Introduction: The escalating prevalence of infectious diseases is an important cause of concern in society. Particularly in several developing countries, infectious diarrhea poses a major problem, with a high fatality rate, especially among young children. The condition is divided into four classes, namely, acute diarrhea, invasive diarrhea, acute bloody diarrhea, and chronic diarrhea. Various pathogenic agents, such as bacteria, viruses, protozoans, and helminths, contribute to the onset of this condition.
Areas covered: The review discusses the scenario of infectious diarrhea, the prevalent types, as well as approaches to management including preventive, therapeutic, and vaccination strategies. The vaccination techniques are extensively discussed including the available vaccines, their advantages as well as limitations.
Expert opinion: There are several approaches available to develop new-improved vaccines. In addition, route of immunization is important and aerosols/nasal sprays, oral route, skin patches, powders, and liquid jets to minimize needles can be used. Plant-based vaccines, such as rice, might save packing and refrigeration costs by being long-lasting, non-refrigerable, and immunogenic. Future research should utilize predetermined PCR testing intervals and symptom monitoring to identify persistent pathogens after therapy and symptom remission.
{"title":"Combatting infectious diarrhea: innovations in treatment and vaccination strategies.","authors":"Vivek P Chavda, Suneetha Vuppu, Toshika Mishra, Sathvika Kamaraj, Nikita Sharma, Swati Punetha, Anand Sairam, Dixa Vaghela, Narges Dargahi, Vasso Apostolopoulos","doi":"10.1080/14760584.2023.2295015","DOIUrl":"10.1080/14760584.2023.2295015","url":null,"abstract":"<p><strong>Introduction: </strong>The escalating prevalence of infectious diseases is an important cause of concern in society. Particularly in several developing countries, infectious diarrhea poses a major problem, with a high fatality rate, especially among young children. The condition is divided into four classes, namely, acute diarrhea, invasive diarrhea, acute bloody diarrhea, and chronic diarrhea. Various pathogenic agents, such as bacteria, viruses, protozoans, and helminths, contribute to the onset of this condition.</p><p><strong>Areas covered: </strong>The review discusses the scenario of infectious diarrhea, the prevalent types, as well as approaches to management including preventive, therapeutic, and vaccination strategies. The vaccination techniques are extensively discussed including the available vaccines, their advantages as well as limitations.</p><p><strong>Expert opinion: </strong>There are several approaches available to develop new-improved vaccines. In addition, route of immunization is important and aerosols/nasal sprays, oral route, skin patches, powders, and liquid jets to minimize needles can be used. Plant-based vaccines, such as rice, might save packing and refrigeration costs by being long-lasting, non-refrigerable, and immunogenic. Future research should utilize predetermined PCR testing intervals and symptom monitoring to identify persistent pathogens after therapy and symptom remission.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139899633","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-01Epub Date: 2024-05-31DOI: 10.1080/14760584.2024.2360212
Tanmoy Bose, Ray Borrow, Peter D Arkwright
Introduction: Rotavirus is a leading cause of severe diarrheal disease and death in children under five years of age worldwide. Vaccination is one of the most important public health interventions to reduce this significant burden.
Areas covered: This literature review examined vaccination coverage, hospitalization rate, mortality, genotypic distribution, immunogenicity, cost-effectiveness, and risk versus benefit of rotavirus vaccination in children in South America. Nine out of twelve countries in South America currently include a rotavirus vaccine in their national immunization program with coverage rates in 2022 above 90%.
Expert opinion: Introduction of the rotavirus vaccination has led to a marked reduction in hospitalizations and deaths from diarrheal diseases in children under 5 years, particularly infants under 1 year, in several South American countries. In Brazil, hospitalizations decreased by 59% and deaths by 21% (30-38% in infants). In Peru, hospitalizations in infants fell by 46% and deaths by 37% (56% in infants). Overall, data suggest that rotavirus vaccination has reduced rotavirus deaths by 15-50% in various South American countries. There is some evidence that immunity wanes after the age of 1-year old. Ongoing surveillance of vaccine coverage and changes in morbidity and mortality is important to maximize protection against this disease.
