Rotavac (rotavirus vaccine (live attenuated, oral)) / Bharat Biotech - LARVOL DELTA

Sociodemographic and Clinical Characteristics of Rotavirus Diarrhea in Children Aged Under 5 Years in Odisha After the Introduction of Rotavirus Vaccine: A Hospital-Based Surveillance Study. (PubMed, Indian J Pediatr) - "Rotavirus remains an important cause of AGE in children aged under 5 y in Odisha, despite the introduction of rotavirus vaccination. The rotavirus positivity rate was lower than that reported in previous studies, suggesting a positive effect of vaccination. High vaccination coverage, addressing poverty, and prompt clinical management are essential to mitigate the impact of rotavirus diarrhea in Odisha."

Journal • Gastroenterology • Gastrointestinal Disorder • Rotavirus Infections

Structure-Guided Design and in Vivo Validation of a VP4-Derived Subunit Vaccine Candidate against Bovine Rotavirus. (PubMed, Mol Biotechnol) - "A comparative immune response study of the VP4* antigen with the rotavirus vaccine (ROTAVAC) or as a booster dose after vaccination was observed in Wistar rats. A high IgG level was shown in the group where the antigen was given as a booster dose after vaccination with no side effects in the rats, indicating that the protein is non-toxic, non-allergenic, potentially immunogenic, and represents a promising candidate for further evaluation in rotavirus prevention."

Journal • Preclinical • Rotavirus Infections

An impact and cost-effectiveness analysis of rotavirus vaccine introduction in Egypt. (PubMed, Vaccine) - "Rotavirus vaccination could prevent a substantial number of RVGE cases, visits, hospitalizations and deaths in children. To be considered a cost-effective use of government health spending, the vaccine price would need to be reduced and/or lower health system delivery cost assumptions would need to be justified."

HEOR • Journal • Gastroenterology • Gastrointestinal Disorder • Psychiatry • Rotavirus Infections

Genotype Diversity of Rotavirus in Odisha, India: Postvaccine Changes. (PubMed, Indian J Pediatr) - "The introduction of rotavirus vaccines has reduced the prevalence of rotavirus infections and altered the rotavirus genotype distribution in Odisha. The predominance of G3P[8] and resurgence of G2P[4] indicate evolving strain dynamics after vaccine introduction. This study, thus, highlights the importance of vaccination programs in mitigating rotavirus-associated morbidity, emphasizing the need for sustained monitoring to guide future vaccine strategies."

Journal • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Rotavirus Infections

Pathogen-Focused Metagenomic Analysis of Pediatric Diarrheal Cases among Children under Five in Zambia Reveals Predominance of Human Rotavirus Genotypes G3 and G12 (ASTMH 2025) - "VP7 analysis revealed the presence of genotypes G1, G2, G3, G8, G9, and G12, which mostly clustered with global reference strains, while VP4 analysis identified P[4], P[6], P[8], and P[11] genotypes that form clades with vaccine strains (Rotarix & Rotavac) and wild-type lineages. Importantly, fully vaccinated children experienced milder disease compared to partially vaccinated or unvaccinated children (p = 0.002).This study demonstrates the significant value of VCS in genomic surveillance of vaccine-preventable diseases. It enables high-resolution detection of viral genotypes, reassortants, and antigenic variants, thereby facilitating real-time monitoring of viral evolution and guiding adaptive immunization programs and public health responses."

Clinical • Genomic analysis • Omic analysis • Pediatrics • Rotavirus Infections

Impact of the indigenous rotavirus vaccine Rotavac in the Universal Immunization Program in India during 2016-2020. (PubMed, Nat Med) - "Following vaccine introduction, rotavirus positivity among hospitalized children declined from 40% to 20%. These findings confirm that Rotavac provides substantial protection against severe rotavirus disease, including nonvaccine strains, and performs comparably to internationally licensed vaccines in similar settings."

Journal • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Rotavirus Infections

Impact of Rotavac Vaccine on Hospital-Based Disease Prevalence and Strain Diversity in India: A Systematic Review and Meta-Analysis. (PubMed, Rev Med Virol) - "The spatio-temporal change in the genotype distribution in the post-vaccination era warrants the need for further surveillance studies to provide information on RV-associated hospital visits. Additionally, this will also provide information on detection of emerging strains that can assist in designing future policies for the implementation and development of new-generation vaccines against rotavirus disease."

Clinical • Journal • Retrospective data • Review • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Rotavirus Infections

Cost-effectiveness and benefit-risk of rotavirus vaccination in Afghanistan: a modelling analysis informed by post-licensure surveillance. (PubMed, BMC Health Serv Res) - "Our study supports the sustained use of rotavirus vaccination in Afghanistan. The health benefits of the vaccine greatly exceed the potential risks."

Benefit-risk assessment • HEOR • Journal • Gastroenterology • Gastrointestinal Disorder • Rotavirus Infections

Rota5DCHILE: The Efficacy of Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants (clinicaltrials.gov) - P3 | N=5800 | Active, not recruiting | Sponsor: Bharat Biotech International Limited | Recruiting ➔ Active, not recruiting | Trial completion date: Feb 2025 ➔ Jul 2026

Enrollment closed • Trial completion date • Infectious Disease • Rotavirus Infections

Efficacy of rotavirus vaccines in Indonesia: A review of genotype distribution and impact. (PubMed, Narra J) - "The Indonesian government procured ROTAVAC with a G9P[11] genotype for the national immunization program, which showed 31.3-69.1% protective efficacy against severe gastroenteritis caused by other strains...Another alternative is the rotavirus vaccine, which showed efficacy data in multiple high-mortality countries. In addition, regular surveillance of the rotavirus genotypes and the clinical manifestations of diarrhea are necessary to design vaccination strategies in Indonesia."

