Vaccination strategies for people living with inborn errors of metabolism in Brazil.

OBJECTIVE: Through a literature review, make recommendations regarding immunizations in people living with Inborn Error of Metabolism (IEM) in Brazil, assess the possible impact on metabolic decompensations after immunization, and if this specific population may have an impaired immune response to vaccines. SOURCE OF DATA: The MeSH Terms vaccination OR vaccine OR immunization associated with the term inborn error of metabolism AND recommendation were used in combination with search databases. Only articles published after 1990, in the languages English, Spanish, French or Portuguese, human-related were included. SYNTHESIS OF DATA: A total of 44 articles were included to make the following recommendations. Individuals with IEMs need to be up to date with their immunizations. Regarding which vaccines should be offered, children and adults should follow the routine immunization schedules locally available, including the COVID-19 vaccines. The only exception is the rotavirus vaccine for hereditary fructose intolerance. The benefit of immunization outweighs the very low risk of metabolic decompensation. Since not all patients will have an adequate immune response, measuring antibody conversion and titers is recommended CONCLUSIONS: All patients should receive age-appropriate immunizations in their respective schedules without delays. The only situation when vaccination may be contraindicated is with oral rotavirus vaccine in hereditary fructose intolerance. Monitoring the levels of antibodies should be done to detect any immune dysfunction or the necessity for boosters. A personalized immunization schedule is ideal for patients with IEMs. The reference organizations could improve their recommendations to address all IEMs, not only some of them.

Characteristics of intussusception in the period of arbitrary Rotavirus vaccination.

BACKGROUND: In November 2011, rotavirus (RV) vaccine was launched in Japan as a voluntary vaccination to prevent RV-associated gastroenterocolitis. We examined the characteristics of intussusception following RV vaccination in our two centers. METHODS: We investigated intussusception patients <16 years old from January 2006 to September 2020. Patients were categorized according to the period (before [Group A] or after the introduction of arbitrary RV vaccination [Group B]). The patient characteristics and treatment of intussusception were retrospectively investigated. RESULTS: During the study period, 560 patients (group A, n = 233; group B, n = 327) were identified. The distribution of patients who were 0-6 months old was not significantly different between the groups (group A, n = 12, 5.2%; group B, n = 18, 5.5%). Among these 18 patients in Group B, 7 were vaccinated against RV, and 10 were not. One patient was excluded due to incomplete data. On comparing patients with and without RV vaccination, the mean age at the onset of intussusception was 3.3 ± 0.4 versus 4.0 ± 0.3 months (P = 0.19), the mean interval from the onset to treatment was 7.5 ± 2.4 versus 16.0 ± 2.2 h (P = 0.03), the time of the contrast enema for treatment was 9.1 ± 3.3 versus 7.7 ± 2.8 min (P = 0.76), and the final pressure of the contrast enema was 92.5 ± 4.4 versus 92.2 ± 4.4 cmH2 O (P = 0.97). CONCLUSIONS: Arbitrary RV vaccination did not influence the age distribution of intussusception, and the interval from the onset to treatment was significantly shorter in the patients with RV vaccination than in those without it. Recognizing the presence of intussusception following RV vaccination enables accurate treatment.

Change in Rotavirus Vaccine Coverage in Brazil from before (2015-2019) through the COVID-19 Pandemic Period (2020-2021).

During the COVID-19 pandemic, a reduction in vaccination coverage of children and adolescents was observed in several countries. The aim of this study was to assess the impact of the pandemic, in the first two years, on human rotavirus vaccine (HRV) coverage in Brazil compared with previous years. The number of doses of HRV administered in the period from January 2015 to December 2021 and its annual vaccination coverage were analyzed. The vaccination coverage decreased to 77.3% in 2020 and to 70.4% in 2021, substantially lower than the minimum that would be expected (89.2%); the decline was more pronounced in the second year of the pandemic despite the fact that in this period, the circulation restrictions were already less tight. Of the five Brazilian macro-regions, the northeast had the largest decline, and the south had the smallest impact on coverage. At the municipal level, less than half of the Brazilian municipalities managed to achieve vaccination coverage above 90% in either pandemic year. Although there was already a downward trend in coverage in the pre-pandemic years, the present study shows that the values recorded in 2020 and 2021 were significantly lower. Monitoring of vaccination coverage in the coming years should be carried out continuously in order to avoid a possible resurgence of rotavirus-induced diarrhea.

