Materiały źródłowe

• #1 Chapter 13: Rotavirus | Manual for the Surveillance of Vaccine-Preventable Diseases | CDC

  https://www.cdc.gov/surv-manual/php/table-of-contents/chapter-13-rotavirus.html

  This chapter provides general guidance for vaccine-preventable disease surveillance, describing the disease background/epidemiology, case investigation and reporting/notification, disease case definitions, and activities for enhancing surveillance, case investigation, and outbreak control for rotavirus. […] Introduction of the rotavirus vaccine into national immunization programs of over 120 countries has resulted in dramatic decreases in rotavirus infections and transmission in those settings, including the United States. […] For this reason, rotavirus vaccines have been identified as and remain the optimal strategy to decrease the burden associated with severe and fatal rotavirus diarrhea worldwide. […] Surveillance efforts should focus on monitoring trends of severe rotavirus disease, such as rotavirus hospitalizations or emergency room visits, at the national level and through more intensive efforts at sentinel sites.

• #2 Chapter 19: Rotavirus | Pink Book | CDC

  https://www.cdc.gov/pinkbook/hcp/table-of-contents/chapter-19-rotavirus.html

  This chapter discusses pathogenesis, clinical features, epidemiology, vaccination, and surveillance of rotavirus. […] Rotavirus occurs throughout the world. In the prevaccine era, the proportion of severe diarrhea in children younger than age 5 years that was due to rotavirus was similar (about 35% to 40%) in developed and developing countries, suggesting that improved sanitation alone is not sufficient to prevent infection. The distribution of specific rotavirus genotypes can differ by geographic area and time period. […] Rotaviruses are shed in high concentration in the stool of infected persons. Transmission is by fecal-oral route, both through close person-to-person contact and by fomites (such as toys and other environmental surfaces contaminated by stool). Transmission of rotavirus through contaminated water or food appears to be uncommon.

• #3 Chapter 19: Rotavirus | Pink Book | CDC

  https://www.cdc.gov/pinkbook/hcp/table-of-contents/chapter-19-rotavirus.html

  In temperate climates, disease is more prevalent during fall and winter. In the United States in the prevaccine era, annual epidemic peaks usually progressed from the Southwest during November and December to the Northeast by April and May. Following vaccine introduction, a biennial pattern of disease activity has emerged with less notable differences in timing by geographic region. In tropical climates, the disease is less seasonal than in temperate areas. […] Rotavirus is highly communicable, as evidenced by the nearly universal infection of children by age 5 years in the prevaccine era. Infected persons shed large quantities of virus in their stool beginning 2 days before the onset of diarrhea and for several days after the onset of symptoms. Rotavirus may be detected in the stool of immunocompromised persons for more than 30 days after infection. Spread is common within families, institutions, hospitals, and child care settings.

• #4

  https://www.who.int/publications/m/item/vaccine-preventable-diseases-surveillance-standards-rotavirus

  Rotavirus, a member of the reovirus family, causes watery diarrhoea, vomiting and severe dehydration in young children. […] Rotavirus is common, accounting for 3560% of acute severe diarrhoea in children 5 years of age in countries without rotavirus vaccine, with the highest attributable percentage in infants. […] Rotavirus has a case-fatality rate (CFR) of approximately 2.5% among children in developing countries who present to health facilities. […] In 2013, rotavirus caused an estimated 215 000 deaths worldwide. […] Rotavirus is highly communicable; it is shed in the stool at high concentration, and transmission is through faecal-oral route, either person-to-person or through fomites in the environment. […] Rotavirus peaks in cool, dry seasons in temperate climates but exhibits less pronounced seasonality in tropical settings.

• #5 Rotavirus vaccine support

  https://www.gavi.org/types-support/vaccine-support/rotavirus

  Over 95% of rotavirus deaths are in low-income countries in Africa and Asia. In these countries, access to diarrhoea treatment is often limited or unavailable. […] WHO recommends that all countries introduce rotavirus vaccines in their national programmes. […] Recent studies show significant impact of rotavirus vaccines. Following introductions of the vaccine, diarrhoeal deaths in young children fell by 19–43% in Bolivia, 43–55% in Mexico and 57–64% in Venezuela. […] Increasing access to these vaccines in Gavi-supported countries can prevent more than 2.4 million deaths by 2030. […] Short-term supply constraints resulted in several rotavirus vaccine introductions being delayed in 2018. […] Gavi offers support for low-income countries to introduce rotavirus vaccines. […] Gavi opened a funding window for rotavirus vaccines in Europe and Latin America in 2007.

• #6 Rotavirus – PAHO/WHO | Pan American Health Organization

  https://www.paho.org/en/topics/rotavirus

  In 2015, an estimated 125,000 rotavirus-associated hospitalizations and 800 rotavirus-related deaths were prevented in countries that implemented rotavirus vaccines in the Region of the Americas and the Caribbean. […] PAHO’s rotavirus sentinel surveillance network began in 2006. […] PAHO’s Technical Advisory Group (TAG) on Vaccine-preventable Diseases recommends that countries in the Region of the Americas should continue making efforts to administer rotavirus vaccines as part of their routine immunization schedules, at the recommended ages, usually at 2 and 4 months or 2, 4 and 6 months. […] Since 2006, 22 countries and one territory of the Region have introduced this vaccine into their national vaccination schedules. […] Epidemiologic surveillance is the ongoing observation of the distribution and trends in the incidence of diseases through systematic collection, compilation, and analysis of morbidity and mortality reports, as well as other relevant data, and dissemination of that information to all interested parties.

