' opinions and recommendations with respect to pediatric vaccine implementation.

Streptococcus pneumoniae serotype distribution in children in the Russian Federation before the introduction of pneumococcal conjugate vaccines into the National Immunization Program.

WHO recommends the inclusion of PCVs in childhood vaccination programs world-wide. Many countries including the Russian Federation are currently planning the inclusion of PCVs in their National Immunization Programs and, therefore, data on the pneumococcal serotype distribution is important to estimate the potential disease impact. Here we review eight recent epidemiological studies on the pneumococcal serotype distribution from Russia. Across all studies, serotypes 6B, 14, 19F and 23F were the most prevalent. Interestingly, serotype 3 was relatively common. Serotype 19A was prevalent among AOM, CAP and nasopharyngeal isolates and among antibiotic resistant isolates in all age groups. The differences in serotype coverage between PCV10 and PCV13 were up to 26%. Based on the current data on serotype distribution, a wide use of PCVs in Russia may lead to a significant reduction of the pneumococcal disease burden.

Epidemiology of respiratory syncytial virus in children ≤2 years of age hospitalized with lower respiratory tract infections in the Russian Federation: a prospective, multicenter study.

BACKGROUND: Respiratory syncytial virus (RSV) is the leading cause of severe lower respiratory tract infections among infants and young children, and is responsible for an estimated four million deaths per year globally. A monthly injection of palivizumab has been used for prophylaxis of serious RSV infections among high-risk children in 71 countries since 1998 and approval for use in the Russian Federation was obtained in February 2010. A recommendation for RSV prophylaxis in the Russian Federation would require knowledge of the prevalence and seasonality of RSV in that country. METHODS: In a prospective, multicenter, epidemiological study of the prevalence, seasonality, and peak occurrence of RSV infection, children aged ≤2 years hospitalized for lower respiratory tract infections in three regions of the Russian Federation, from September 2008 through April 2009, were screened and tested for RSV using rapid immunochromatography of nasopharyngeal lavage. For subjects who were tested positive, hospitalization data were collected. RESULTS: Of 519 children aged ≤2 years enrolled from September 11, 2008 through April 26, 2009, 197 tested positive for RSV (38.0%, 95% CI: 33.8, 42.3). The onset of the 2008-2009 RSV season in the Russian Federation occurred in late October 2008, similar to what is observed in other northern temperate zones. Peak activity occurred in early April 2009, when 62% of children enrolled tested positive for RSV. CONCLUSION: The prevalence of serious RSV infections in the Russian Federation is similar to the prevalence previously identified in other temperate zones of the northern hemisphere. The seasonality of disease shifted towards early spring, with peak activity later in the season, within a range reported in other countries. These data provide further evidence of serious RSV infection in children in the Russian Federation, as well as guidance for timing of seasonal RSV prophylaxis, especially among individuals at high risk for serious RSV infection.

Recommendations for rotavirus vaccination: A worldwide perspective.

Official guidelines are crucial for new vaccines to be accepted by physicians and policy makers, and for reimbursement decisions, particularly for vaccines against diseases with an under-appreciated burden, such as rotavirus gastroenteritis (RVGE). Evidence-based guidelines, which take into account the best available data, ensure that new vaccine introductions achieve the greatest sustainable impact. For rotavirus vaccination, guidelines are specific to the locality for which they are developed, reflecting, for example, potential differences in disease burden, prevalence of co-infections (e.g. human immunodeficiency virus) and existing vaccination schedules. By adapting existing evidence-based guidelines, local strategies can be devised to optimise protection against RVGE in different settings.

Nosocomial rotavirus infection in European countries: a review of the epidemiology, severity and economic burden of hospital-acquired rotavirus disease.

The data currently available on the epidemiology, severity and economic burden of nosocomial rotavirus (RV) infections in children younger than 5 years of age in the major European countries are reviewed. In most studies, RV was found to be the major etiologic agent of pediatric nosocomial diarrhea (31-87%), although the number of diarrhea cases associated with other virus infections (eg, noroviruses, astroviruses, adenoviruses) is increasing quickly and almost equals that caused by RVs. Nosocomial RV (NRV) infections are mainly associated with infants 0-5 months of age, whereas community-acquired RV disease is more prevalent in children 6-23 months of age. NRV infections are seasonal in most countries, occurring in winter; this coincides with the winter seasonal peak of other childhood virus infections (eg, respiratory syncytial virus and influenza viruses), thus placing a heavy burden on health infrastructures. A significant proportion (20-40%) of infections are asymptomatic, which contributes to the spread of the virus and might reduce the efficiency of prevention measures given as they are implemented too late. The absence of effective surveillance and of reporting of NRV infections in any of the 6 countries studied (France, Germany, Italy, Poland, Spain and the United Kingdom) results in severe underreporting of NRV cases in hospital databases and therefore in limited awareness of the importance of NRV disease at country level. The burden reported in the medical literature is potentially significant and includes temporary reduction in the quality of children's lives, increased costs associated with the additional consumption of medical resources (increased length of hospital stay) and constraints on parents'/hospital staff's professional lives. The limited robustness and comparability of studies, together with an evolving baseline caused by national changes in health care systems, do not presently allow a complete and accurate overview of NRV disease at country level to be obtained. RV is highly contagious, and the efficiency of existing prevention measures (such as handwashing, isolation and cohorting) is variable, but low at the global level because of the existence of numerous barriers to implementation (eg, lack of staff, high staff turnover, inadequate hospital infrastructure). Prevention of RV infection by mass vaccination could have a positive impact on the incidence of NRV by reducing the number of children hospitalized for gastroenteritis, therefore reducing the number of hospital cross-infections and associated costs.