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Prevention of rotavirus gastroenteritis in infants and children: rotavirus vaccine safety, efficacy, and potential impact of vaccines.

Chandran A, Fitzwater S, Zhen A, Santosham M - Biologics (2010)

Bottom Line: There are two rotavirus vaccines currently licensed in the United States and prequalified by the World Health Organization.Should rotavirus vaccines be introduced in the routine immunization programs of all countries, a potential of 170,000 deaths could be prevented annually.The largest impact on mortality would be seen in low-income and middle-income countries, despite poor immunization coverage and lower efficacy.

View Article: PubMed Central - PubMed

Affiliation: Department of International Health, Division of Health Systems.

ABSTRACT
Rotavirus infection is the most common cause of severe gastroenteritis globally, with greater than 86% of deaths occurring in low-income and middle-income countries. There are two rotavirus vaccines currently licensed in the United States and prequalified by the World Health Organization. RV1 is a monovalent attenuated human rotavirus strain, given orally in two doses. RV5 is a pentavalent human-bovine reassortant rotavirus vaccine, given orally in three doses. A third rotavirus vaccine, LLV, is a lamb rotavirus strain given orally as a single dose, which is currently available only in China. RV1 and RV5 have been shown to be highly efficacious in developed countries, and initial results from trials in Africa and Asia are promising as well. At least three other vaccines are in development, which are being developed by manufacturers of developing countries. Further studies are needed to clarify issues including administration of oral rotavirus vaccines with breastfeeding and other oral vaccines, and alterations in dosing schedule. Using new data on global diarrheal burden, rotavirus is estimated to cause 390,000 deaths in children younger than 5 years. Should rotavirus vaccines be introduced in the routine immunization programs of all countries, a potential of 170,000 deaths could be prevented annually. The largest impact on mortality would be seen in low-income and middle-income countries, despite poor immunization coverage and lower efficacy. Therefore, international efforts are needed to ensure that rotavirus vaccines reach the populations with highest burden of rotavirus disease.

No MeSH data available.


Related in: MedlinePlus

Comparison of vaccine efficacy and effectiveness estimations from clinical trials of RV1 and RV5 against any serotype severe rotavirus gastroenteritis, stratified by country income status.Note: Efficacies and effectiveness estimates are taken from the following sources (from left to right): Asia,86 USA,70 Europe,70 Europe,85 Israel,126 Finland,84 Australia,92 USA,75 Latin America,70 Brazil,89 Finland/Latin America,83 South Africa,87 El Salvador,93 Nicaragua,76 Sub-Saharan Africa and Southeast Asia,71 Malawi.87aThis study took place in a native population characterized by diarrheal pathogens that are similar to lower income settings.130 bAlthough countries ranged from lower middle to high income, most study countries are from the upper middle income category.
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f1-btt-4-213: Comparison of vaccine efficacy and effectiveness estimations from clinical trials of RV1 and RV5 against any serotype severe rotavirus gastroenteritis, stratified by country income status.Note: Efficacies and effectiveness estimates are taken from the following sources (from left to right): Asia,86 USA,70 Europe,70 Europe,85 Israel,126 Finland,84 Australia,92 USA,75 Latin America,70 Brazil,89 Finland/Latin America,83 South Africa,87 El Salvador,93 Nicaragua,76 Sub-Saharan Africa and Southeast Asia,71 Malawi.87aThis study took place in a native population characterized by diarrheal pathogens that are similar to lower income settings.130 bAlthough countries ranged from lower middle to high income, most study countries are from the upper middle income category.

Mentions: Subsequently, clinical trials and postintroduction studies have demonstrated the efficacy of three doses of vaccine given with routine infant immunizations (Figure 1). From 2001 to 2004, the Rotavirus Efficacy and Safety Trial (REST), a double-blind, placebo-controlled, randomized trial, was conducted in over 68,000 infants in 11 countries.69 In an immunogenicity study in a small subset of the children, seroconversion rates for serum antirotavirus IgA were 95.2% (95% CI: 91.2–97.8) in 189 vaccine recipients and 14.3% (95% CI: 9.3–20.7) in 161 placebo recipients. In the per-protocol efficacy analysis, among 4,512 subjects, vaccine efficacy against G1–G4 gastroenteritis of any severity was 74% (95% CI: 66.8–79.9) and 98% (95% CI: 88.3–100) for severe disease in the first rotavirus season. Vaccine efficacy in the second season of RV gastroenteritis was 62.6% (95% CI: 44.3–75.4) against any disease and 88% (95% CI: 49.4–98.7) against severe disease. Efficacy has been shown across several regions. In fully vaccinated infants in the REST trial, reductions in RV-associated hospitalizations and emergency department visits up to 2 years after vaccination were 94.7% (95% CI: 90.9–96.9) in Europe, 94.9% (95% CI: 84.0–98.9) in the United States, and 90.0% (95% CI: 29.4–99.8) in Latin America/Caribbean.70


Prevention of rotavirus gastroenteritis in infants and children: rotavirus vaccine safety, efficacy, and potential impact of vaccines.

