Safety Of Rotavirus Vaccine Research Articles

Safety of Rotavirus Vaccination in Infants That Were Exposed to Biologics In Utero: A Systematic Review

Safety of Rotavirus Vaccination in Infants That Were Exposed to Biologics In Utero: A Systematic Review

Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications.

The self-controlled case series (SCCS) is often used to monitor vaccine safety. The evaluation of intussusception after the rotavirus vaccine is complicated because the baseline rate varies with age. Time-varying baseline risk adjustments with data from unexposed cohorts are utilised. Self-controlled risk interval (SCRI), with a shorter observation period, can also mitigate the problem by studying a control period close to the risk period. An Indian rotavirus vaccine has previously been studied using SCCS. The risk of intussusception in the high-risk windows (21 days after vaccination) was comparable to the background risk. The aim was to re-analyse data of an existing SCCS study using alternate statistical methods to examine vaccine safety. We examined the mean age of intussusception in the vaccinated and the unvaccinated. We performed an SCRI analysis of the surveillance data from the SCCS study, limiting the observation period to 180 days. We analysed the time-to-intussusception from the last vaccination. Finally, we performed an SCCS analysis, excluding unvaccinated cases from the analysis. We found that the mean age of intussusception was significantly lower in the vaccinated (205 days) compared to the unvaccinated (223 days) (p-value 0.0026). The Incident Risk Ratio (IRR) on SCRI analysis was 1.62 (95% CI 1.07-2.44). There were significantly more intussusceptions in the first 30 days after vaccination compared to the next 30-day window. (92 vs 63 p-value = 0.009). We found that excluding unvaccinated infants from the SCCS analysis demonstrated significantly increased risk for the risk period 1-21 days after the 3rd dose (IRR 2.47, 95% CI 1.70-3.59). The risks of intussusception were missed in traditional SCCS analysis using unvaccinated infants as controls. Traditional risk adjustments using data from unexposed cohorts in SCCS may not be appropriate for investigating the risk of intussusception where vaccination lowers the mean age of intussusception.

Intussusception risk following oral monovalent rotavirus vaccination in 3 Asian countries: A self-control case series evaluation

Rotavirus vaccines have substantially decreased rotavirus hospitalizations in countries where they have been implemented. In some high- and middle-income countries, a low-level of increased risk of intussusception, a type of acute bowel obstruction, has been detected following rotavirus vaccination. However, no increased risk of intussusception was found in India, South Africa, or a network of 7 other African countries. We assessed the association between a 2-dose monovalent rotavirus vaccine (Rotarix) and intussusception in 3 early-adopter low-income Asian countries -- Afghanistan, Myanmar, and Pakistan. Children <12 months of age admitted to a sentinel surveillance hospital with Brighton level 1 intussusception were eligible for enrollment. We collected information about each child’s vaccination status and used the self-controlled case series method to calculate the relative incidence of intussusception 1–7 days, 8–21 days, and 1–21 days following each dose of vaccine and derived confidence intervals with bootstrapping. Of the 585 children meeting the analytic criteria, the median age at intussusception symptom onset was 24 weeks (IQR: 19–29). Overall, 494 (84 %) children received the first Rotarix dose and 398 (68 %) received the second dose. There was no increased intussusception risk during any of the risk periods following the first (1–7 days: 1.01 (95 %CI: 0.39, 2.60); 8–21 days: 1.37 (95 %CI: 0.81, 2.32); 1–21 days: 1.28 (95 %CI: 0.78, 2.11)) or second (1–7 days: 0.81 (95 %CI: 0.42, 1.54); 8–21 days: 0.77 (95 %CI: 0.53, 1.16); 1–21 days: 0.78 (95 %CI: 0.53, 1.16)) rotavirus vaccine dose. Our findings are consistent with other data showing no increased intussusception risk with rotavirus vaccination in low-income countries and add to the growing body of evidence demonstrating safety of rotavirus vaccines.

Rotavirus Vaccination of Premature Newborns in the NICU: Evaluation of Vaccination Rates and Safety Based on a Single-Centre Study.