• #7 Understanding Variation in Rotavirus Vaccine Effectiveness Estimates in the United States

  https://pmc.ncbi.nlm.nih.gov/articles/PMC10100583/

  A recent meta-analysis of 13 US-based case-control studies reported 84% [95% confidence interval (CI) = 80%, 87%] and 83% (95% CI = 72%, 89%) vaccine effectiveness (VE) for the two rotavirus vaccine products. […] The few studies examining annual VE in the United States report fluctuating estimates. […] Specifically, these estimates of rotavirus VE appear to vary in a biennial pattern, with higher estimates of rotavirus VE in odd-numbered, high-activity years and lower estimates of rotavirus VE in even-numbered, low-activity years. […] The force of infection also influences misclassification bias. […] We hypothesized that true rotavirus VE is constant over time in the United States and aimed to (1) estimate crude annual observed VE; (2) estimate VE adjusted for the force of infection; and (3) model the impact of diagnostic misclassification using multiyear US surveillance data.

• #8 Chapter 13: Rotavirus | Manual for the Surveillance of Vaccine-Preventable Diseases | CDC

  https://www.cdc.gov/surv-manual/php/table-of-contents/chapter-13-rotavirus.html

  Current active, passive, and laboratory-based national rotavirus surveillance includes the following: New Vaccine Surveillance Network (NVSN): Active rotavirus surveillance activities through NVSN began in the 2005-06 rotavirus season with three original sites and have continued prospectively with seven sites. […] The licensure and approval by ACIP of rotavirus vaccines brought dramatic overall declines in the rotavirus disease burden among US children, which have been consistently observed in various surveillance efforts. […] Numerous post-licensure publications documenting rotavirus vaccine impact have demonstrated great declines in the incidence of rotavirus gastroenteritis. […] Analyses in other databases and clinical settings have reinforced those findings. […] Rotavirus vaccination rates among US children 19-35 months of age have been estimated using systematic sampling methods by the National Immunization Survey since 2009.

• #9 Chapter 13: Rotavirus | Manual for the Surveillance of Vaccine-Preventable Diseases | CDC

  https://www.cdc.gov/surv-manual/php/table-of-contents/chapter-13-rotavirus.html

  Current active, passive, and laboratory-based national rotavirus surveillance includes the following: New Vaccine Surveillance Network (NVSN): Active rotavirus surveillance activities through NVSN began in the 2005-06 rotavirus season with three original sites and have continued prospectively with seven sites. […] The licensure and approval by ACIP of rotavirus vaccines brought dramatic overall declines in the rotavirus disease burden among US children, which have been consistently observed in various surveillance efforts. […] Numerous post-licensure publications documenting rotavirus vaccine impact have demonstrated great declines in the incidence of rotavirus gastroenteritis. […] Analyses in other databases and clinical settings have reinforced those findings. […] Rotavirus vaccination rates among US children 19-35 months of age have been estimated using systematic sampling methods by the National Immunization Survey since 2009.

• #10 Continued Evidence of the Impact of Rotavirus Vaccine in Children Less Than 3 Years of Age From the United States New Vaccine Surveillance Network: A Multisite Active Surveillance Program, 2006-2016 – PubMed

  https://pubmed.ncbi.nlm.nih.gov/32060546/

  Since 2006, the New Vaccine Surveillance Network has conducted active, population-based surveillance for acute gastroenteritis (AGE) hospitalizations and emergency department (ED) visits in 3 United States counties. Trends in the epidemiology and disease burden of rotavirus hospitalizations and ED visits were examined from 2006 to 2016. […] Children 3 years of age hospitalized or visiting the ED with AGE were enrolled from January 2006 through June 2016. […] Comparing pre- and postvaccine periods, the proportion of children with rotavirus dramatically declined for hospitalization (49% vs 10%) and ED visits (49% vs 8%). […] The epidemiology and disease burden of rotavirus has been altered by rotavirus vaccination with a biennial disease pattern, sustained low rates of rotavirus in children 3 years of age, and a shift in the residual genotypes from G1P[8] to other genotypes.

• #11 Continued Evidence of the Impact of Rotavirus Vaccine in Children Less Than 3 Years of Age From the United States New Vaccine Surveillance Network: A Multisite Active Surveillance Program, 2006-2016 – PubMed

  https://pubmed.ncbi.nlm.nih.gov/32060546/

  Since 2006, the New Vaccine Surveillance Network has conducted active, population-based surveillance for acute gastroenteritis (AGE) hospitalizations and emergency department (ED) visits in 3 United States counties. Trends in the epidemiology and disease burden of rotavirus hospitalizations and ED visits were examined from 2006 to 2016. […] Children 3 years of age hospitalized or visiting the ED with AGE were enrolled from January 2006 through June 2016. […] Comparing pre- and postvaccine periods, the proportion of children with rotavirus dramatically declined for hospitalization (49% vs 10%) and ED visits (49% vs 8%). […] The epidemiology and disease burden of rotavirus has been altered by rotavirus vaccination with a biennial disease pattern, sustained low rates of rotavirus in children 3 years of age, and a shift in the residual genotypes from G1P[8] to other genotypes.