Chandran A, Fitzwater S, Zhen A, Santosham M - Biologics (2010)

Comparison of vaccine efficacy and effectiveness estimations from clinical trials of RV1 and RV5 against any serotype severe rotavirus gastroenteritis, stratified by country income status.Note: Efficacies and effectiveness estimates are taken from the following sources (from left to right): Asia,86 USA,70 Europe,70 Europe,85 Israel,126 Finland,84 Australia,92 USA,75 Latin America,70 Brazil,89 Finland/Latin America,83 South Africa,87 El Salvador,93 Nicaragua,76 Sub-Saharan Africa and Southeast Asia,71 Malawi.87aThis study took place in a native population characterized by diarrheal pathogens that are similar to lower income settings.130 bAlthough countries ranged from lower middle to high income, most study countries are from the upper middle income category.
© Copyright Policy
Related In: Results  -  Collection

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getmorefigures.php?uid=PMC2921258&req=5

f1-btt-4-213: Comparison of vaccine efficacy and effectiveness estimations from clinical trials of RV1 and RV5 against any serotype severe rotavirus gastroenteritis, stratified by country income status.Note: Efficacies and effectiveness estimates are taken from the following sources (from left to right): Asia,86 USA,70 Europe,70 Europe,85 Israel,126 Finland,84 Australia,92 USA,75 Latin America,70 Brazil,89 Finland/Latin America,83 South Africa,87 El Salvador,93 Nicaragua,76 Sub-Saharan Africa and Southeast Asia,71 Malawi.87aThis study took place in a native population characterized by diarrheal pathogens that are similar to lower income settings.130 bAlthough countries ranged from lower middle to high income, most study countries are from the upper middle income category.
Mentions: Subsequently, clinical trials and postintroduction studies have demonstrated the efficacy of three doses of vaccine given with routine infant immunizations (Figure 1). From 2001 to 2004, the Rotavirus Efficacy and Safety Trial (REST), a double-blind, placebo-controlled, randomized trial, was conducted in over 68,000 infants in 11 countries.69 In an immunogenicity study in a small subset of the children, seroconversion rates for serum antirotavirus IgA were 95.2% (95% CI: 91.2–97.8) in 189 vaccine recipients and 14.3% (95% CI: 9.3–20.7) in 161 placebo recipients. In the per-protocol efficacy analysis, among 4,512 subjects, vaccine efficacy against G1–G4 gastroenteritis of any severity was 74% (95% CI: 66.8–79.9) and 98% (95% CI: 88.3–100) for severe disease in the first rotavirus season. Vaccine efficacy in the second season of RV gastroenteritis was 62.6% (95% CI: 44.3–75.4) against any disease and 88% (95% CI: 49.4–98.7) against severe disease. Efficacy has been shown across several regions. In fully vaccinated infants in the REST trial, reductions in RV-associated hospitalizations and emergency department visits up to 2 years after vaccination were 94.7% (95% CI: 90.9–96.9) in Europe, 94.9% (95% CI: 84.0–98.9) in the United States, and 90.0% (95% CI: 29.4–99.8) in Latin America/Caribbean.70

Bottom Line: There are two rotavirus vaccines currently licensed in the United States and prequalified by the World Health Organization.Should rotavirus vaccines be introduced in the routine immunization programs of all countries, a potential of 170,000 deaths could be prevented annually.The largest impact on mortality would be seen in low-income and middle-income countries, despite poor immunization coverage and lower efficacy.

View Article: PubMed Central - PubMed

Affiliation: Department of International Health, Division of Health Systems.

ABSTRACT
Rotavirus infection is the most common cause of severe gastroenteritis globally, with greater than 86% of deaths occurring in low-income and middle-income countries. There are two rotavirus vaccines currently licensed in the United States and prequalified by the World Health Organization. RV1 is a monovalent attenuated human rotavirus strain, given orally in two doses. RV5 is a pentavalent human-bovine reassortant rotavirus vaccine, given orally in three doses. A third rotavirus vaccine, LLV, is a lamb rotavirus strain given orally as a single dose, which is currently available only in China. RV1 and RV5 have been shown to be highly efficacious in developed countries, and initial results from trials in Africa and Asia are promising as well. At least three other vaccines are in development, which are being developed by manufacturers of developing countries. Further studies are needed to clarify issues including administration of oral rotavirus vaccines with breastfeeding and other oral vaccines, and alterations in dosing schedule. Using new data on global diarrheal burden, rotavirus is estimated to cause 390,000 deaths in children younger than 5 years. Should rotavirus vaccines be introduced in the routine immunization programs of all countries, a potential of 170,000 deaths could be prevented annually. The largest impact on mortality would be seen in low-income and middle-income countries, despite poor immunization coverage and lower efficacy. Therefore, international efforts are needed to ensure that rotavirus vaccines reach the populations with highest burden of rotavirus disease.

No MeSH data available.


Related in: MedlinePlus