Preterm newborns are babies born before the end of the 36th week of gestational life. They are at increased risk of infection and death from infectious diseases. This is due, among other things, to the immaturity of the immune system and the long hospitalisation period. One common infectious disease in the paediatric population is rotavirus (RV) infection. We now have specific vaccines against this pathogen. The aim of this study was to evaluate the safety of rotavirus vaccination in the neonatal intensive care unit (NICU) setting and to determine the tolerance of this vaccine in low- and extremely low-weight children. The study carried out at a single centre, the University Hospital in Kraków, also allowed the assessment of vaccination trends during the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. During the observation period, 126 premature newborns received the RV vaccine. We observed no adverse effects, and our analysis shows safety and good tolerance of the vaccine among preterm babies. In addition, we observed an increase in vaccination rates between 2019 and 2021, partly explained by parents' anxiety about infectious diseases in the era of pandemics and partly explained by a change in vaccination policy in Poland and the introduction of refunding for RV vaccination.

Safety of Rotavirus Vaccination in Preterm Infants Admitted in Neonatal Intensive Care Units in Sicily, Italy: A Multicenter Observational Study.

Rotavirus (RV) is among the most common vaccine-preventable diseases in children under five years of age. Despite the severity of rotavirus pathology in early childhood, rotavirus vaccination for children admitted to the neonatal intensive care unit (NICU), who are often born preterm and with various previous illnesses, is not performed. This multicenter, 3-year project aims to evaluate the safety of RV vaccine administration within the six main neonatal intensive care units of the Sicilian Region to preterm infants. Methods: Monovalent live attenuated anti-RV vaccination (RV1) was administered from April 2018 to December 2019 to preterm infants with gestational age ≥ 28 weeks. Vaccine administrations were performed in both inpatient and outpatient hospital settings as a post-discharge follow-up (NICU setting) starting at 6 weeks of age according to the official immunization schedule. Any adverse events (expected, unexpected, and serious) were monitored from vaccine administration up to 14 days (first assessment) and 28 days (second assessment) after each of the two scheduled vaccine doses. Results: At the end of December 2019, 449 preterm infants were vaccinated with both doses of rotavirus vaccine within the six participating Sicilian NICUs. Mean gestational age in weeks was 33.1 (±3.8 SD) and the first dose of RV vaccine was administered at 55 days (±12.9 SD) on average. The mean weight at the first dose was 3388 (SD ± 903) grams. Only 0.6% and 0.2% of infants reported abdominal colic and fever above 38.5 °C in the 14 days after the first dose, respectively. Overall, 1.9% EAEs were observed at 14 days and 0.4% at 28 days after the first/second dose administration. Conclusions: Data obtained from this study confirm the safety of the monovalent rotavirus vaccine even in preterm infants with gestational age ≥ 28 weeks, presenting an opportunity to improve the vaccination offer both in Sicily and in Italy by protecting the most fragile infants who are more at risk of contracting severe rotavirus gastroenteritis and nosocomial RV infection.

New Possibilities of Preventive Immunization for Rotavirus Infection in Russian Federation. Overview of the Innovative Rotavirus Vaccine Profile

This article is devoted to the issue of rotavirus infection in pediatric population and demonstrates worldwide prevalence of rotavirus among the causes of viral gastroenteritis and its persistent leadership among the causes of fatal diarrhea in children of the first 5 years of life. Specific prevention of rotavirus infection has been actively carried out around the world since 2005. Nowadays, we have adequate experience in the use of various rotavirus vaccines bolstered by their implementation in immunisation schedules for infants. The authors provide data on the efficacy and safety of rotavirus vaccines licensed and used in Russian Federation, involving the results of studies on safety, immunological and clinical efficacy of one of the pentavalent rotavirus vaccines.

