Materiały źródłowe

• #1 Predicting the long-term impact of rotavirus vaccination in 112 countries from 2006-2034: a transmission modeling analysis

  https://pmc.ncbi.nlm.nih.gov/articles/PMC10351612/

  Overall, our models predicted that a total of 102,000 (95% UI: 96,000112,000) deaths per year would be averted among children under five for all 112 countries considered by 2034 under the default scenario, and 110,000 (95% UI: 103,000121,000) deaths per year would be averted under the best-case scenario. These values correspond to a 49.1% (95% UI: 46.654.3%) decline in annual deaths for the default scenario in 2034 or 52.7% (95% UI: 50.058.6%) for the best-case scenario compared with no vaccination. A total of 1.59 million (95% UI: 1.50 1.75 million) deaths could be averted between 2006 and 2034 in the best-case scenario compared to the no vaccination scenario. […] Overall, vaccination was expected to avert 51.4% (UI: 46.459.1%) to 55.4% (UI: 50.064.0%) of all rotavirus deaths per year by 2034 in PINE countries. Most of this predicted benefit was due to the direct effect of rotavirus vaccination, with direct effects accounting for 69-97% of the overall vaccine impact. […] While administering only one dose of vaccine provides protection, in the long-term, using a one-dose schedule is only about half as effective as a full two-dose schedule.

• #2 Prediction of effectiveness of universal rotavirus vaccination in Southwestern Vietnam based on a dynamic mathematical model | Scientific Reports

  https://www.nature.com/articles/s41598-024-54775-6

  Vaccinating young children against rotavirus (RV) is a promising preventive strategy against rotavirus gastroenteritis (RVGE). […] We evaluated the relative risk reduction of RVGE induced by universal vaccination in Vietnam through dynamic model analysis. […] Assuming a vaccination rate of 95%, the number of RVGE hospitalizations after 5 years from universal RV vaccination decreased from 92,502 cases to 45,626 with 85% efficacy, to 54,576 cases with 70% efficacy, and to 63,209 cases with 55% efficacy. […] The relative risk reductions of RVGE after 10 years were 49.7% with 85% efficacy, 40.6% with 70% efficacy, and 31.5% with 55% efficacy. […] In conclusion, despite its relatively lower efficacy compared to high-income countries, RV vaccination remains an effective intervention in Southwestern Vietnam.

• #3 Rotavirus: The Disease and The Vaccine

  https://www.hse.ie/eng/health/immunisation/hcpinfo/othervaccines/rotavirus/

  Is the rotavirus vaccine reducing the incidence of rotavirus disease? […] With the introduction of rotavirus vaccine to the primary immunisation schedule for all infants born on or after 1st October 2016, the number of cases of rotavirus infection reported in Ireland has fallen from 2305 cases in 2017 to 636 cases in 2018 (72%). […] How effective is rotavirus oral vaccine? […] Rotavirus oral vaccine is very effective in preventing rotavirus disease in young infants. Since the vaccine was introduced into the immunisation schedule in Australia, they have seen a 70% decline in hospitalisations due to rotavirus gastroenteritis in the under-five years age group. Preliminary laboratory data from the UK has also identified a 70% reduction in rotavirus reports since the vaccine programme was implemented there. A European study identified a reduction in hospitalisations from rotavirus infection of between 65 to 84%. It estimated the vaccine effectiveness at between 82-94%. […] What if a infant has already had a confirmed rotavirus vaccine infection? […] Even if the infant has had a confirmed rotavirus infection, they are still recommended to receive the vaccine. This is to help better protect against further episodes of infection.