• #12 Chapter 13: Rotavirus | Manual for the Surveillance of Vaccine-Preventable Diseases | CDC

  https://www.cdc.gov/surv-manual/php/table-of-contents/chapter-13-rotavirus.html

  This chapter provides general guidance for vaccine-preventable disease surveillance, describing the disease background/epidemiology, case investigation and reporting/notification, disease case definitions, and activities for enhancing surveillance, case investigation, and outbreak control for rotavirus. […] Introduction of the rotavirus vaccine into national immunization programs of over 120 countries has resulted in dramatic decreases in rotavirus infections and transmission in those settings, including the United States. […] For this reason, rotavirus vaccines have been identified as and remain the optimal strategy to decrease the burden associated with severe and fatal rotavirus diarrhea worldwide. […] Surveillance efforts should focus on monitoring trends of severe rotavirus disease, such as rotavirus hospitalizations or emergency room visits, at the national level and through more intensive efforts at sentinel sites.

• #13 Chapter 13: Rotavirus | Manual for the Surveillance of Vaccine-Preventable Diseases | CDC

  https://www.cdc.gov/surv-manual/php/table-of-contents/chapter-13-rotavirus.html

  Current active, passive, and laboratory-based national rotavirus surveillance includes the following: New Vaccine Surveillance Network (NVSN): Active rotavirus surveillance activities through NVSN began in the 2005-06 rotavirus season with three original sites and have continued prospectively with seven sites. […] The licensure and approval by ACIP of rotavirus vaccines brought dramatic overall declines in the rotavirus disease burden among US children, which have been consistently observed in various surveillance efforts. […] Numerous post-licensure publications documenting rotavirus vaccine impact have demonstrated great declines in the incidence of rotavirus gastroenteritis. […] Analyses in other databases and clinical settings have reinforced those findings. […] Rotavirus vaccination rates among US children 19-35 months of age have been estimated using systematic sampling methods by the National Immunization Survey since 2009.

• #14 Chapter 19: Rotavirus | Pink Book | CDC

  https://www.cdc.gov/pinkbook/hcp/table-of-contents/chapter-19-rotavirus.html

  Rotavirus gastroenteritis is not a nationally notifiable disease in the United States. Estimates of incidence and disease burden are based on special surveys, cohort studies, and hospital discharge data. Methods of surveillance for rotavirus disease at the national level include review of national hospital discharge databases for rotavirus-specific or rotavirus-compatible diagnoses, surveillance for rotavirus disease at sites that participate in the New Vaccine Surveillance Network, and reports of rotavirus detection from a sentinel system of laboratories. Special evaluations (e.g., case control and retrospective cohort methods) have been used to measure the effectiveness of rotavirus vaccine under routine use in the United States. CDC has also established a national strain surveillance system of sentinel laboratories that monitors circulating rotavirus strains.

• #15 Chapter 19: Rotavirus | Pink Book | CDC

  https://www.cdc.gov/pinkbook/hcp/table-of-contents/chapter-19-rotavirus.html

  Rotavirus gastroenteritis is not a nationally notifiable disease in the United States. Estimates of incidence and disease burden are based on special surveys, cohort studies, and hospital discharge data. Methods of surveillance for rotavirus disease at the national level include review of national hospital discharge databases for rotavirus-specific or rotavirus-compatible diagnoses, surveillance for rotavirus disease at sites that participate in the New Vaccine Surveillance Network, and reports of rotavirus detection from a sentinel system of laboratories. Special evaluations (e.g., case control and retrospective cohort methods) have been used to measure the effectiveness of rotavirus vaccine under routine use in the United States. CDC has also established a national strain surveillance system of sentinel laboratories that monitors circulating rotavirus strains.

• #16 Chapter 19: Rotavirus | Pink Book | CDC

  https://www.cdc.gov/pinkbook/hcp/table-of-contents/chapter-19-rotavirus.html

  Rotavirus gastroenteritis is not a nationally notifiable disease in the United States. Estimates of incidence and disease burden are based on special surveys, cohort studies, and hospital discharge data. Methods of surveillance for rotavirus disease at the national level include review of national hospital discharge databases for rotavirus-specific or rotavirus-compatible diagnoses, surveillance for rotavirus disease at sites that participate in the New Vaccine Surveillance Network, and reports of rotavirus detection from a sentinel system of laboratories. Special evaluations (e.g., case control and retrospective cohort methods) have been used to measure the effectiveness of rotavirus vaccine under routine use in the United States. CDC has also established a national strain surveillance system of sentinel laboratories that monitors circulating rotavirus strains.

• #17 Rotavirus – PAHO/WHO | Pan American Health Organization

  https://www.paho.org/en/topics/rotavirus

  PAHO’s rotavirus sentinel surveillance network began in 2006. In the beginning, the data collected was aggregated, but since 2014 when the regional network integrated the WHO Global Sentinel Surveillance Network, the collection has been case-by-case using the VINUVA case data system. Currently, seven countries and 16 hospitals are included in this network.