Bivalent rotavirus VP4∗ stimulates protective antibodies against common genotypes of human rotaviruses

SummaryNon-replicating rotavirus vaccines are an alternative strategy to improve the efficacy and safety of rotavirus vaccines. The spike protein VP4, which could be enzymatically cleaved into VP8∗ and VP5∗, is an ideal target for the development of recombinant rotavirus vaccine. In our previous studies, we demonstrated that the truncated VP4 (aa26-476, VP4∗) could be a more viable vaccine candidate compared to VP8∗ and VP5∗. Here, to develop a human rotavirus vaccine, the VP4∗ proteins of P[4], P[6], and P[8] genotype rotaviruses were expressed. All VP4∗ proteins can stimulate high levels of neutralizing antibodies in both guinea pigs and rabbits when formulated in aluminum adjuvant. Furthermore, bivalent VP4∗-based vaccine (P[8] + P[6]-VP4∗) can stimulate high levels of neutralizing antibodies against various genotypes of rotavirus with no significant difference as compared to the trivalent vaccines. Therefore, bivalent VP4∗ has the potential to be a viable rotavirus vaccine candidate for further development.

Why Aren't We Achieving High Vaccination Rates for Rotavirus Vaccine in the United States?

Rotavirus vaccine (RV) coverage levels for US infants are <80%. We surveyed nationally representative networks of pediatricians by internet/mail from April to June, 2019. Multivariable regression assessed factors associated with difficulty administering the first RV dose (RV#1) by the maximum age. Response rate was 68% (303/448). Ninety-nine percent of providers reported strongly recommending RV. The most common barriers to RV delivery overall (definite/somewhat of a barrier) were: parental concerns about vaccine safety overall (27%), parents wanting to defer (25%), parents not thinking RV was necessary (12%), and parent concerns about RV safety (6%). The most commonly reported reasons for nonreceipt of RV#1 by 4 to 5 months (often/always) were parental vaccine refusal (9%), hospitals not giving RV at discharge from nursery (7%), infants past the maximum age when discharged from neonatal intensive care unit/nursery (6%), and infant not seen before maximum age for well care visit (3%) or seen but no vaccine given (4%). Among respondents 4% strongly agreed and 25% somewhat agreed that they sometimes have difficulty giving RV#1 before the maximum age. Higher percentage of State Child Health Insurance Program/Medicaid-insured children in the practice and reporting that recommendations for timing of RV doses are too complicated were associated with reporting difficulty delivering the RV#1 by the maximum age. US pediatricians identified multiple, actionable issues that may contribute to suboptimal RV immunization rates including lack of vaccination prior to leaving nurseries after prolonged stays, infants not being seen for well care visits by the maximum age, missed opportunities at visits and parents refusing/deferring.

The efficacy and safety of rotavirus vaccines in countries in Africa and Asia with high child mortality

Rotavirus remains a leading cause of diarrhoeal morbidity and mortality in young children and rotavirus vaccines are critical for reducing global disease burden. This report addresses the performance of rotavirus vaccines in countries with high child mortality. We performed a sensitivity analysis as part of a systematic review on rotavirus vaccines to inform development of World Health Organization vaccine recommendations. The efficacy of four prequalified vaccines against severe rotavirus gastroenteritis was similar across high mortality settings in Asia and Africa. Within the first year following vaccination, vaccine efficacy for the four vaccines ranged from 48% to 57% while in the second year, efficacy ranged from 29% to 54%. The four vaccines showed no increase in intussusception risk in these settings. All four vaccines appear to prevent significant numbers of severe rotavirus gastroenteritis episodes with no measurable increase in intussusception risk in high mortality settings in Africa and Asia.

Rotavirus Vaccine Safety and Effectiveness in Infants With High-Risk Medical Conditions.