Journal • Review • Gastroenterology • Gastrointestinal Disorder • Rotavirus Infections

Challenges and lessons learned during the switching of rotavirus vaccine from Rotarix to Rotavac in Zambia. (PubMed, Vaccine) - "The impact of the Rotarix vaccine era was reversed due to the global supply chain disruptions, leading to missed vaccinations, increased diarrhea-related hospitalizations, and higher infant mortality in Zambia. The COVID-19 pandemic may also have further disrupted the vaccination sessions, further impacting rotavirus vaccination. Rotarix shortages likely contributed to rising rotavirus cases. There is an urgent need to completely replace the old under-5 vaccination card with a revised one to improve documentation for new rotavirus vaccines."

Journal • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Novel Coronavirus Disease • Rotavirus Infections

Cost effectiveness analysis of rotavirus vaccination in Indonesia. (PubMed, Vaccine) - "The introduction of RVV into the National Immunization Program is likely to be highly cost-effective in Indonesia."

Cost effectiveness • HEOR • Journal • Gastroenterology • Gastrointestinal Disorder • Rotavirus Infections

Transforming Global Health: Dr. Gagandeep Kang's Legacy in Microbiology and Public Health. (PubMed, Cureus) - "It was in honor of her achievements in science and the continuing impact of her studies on microbiology and public health that this review article was undertaken. The purpose of the article, therefore, was to incorporate a detailed analysis of her work primarily for an advanced and professional audience of microbiologists."

Journal • Review • Infectious Disease

The Vaccine Godmother: Dr. Gagandeep Kang's Pioneering Journey in Global Health and Vaccine Development. (PubMed, Cureus) - "Over the course of her distinguished career, she has led groundbreaking research on rotavirus, contributing to the development of two WHO-approved vaccines tailored for Indian communities: Rotavac (Bharat Biotech, Hyderabad, India) and Rotasiil (Serum Institute of India, Pune, India). Dr. Kang's career exemplifies her dedication to advancing public health, vaccine development, and global health initiatives, making her a trailblazer in the field of microbiology and virology."

Journal • Review • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Novel Coronavirus Disease • Rotavirus Infections

Infectious etiology of intussusception in Indian children less than 2 years old: a matched case-control analysis. (PubMed, Gut Pathog) - "Adenovirus C serotypes and enteroviruses were significantly associated with intussusception in Indian children. Rotavirus was not associated with risk of intussusception."

Journal • Infectious Disease • Rotavirus Infections

Has Ghana's Rotavirus Vaccine Switch Met Programmatic Expectations? An Analysis of National Surveillance Data; 2018-2022. (PubMed, Open Forum Infect Dis) - "Ghana introduced a 2-dose schedule rotavirus vaccine, Rotarix, into childhood immunization in 2012 but switched to a 3-dose schedule vaccine, Rotavac, in 2020 on account of programmatic advantages offered by the latter, including lower cost per fully immunized child and lower cold chain volume requirement. The trends of vaccine uptake and reduction in diarrhea morbidity were sustained. These experiences and lessons from the rotavirus vaccine switch are vital for potential switches for other vaccines in the current immunization schedule to mitigate the annual vaccine expenditure."

Journal • Rotavirus Infections

Circulating rotavirus strains in children with acute gastroenteritis in Iran, 1986 to 2023 and their genetic/antigenic divergence compared to approved vaccines strains (Rotarix, RotaTeq, ROTAVAC, ROTASIIL) before mass vaccination: Clues for vaccination policy makers. (PubMed, Virus Res) - "However, considering the rotavirus genotypic pattern, ROTAVAC might not be a good choice for Iran. Overall, the findings of this study provide valuable insights into the prevalence of rotavirus strains and the potential effectiveness of different vaccines in the Iranian and similar populations."

Journal • Review • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Rotavirus Infections

Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications. (PubMed, Int J Risk Saf Med) - "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."

Journal • Rotavirus Infections

Rota5DCHILE: The Efficacy of Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants (clinicaltrials.gov) - P3 | N=5800 | Recruiting | Sponsor: Bharat Biotech International Limited

New P3 trial • Infectious Disease • Rotavirus Infections

Association of biomarkers of enteric dysfunction, systemic inflammation, and growth hormone resistance with seroconversion to oral rotavirus vaccine: A lasso for inference approach. (PubMed, PLoS One) - "MEEDAT successfully measured biomarkers of growth, systemic inflammation, and EED in infants undergoing vaccination, with RBP4 being the only analyte associated with both oral and parenteral rotavirus vaccine responses. Tg and HRP2 were associated with responses to all three serotypes in the parenteral vaccine, while I-FABP and sTfR results indicated possible strain specific immune responses to parenteral immunization."

Biomarker • Journal • Gastroenterology • Gastrointestinal Disorder • Inflammation • Rotavirus Infections • RBP4

Phase III randomized clinical studies to evaluate the immunogenicity, lot-to-lot consistency, and safety of ROTAVAC® liquid formulations (ROTAVAC 5C & 5D) and non-inferiority comparisons with licensed ROTAVAC® (frozen formulation) in healthy infants. (PubMed, Hum Vaccin Immunother) - "ROTAVAC 5C and ROTAVAC 5D® were immunogenic and well tolerated as ROTAVAC®. ROTAVAC 5D® had comparable immunogenicity and safety profiles with ROTAVAC® and can be stored at 2-8°C, leading to WHO pre-qualification.Clinical Trials Registration: Clinical Trials Registry of India (CTRI): CTRI/2015/02/005577CTRI/2016/11/007481 and CTRI/2019/03/017934."

Head-to-Head • Journal • P3 data • Gastroenterology • Gastrointestinal Disorder • Rotavirus Infections