Introducing ROTAVAC® to the occupied Palestinian Territories: Impact on diarrhea incidence, rotavirus prevalence and genotype composition.

BACKGROUND: Rotavirus infection remains an important cause of morbidity and mortality in children. The introduction of vaccination programs in more than 100 countries has contributed to a decrease in hospitalizations and mortality. This study investigates the epidemiological impact of the rotavirus vaccine ROTAVAC® in the Palestinian Territories, the first country to switch from ROTARIX® to this new vaccine. METHODS: Clinical surveillance data was collected fromchildren younger than 5attendingoutpatient clinics throughout Gaza withdiarrhea between 2015 and 2020. The incidence of all-cause diarrhea was assessed using an interrupted time-series approach. Rotavirus prevalence was determined at the Caritas Baby Hospital in the West Bank usingELISA on stool specimen of children younger than 5with diarrhea. Genotyping was performed on 325 randomly selected rotavirus-positive samples from January 2015 through December 2020 using multiplex PCR analysis. RESULTS: Average monthly diarrhea casesdropped by 16.7% annually fromintroduction of rotavirus vaccination in May 2016 to the beginning of the SARS-CoV-2 epidemic in March 2020 for a total of 53%. Case count declines were maintained afterthe switchto ROTAVAC® in October 2018. Rotavirus positivity in stool samples declined by 67.1% over the same period without change followingthe switch to ROTAVAC®. The distribution of predominant genotypes in rotavirus-positive stool samples changed from a pre-vaccination G1P [8] to G9P[8] and G12P[8] during the ROTARIX® period and G2P[4] after the introduction of ROTAVAC®. CONCLUSION: ROTAVAC® has shown epidemiological impact on par with ROTARIX® after its introduction to the national immunization schedule in the Palestinian Territories. A molecular genotype shift from a pre-vaccination predominance of G1P[8] to a current predominance of G2P[4] requires more long-term surveillance.

Immunisation schedule of the Spanish Association of Paediatrics: 2023 Recommendations.

As it does every year, the CAV-AEP publishes the update of its recommendations for the use of vaccines in children, adolescents and pregnant women residing in Spain. The 2 + 1 schedule is maintained in infants (at 2, 4 and 11 months), including preterm infants, with the hexavalent vaccine (DTaP-IPV-Hib-HB) and the pneumococcal 13-valent conjugate vaccine. A booster dose with DTaP-IPV is needed at 6 years for those who received the 2 + 1 series with hexavalent vaccine as infants, in addition to 1 dose of dTap in adolescence. Routine vaccination of pregnant women with a dose of dTap is recommended in each pregnancy, preferably between weeks 27 and 32 of gestation, although can be given from 20 weeks if there is risk of preterm delivery. All infants should receive the rotavirus vaccine (2-3 doses) and the 4CMenB vaccine (2 + 1 series). All children aged 6-59 months should be vaccinated against influenza each year. The MenACWY vaccine should be given routinely at 12 months of age and in adolescence between ages 12 and 18 years. The recommendations for the MMR vaccine (12 months and 3-4 years) and varicella vaccine (15 months and 3-4 years) also remain unchanged, using the MMRV vaccine for the second dose. Recommendations for the use of SARS-CoV-2 vaccines in the paediatric age group will be updated periodically on the CAV-AEP website. The HPV vaccine is indicated in all adolescents, regardless of sex, at age 12 years. Novelties include the recommendation of routine administration of nirsevimab to neonates and infants aged less than 6 months for passive immunization against RSV, and the recommendations regarding the hexavalent vaccine are consolidated in a single section.

The COVID-19 pandemic and vaccination abandonment in children: spatial heterogeneity maps.

OBJECTIVE: to identify spatial clusters corresponding to abandonment of routine vaccines in children. METHOD: an ecological study, according to data from the 853 municipalities of a Brazilian state. The records analyzed were those of the multidose pentavalent, pneumococcal 10-valent, inactivated poliomyelitis and oral human rotavirus vaccines of 781,489 children aged less than one year old. The spatial scan statistics was used to identify spatial clusters and assess the relative risk based on the vaccination abandonment indicator. RESULTS: the spatial scan statistics detected the presence of statistically significant clusters for abandonment regarding the four vaccines in all the years analyzed. However, the highest number of clusters with high relative risk estimates was identified in 2020. The Vale do Aço and West, North and West, and Southwest regions stand out for the pentavalent, poliomyelitis and rotavirus vaccines, respectively. CONCLUSION: in an attempt to mitigate the devastating impact of the COVID-19 pandemic, the immunization program experienced setbacks. The presence of clusters points to the need to implement integrated strategies that may involve different sectors for an active search for children and prevent outbreaks of vaccine-preventable diseases in the near future.