Rotavirus vaccination has 87% to 100% effectiveness against severe rotavirus acute gastroenteritis (AGE) in healthy infants in high-income countries. Little is known whether infants with medical risk conditions (MRCs) are equally protected and if the vaccine is equally well tolerated. We conducted a quasi-experimental prospective multicenter before-after cohort study to assess the vaccine effectiveness (VE) and safety profile of the human rotavirus vaccine (HRV) among MRC infants that required prolonged or frequent postnatal care. The Netherlands has no national rotavirus immunization program, but HRV was implemented in routine care for MRC infants in 13 Dutch hospitals. Participants in the before and after cohort, HRV unvaccinated and vaccinated, respectively, were followed for occurrence of (rotavirus) AGE. VE of at least 1 dose was estimated by using time-to-event analysis for severe rotavirus AGE. Vaccine-related serious adverse event (AEs) after HRV were retrieved systematically from medical charts. Solicited AEs after vaccinations were prospectively collected and compared between vaccination time points with or without HRV. In total, 1482 high-risk infants with MRC were enrolled, including 631 in the before and 851 in the after cohorts; 1302 infants were premature (88.3%), 447 were small for gestational age (30.2%), and 251 had at least 1 congenital disorder (17.0%). VE against severe rotavirus AGE was 30% (95% confidence interval [CI]: -36% to 65%). Overall, the observed number of rotavirus hospitalizations was low and not significantly different between the cohorts (2 and 2, respectively). The rate of vaccine-related serious AE was 0.24 per 100 vaccine doses. The adjusted risk ratio for any AE after HRV vaccination compared with other routine vaccinations was 1.09 (95% CI: 1.05 to 1.12) for concomitant administration and 0.91 (95% CI: 0.81 to 0.99) for single HRV administration. Gastrointestinal AEs were 10% more frequent after HRV. In contrast to previous findings among healthy term infants, in routine use, HRV offered limited protection to vulnerable medical risk infants. HRV is generally well tolerated in this group in single administration, but when coadministered with routine vaccines, it is associated with higher risk of (mostly gastrointestinal) AE. Our study highlights the importance of studying vaccine performance in subgroups of medically vulnerable infants.

Paediatric rotavirus vaccination, coeliac disease and type 1 diabetes in children: a population-based cohort study

BackgroundRotavirus infection has been proposed as a risk factor for coeliac disease (CD) and type 1 diabetes (T1D). The UK introduced infant rotavirus vaccination in 2013. We have previously shown that rotavirus vaccination can have beneficial off-target effects on syndromes, such as hospitalised seizures. We therefore investigated whether rotavirus vaccination prevents CD and T1D in the UK.MethodsA cohort study of children born between 2010 and 2015 was conducted using primary care records from the Clinical Practice Research Datalink. Children were followed up from 6 months to 7 years old, with censoring for outcome, death or leaving the practice. CD was defined as diagnosis of CD or the prescription of gluten-free goods. T1D was defined as a T1D diagnosis. The exposure was rotavirus vaccination, defined as one or more doses. Mixed-effects Cox regression was used to estimate hazard ratios (HR) and 95% confidence intervals (CIs). Models were adjusted for potential confounders and included random intercepts for general practices.ResultsThere were 880,629 children in the cohort (48.8% female). A total of 343,113 (39.0%) participants received rotavirus vaccine; among those born after the introduction of rotavirus vaccination, 93.4% were vaccinated. Study participants contributed 4,388,355 person-years, with median follow-up 5.66 person-years. There were 1657 CD cases, an incidence of 38.0 cases per 100,000 person-years. Compared with unvaccinated children, the adjusted HR for a CD was 1.05 (95% CI 0.86–1.28) for vaccinated children. Females had a 40% higher hazard than males. T1D was recorded for 733 participants, an incidence of 17.1 cases per 100,000 person-years. In adjusted analysis, rotavirus vaccination was not associated with risk of T1D (HR = 0.89, 95% CI 0.68–1.19).ConclusionsRotavirus vaccination has reduced diarrhoeal disease morbidity and mortality substantial since licencing in 2006. Our finding from this large cohort study did not provide evidence that rotavirus vaccination prevents CD or T1D, nor is it associated with increased risk, delivering further evidence of rotavirus vaccine safety.

Paediatric Rotavirus Vaccination, Coeliac Disease and Type 1 Diabetes in Children: A Population-Based Cohort Study