• #4 Rotavirus vaccine impact and socioeconomic deprivation: an interrupted time-series analysis of gastrointestinal disease outcomes across primary and secondary care in the UK | BMC Medicine | Full Text

  https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-017-0989-z

  Rotavirus causes severe gastroenteritis in infants and young children worldwide. The UK introduced the monovalent rotavirus vaccine (Rotarix) in July 2013. Vaccination is free of charge to parents, with two doses delivered at 8 and 12 weeks of age. We evaluated vaccine impact across a health system in relation to socioeconomic deprivation. […] The uptake of the first and second doses of rotavirus vaccine was 91.4% (29,108/31,836) and 86.7% (27,594/31,836), respectively. Among children aged 5 years, the incidence of gastrointestinal disease decreased across all outcomes post-vaccine introduction: 80% (95% confidence interval [CI] 7087%; p0.001) for RVGE hospitalisation, 44% (95% CI 3553%; p0.001) for AGE hospitalisations, 23% (95% CI 1133%; p0.001) for ED, 32% (95% CI 750%; p=0.02) for WIC and 13% (95% CI -326%; p=0.10) for GP. The impact was greatest during the rotavirus season and for vaccine-eligible age groups. In adults aged 65+ years, AGE hospitalisations fell by 25% (95% CI 1930%; p0.001).

• #5 Global estimates of rotavirus vaccine efficacy and effectiveness: a rapid review and meta-regression analysis

  https://pmc.ncbi.nlm.nih.gov/articles/PMC11925534/

  Predicted vaccine efficacy ranged from 69.6% to 94.3% across countries in the Americas, European, and Western Pacific Regions, with a decreased efficacy ranging from 18.6% to 85.3% in the African, South-East Asian, and Eastern Mediterranean regions. […] Estimates of vaccine effectiveness were generally lower than vaccine efficacy when efficacy was greater than 60%, but effectiveness was predicted to be higher when vaccine efficacy was low. […] Our approach enhances the understanding of global variation in rotavirus vaccine performance and can be used to inform predictions of the potential impact of rotavirus vaccines for countries that have yet to introduce them. […] Despite uncertainties in the predictions, our findings underscore the potential benefits of rotavirus vaccination. […] Our results align with the World Health Organization recommendations advocating for universal introduction of rotavirus vaccine into routine infant immunization programs.

• #6 Global estimates of rotavirus vaccine efficacy and effectiveness: a rapid review and meta-regression analysis

  https://pmc.ncbi.nlm.nih.gov/articles/PMC11925534/

  Variability in the efficacy and effectiveness of rotavirus vaccines has been observed in countries across the world, with higher vaccine performance generally observed in high-income and low-child-mortality countries. […] Our analysis provides country-specific estimates for both vaccine efficacy and effectiveness, offering valuable evidence for decision-making processes concerning the introduction of rotavirus vaccines in countries yet to adopt them. […] Our findings indicate substantial variations in both vaccine efficacy and effectiveness across countries and WHO regions. […] Our framework provides country-specific estimates for both vaccine efficacy and effectiveness, which is a valuable resource for decision-makers contemplating the introduction of rotavirus vaccines in countries burdened by rotavirus but lacking a clear vaccination strategy and context-specific data.

• #7 Impact of maternal antibodies and microbiota development on the immunogenicity of oral rotavirus vaccine in African, Indian, and European infants | Nature Communications

  https://www.nature.com/articles/s41467-021-27074-1

  Identifying risk factors for impaired oral rotavirus vaccine (ORV) efficacy in low-income countries may lead to improvements in vaccine design and delivery. […] We observe ORV shedding and seroconversion rates to be significantly lower in Malawi and India than the UK. […] Maternal rotavirus-specific antibodies in serum and breastmilk are negatively correlated with ORV response in India and Malawi, mediated partly by a reduction in ORV shedding. […] In both India and Malawi, increased microbiota diversity is negatively correlated with ORV immunogenicity, suggesting that high early-life microbial exposure may contribute to impaired vaccine efficacy. […] The 1-year protective efficacy of Rotarix against severe rotavirus-associated gastroenteritis is 95% in Europe but may fall below 50% in sub-Saharan Africa.