• #18 Understanding Variation in Rotavirus Vaccine Effectiveness Estimates in the United States

  https://pmc.ncbi.nlm.nih.gov/articles/PMC10100583/

  A recent meta-analysis of 13 US-based case-control studies reported 84% [95% confidence interval (CI) = 80%, 87%] and 83% (95% CI = 72%, 89%) vaccine effectiveness (VE) for the two rotavirus vaccine products. […] The few studies examining annual VE in the United States report fluctuating estimates. […] Specifically, these estimates of rotavirus VE appear to vary in a biennial pattern, with higher estimates of rotavirus VE in odd-numbered, high-activity years and lower estimates of rotavirus VE in even-numbered, low-activity years. […] The force of infection also influences misclassification bias. […] We hypothesized that true rotavirus VE is constant over time in the United States and aimed to (1) estimate crude annual observed VE; (2) estimate VE adjusted for the force of infection; and (3) model the impact of diagnostic misclassification using multiyear US surveillance data.

• #19 CDC: Rotavirus vaccine 78% effective against serious illness in preschoolers, 53% in older kids | CIDRAP

  https://www.cidrap.umn.edu/rotavirus/cdc-rotavirus-vaccine-78-effective-against-serious-illness-preschoolers-53-older-kids

  The effectiveness of a single dose of the rotavirus vaccine against emergency department (ED) visits or hospitalizations for inflammation of the gastrointestinal tract was 78% in children younger than 5 years and 53% in older children from 2009 to 2022, estimates a US Centers for Disease Control and Prevention (CDC)-led study published yesterday in Pediatrics. […] „Rotavirus was the leading cause of acute gastroenteritis among US children until vaccine introduction in 2006, after which, substantial declines in severe rotavirus disease occurred,” the study authors noted. „To maintain the public’s confidence in the rotavirus vaccination program, it is critical to monitor long-term effectiveness of rotavirus vaccines, especially against severe illness.” […] Rotavirus vaccines remain highly effective in preventing rotavirus-associated ED visits and hospitalizations across time, disease severity, and common genotypes in the US. […] „Rotavirus vaccines remain highly effective in preventing rotavirus-associated ED visits and hospitalizations across time, disease severity, and common genotypes in the US,” the researchers wrote.

• #20 CDC: Rotavirus vaccine 78% effective against serious illness in preschoolers, 53% in older kids | CIDRAP

  https://www.cidrap.umn.edu/rotavirus/cdc-rotavirus-vaccine-78-effective-against-serious-illness-preschoolers-53-older-kids

  The effectiveness of a single dose of the rotavirus vaccine against emergency department (ED) visits or hospitalizations for inflammation of the gastrointestinal tract was 78% in children younger than 5 years and 53% in older children from 2009 to 2022, estimates a US Centers for Disease Control and Prevention (CDC)-led study published yesterday in Pediatrics. […] „Rotavirus was the leading cause of acute gastroenteritis among US children until vaccine introduction in 2006, after which, substantial declines in severe rotavirus disease occurred,” the study authors noted. „To maintain the public’s confidence in the rotavirus vaccination program, it is critical to monitor long-term effectiveness of rotavirus vaccines, especially against severe illness.” […] Rotavirus vaccines remain highly effective in preventing rotavirus-associated ED visits and hospitalizations across time, disease severity, and common genotypes in the US. […] „Rotavirus vaccines remain highly effective in preventing rotavirus-associated ED visits and hospitalizations across time, disease severity, and common genotypes in the US,” the researchers wrote.

• #21 Rotavirus A in Brazil: Molecular Epidemiology and Surveillance during 2018–2019

  https://www.mdpi.com/2076-0817/9/7/515

  We detected RVA in 12% of samples, 10.5% in 2018 and 13.7% in 2019. A marked winter/spring seasonality was observed, especially in Southern Brazil. […] The genotype G3P[8] was the most prevalent during the two years (83.7% in 2018 and 65.5% in 2019), and nucleotide sequencing of some strains demonstrated that they belonged to the emergent equine-like G3P[8] genotype. […] The dominance of an emergent genotype causing AGE reinforces the need for continuous epidemiological surveillance to assess the impact of mass RVA immunization as well as to monitor the emergence of novel genotypes. […] Brazil has implemented the Rotarix™ vaccine in the National Immunization Program (NIP) in March 2006, which led to a significant reduction of diarrhea-associated mortality and hospitalization. […] It has been demonstrated that the distribution of RVA genotypes over the years is characterized by natural and cyclical genotype fluctuations.

• #22 Australian Rotavirus Surveillance Program annual report, 2008/2009

  https://www1.health.gov.au/internet/main/publishing.nsf/Content/cda-cdi3304b.htm

  The national rotavirus surveillance program has been reporting the changing annual pattern of dominant serotypes in the Australian population since 1999. Over this period our results have highlighted the diversity of rotavirus strains capable of causing disease in children, and providing the baseline information of the changing pattern of circulating strains, prior to vaccine introduction. […] The impact of these 2 widely used vaccines on the natural pattern of circulating rotavirus strains is unknown and difficult to predict, given the different components of each vaccine. Continuing genotype surveillance should identify the effects that each vaccine program has on circulating strains in particular, whether changes occur in genotype incidence and whether increased proportions of rare or uncommon types result.