{"title":"Impact of rotavirus vaccination on diarrheal disease burden of children in South America.","authors":"Tanmoy Bose, Ray Borrow, Peter D Arkwright","doi":"10.1080/14760584.2024.2360212","DOIUrl":"10.1080/14760584.2024.2360212","url":null,"abstract":"<p><strong>Introduction: </strong>Rotavirus is a leading cause of severe diarrheal disease and death in children under five years of age worldwide. Vaccination is one of the most important public health interventions to reduce this significant burden.</p><p><strong>Areas covered: </strong>This literature review examined vaccination coverage, hospitalization rate, mortality, genotypic distribution, immunogenicity, cost-effectiveness, and risk versus benefit of rotavirus vaccination in children in South America. Nine out of twelve countries in South America currently include a rotavirus vaccine in their national immunization program with coverage rates in 2022 above 90%.</p><p><strong>Expert opinion: </strong>Introduction of the rotavirus vaccination has led to a marked reduction in hospitalizations and deaths from diarrheal diseases in children under 5 years, particularly infants under 1 year, in several South American countries. In Brazil, hospitalizations decreased by 59% and deaths by 21% (30-38% in infants). In Peru, hospitalizations in infants fell by 46% and deaths by 37% (56% in infants). Overall, data suggest that rotavirus vaccination has reduced rotavirus deaths by 15-50% in various South American countries. There is some evidence that immunity wanes after the age of 1-year old. Ongoing surveillance of vaccine coverage and changes in morbidity and mortality is important to maximize protection against this disease.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141173734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-01Epub Date: 2024-04-09DOI: 10.1080/14760584.2024.2335323
Josiah Ryman, Jeffrey R Sachs, Natalie Banniettis, Thomas Weiss, Maurice Ahsman, Ka Lai Yee, Jessica Weaver
Background: Next generation, higher valency pneumococcal conjugate vaccines (PCVs) are assessed and licensed by comparing the immune response across serotypes shared with the PCVs that are standard of care for prevention of pneumococcal disease.
Methods: Using a previously qualified method we predicted the serotype-specific vaccine effectiveness (VE) against invasive pneumococcal disease of V114 and PCV20 for the serotypes shared with PCV13 in an EU, Russian, and Australian pediatric population that is recommended to receive a 2 + 1 dosing regimen.
Results: The estimated protective antibody concentrations ranged from 0.03 (serotype 23F) to 1.49 µg/mL (serotype 19F). Predicted VE values for V114 ranged from 79% (serotype 5) to 100% (serotype 23F). V114 had comparable effectiveness to PCV13 for all but one of shared serotypes, with predicted higher effectiveness (in V114) against serotype 3 (93% vs. 65%). Predicted VE values for PCV20 ranged from 47% (serotype 3) to 91% (serotype 14). PCV20 predicted VE was lower than PCV13's for serotypes 4, 19F, 23F, 1, 3, 5, 6A, 7F, and 19A.
Conclusions: Predicted serotype-specific VE values suggest that, with a 2 + 1 dosing regimen, V114 will have greater effectiveness than PCV20 against PCV13 serotypes, particularly for the still-prevalent serotype 3. Real-world VE studies will ultimately provide clarity on the effectiveness of novel PCVs and support further confidence in and/or improvements to modeling efforts.