Safety and immunogenicity of the Rotavac and Rotasiil rotavirus vaccines administered in an interchangeable dosing schedule among healthy Indian infants: a multicentre, open-label, randomised, controlled, phase 4, non-inferiority trial.

BACKGROUND: Rotavirus is the leading cause of severe dehydrating gastroenteritis among children younger than 5 years in low-income and middle-income countries. Two vaccines-Rotavac and Rotasiil-are used in routine immunisation in India. The safety and immunogenicity of these vaccines administered in a mixed regimen is not documented. We therefore aimed to compare the safety and seroresponse of recipients of a mixed regimen versus a single regimen. METHODS: We did a multicentre, open-label, randomised, controlled, phase 4, non-inferiority trial at two sites in India. We recruited healthy infants aged 6-8 weeks. Infants with systemic disorders, weight-for-height Z scores of less than minus three SDs, or a history of persistent diarrhoea were excluded. Eligible infants were randomly allocated to six groups in equal numbers to receive either the single vaccine regimen (ie, Rotavac-Rotavac-Rotavac [group 1] or Rotasiil-Rotasiil-Rotasiil [group 2]) or the mixed vaccine regimen (ie, Rotavac-Rotasiil-Rotavac [group 3], Rotasiil-Rotavac-Rotasiil [group 4], Rotavac-Rotasiil-Rotasiil [group 5], or Rotasiil-Rotavac-Rotavac [group 6]). Randomisation was done using an online software by site in blocks of at least 12. The primary outcome was seroresponse to rotavirus vaccine, measured using rotavirus-specific serum IgA antibodies 4 weeks after the third dose. The seroresponse rates were compared between recipients of the four mixed vaccine regimens (consisting of various combinations of Rotavac and Rotasiil) with recipients of the single vaccine regimens (consisting of Rotavac or Rotasiil only for all three doses). The non-inferiority margin was set at 10%. Safety follow-ups were done for the duration of study participation. This trial was registered with the Clinical Trials Registry India, number CTRI/2018/08/015317. FINDINGS: Between March 25, 2019, and Jan 15, 2020, a total of 1979 eligible infants were randomly assigned to receive a single vaccine regimen (n=659; 329 in group 1 and 330 in group 2) or a mixed vaccine regimen (n=1320; 329 each in groups 3 and 4, and 331 each in groups 5 and 6). All eligible participants received the first dose, 1925 (97·3%) of 1979 received the second dose, and 1894 (95·7%) received all three doses of vaccine. 1852 (93·6%) of 1979 participants completed the follow-up. The immunogenicity analysis consisted of 1839 infants (1238 [67·3%] in the mixed vaccine regimen and 601 [32·7%] in the single vaccine regimen; 13 samples were insufficient in quantity) who completed vaccination and provided post-vaccination sera. The seroresponse rate in the mixed vaccine regimen group (33·5% [95% CI 30·9-36·2]) was non-inferior compared with the single vaccine regimen group (29·6% [26·1-33·4]); the seroresponse rate difference was 3·9% (95% CI -0·7 to 8·3). The proportion of participants with any type of solicited adverse events was 90·9% (95% CI 88·4-93·0) in the single vaccine regimen group and 91·1% (89·5-92·6) in the mixed vaccine regimen group. No vaccine-related serious adverse events or intussusception were reported during the study. INTERPRETATION: Rotavac and Rotasiil can be safely used in an interchangeable manner for routine immunisation since the seroresponse was non-inferior in the mixed vaccine regimen compared with the single vaccine regimen. These results allow for flexibility in administering the vaccines, helping to overcome vaccine shortages and supply chain issues, and targeting migrant populations easily. FUNDING: Ministry of Health and Family Welfare, Government of India. TRANSLATION: For the Hindi translation of the abstract see Supplementary Materials section.

Impact and effectiveness of monovalent rotavirus vaccine in Tajik children.

