Rotavirus vaccine for infants — what should parents know?

Aim of the study: Understanding the safety of vaccines is critical to inform decisions about vaccination. Our objective was to conduct a systematic review of the safety of vaccines recommended for children, adults, and pregnant women in the United States.

Results: Of 56,603 reviewed citations, 338 studies reported in 518 publications met inclusion criteria. For children, SoE was high for no increased risk of autism following measles, mumps, and rubella (MMR) vaccine. SoE was high for increased risk of febrile seizures with MMR. There was no evidence of increased risk of intussusception with rotavirus vaccine at the latest follow-up (moderate SoE), nor of diabetes (high SoE). There was no evidence of increased risk or insufficient evidence for key adverse events for newer vaccines such as 9-valent human papillomavirus and meningococcal B vaccines. For adults, there was no evidence of increased risk (varied SoE) or insufficient evidence for key adverse events for the new adjuvanted inactivated influenza vaccine and recombinant adjuvanted zoster vaccine. We found no evidence of increased risk (varied SoE) for key adverse events among pregnant women following tetanus, diphtheria, and acellular pertussis vaccine, including stillbirth (moderate SoE).

Aim of the study: RotaTeq is a live, oral, pentavalent human-bovine reassortant rotavirus vaccine approved for use in the prevention of G1-G4 rotavirus gastroenteritis in infants and children. Rotavirus vaccine demonstrated good immunogenicity in healthy infants.

Results: Healthcare resource use was reduced by rotavirus vaccine, with a 94.5% reduction in the incidence of hospitalization or emergency department care because of G1-G4 rotavirus gastroenteritis. This analysis of the REST trial included >57,000 infants. Rotavirus vaccine did not increase the risk of intussusception within 42 days of any dose, according to an analysis of the REST trial including almost 70,000 infants. Rotavirus vaccine and placebo were associated with serious adverse events in <3% of infants in either group.

Aim of the study: Infants born preterm are at a higher risk of complications and hospitalization in cases of rotavirus diarrhea than children born at term. We evaluated the impact of a rotavirus vaccination campaign (May 2007 to May 2010) on hospitalizations for rotavirus gastroenteritis in a population of children under 3 years old born prematurely (before 37 weeks of gestation) in the Brest University Hospital birth zone.

Results: We observed significant effectiveness of the pentavalent rotavirus vaccine on the number of hospitalizations in a population of prematurely born infants younger than 3 years of age. A multicenter national study would provide better assessment of this impact. (This study [Impact of Systematic Infants Vaccination Against Rotavirus on Gastroenteritis Hospitalization: a Prospective Study in Brest District, France (IVANHOE)] has been registered at ClinicalTrials.gov under registration no. NCT00740935.).

Aim of the study: Oral, live-attenuated rotavirus vaccines (ORVs) have significantly reduced severe diarrheal disease and deaths; however, vaccine performance in low- and middle-income countries (LMICs) remains lower than in high-income countries. With increasing global use, real-world data now provide important insights into strategies to improve vaccine impact in these settings.

Results: The review also highlights the growing importance of economic sustainability, particularly in the context of transitions from external funding support. Despite lower efficacy, ORVs continue to provide substantial public health benefits in LMICs. Sustained impact will depend on strengthening programme delivery, ensuring stable vaccine supply, and advancing next-generation vaccines. Continued evaluation of effectiveness, cost, and implementation strategies will be critical to maximizing long-term benefits in high-burden settings.

Aim of the study: Rotavirus infection is the most common cause of severe diarrhea disease in infants and young children worldwide and continues to have a major global impact on childhood morbidity and mortality. Vaccination is the only control measure likely to have a significant impact on the incidence of severe dehydrating rotavirus disease.

Results: Vaccination is the only control measure likely to have a significant impact on the incidence of severe dehydrating rotavirus disease. Rotavirus disease prevention efforts suffered a severe setback in 1999 with the withdrawal of the RRV-TV vaccine less than a year after its introduction. Several new rotavirus vaccines have been developed and have proven to be safe and efficacious. These new safe and effective rotavirus vaccines offer the best hope of reducing the toll of acute rotavirus gastroenteritis in both developed and developing countries.