{"title":"Potential serotype-specific effectiveness against IPD of pneumococcal conjugate vaccines V114 and PCV20 in children given a 2+1 dosing regimen.","authors":"Josiah Ryman, Jeffrey R Sachs, Natalie Banniettis, Thomas Weiss, Maurice Ahsman, Ka Lai Yee, Jessica Weaver","doi":"10.1080/14760584.2024.2335323","DOIUrl":"10.1080/14760584.2024.2335323","url":null,"abstract":"<p><strong>Background: </strong>Next generation, higher valency pneumococcal conjugate vaccines (PCVs) are assessed and licensed by comparing the immune response across serotypes shared with the PCVs that are standard of care for prevention of pneumococcal disease.</p><p><strong>Methods: </strong>Using a previously qualified method we predicted the serotype-specific vaccine effectiveness (VE) against invasive pneumococcal disease of V114 and PCV20 for the serotypes shared with PCV13 in an EU, Russian, and Australian pediatric population that is recommended to receive a 2 + 1 dosing regimen.</p><p><strong>Results: </strong>The estimated protective antibody concentrations ranged from 0.03 (serotype 23F) to 1.49 µg/mL (serotype 19F). Predicted VE values for V114 ranged from 79% (serotype 5) to 100% (serotype 23F). V114 had comparable effectiveness to PCV13 for all but one of shared serotypes, with predicted higher effectiveness (in V114) against serotype 3 (93% vs. 65%). Predicted VE values for PCV20 ranged from 47% (serotype 3) to 91% (serotype 14). PCV20 predicted VE was lower than PCV13's for serotypes 4, 19F, 23F, 1, 3, 5, 6A, 7F, and 19A.</p><p><strong>Conclusions: </strong>Predicted serotype-specific VE values suggest that, with a 2 + 1 dosing regimen, V114 will have greater effectiveness than PCV20 against PCV13 serotypes, particularly for the still-prevalent serotype 3. Real-world VE studies will ultimately provide clarity on the effectiveness of novel PCVs and support further confidence in and/or improvements to modeling efforts.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140305373","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-01Epub Date: 2024-09-11DOI: 10.1080/14760584.2024.2397705
Diana E Clements, Tosin Olaiya, Cindy Burman, Oscar Herrera-Restrepo, Woo-Yun Sohn, Temi Folaranmi, Victoria Abbing-Karahagopian, Gary S Marshall, James H Conway
Introduction: In 2005, the United States Advisory Committee on Immunization Practices (ACIP) recommended routine vaccination against invasive meningococcal disease (IMD) caused by serogroups A, C, W, and Y (MenACWY) for all 11-12-year-olds, as well as 2-10-year-olds at high risk. In 2010, a booster dose was recommended for all 16-year-olds, as well as for high-risk patients every 3-5 years. In 2015, optional (as opposed to routine) vaccination against meningococcal serogroup B (MenB) at the preferred age of 16-18 years was recommended (Category B, later changed to shared clinical decision-making). In 2023, a vaccine (MenABCWY) against the five serogroups primarily responsible for IMD in the U.S. became available.
Areas covered: This review summarizes the evolution of public policy that led to each milestone vaccine recommendation, reviews epidemiologic data published following the recommendations, and discusses the current state of meningococcal immunization policy.
Expert opinion: The use of MenABCWY has the potential to consolidate policy, improve coverage rates for the five serogroups, address disparities in vaccination coverage, and simplify vaccine delivery.
{"title":"Past, present, and future policy considerations regarding meningococcal vaccination in the United States.","authors":"Diana E Clements, Tosin Olaiya, Cindy Burman, Oscar Herrera-Restrepo, Woo-Yun Sohn, Temi Folaranmi, Victoria Abbing-Karahagopian, Gary S Marshall, James H Conway","doi":"10.1080/14760584.2024.2397705","DOIUrl":"10.1080/14760584.2024.2397705","url":null,"abstract":"<p><strong>Introduction: </strong>In 2005, the United States Advisory Committee on Immunization Practices (ACIP) recommended routine vaccination against invasive meningococcal disease (IMD) caused by serogroups A, C, W, and Y (MenACWY) for all 11-12-year-olds, as well as 2-10-year-olds at high risk. In 2010, a booster dose was recommended for all 16-year-olds, as well as for high-risk patients every 3-5 years. In 2015, optional (as opposed to routine) vaccination against meningococcal serogroup B (MenB) at the preferred age of 16-18 years was recommended (Category B, later changed to shared clinical decision-making). In 2023, a vaccine (MenABCWY) against the five serogroups primarily responsible for IMD in the U.S. became available.</p><p><strong>Areas covered: </strong>This review summarizes the evolution of public policy that led to each milestone vaccine recommendation, reviews epidemiologic data published following the recommendations, and discusses the current state of meningococcal immunization policy.</p><p><strong>Expert opinion: </strong>The use of MenABCWY has the potential to consolidate policy, improve coverage rates for the five serogroups, address disparities in vaccination coverage, and simplify vaccine delivery.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":null,"pages":null},"PeriodicalIF":5.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142125263","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-01Epub Date: 2023-12-12DOI: 10.1080/14760584.2023.2290931
Karan Thakkar, Julia Spinardi, Moe H Kyaw, Jingyan Yang, Carlos Fernando Mendoza, Egemen Ozbilgili, Bulent Taysi, Josie Dodd, Ben Yarnoff, Helen M Oh
Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing COVID-19 has been a dynamically changing virus, requiring the development of adapted vaccines. This study estimated the potential public health impact alternative vaccination strategies for COVID-19 in Singapore.