Background: Rotavirus infection has been proposed as a risk factor for coeliac disease (CD) and type 1 diabetes (T1D). The UK introduced infant rotavirus vaccination in 2013. We therefore investigated whether rotavirus vaccination prevents CD and T1D in the UK. Methods: A cohort study of children born between 2010 and 2015 was conducted using primary care records from the Clinical Practice Research Datalink. Children were followed-up from three months to seven years old, with censoring for outcome, death or leaving the practice. CD was defined as diagnosis of CD or the prescription of gluten-free goods. T1D was defined as a T1D diagnosis. The exposure was rotavirus vaccination, defined as one or more doses. Mixed-effects Cox regression was used to estimate Hazard ratios (HR) and 95% confidence intervals (CIs). Models were adjusted for potential confounders and included random intercepts for general practices. Findings: There were 880 629 children in the cohort (48·8% female). A total of 343 113 (39·0%) participants received rotavirus vaccine; among those born after the introduction of rotavirus vaccination, 93·4% were vaccinated. Study participants contributed 4 526 794 person-years, with median follow-up 5·85 person-years. There were 1 657 CD cases, an incidence of 36·6 cases per 100 000 person-years. Compared with unvaccinated children the adjusted HR for a CD was 1·03 (95% CI 0·84-1·26) for vaccinated children. Females had a 40% higher hazard than males. T1D was recorded for 733 participants, an incidence of 16·2 cases per 100 000 person-years. In adjusted analysis rotavirus vaccination was not associated with risk of T1D (HR 0·9, 95% CI 0·69-1·20). Interpretation: This study did not provide evidence that rotavirus vaccination prevents CD or T1D, nor is it associated with increased risk, delivering further evidence of rotavirus vaccine safety. Funding: This study is funded by the National Institute for Health Research. Declaration of Interests: DH and MIG report grants on the topic of rotavirus vaccines, outside of the submitted work, from GlaxoSmithKline Biologicals, Sanofi Pasteur and Merck and Co (Kenilworth, New Jersey, US) after the closure of Sanofi Pasteur-MSD in December 2016. MIG also reports personal fees for consultancy, outside the submitted work, from GlaxoSmithKline Biologicals. TI and KF have nothing to disclose. Ethics Approval Statement: Ethical approval for this research was given by the Independent Scientific and Ethical Committee (ISAC) of the CPRD (reference 20_024RA2). CPRD obtains annual rolling ethical approval (reference number 05/MRE04/87) and no additional ethical approval was required for this project which meets ISAC requirements.

Rotavirus vaccine safety profile beyond the recommended age

Rotavirus vaccine safety profile beyond the recommended age

Rotavirus Vaccination in the NICU: Where Are We? A Rapid Review of Recent Evidence

Background: Rotavirus is a leading cause of viral acute gastroenteritis (AGE) in infants. Neonates hospitalized in neonatal intensive care units (NICUs) are at risk of rotavirus infections with severe outcomes. The administration of rotavirus vaccines is only recommended, in the United States and Canada, upon discharge from the NICU despite rotavirus vaccine being proven safe and effective in these populations, due to risks of live-attenuated vaccine administration in immunocompromised patients and theoretical risks of rotavirus vaccines strains shedding and transmission. We summarized recent evidence regarding rotavirus vaccines administration in the NICU setting and safety of rotavirus vaccines in preterm infants. Methods: We conducted a rapid review of the literature from the past 10 years, searching Medline and Embase, including all study types except reviews, reporting on rotavirus vaccine 1 and rotavirus vaccine 5; NICU setting; shedding or transmission; and/or safety in preterm. One reviewer performed data extraction and quality assessment. Results: In total, 31 articles were analyzed. Vaccine-derived virus shedding following rotavirus vaccination existed for nearly all infants, mostly during the first week after dose 1, with rare transmission described only in the household setting. No case of transmission in the NICU was reported. Adverse events were mild to moderate, occurring in 10%–60% of vaccinated infants. Extreme premature infants or with underlying gastrointestinal failure requiring surgery presented more severe adverse events. Conclusions: Recommendations regarding rotavirus vaccine administration in the NICU should be reassessed in light of the relative safety and absence of transmission of rotavirus vaccine strains in the NICU.Funding: NoneDisclosures: Sicard Mélanie: I reference the use of rotavirus vaccines in the NICU setting, which is not recommended; I discuss possible reassessment of these recommendations.

Rotavirus vaccination in the neonatal intensive care units: where are we? A rapid review of recent evidence.