BACKGROUND: In 2015, Tajikistan became the second country in Central Asia to introduce rotavirus vaccine into its national immunization program. Before vaccine introduction, rotavirus was estimated to cause > 40% of pediatric diarrhea hospitalizations in Tajikistan. We aimed to assess the impact of rotavirus vaccine introduction on rotavirus disease burden and estimate rotavirus vaccine effectiveness (VE). METHODS: Using surveillance data from 2013 through 2019, we examined trends in monthly hospital admissions among children < 5 years old, before and after rotavirus vaccine introduction. Poisson regression was used to quantify decreases. VE was estimated using a test-negative case control design, with data from admissions during 2017 - 2019. Immunization records were obtained from clinics. RESULTS: Among enrolled children, rotavirus positivity declined from 42% to 25% in the post-vaccine introduction period, a decrease of 41% (95% Confidence Interval [CI]: 36 - 45%). Declines were greatest in children < 12 months of age. Estimated VE of a complete course of rotavirus vaccine was 55% (95% CI: 21 - 73%) among children 5 - 59 months of age and 64% (95% CI: 36 - 80%) among children 5 - 23 months of age. VE point estimates were higher among children receiving both doses of rotavirus vaccine non-concurrently with OPV and among children receiving their first dose of rotavirus vaccine at 4 - 11 months of age, but CIs were wide and overlapping. CONCLUSIONS: Our data demonstrate that rotavirus vaccine introduction was associated with a substantial reduction in pediatric rotavirus hospitalization burden in Tajikistan, and that rotavirus vaccination is effective in Tajik children.

Trends in Rotavirus Laboratory Detections and Internet Search Volume Before and After Rotavirus Vaccine Introduction and in the Context of the Coronavirus Disease 2019 Pandemic-United States, 2000-2021.

BACKGROUND: Since rotavirus vaccines became available in the United States in 2006, there have been reductions in rotavirus hospitalizations, changes in seasonality, and the emergence of a biennial trend of rotavirus activity. Reductions in other pathogens have been associated with coronavirus disease 2019 (COVID-19) mitigation measures. We assessed ongoing rotavirus disease trends during the COVID-19 pandemic. METHODS: We report a 3-week moving average of the number of rotavirus tests, positive tests, and the percent positivity from laboratories reporting to the National Respiratory and Enteric Virus Surveillance System (NREVSS) from July 2000 through June 2021. To complement NREVSS data, we analyzed Google internet search interest in "rotavirus" from July 2004 to June 2021. RESULTS: Declines in rotavirus activity following vaccine introduction and the biennial trend are evident through the 2018-2019 surveillance year. In 2019-2021, rotavirus test positivity was below the historic ranges during the months of typically high rotavirus activity, and precipitous declines were noted in March 2020. CONCLUSIONS: In the 15 years since rotavirus vaccine was introduced, the number of laboratory-detected rotavirus infections has been consistently lower than during the prevaccine era. During the COVID-19 pandemic, rotavirus activity was suppressed. There may be many rotavirus-susceptible children during the 2021-2022 rotavirus season.

Rotavirus and the web: analysis of online conversations in Italy during 2020.

Rotavirus is the most common cause of severe diarrhea among children worldwide. In 2017, Italy included rotavirus vaccination in its National Immunization Program. The use of social media monitoring, an efficient tool to understand vaccine hesitancy, has increased in recent years; however, only a few examples of such monitoring are available for Italy. Present study analyzed content on online sources, including social media, to identify factors contributing to Italian parents' decisions to vaccinate or not their children against rotavirus. Blogmeter Suite was used to search and analyze conversations related to rotavirus in Italian on online sources during 2020. These data were compared with data from 2019. There were 2250 mentions of "rotavirus" recorded; 1080 were related to the rotavirus vaccine. Terms and hashtags used were similar in both years. Facebook was the main source of influence, Instagram dominated the engagement (the sum of interactions related to a post), and Google Trends showed a 5-year upward trend in searches for rotavirus vaccine. Of 1270 sentiment opinions, 60.7% were negative. More parents were familiar with the disease and the vaccine in 2020 compared with 2019. Pediatricians were the most influential healthcare professionals (59.2% of mentions), followed by vaccination staff (33.4%). The most relevant factors for vaccine hesitancy were fear of adverse events, concerns about the vaccination schedule, and COVID-19. Present study represents the first web listening analysis of online discussions about rotavirus. The results can be used to inform targeted communication to counteract misinformation and raise awareness about rotavirus vaccination among parents.

Australian Rotavirus Surveillance Program: Annual Report, 2020.