Research design and methods: The outcomes of alternative vaccination strategies with a future adapted vaccine were estimated using a combined Markov decision tree model. The population was stratified by high- and standard-risk. Using age-specific inputs informed by local surveillance data and published sources, the model estimated health (case numbers, hospitalizations, and deaths) and economic (medical costs and productivity losses) outcomes in different age and risk subpopulations.
Results: Booster vaccination in only the elderly and high-risk subpopulation was estimated to avert 278,614 cases 21,558 hospitalizations, 239 deaths, Singapore dollars (SGD) 277 million in direct medical costs, and SGD 684 million in indirect medical costs. These benefits increased as vaccination was expanded to other subpopulations. Increasing the booster vaccination coverage to 75% of the standard-risk population averted more deaths (3%), hospitalizations (29%), infections (145%), direct costs (90%), and indirect costs (192%) compared to the base case.
Conclusions: Broader vaccination strategies using an adapted booster vaccine could have substantial public health and economic impact in Singapore.
{"title":"Modelling the Potential Public Health Impact of Different COVID-19 Vaccination Strategies with an Adapted Vaccine in Singapore.","authors":"Karan Thakkar, Julia Spinardi, Moe H Kyaw, Jingyan Yang, Carlos Fernando Mendoza, Egemen Ozbilgili, Bulent Taysi, Josie Dodd, Ben Yarnoff, Helen M Oh","doi":"10.1080/14760584.2023.2290931","DOIUrl":"10.1080/14760584.2023.2290931","url":null,"abstract":"<p><strong>Background: </strong>Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing COVID-19 has been a dynamically changing virus, requiring the development of adapted vaccines. This study estimated the potential public health impact alternative vaccination strategies for COVID-19 in Singapore.</p><p><strong>Research design and methods: </strong>The outcomes of alternative vaccination strategies with a future adapted vaccine were estimated using a combined Markov decision tree model. The population was stratified by high- and standard-risk. Using age-specific inputs informed by local surveillance data and published sources, the model estimated health (case numbers, hospitalizations, and deaths) and economic (medical costs and productivity losses) outcomes in different age and risk subpopulations.</p><p><strong>Results: </strong>Booster vaccination in only the elderly and high-risk subpopulation was estimated to avert 278,614 cases 21,558 hospitalizations, 239 deaths, Singapore dollars (SGD) 277 million in direct medical costs, and SGD 684 million in indirect medical costs. These benefits increased as vaccination was expanded to other subpopulations. Increasing the booster vaccination coverage to 75% of the standard-risk population averted more deaths (3%), hospitalizations (29%), infections (145%), direct costs (90%), and indirect costs (192%) compared to the base case.</p><p><strong>Conclusions: </strong>Broader vaccination strategies using an adapted booster vaccine could have substantial public health and economic impact in Singapore.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138477188","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-01Epub Date: 2023-12-11DOI: 10.1080/14760584.2023.2290683
Hinh Ly
{"title":"Progress toward the development of Lassa vaccines.","authors":"Hinh Ly","doi":"10.1080/14760584.2023.2290683","DOIUrl":"10.1080/14760584.2023.2290683","url":null,"abstract":"","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10757453/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138477189","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-01Epub Date: 2024-03-01DOI: 10.1080/14760584.2024.2324939
Ugne Sabale, Janice Murtagh, James Cochrane, Danielle Riley, Richard Perry, Louise Heron, Paolo Bonanni, Jose Navarro Alonso, Juhani Eskola, Valerie Laigle
Background: The breadth of protection of National Immunisation Programmes (NIPs) across Europe varies, however, this has not been assessed within published literature. Therefore, a framework was developed to assess the comprehensiveness of pediatric NIPs in Europe. This study aimed to validate and further develop criteria used to cluster countries into three tiers.