Rotavirus is a leading cause of viral acute gastroenteritis in infants. Neonates hospitalized in neonatal intensive care units (NICUs) are at risk of rotavirus infections with severe outcomes. The administration of rotavirus vaccines is only recommended, in the United States and Canada, upon discharge from the NICU despite rotavirus vaccines being proven well tolerated and effective in these populations, because of risks of live-attenuated vaccine administration in immunocompromised patients and theoretical risks of rotavirus vaccine strains shedding and transmission.We aimed to summarize recent evidence regarding rotavirus vaccine administration in the NICU setting and safety of rotavirus vaccines in preterm infants. We conducted a rapid review of the literature from the past 10 years, searching Medline and Embase, including all study types except reviews, reporting on rotavirus vaccines 1 and 5; NICU setting; shedding or transmission; safety in preterm. One reviewer performed data extraction and quality assessment. Thirty-one articles were analyzed. Vaccine-derived virus shedding following rotavirus vaccines existed for nearly all infants, mostly during the first week after dose 1, but with rare transmission only described in the household setting. No case of transmission in the NICU was reported. Adverse events were mild to moderate, occurring in 10-60% of vaccinated infants. Extreme premature infants or those with underlying gastrointestinal failure requiring surgery presented with more severe adverse events. Recommendations regarding rotavirus vaccine administration in the NICU should be reassessed in light of the relative safety and absence of transmission of rotavirus vaccine strains in the NICU.

Dilemmas With Rotavirus Vaccine: The Neonate and Immunocompromised.

Rotavirus (RV) is the leading cause of severe gastroenteritis in young children. However, because the incorporation of live-attenuated RV vaccines as part routine childhood immunization schedules, the rates of hospitalization from RV infections have decreased significantly across the globe. While RV vaccine safety and effectiveness have been well documented in the general population, there is controversy surrounding its use in preterm and immunocompromised infants. In this article, we review current research and consensus statements on the safety of the RV vaccine, the immunogenicity of the response and the potential for transmission and shedding of the virus postvaccination in both preterm infants and immunocompromised infants. RV vaccines are well tolerated in hospitalized preterm infants with no significant increase in nosocomial infections, gastrointestinal complications or feeding difficulties. In select immunocompromised infants (such as HIV-infected or HIV-exposed infants), RV vaccine administration did not increase the rate of adverse events. However, multiple case reports noted increased rates of adverse events in infants with severe combined immunodeficiency. The risk of viral shedding and transmission between vaccinated neonates and household contacts remain low and does not outweigh the benefit of vaccination.

Epidemiology study of pediatric primary intussusception aged ≤24 months in pre-rotavirus vaccine era of Jinan, China

IntroductionFew studies have reported on the epidemiological characteristics of pediatric primary intussusception in the pre-rotavirus vaccine era of China. It is important to complementary baseline data before rotavirus vaccine introduction in China. This study conduct a retrospective investigation and evaluated the incidence rate, described the epidemiology of pediatric primary intussusception aged ≤24 months. MethodsWe conducted a retrospective investigation in all secondary- and tertiary-hospitals in Jinan. Pediatric primary intussusception inpatients aged ≤24 months were identified depending on ICD-10 discharge code from a total of 63 hospitals from 2011 to 2015. Demographic and clinical information were extracting from the electronic clinical record systems. ResultsA total of 575 pediatric primary intussusception inpatients were identified with average annual incidence of 86.5 per 100,000. A significantly higher incidence was observed in males (χ2 = 13.8, P < 0.01), in the ≤12 months old age group (χ2 = 19.5, P < 0.01) and from the urban areas (χ2 = 63.31, P < 0.001). No clear seasonality found. Abdominal pain (80.9%) and vomiting (63.3%) were the most frequently reported. Most intussusception cases occurred in ileo-cecum. Over 92% of intussusception cases were diagnosed by ultrasound alone and 77.4% was successfully treated by air enema. 99.7% were cured. The median time of hospitalization was 2 days (range: 0–35 days). ConclusionThis retrospective study provides baseline information of incidence, epidemiologyand clinical characteristics of pediatric primary intussusception in Jinan City during 2011–2016 before the introduction of rotavirus vaccine. It will be important for evaluating safety of rotavirus vaccine if it will be introduced to the routine immunization program in China.

