Safety and Efficacy of an Attenuated Vaccine against Severe Rotavirus Gastroenteritis

Ruíz-Palacios, Guillermo M.; Pérez‐Schael, Irene; Velázquez, F. Raúl; Abate, Héctor; Breuer, Thomas; Clemens, Sue Ann Costa; Cheuvart, Brigitte; Espinoza, Félix; Gillard, Paul; Innis, Bruce L.; Cervantes, Yolanda; Linhares, Alexandre C.; López, Pío; Macías-Parra, Mercedes; Ortega-Barrı́a, Eduardo; Richardson, Vesta; Rivera-Medina, Doris Maribel; Rivera, Luis; Salinas, Belén; Pavía-Ruz, Noris; Salmerón, Jorge; Rüttimann, Ricardo; Tinoco, Juan Carlos; Rubio, Pilar; Núñez, Ernesto; Guerrero, M. Lourdes; Yarzábal, Juan Pablo; Damaso, Silvia; Tornieporth, Nadia; Sáez-Llorens, Xavier; Vergara, Rodrigo; Vesikari, Timo; Bouckenooghe, Alain; Clemens, Ralf; Vos, B. De; O’Ryan, Miguel

doi:10.1056/nejmoa052434

Cited by 1,636 publications

(1,082 citation statements)

References 38 publications

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“…During the study until the end of the 2003-2004 winter season the G1;P [8] genotype was widespread while G9:P [8] remained rare. A majority of severe rotavirus gastroenteritis requiring hospitalization may be prevented by the widespread use of rotavirus vaccines [52][53][54]. Noroviruses are the second leading causative agent of gastroenteritis in hospitalized young children and such infections are less severe than those caused by rotavirus.…”

Section: Discussionmentioning

confidence: 99%

Epidemiology and clinical features of gastroenteritis in hospitalised children: prospective survey during a 2-year period in a Parisian hospital, France

Lorrot

Bon

Hajje

et al. 2010

Eur J Clin Microbiol Infect Dis

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International audienceRotavirus is recognised as the most important agent of severe acute gastroenteritis (AGE) in young children. In a 2-year prospective survey, we investigated the epidemiology and clinical features of the viral and bacterial pathogens in children hospitalised for AGE. The study was performed in a Parisian teaching hospital from November 2001 to May 2004. Clinical data were prospectively collected to assess the gastroenteritis severity (20-point Vesikari severity score, the need for intravenous rehydration, duration of hospitalisation). Stools were systematically tested for group A rotavirus, norovirus, astrovirus and adenovirus 40/41, sapovirus and Aichi virus and enteropathogenic bacteria. A total of 457 children (mean age 15.9 months) were enrolled. Viruses were detected in 305 cases (66.7%) and bacteria in 31 cases (6.8%). Rotaviruses were the most frequent pathogen (48.8%), followed by noroviruses (8.3%) and adenoviruses, astroviruses, Aichi viruses and sapoviruses in 3.5%, 1.5%, 0.9% and 0.4%, respectively. Cases of rotavirus gastroenteritis were significantly more severe than those of norovirus with respect to the Vesikari score, duration of hospitalisation and the need for intravenous rehydration. Rotaviruses were the most frequent and most severe cause in children hospitalised for AGE, and noroviruses also account for a large number of cases in this population

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Section: Discussionmentioning

confidence: 99%

Epidemiology and clinical features of gastroenteritis in hospitalised children: prospective survey during a 2-year period in a Parisian hospital, France

Lorrot

Bon

Hajje

et al. 2010

Eur J Clin Microbiol Infect Dis

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“…Two of the largest clinical trials in history showed that these vaccines are safe and highly effective for preventing life-threatening dehydrating rotavirus diarrhea, providing either serotype-specific or crossreactive protective immune responses [24,25].…”

Section: Introductionmentioning

confidence: 99%

Molecular epidemiology of rotaviruses in Bulgaria: annual shift of the predominant genotype

Mladenova

Korsun²,

Geonova³

et al. 2010

Eur J Clin Microbiol Infect Dis

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“…That sort of benefit is challenging to measure, especially when there is a long interval between the initial vaccine administration and the health benefit, e.g., vaccination of adolescent girls against human papillomavirus (HPV) to prevent cervical cancer in adulthood [15]. Therefore any new vaccine needs close monitoring to detect events not prevented by the vaccine [16]. …”

Section: Consequences At Individual and Population Levelmentioning

confidence: 99%

2. How is the economic assessment of vaccines performed today?

Standaert

Rappuoli²

2017

Journal of Market Access & Health Policy

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This paper describes how the economic assessment of vaccines is performed today. It discusses why it may be incomplete and explores potential approaches to adjust the analysis to be more comprehensive. Besides helping protect against serious disease, vaccines also help avoid mild disease episodes that may not receive medical attention but which have important societal consequences. They also benefit unvaccinated individuals by reducing disease transmission. Wider societal benefits may extend beyond a decrease in disease incidence, as lower transmission rates reduce the risk of epidemics, which in turn reduces the pressure on healthcare providers, and may improve the quality of care for patients with unrelated diseases. Vaccines also lower the use of antibiotics leading to less pressure on anti-microbial resistance. Conventional ICUA focuses on individual health benefits, like increased survival. Therefore, this approach may not adequately capture the wider vaccination benefits. We discuss differences between treatment and vaccine prevention in the economic assessment, and how ICUA has been adapted to cope with the inconsistencies. Although such adaptations may fulfil the demand of one specific stakeholder, they may not meet the needs of other stakeholders who operate at the societal level, such as ministries other than healthcare, employers, caregivers, and insurers.

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Safety and Efficacy of an Attenuated Vaccine against Severe Rotavirus Gastroenteritis

Cited by 1,636 publications

References 38 publications

Epidemiology and clinical features of gastroenteritis in hospitalised children: prospective survey during a 2-year period in a Parisian hospital, France

Epidemiology and clinical features of gastroenteritis in hospitalised children: prospective survey during a 2-year period in a Parisian hospital, France

Molecular epidemiology of rotaviruses in Bulgaria: annual shift of the predominant genotype

2. How is the economic assessment of vaccines performed today?

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