Research design and methods: Independent Europe-based experts (n = 23) in the field of pediatric vaccination were invited to participate in a double-blinded modified Delphi panel, with two online survey rounds and a virtual consensus meeting. Consensus was defined as ≥ 80% of experts rating their agreement/disagreement on a 9-point Likert scale.
Results: The number of preventable diseases covered by an NIP, simplification of the vaccination calendar, strengthened protection by increasing serotype, degree of funding and epidemiological factors were considered key concepts for consideration of the comprehensiveness of pediatric NIPs in Europe. Experts highlighted that the framework should be extended to include adolescent vaccines and populations up to 18 years of age. Consensus regarding further amendments to the framework was also reached.
Conclusions: This Delphi panel validated a framework to assess the comprehensiveness of European NIPs. The framework can be used to facilitate discussions to help countries improve and expand the breadth of protection provided by their NIP.
{"title":"Assessment of the comprehensiveness of paediatric national immunisation programmes in Europe: expert validation and future perspectives.","authors":"Ugne Sabale, Janice Murtagh, James Cochrane, Danielle Riley, Richard Perry, Louise Heron, Paolo Bonanni, Jose Navarro Alonso, Juhani Eskola, Valerie Laigle","doi":"10.1080/14760584.2024.2324939","DOIUrl":"10.1080/14760584.2024.2324939","url":null,"abstract":"<p><strong>Background: </strong>The breadth of protection of National Immunisation Programmes (NIPs) across Europe varies, however, this has not been assessed within published literature. Therefore, a framework was developed to assess the comprehensiveness of pediatric NIPs in Europe. This study aimed to validate and further develop criteria used to cluster countries into three tiers.</p><p><strong>Research design and methods: </strong>Independent Europe-based experts (<i>n</i> = 23) in the field of pediatric vaccination were invited to participate in a double-blinded modified Delphi panel, with two online survey rounds and a virtual consensus meeting. Consensus was defined as ≥ 80% of experts rating their agreement/disagreement on a 9-point Likert scale.</p><p><strong>Results: </strong>The number of preventable diseases covered by an NIP, simplification of the vaccination calendar, strengthened protection by increasing serotype, degree of funding and epidemiological factors were considered key concepts for consideration of the comprehensiveness of pediatric NIPs in Europe. Experts highlighted that the framework should be extended to include adolescent vaccines and populations up to 18 years of age. Consensus regarding further amendments to the framework was also reached.</p><p><strong>Conclusions: </strong>This Delphi panel validated a framework to assess the comprehensiveness of European NIPs. The framework can be used to facilitate discussions to help countries improve and expand the breadth of protection provided by their NIP.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139989767","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: This study aimed to evaluate VE of primary, first, and second booster ancestral-strain monovalent mRNA COVID-19 vaccination against symptomatic infections and severe diseases in Japan.
Methods: We conducted a test-negative case-control study. We included medically attended episodes and hospitalizations involving individuals aged 16 with signs and symptoms from July to November 2022, when Omicron BA.5 was dominant nationwide. To evaluate VE, we calculated adjusted ORs of vaccination among test-positive versus test-negative individuals using a mixed-effects logistic regression.