• #23 Estimation of Rotavirus Vaccine Effectiveness Based on Whole Genome Sequences

  https://elifesciences.org/reviewed-preprints/104086

  Kwon et al. present an important paper using a novel approach to estimating rotavirus vaccine efficacy using data from a passive surveillance network in the US. […] These findings have implications for this vaccine specifically as well as type-specific vaccine evaluation more generally. […] We incorporated whole genome sequence (WGS) data to characterize viruses responsible for rotavirus-associated gastroenteritis (RVGE) between vaccinated and unvaccinated individuals in the United States (U.S.). […] We analyzed 254 RVGE cases with WGS data from seven U.S. New Vaccine Surveillance Network sites during 2012-2016. […] The RV1 vaccine showed evidence of substantially better protection against strains with lower GD to the RV1 strain (VE = 80%, 95% CI: 68%, 89%) compared to more distant strains (VE = 51%, 95% CI: = -29%, 82%).

• #24 Estimation of Rotavirus Vaccine Effectiveness Based on Whole Genome Sequences

  https://elifesciences.org/reviewed-preprints/104086

  Incorporating the complete genomic structure of RVA reveals that vaccine protection correlates with the diversity of non-outer capsid proteins. […] Our WGS-based analysis more clearly differentiated vaccine protection than analyses based on VP7 and VP4 alone. […] In the U.S., the New Vaccine Surveillance Network (NVSN) has been conducting pre- and post-vaccination surveillance for RVGE beginning in 2006. […] Following vaccine introduction, the genomic analysis of RVA strains at both genotype and whole-genome levels provided valuable insights into the evolutionary patterns of circulating strains and revealed targets in the sequences that may potentially affect vaccine performance, thus requiring ongoing surveillance. […] Our analysis provides an improved understanding of how the full genomic composition of RVA contributes to vaccine protection.

• #25

  https://link.springer.com/article/10.1007/s40272-018-0283-3

  Rotavirus is the leading cause of diarrheal death among children 5 years old worldwide, estimated to have caused ~ 215,000 deaths in 2013. […] Two live, oral rotavirus vaccines have been implemented nationally in 100 countries since 2006 and their use has substantially reduced the burden of severe diarrheal illness in all settings. […] Vaccine efficacy and effectiveness estimates suggest there is a gradient in vaccine performance between low child-mortality countries ( 90%) and medium and high child-mortality countries (5775%). […] Two additional live, oral rotavirus vaccines were recently licensed and these have improved on some programmatic limitations of earlier vaccines, such as heat stability, cost, and cold-chain footprint. […] Non-replicating rotavirus vaccines that are parenterally administered are in clinical testing, and these have the potential to reduce the performance differential and safety concerns associated with live oral rotavirus vaccines.

• #26 Vaccine profiles: Rotavirusverifiedverifiedverifiedverifiedverifiedverifiedverifiedverifiedverifiedverified

  https://www.gavi.org/vaccineswork/routine-vaccines-extraordinary-impact-rotavirus

  According to a recent Cochrane Review, which assessed the efficacy of all four WHO prequalified vaccines, rotavirus vaccines prevent more than 90% of severe cases of rotavirus diarrhoea in countries with low child mortality rates, more than 75% in countries with medium child mortality rates, and 35% to 58% in countries with high child mortality rates. […] So far, more than 100 countries have introduced rotavirus vaccines into their routine immunisation programs. The impact of this has been substantial. An analysis of data from 69 countries participating in the WHO’s Global Rotavirus Surveillance Network (GRSN) found a 40% reduction in the prevalence of rotavirus among children admitted to hospital with severe gastroenteritis, following vaccine introductions. […] Rotavirus vaccine and improved sanitation have dramatically reduced the toll from diarrhoeal illness in recent decades, but too many children still die from the dehydration it causes. The next-generation of rotavirus vaccines may address key barriers to their uptake, and further reduce this toll.

• #27

  https://journals.lww.com/pidj/fulltext/2017/02000/hospital_based_surveillance_for_rotavirus.8.aspx

  In anticipation of introduction of a rotavirus vaccine into the national immunization program of Bangladesh, active hospital-based surveillance was initiated to provide prevaccine baseline data on rotavirus disease. […] These data highlight the potential value of rotavirus vaccination in Bangladesh, and will be the key for future measurement of vaccine impact. […] A key factor in the decision by countries to introduce rotavirus vaccines has been demonstrating high rotavirus disease burden through establishment of surveillance for rotavirus diarrhea. […] Assessing vaccine impact in resource-limited settings is particularly important given the lower efficacy of RV1 and RV5 shown in clinical trials in Africa and Asia, compared with that seen in Europe and America. […] This study aims to provide baseline data on the burden of rotavirus gastroenteritis and circulating strains at sentinel hospitals nationwide.