THE IMMUNOPROPHYLAXIS OF ROTAVIRUS INFECTIONS IN KRASNODAR

Aim. This research was performed to study the specific immunoprophylaxis of rotavirus infection among child population in Krasnodar.Materials and methods. There was conducted the analysis of 2386 medical records of patients who were immunized against the rotavirus infection by the pentavalent reassortant vaccine "Rotatec" for the period of 2013-2017, the assessment of the incidence of acute intestinal infections (AII) and rotavirus infection among vaccinated and unvaccinated children of the first two years of life as well as a comparative analysis of primary prophylaxis of rotavirus infection with the incidence of rotavirus infection according to data of Rospotrebnadzor for the study period.Results. Coverage of the vaccination against rotavirus infection among children in Krasnodar for the period of 2013−2017 was 5,6 % of the target cohort which is not enough to reduce the incidence of rotavirus gastroenteritis. There was demonstrated the efficacy and safety of rotavirus vaccine. During the study period vaccinated children were 2.5 times less likely to suffer from AII. No cases of rotavirus infection were reported among the vaccinated respondents.Conclusion. The leading role of rotavirus infection in severe forms of acute gastroenteritis in children of the first 5 years of life as well as the high efficiency of vaccine prophylaxis gives hope that vaccination against rotavirus infection will be included in the Russian national calendar of preventive vaccinations everywhere in the nearest future.

Safety monitoring of ROTAVAC vaccine and etiological investigation of intussusception in India: study protocol

BackgroundROTAVAC, an indigenous rotavirus vaccine, was introduced in the universal immunization program of India in four states in 2016 and expanded to five more states in 2017. The clinical trial on efficacy of ROTAVAC did not detect an increased risk of intussusception, but the trial was not large enough to detect a small risk. This protocol paper describes the establishment and implementation of a surveillance system to monitor the safety of rotavirus vaccine and investigate the potential infectious etiologies of intussusception.MethodsThis is a multi-centric hospital-based active surveillance being conducted at 28 hospitals in nine states of India. Data gathered from surveillance will be used to assess the risk of intussusception after ROTAVAC administration and to determine the infectious etiologies of intussusception. For safety assessment of ROTAVAC vaccine, children aged less than two years with intussusception admitted at the sentinel hospitals are enrolled into surveillance, a case report form completed, and a copy of the vaccination card obtained. The risk of intussusception following rotavirus vaccination will be assessed using a self-controlled case-series design. The investigation for potential infectious etiologies of intussusception is through a matched case-control design. Children enrolled for the safety assessment serve as cases and for each case, an age, gender and location matched control is enrolled within 30 days of case enrollment. Stool specimens are obtained from cases and controls. All forms and specimens are sent to the referral laboratory for data entry, analysis, multiplexed molecular testing, and storage.DiscussionAnticipated public health benefits of this surveillance include the generation of information useful to national government on safety of vaccine and to make future decisions on vaccine use through risk-benefit analysis. Investigating infectious agents may help to determine the potential infectious etiologies of intussusception.

Rotarix® and RotaTeq® administration to preterm infants in the neonatal intensive care unit: Review of available evidence

Rotavirus (RV) is the leading cause of severe acute gastroenteritis (GE) in infants worldwide. Several vaccines against RV were developed to reduce disease burden, hospitalization rates and health utilization costs. RV GE is a serious disease in preterm (PT) infants, and the administration of RV vaccine to these at-risk subjects at the proper time could have great clinical relevance. However, most data on the efficacy and safety of RV vaccinations were collected in healthy full-term infants, and few studies investigated PT infants. The lack of studies in PT infants may explain why neonatologists in several neonatal intensive care units (NICUs) do not follow the official recommendations, which indicate that RV vaccine may be administered in hospitals. Increasing neonatologists’ knowledge on the efficacy and safety of RV vaccines and defining PT candidates for vaccination and the necessary precautions are extremely important to avoid potential vaccine virus transmission and improve RV vaccination coverage in PT infants. Further studies should analyse the impact of vaccination of PT infants of different gestational ages and various clinical histories in stable conditions in the NICU with a careful monitoring of adverse events to the vaccine and RV GE occurrence. Only data that confirm the efficacy and safety of RV vaccines in large numbers of PT infants with different characteristics will convince neonatologists to use RV vaccines in PT infants hospitalized in NICUs.