Results: For VE against symptomatic infections among individuals aged 16 to 59, VE of primary vaccination at > 180 days was 26.1% (95% CI: 10.6-38.8%); VE of the first booster was 58.5% (48.4-66.7%) at 90 days, decreasing to 41.1% (29.5-50.8%) at 91 to 180 days. For individuals aged 60, VE of the first booster was 42.8% (1.7-66.7%) at 90 days, dropping to 15.4% (-25.9-43.2%) at 91 to 180 days, and then increasing to 44.0% (16.4-62.5%) after the second booster. For VE against severe diseases, VE of the first and second booster was 77.3% (61.2-86.7%) at 90 days and 55.9% (23.4-74.6%) afterward.
Conclusion: mRNA booster vaccination provided moderate protection against symptomatic infections and high-level protection against severe diseases during the BA.5 epidemic in Japan.
{"title":"Effectiveness of primary series, first, and second booster vaccination of monovalent mRNA COVID-19 vaccines against symptomatic SARS-CoV-2 infections and severe diseases during the SARS-CoV-2 omicron BA.5 epidemic in Japan: vaccine effectiveness real-time surveillance for SARS-CoV-2 (VERSUS).","authors":"Haruka Maeda, Nobuo Saito, Ataru Igarashi, Masayuki Ishida, Mayumi Terada, Shingo Masuda, Ryosuke Osawa, Naoto Hosokawa, Kei Nakashima, Hiroshi Kamura, Haruki Imura, Hiroki Inoue, Suguru Matsuzaka, Yukihiro Sugimoto, Osamu Kuwamitsu, Iori Motohashi, Toru Morikawa, Rentaro Oda, Yuiko Hoshina, Takashi Matono, Osamu Teshigahara, Eiichiro Sando, Sadaharu Asami, Satoshi Kudo, Noboru Akizuki, Yoshikazu Muto, Tomoichiro Hayakawa, Tomoo Kishaba, Yasuji Ohara, Yoshinao Kubo, Motoi Suzuki, Konosuke Morimoto","doi":"10.1080/14760584.2024.2310807","DOIUrl":"10.1080/14760584.2024.2310807","url":null,"abstract":"<p><strong>Background: </strong>This study aimed to evaluate VE of primary, first, and second booster ancestral-strain monovalent mRNA COVID-19 vaccination against symptomatic infections and severe diseases in Japan.</p><p><strong>Methods: </strong>We conducted a test-negative case-control study. We included medically attended episodes and hospitalizations involving individuals aged <math><mo>≥</mo></math>16 with signs and symptoms from July to November 2022, when Omicron BA.5 was dominant nationwide. To evaluate VE, we calculated adjusted ORs of vaccination among test-positive versus test-negative individuals using a mixed-effects logistic regression.</p><p><strong>Results: </strong>For VE against symptomatic infections among individuals aged 16 to 59, VE of primary vaccination at > 180 days was 26.1% (95% CI: 10.6-38.8%); VE of the first booster was 58.5% (48.4-66.7%) at <math><mo>≤</mo></math>90 days, decreasing to 41.1% (29.5-50.8%) at 91 to 180 days. For individuals aged <math><mo>≥</mo></math>60, VE of the first booster was 42.8% (1.7-66.7%) at <math><mo>≤</mo></math>90 days, dropping to 15.4% (-25.9-43.2%) at 91 to 180 days, and then increasing to 44.0% (16.4-62.5%) after the second booster. For VE against severe diseases, VE of the first and second booster was 77.3% (61.2-86.7%) at <math><mo>≤</mo></math>90 days and 55.9% (23.4-74.6%) afterward.</p><p><strong>Conclusion: </strong>mRNA booster vaccination provided moderate protection against symptomatic infections and high-level protection against severe diseases during the BA.5 epidemic in Japan.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139575522","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-01Epub Date: 2024-04-02DOI: 10.1080/14760584.2024.2334423
Abundio Balgos, Suad Hannawi, Wen-Li Chen, Alaa Abuquta, Linda Safeldin, Aala Hassan, Ahmad Alamadi, Louie Tirador, Anjuli May Jaen, Ralph Elvi Villalobos, Chen Mo, Zi-Jing Yue, Ying Ma, Qing-Shuang Wang, Ren-Du Wen, Zheng Yao, Jia-Ping Yu, Wen-Rong Yao, Jian-Hui Zhang, Kun-Xue Hong, Yong Liu, Jing-Xin Li
Background: Recombinant protein vaccines are vital for broad protection against SARS-CoV-2 variants. This study assessed ReCOV as a booster in two Phase 2 trials.