• #28

  https://link.springer.com/article/10.1007/s40264-021-01141-4

  Continuous postmarketing surveillance is important for monitoring this safety concern, especially for the newly introduced RV vaccines, to provide real-time safety data for such less frequent events that are difficult to observe in prelicensure clinical trials or postmarketing data with a small proportion of the exposed population analysed. […] The current review of GSK’s safety database has shown a relatively low number of confirmed reports in which the infants underwent surgery, making it difficult to confirm a correlation between time-to-treatment and the risk of surgery or resection. […] The findings of the O/E analysis are also consistent with the known IS safety profile of the vaccine, i.e., the transient increased incidence of IS after vaccination, mostly within 7 days of the first dose and, to a lesser extent, after the second dose.

• #29

  https://link.springer.com/article/10.1007/s40264-021-01141-4

  Rotavirus (RV) is the most common cause of acute gastroenteritis in children 5 years of age worldwide, and vaccination reduces the disease burden. Evidence from postmarketing surveillance studies suggested an increased risk of intussusception (IS) in infants post-RV vaccination. An overall positive benefit-risk balance for the human RV vaccine (HRV) Rotarix (GlaxoSmithKline [GSK], Belgium) has been established and recent findings indicate an indirect effect of reduced IS over the long term. […] The aim of this study was to discuss spontaneous data from the GSK worldwide safety database on IS post-Rotarix administration. […] A male predominance of IS patients was observed, consistent with earlier reports. […] The observations from the IS spontaneous cases review and results of the O/E analysis are consistent with the known IS safety profile of RV vaccines: a transient increased incidence of IS post-vaccination (primarily in Europe/Japan/worldwide), mostly within 7 days postdose 1.

• #30 Viewpoint: Proposed system for vaccine approval, safety monitoring begs crucial questions | CIDRAP

  https://www.cidrap.umn.edu/anti-science/viewpoint-proposed-system-vaccine-approval-safety-monitoring-begs-crucial-questions

  Background information on vaccine safety monitoring and standards for approving new vaccines can help Americans better follow the discussion and watch for key developments. […] In 1999, after VAERS detected just nine cases of intussusception, a rare bowel obstruction, following the administration of the first rotavirus vaccine in 500,000 children, the CDC’s Advisory Committee on Immunization Practices (ACIP) withdrew its recommendation, and the manufacturer withdrew its license. […] The current vaccine monitoring system is substantially more sensitive and expansive than, for example, a 1,000-person placebo-controlled trial, so it’s unclear how this new standard would improve vaccine safety.

• #31 Road to Rotavirus Vaccine Highlights Strength of Vaccine Safety Surveillance | MedPage Today

  https://www.medpagetoday.com/spotlight/rotavirus/114909

  „If there is a real concern with a vaccine, then it shows that we have very good systems in place to detect it, confirm it, and make changes in a timely manner,” he added. […] „The takeaway is the importance of the post-release vaccine monitoring. That is really the key to picking up those rare events,” Boonstra said. „We were looking at a one in 10,000 risk, and that’s going to be rare and difficult to pick up in a clinical trial if your trial is something that can be feasibly done.” […] Large federally funded post-licensure studies of those vaccines have since identified a risk of approximately one to five excess cases of intussusception per 100,000 first vaccine doses, a risk-benefit ratio that continues to favor vaccination. […] But that, again, points to the strength of post-licensure surveillance programs. As Boonstra noted, „it’s a testament to how well VAERS works to detect those events when used appropriately.” […] „Rotavirus was a really common cause of hospitalization for children before vaccination, and vaccination has been a wonderful advance,” she said.

• #32 Rotavirus A in Brazil: Molecular Epidemiology and Surveillance during 2018–2019

  https://www.mdpi.com/2076-0817/9/7/515

  Therefore, the new and dynamic epidemiological scenario reinforces the need to continuously document RVA prevalence in AGE cases, molecular epidemiology and the potential emergence of unusual genotypes. […] In this study, we provide laboratory-based RVA national surveillance in eleven states from three regions in Brazil, during 2018–2019. We tested 1536 AGE stool samples and found an overall RVA-positivity of 12%. RVA detection rates were higher during winter/spring months and among children aged 24–60 months. By far, G3P[8] was the most frequently detected genotype, and showed a year-round circulation. […] The constant shifting of RVA genotypes circulation and the potential emergence of unusual/reassortant strains reinforces the importance and the need for continuous country-based epidemiological and molecular surveillance programs.

• #33 Estimation of Rotavirus Vaccine Effectiveness Based on Whole Genome Sequences

  https://elifesciences.org/reviewed-preprints/104086

  Incorporating the complete genomic structure of RVA reveals that vaccine protection correlates with the diversity of non-outer capsid proteins. […] Our WGS-based analysis more clearly differentiated vaccine protection than analyses based on VP7 and VP4 alone. […] In the U.S., the New Vaccine Surveillance Network (NVSN) has been conducting pre- and post-vaccination surveillance for RVGE beginning in 2006. […] Following vaccine introduction, the genomic analysis of RVA strains at both genotype and whole-genome levels provided valuable insights into the evolutionary patterns of circulating strains and revealed targets in the sequences that may potentially affect vaccine performance, thus requiring ongoing surveillance. […] Our analysis provides an improved understanding of how the full genomic composition of RVA contributes to vaccine protection.