ABSTRACT: This report from the Australian Rotavirus Surveillance Network describes the circulating rotavirus genotypes identified in children and adults during the period 1 January - 31 December 2020. During this period, 229 faecal specimens were referred for rotavirus G- and P- genotype analysis, including 189 samples that were confirmed as rotavirus positive. Of these, 98/189 were wildtype rotavirus strains and 86/189 were identified as vaccine-like. A further five samples could not be determined as wildtype or vaccine-like due to poor sequence reads. Genotype analysis of the 98 wildtype rotavirus samples from both children and adults demonstrated that G3P[8] was the dominant genotype identified for the third consecutive year, identified in 27.6% of samples, followed by G2P[4] in 20.4% of samples. Forty-six percent of rotavirus positive samples received were identified as vaccine-like, highlighting the need to add caution in interpreting rotavirus positive results in children aged 0-8 months. This surveillance period was significantly impacted by the coronavirus disease 2019 ( COVID-19 ) pandemic. The reduction in rotavirus notifications reflected reduced healthcare-seeking behaviour and a decrease in community spread, with 'community lockdowns', school and day-care centre closure and improved compliance with hand hygiene. Fewer stool samples were collected throughout Australia during this period. There was a reluctance to store samples at collaborating laboratories and uncertainties regarding the safety and feasibility of the transport of samples to the central laboratory during the closure of state and territory borders. Systems have now been adapted to manage and send biological samples safely and confidently. Ongoing rotavirus surveillance is crucial to identify changes in genotypic patterns and to provide diagnostic laboratories quality assurance by reporting incidences of wildtype, vaccine-like, or false positive rotavirus results.

Assessing vaccine introduction and uptake timelines in Gavi-supported countries: are introduction timelines accelerating across vaccine delivery platforms?

BACKGROUND: Previous studies identified factors influencing regulatory approval to introduction timelines for individual vaccines. However, introduction and uptake timelines have not been comprehensively assessed across the portfolio of Gavi-supported vaccines. METHODS: We analysed median times between introduction milestones from vaccine licensure to country introduction and uptake across six vaccine-preventable diseases (VPDs), three delivery platforms and 69 Gavi-supported countries. Data were gathered from public, partner and manufacturer records. VPDs and prequalified vaccines analysed included Haemophilus influenzae type b (DTwP-HepB-Hib, pentavalent), pneumococcal disease (pneumococcal conjugate vaccine, PCV), rotavirus diarrhoea (rotavirus vaccine, RVV), cervical cancer (human papillomavirus vaccine, HPV), polio (inactivated polio vaccine, IPV) and meningococcal meningitis (meningococcal group A conjugate vaccine, MenA). RESULTS: Median time from first vaccine licensure to first Gavi-supported country introduction across VPDs at a 'global level' (Gavi-supported countries) was 5.4 years. Once licensed, MenA vaccines reached first introduction fastest (campaign=0.6 years; routine immunisation (RI)=1.7 years). Most introductions were delayed. Country uptake following first introduction was accelerated for more recently Gavi-supported RI vaccines compared with older ones. CONCLUSION: Factors accelerating timelines across delivery platforms included rapid product prequalifications by WHO, strong initial recommendations by the WHO Strategic Advisory Group of Experts (SAGE) on Immunization, achieving target product profiles on first vaccine licensure within a VPD and completing several VPD milestones at a global level prior to licensure. Milestones required for introduction in Gavi-supported countries should start prior or in parallel to licensure to accelerate uptake of vaccines delivered through diverse delivery platforms.

Implementing vaccination policies based upon scientific evidence in Japan.

The theme of the 24th Annual Meeting of the Japanese Society for Vaccinology was "Sustainable Future Medical Care Created by Vaccines." This theme includes topics such as the proposal to reduce the medical costs incurred by societies with aging populations through prophylactic vaccination. The coronavirus disease 2019 (COVID-19) pandemic alerted us to the important roles that preventive measures, such as vaccines, play in fighting infectious diseases. In order to inform the public of the benefits of vaccines, it is important to provide society with information regarding new vaccine developments, adjuvants, the cost-benefit ratio of vaccine introduction, and vaccine effectiveness and safety. Clinical research is essential for obtaining evidence of vaccine effectiveness and safety. The United States Centers for Disease Control and Prevention (CDC) conducts active surveillance in defined areas before and after the introduction of vaccines and documents the reduction in infection rates as a measure of vaccine effectiveness. However, vaccine efficacy and side effects may vary by country and ethnicity. Therefore, it is necessary for individual countries to develop their own evidence-based surveillance programs. We have studied vaccine efficacy and documented side-effects observed in patients for the varicella and rotavirus vaccines in Japan. This review outlines the importance of providing scientific evidence for vaccine effectiveness and safety.