Research design and methods: Study-1 involved subjects were randomized (1:1:1) to receive 20 μg ReCOV, 40 μg ReCOV, or an inactivated vaccine (COVILO®) in the United Arab Emirates. Study-2 participating individuals were randomized (1:1:1) to receive 20 μg ReCOV (pilot batch, ReCOV HA), 20 μg ReCOV (commercial batch, ReCOV TC), or 30 μg BNT162b2 (COMIRNATY®) in the Philippines. The primary immunogenicity objectives was to compare the geometric mean titer (GMT) and seroconversion rate (SCR) of neutralizing antibodies induced by one ReCOV booster dose with those of inactivated vaccine and BNT162b2, respectively, at 14 days post-booster.
Results: Heterologous ReCOV booster doses were safe and induced comparable immune responses to inactivated vaccines and BNT162b2 against Omicron variants and the prototype. They showed significant advantages in cross-neutralization against multiple SARS-CoV-2 variants, surpassing inactivated vaccines and BNT162b2, with good immune persistence.
Conclusions: Heterologous ReCOV boosting was safe and effective, showing promise in combating COVID-19. The study highlights ReCOV's potential for enhanced protection, supported by strong cross-neutralization and immune persistence.
Clinical trial registration: Study-1, www.clinicaltrials.gov, identifier is NCT05323435; Study-2, www.clinicaltrials.gov, identifier is NCT05084989.
{"title":"Immunogenicity and safety of boosting with a recombinant two-component SARS-CoV-2 vaccine: two randomized, parallel-controlled, phase 2 studies.","authors":"Abundio Balgos, Suad Hannawi, Wen-Li Chen, Alaa Abuquta, Linda Safeldin, Aala Hassan, Ahmad Alamadi, Louie Tirador, Anjuli May Jaen, Ralph Elvi Villalobos, Chen Mo, Zi-Jing Yue, Ying Ma, Qing-Shuang Wang, Ren-Du Wen, Zheng Yao, Jia-Ping Yu, Wen-Rong Yao, Jian-Hui Zhang, Kun-Xue Hong, Yong Liu, Jing-Xin Li","doi":"10.1080/14760584.2024.2334423","DOIUrl":"10.1080/14760584.2024.2334423","url":null,"abstract":"<p><strong>Background: </strong>Recombinant protein vaccines are vital for broad protection against SARS-CoV-2 variants. This study assessed ReCOV as a booster in two Phase 2 trials.</p><p><strong>Research design and methods: </strong>Study-1 involved subjects were randomized (1:1:1) to receive 20 μg ReCOV, 40 μg ReCOV, or an inactivated vaccine (COVILO®) in the United Arab Emirates. Study-2 participating individuals were randomized (1:1:1) to receive 20 μg ReCOV (pilot batch, ReCOV HA), 20 μg ReCOV (commercial batch, ReCOV TC), or 30 μg BNT162b2 (COMIRNATY®) in the Philippines. The primary immunogenicity objectives was to compare the geometric mean titer (GMT) and seroconversion rate (SCR) of neutralizing antibodies induced by one ReCOV booster dose with those of inactivated vaccine and BNT162b2, respectively, at 14 days post-booster.</p><p><strong>Results: </strong>Heterologous ReCOV booster doses were safe and induced comparable immune responses to inactivated vaccines and BNT162b2 against Omicron variants and the prototype. They showed significant advantages in cross-neutralization against multiple SARS-CoV-2 variants, surpassing inactivated vaccines and BNT162b2, with good immune persistence.</p><p><strong>Conclusions: </strong>Heterologous ReCOV boosting was safe and effective, showing promise in combating COVID-19. The study highlights ReCOV's potential for enhanced protection, supported by strong cross-neutralization and immune persistence.</p><p><strong>Clinical trial registration: </strong>Study-1, www.clinicaltrials.gov, identifier is NCT05323435; Study-2, www.clinicaltrials.gov, identifier is NCT05084989.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":null,"pages":null},"PeriodicalIF":6.2,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140287217","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: The 23-valent pneumococcal polysaccharide vaccine (PPSV23) is used in the Japanese National Immunization Program for older adults and adults with increased risk for pneumococcal disease, however, disease incidence and associated burden remain high. We evaluated the cost-effectiveness of pneumococcal conjugate vaccines (PCVs) for adults aged 65 years and high-risk adults aged 60-64 years in Japan.