• #34 Disease burden of rotavirus related diarrhea in children under 5 years in China: a meta-analysis | Scientific Reports

  https://www.nature.com/articles/s41598-025-00778-w

  Rotavirus (RV) is a leading cause of severe diarrhea among children under five years of age in China. […] Given the dynamic nature of the incidence rate of RV-related diarrhea and the prevalence of the G9P[8] genotype, it is imperative to enhance surveillance efforts targeting incidence of RV-related diarrhea and the circulating genotypes of rotavirus. […] Pursuant to the Infectious Disease Prevention and Control Law of China, hospitals are required to report confirmed cases of rotavirus-related diarrhea to the National Notifiable Infectious Diseases Surveillance System (NNIDSS) within 24 h. […] However, RV-related diarrhea is not classified as a distinct notifiable infectious disease. […] Many international studies have shown that the incidence of RV-related diarrhea has decreased following the use of RotaTeq vaccine.

• #35 Chapter 13: Rotavirus | Manual for the Surveillance of Vaccine-Preventable Diseases | CDC

  https://www.cdc.gov/surv-manual/php/table-of-contents/chapter-13-rotavirus.html

  The ACIP recommends that a child’s rotavirus vaccine series be completed with the same product whenever possible but allows interchanging vaccine types if the product used for a previous dose(s) is not available or is unknown. […] Rotavirus vaccines have been introduced into the national immunization programs of more than 120 countries. […] Rotavirus vaccination rates among US children 19-35 months of age have been estimated using systematic sampling methods by the National Immunization Survey since 2009. […] The ACIP recommends that a child’s rotavirus vaccine series be completed with the same product whenever possible but allows interchanging vaccine types if the product used for a previous dose(s) is not available or is unknown. […] The ACIP recommends that a child’s rotavirus vaccine series be completed with the same product whenever possible but allows interchanging vaccine types if the product used for a previous dose(s) is not available or is unknown.

• #36 Chapter 13: Rotavirus | Manual for the Surveillance of Vaccine-Preventable Diseases | CDC

  https://www.cdc.gov/surv-manual/php/table-of-contents/chapter-13-rotavirus.html

  The ACIP recommends that a child’s rotavirus vaccine series be completed with the same product whenever possible but allows interchanging vaccine types if the product used for a previous dose(s) is not available or is unknown. […] Rotavirus vaccines have been introduced into the national immunization programs of more than 120 countries. […] Rotavirus vaccination rates among US children 19-35 months of age have been estimated using systematic sampling methods by the National Immunization Survey since 2009. […] The ACIP recommends that a child’s rotavirus vaccine series be completed with the same product whenever possible but allows interchanging vaccine types if the product used for a previous dose(s) is not available or is unknown. […] The ACIP recommends that a child’s rotavirus vaccine series be completed with the same product whenever possible but allows interchanging vaccine types if the product used for a previous dose(s) is not available or is unknown.

• #37 Rotavirus – Symptoms & causes – Mayo Clinic

  https://www.mayoclinic.org/diseases-conditions/rotavirus/symptoms-causes/syc-20351300

  Rotavirus is a very contagious virus that causes diarrhea. Before the development of a vaccine, most children had been infected with the virus at least once by age 5. […] But vaccination is the best way to prevent rotavirus infection. […] The World Health Organization recommends that all countries give infants a rotavirus vaccine. There are two vaccines available: RotaTeq and Rotarix. […] The vaccines are considered safe and effective, and studies show that they prevent thousands of children from developing rotavirus every year. […] However, rarely, they can cause a part of the intestine to fold back on itself (intussusception), resulting in possibly life-threatening intestinal blockage. […] The U.S. Food and Drug Administration recommends that the vaccine not be given to children who have a history of intussusception. […] For children who don’t have a history of intussusception, there is a very small risk that it can develop after the rotavirus vaccine is given. Even so, the benefits of the vaccine far outweigh the risks.

• #38 Rotavirus – Symptoms & causes – Mayo Clinic

  https://www.mayoclinic.org/diseases-conditions/rotavirus/symptoms-causes/syc-20351300

  Rotavirus is a very contagious virus that causes diarrhea. Before the development of a vaccine, most children had been infected with the virus at least once by age 5. […] But vaccination is the best way to prevent rotavirus infection. […] The World Health Organization recommends that all countries give infants a rotavirus vaccine. There are two vaccines available: RotaTeq and Rotarix. […] The vaccines are considered safe and effective, and studies show that they prevent thousands of children from developing rotavirus every year. […] However, rarely, they can cause a part of the intestine to fold back on itself (intussusception), resulting in possibly life-threatening intestinal blockage. […] The U.S. Food and Drug Administration recommends that the vaccine not be given to children who have a history of intussusception. […] For children who don’t have a history of intussusception, there is a very small risk that it can develop after the rotavirus vaccine is given. Even so, the benefits of the vaccine far outweigh the risks.