Should countries switch to using five- or ten-dose rotavirus vaccines now that they are available?

INTRODUCTION: Single-dose rotavirus vaccines, which are used by a majority of countries, are some of the largest-sized vaccines in immunization programs, and have been shown to constrain supply chains and cause bottlenecks. Efforts have been made to reduce the size of the single-dose vaccines; however, with two-dose, five-dose and ten-dose options available, the question then is whether using multi-dose instead of single-dose rotavirus vaccines will improve vaccine availability. METHODS: We used HERMES-generated simulation models of the vaccine supply chains of the Republic of Benin, Mozambique, and Bihar, a state in India, to evaluate the operational and economic impact of implementing each of the nine different rotavirus vaccine presentations. RESULTS: Among single-dose rotavirus vaccines, using Rotarix RV1 MMP (multi-monodose presentation) led to the highest rotavirus vaccine availability (49-80%) and total vaccine availability (56-79%), and decreased total costs per dose administered ($0.02-$0.10) compared to using any other single-dose rotavirus vaccine. Using two-dose ROTASIIL decreased rotavirus vaccine availability by 3-6% across each supply chain compared to Rotarix RV1 MMP, the smallest single-dose vaccine. Using a five-dose rotavirus vaccine improved rotavirus vaccine availability (52-92%) and total vaccine availability (60-85%) compared to single-dose and two-dose vaccines. Further, using the ten-dose vaccine led to the highest rotavirus vaccine availability compared to all other rotavirus vaccines in both Benin and Bihar. CONCLUSION: Our results show that countries that implement five-dose or ten-dose rotavirus vaccines consistently reduce cold chain constraints and achieve higher rotavirus and total vaccine availability compared to using either single-dose or two-dose rotavirus vaccines.

Measurement of Cellular Immune Response to Viral Infection and Vaccination.

Combined cellular and humoral host immune response determine the clinical course of a viral infection and effectiveness of vaccination, but currently the cellular immune response cannot be measured on simple blood samples. As functional activity of immune cells is determined by coordinated activity of signaling pathways, we developed mRNA-based JAK-STAT signaling pathway activity assays to quantitatively measure the cellular immune response on Affymetrix expression microarray data of various types of blood samples from virally infected patients (influenza, RSV, dengue, yellow fever, rotavirus) or vaccinated individuals, and to determine vaccine immunogenicity. JAK-STAT1/2 pathway activity was increased in blood samples of patients with viral, but not bacterial, infection and was higher in influenza compared to RSV-infected patients, reflecting known differences in immunogenicity. High JAK-STAT3 pathway activity was associated with more severe RSV infection. In contrast to inactivated influenza virus vaccine, live yellow fever vaccine did induce JAK-STAT1/2 pathway activity in blood samples, indicating superior immunogenicity. Normal (healthy) JAK-STAT1/2 pathway activity was established, enabling assay interpretation without the need for a reference sample. The JAK-STAT pathway assays enable measurement of cellular immune response for prognosis, therapy stratification, vaccine development, and clinical testing.

Rotavirus gastroenteritis in children hospitalized in northeastern Poland in 2006-2020: Severity, seasonal trends, and impact of immunization.

OBJECTIVES: The introduction of the rotavirus vaccine in 2006 significantly reduced childhood incidence of acute gastroenteritis (AGE) worldwide. The rotavirus vaccine was included in Poland's national immunization program in 2021. Our study aimed to summarize the epidemiology of AGE in northeastern Poland prior to 2021 and to evaluate the effectiveness of voluntary, out-of-pocket rotavirus childhood vaccination on the incidence of rotavirus AGE. METHODS: A review of patients aged 0-17 years with gastroenteritis hospitalized between 2006 and 2020 in northeastern Poland in the context of rotavirus vaccine coverage in the region. RESULTS: Rotavirus was the most common agent of gastroenteritis in hospitalized patients. The seasonality of rotavirus gastroenteritis peaked between February and May in each year of study, except for 2020, when the COVID-19 pandemic skewed any viable comparison of seasonality. Rotavirus vaccine coverage in northeastern Poland did not exceed 25% during the study period and had no impact on hospitalization numbers. CONCLUSIONS: Rotavirus was the primary causative agent of AGE in children hospitalized in northeastern Poland during the study period. Voluntary vaccinations did not affect the number of hospitalizations due to rotavirus AGE. Our data suggest that universal immunization is key to achieving a significant reduction of rotavirus-associated diarrhea.