Research design and methods: Using a Markov model, we evaluated lifetime costs using societal and healthcare payer perspectives and estimated quality-adjusted life-years (QALYs), and number of prevented cases and deaths caused by invasive pneumococcal disease (IPD) and non-IPD. The base case analysis used a societal perspective.
Results: In comparison with PPSV23, the 20-valent PCV (PCV20) prevented 127 IPD cases 10,813 non-IPD cases (inpatients: 2,461, outpatients: 8,352) and 226 deaths, and gained more QALYs (+0.0015 per person) with less cost (-JPY22,513 per person). All sensitivity and scenario analyses including a payer perspective analysis indicated that the incremental cost-effectiveness ratios (ICERs) were below the cost-effectiveness threshold value in Japan (JPY5 million/QALY).
Conclusions: PCV20 is both cost saving and more effective than PPSV23 for adults aged 65 years and high-risk adults aged 60-64 years in Japan.
{"title":"Cost-effectiveness analysis of adult pneumococcal conjugate vaccines for pneumococcal disease in Japan.","authors":"Shigeki Nakamura, Masashi Mikami, Tomoyuki Hayamizu, Naohiro Yonemoto, Camille Moyon, Mark Gouldson, Catriona Crossan, Jeffrey Vietri, Kazumasa Kamei","doi":"10.1080/14760584.2024.2350246","DOIUrl":"10.1080/14760584.2024.2350246","url":null,"abstract":"<p><strong>Background: </strong>The 23-valent pneumococcal polysaccharide vaccine (PPSV23) is used in the Japanese National Immunization Program for older adults and adults with increased risk for pneumococcal disease, however, disease incidence and associated burden remain high. We evaluated the cost-effectiveness of pneumococcal conjugate vaccines (PCVs) for adults aged 65 years and high-risk adults aged 60-64 years in Japan.</p><p><strong>Research design and methods: </strong>Using a Markov model, we evaluated lifetime costs using societal and healthcare payer perspectives and estimated quality-adjusted life-years (QALYs), and number of prevented cases and deaths caused by invasive pneumococcal disease (IPD) and non-IPD. The base case analysis used a societal perspective.</p><p><strong>Results: </strong>In comparison with PPSV23, the 20-valent PCV (PCV20) prevented 127 IPD cases 10,813 non-IPD cases (inpatients: 2,461, outpatients: 8,352) and 226 deaths, and gained more QALYs (+0.0015 per person) with less cost (-JPY22,513 per person). All sensitivity and scenario analyses including a payer perspective analysis indicated that the incremental cost-effectiveness ratios (ICERs) were below the cost-effectiveness threshold value in Japan (JPY5 million/QALY).</p><p><strong>Conclusions: </strong>PCV20 is both cost saving and more effective than PPSV23 for adults aged 65 years and high-risk adults aged 60-64 years in Japan.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":null,"pages":null},"PeriodicalIF":5.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140850757","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}