• #39 Rotavirus – PAHO/WHO | Pan American Health Organization

  https://www.paho.org/en/topics/rotavirus

  In 2015, an estimated 125,000 rotavirus-associated hospitalizations and 800 rotavirus-related deaths were prevented in countries that implemented rotavirus vaccines in the Region of the Americas and the Caribbean. […] PAHO’s rotavirus sentinel surveillance network began in 2006. […] PAHO’s Technical Advisory Group (TAG) on Vaccine-preventable Diseases recommends that countries in the Region of the Americas should continue making efforts to administer rotavirus vaccines as part of their routine immunization schedules, at the recommended ages, usually at 2 and 4 months or 2, 4 and 6 months. […] Since 2006, 22 countries and one territory of the Region have introduced this vaccine into their national vaccination schedules. […] Epidemiologic surveillance is the ongoing observation of the distribution and trends in the incidence of diseases through systematic collection, compilation, and analysis of morbidity and mortality reports, as well as other relevant data, and dissemination of that information to all interested parties.

• #40 Understanding Variation in Rotavirus Vaccine Effectiveness Estimates in the United States

  https://pmc.ncbi.nlm.nih.gov/articles/PMC10100583/

  When we adjusted for the force of infection and used only site EIA results to define cases, annual estimates of VE against any-severity RVGE ranged between 65% (95% CI = 51%, 75%) in 2016 and 73% (95% CI = 67%, 77%) in 2013 and 2015. […] Overall, estimates from the force-of-infection approach fluctuated less and were more precise than estimates from the standard approach regardless of RVGE case definition used. […] Future analyses should control for the force of infection when comparing estimates of VE over time or between locations.

• #41

  https://link.springer.com/article/10.1007/s40272-018-0283-3

  Rotavirus is the leading cause of diarrheal death among children 5 years old worldwide, estimated to have caused ~ 215,000 deaths in 2013. […] Two live, oral rotavirus vaccines have been implemented nationally in 100 countries since 2006 and their use has substantially reduced the burden of severe diarrheal illness in all settings. […] Vaccine efficacy and effectiveness estimates suggest there is a gradient in vaccine performance between low child-mortality countries ( 90%) and medium and high child-mortality countries (5775%). […] Two additional live, oral rotavirus vaccines were recently licensed and these have improved on some programmatic limitations of earlier vaccines, such as heat stability, cost, and cold-chain footprint. […] Non-replicating rotavirus vaccines that are parenterally administered are in clinical testing, and these have the potential to reduce the performance differential and safety concerns associated with live oral rotavirus vaccines.

• #42 Vaccine profiles: Rotavirusverifiedverifiedverifiedverifiedverifiedverifiedverifiedverifiedverifiedverified

  https://www.gavi.org/vaccineswork/routine-vaccines-extraordinary-impact-rotavirus

  According to a recent Cochrane Review, which assessed the efficacy of all four WHO prequalified vaccines, rotavirus vaccines prevent more than 90% of severe cases of rotavirus diarrhoea in countries with low child mortality rates, more than 75% in countries with medium child mortality rates, and 35% to 58% in countries with high child mortality rates. […] So far, more than 100 countries have introduced rotavirus vaccines into their routine immunisation programs. The impact of this has been substantial. An analysis of data from 69 countries participating in the WHO’s Global Rotavirus Surveillance Network (GRSN) found a 40% reduction in the prevalence of rotavirus among children admitted to hospital with severe gastroenteritis, following vaccine introductions. […] Rotavirus vaccine and improved sanitation have dramatically reduced the toll from diarrhoeal illness in recent decades, but too many children still die from the dehydration it causes. The next-generation of rotavirus vaccines may address key barriers to their uptake, and further reduce this toll.

• #43 Viral ‘backbone’ underlies variation in rotavirus vaccine effectiveness | For the press | eLife

  https://elifesciences.org/for-the-press/79726e57/viral-backbone-underlies-variation-in-rotavirus-vaccine-effectiveness

  Scientists have speculated that genetic differences between circulating rotavirus strains and vaccine strains may affect how well they work. […] We set out to investigate why some vaccinated children still get sick with rotavirus, says lead author Jiye Kwon, a PhD student at the Department of Epidemiology of Microbial Diseases, and the Public Health Modeling Unit, Yale School of Public Health, New Haven, US. […] Previous research has focused on just the outer proteins of the virus, but rotavirus has a total of 11 genetic segments. […] We wanted to look at the full genome to explore whether these remaining nine segments, the viral backbone, may explain the variation in vaccine effectiveness against rotavirus strains. […] Their results revealed that individuals vaccinated with Rotarix (RV1) were more likely to be infected by rotavirus strains that were significantly genetically different from the vaccine more than 9.6% different in their full genome.

• #44 Viral ‘backbone’ underlies variation in rotavirus vaccine effectiveness | For the press | eLife

  https://elifesciences.org/for-the-press/79726e57/viral-backbone-underlies-variation-in-rotavirus-vaccine-effectiveness

  Vaccine effectiveness results also reflected this genetic pattern. […] The Rotarix (RV1) vaccine provided strong protection against genetically similar viral strains, but its protection dropped significantly for more genetically distant strains. […] Current vaccines still provide strong protection against severe illness in rotavirus, but these findings highlight the need to continually monitor viral evolution to maintain vaccine effectiveness in the long term, says Kwon. […] This highlights the importance of incorporating the full genomic structure of viruses when designing vaccines. […] Our framework for using whole genome sequencing data to understand how all gene segments contribute to immune protection could be crucial for maintaining their long-term success.

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