• #8 Maternal and infant factors linked with rotavirus vaccine outcome in three continents | medRxiv

  https://www.medrxiv.org/content/10.1101/2020.11.02.20224576v1.full-text

  Identifying risk factors for impaired oral rotavirus vaccine (ORV) efficacy in low-income countries may lead to improvements in vaccine design and delivery. […] ORV shedding and seroconversion rates were significantly lower in Malawi and India than the UK. […] Maternal rotavirus-specific antibodies in serum and breastmilk were negatively correlated with ORV response in India and Malawi, and this was mediated partly by a reduction in ORV replication. […] In both India and Malawi, pre-vaccination microbiota diversity was negatively correlated with ORV immunogenicity, suggesting that high early-life microbial exposure may contribute to impaired vaccine efficacy. […] ORV response was significantly lower in Malawi and India compared with the UK. […] We also observed significant geographic discrepancies in ORV immunogenicity.

• #9 Impact of maternal antibodies and microbiota development on the immunogenicity of oral rotavirus vaccine in African, Indian, and European infants | Nature Communications

  https://www.nature.com/articles/s41467-021-27074-1

  Our findings confirm the inhibitory effect of maternal antibodies on ORV immunogenicity in LMICs, and suggest this may be mediated partly by a reduction in ORV shedding. […] Neonatal infection was associated with a reduced likelihood of dose 1 ORV shedding. […] Overall, while specific bacterial taxa do not appear to drive within-population differences in ORV response, high microbiota diversity in early life may contribute to the impaired efficacy of this vaccine in LMICs.

• #10 Direct and Indirect Effects of Rotavirus Vaccination: Comparing Predictions from Transmission Dynamic Models | PLOS One

  https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0042320

  Early observations from countries that have introduced rotavirus vaccination suggest that there may be indirect protection for unvaccinated individuals, but it is unclear whether these benefits will extend to the long term. […] Models predicted that during the initial year after vaccine introduction, incidence of severe RVGE would be reduced 1.8-2.9 times more than expected from the direct effects of the vaccine alone (28-50% at 90% coverage), but over a 5-year period following vaccine introduction severe RVGE would be reduced only by 1.1-1.7 times more than expected from the direct effects (54-90% at 90% coverage). […] Projections for the long-term reduction of severe RVGE ranged from a 55% reduction at full coverage to elimination with at least 80% coverage. […] Some of the models predicted that the short-term indirect benefits may be offset by a partial shifting of the burden of RVGE to older unvaccinated individuals.

• #11 Prediction of effectiveness of universal rotavirus vaccination in Southwestern Vietnam based on a dynamic mathematical model | Scientific Reports

  https://www.nature.com/articles/s41598-024-54775-6

  Universal RV vaccination, which can induce high vaccination coverage, can significantly reduce hospitalizations for RVGE in children under 5 years of age in Vietnam. […] In addition, modest protection can also be expected for infants younger than 4 months of age who cannot be fully vaccinated with the RV vaccine.

• #12 Direct and Indirect Effects of Rotavirus Vaccination: Comparing Predictions from Transmission Dynamic Models | PLOS One

  https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0042320

  Nonetheless, even when such a shift occurs, the overall reduction in severe RVGE is considerable. […] The long-term impact of vaccination predicted by the models under scenario 2 was similar to that under scenario 1. […] However, because the efficacy of the vaccine against severe RVGE is assumed to be 99% under scenario 2 compared to 82% under scenario 1, the reduction in the incidence of severe RVGE due to the direct effect of vaccination is expected to be greater. […] Overall, the comparison of these different models of rotavirus transmission and vaccination allowed us to examine the impact of structural uncertainty on the robustness of model projections, as well as identify key gaps in our understanding of rotavirus epidemiology.

• #13 The ORVAC trial: a phase IV, double-blind, randomised, placebo-controlled clinical trial of a third scheduled dose of Rotarix rotavirus vaccine in Australian Indigenous infants to improve protection against gastroenteritis: a statistical analysis plan | T

  https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04602-w

  The purpose of this double-blind, randomised, placebo-controlled, adaptive design trial with frequent interim analyses is to determine if Australian Indigenous children, who receive an additional (third) dose of human rotavirus vaccine (Rotarix, GlaxoSmithKline) for children aged 6 to 12 months, would improve protection against clinically significant all-cause gastroenteritis. […] We hypothesise that the routine addition of a third scheduled dose of Rotarix for NT Indigenous infants, administered between 6 months and less than 12 months old, will improve protection against clinically important rotavirus gastroenteritis. […] The primary objective is quantified through a clinical and an immunological outcome designed to measure the clinical effectiveness of an additional scheduled dose and any change in the immune response.

• #14 The ORVAC trial: a phase IV, double-blind, randomised, placebo-controlled clinical trial of a third scheduled dose of Rotarix rotavirus vaccine in Australian Indigenous infants to improve protection against gastroenteritis: a statistical analysis plan | T

  https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-04602-w

  The clinical outcome is the time from randomisation to first medical attendance (hospitalisation, emergency department presentation, medical clinic presentation) for which the primary reason for presentation is presumed or confirmed all-cause acute gastroenteritis or acute diarrhoea illness between randomisation and age 36 months. […] The immunological outcome will be modelled using logistic regression including a covariate for treatment status (control arm coded as 0, treatment coded as 1). […] We will report the median time to event in each group and hazard ratios to quantify the treatment effect. […] The results from the analyses documented herein will be published in peer-reviewed literature.

• #15 Rotavirus Vaccine Recommendations | Rotavirus | CDC

  https://www.cdc.gov/rotavirus/hcp/vaccine-considerations/index.html

  Rotavirus disease among infants and young children has decreased significantly in the United States since vaccine introduction. Each year, the vaccine prevents an estimated 40,000 to 50,000 hospitalizations among U.S. infants and young children. […] During an infant’s first year, rotavirus vaccine provides: […] 85% to 98% protection against severe rotavirus illness and hospitalization. […] 74% to 87% protection against rotavirus illness of any severity.

• #16 Rotavirus vaccine – NHS

  https://www.nhs.uk/vaccinations/rotavirus-vaccine/

  Most children with rotavirus will get better in a few days, but some children can become very dehydrated and need treatment in hospital. Very rarely, rotavirus can be life-threatening. […] The rotavirus vaccine works very well at stopping babies getting infected by rotavirus. It prevents rotavirus infections in about 8 out of every 10 babies who have it. […] The vaccine does not protect against diarrhoea and vomiting caused by other illnesses, such as norovirus.

• #17 Rotavirus Vaccine – Medical Clinical Policy Bulletins | Aetna

  https://www.aetna.com/cpb/medical/data/700_799/0723.html

  Aetna considers Food and Drug Administration-approved rotavirus vaccines (i.e., RotaTeq and Rotarix) a medically necessary service for prevention of rotavirus gastroenteritis in infants less than 8 months of age. […] Aetna considers rotavirus vaccines experimental, investigational, or unproven for all other indications because their effectiveness for indications other than the one listed in Section I (above) have not been established. […] Among infants observed in phase III clinical trials, RotaTeq prevented 98 % of severe cases of rotavirus gastroenteritis and prevented 74 % of rotavirus gastroenteritis cases of any severity caused by serotypes targeted by the vaccine (G1, G2, G3, G4) compared to placebo through the first full rotavirus season after vaccination. […] In REST, RotaTeq reduced hospitalizations by 96 % and emergency room visits by 94 % for rotavirus gastroenteritis caused by serotypes targeted by the vaccine through the first 2 years after the third dose.

• #18 Rotavirus vaccine impact and socioeconomic deprivation: an interrupted time-series analysis of gastrointestinal disease outcomes across primary and secondary care in the UK | BMC Medicine | Full Text

  https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-017-0989-z

  Following the introduction of rotavirus vaccination, incidence of gastrointestinal disease reduced across the health-care system. Vaccine impact was greatest among the most deprived populations, despite lower vaccine uptake. Prioritising vaccine uptake in socioeconomically deprived communities should give the greatest health benefit in terms of population disease burden.

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