Pub Date : 2024-03-25DOI: 10.1016/j.vaccine.2024.03.060
Jan Biegus, Leszek Szenborn, Robert Zymliński, Michał Zakliczyński, Krzysztof Reczuch, Mateusz Guzik, Szymon Urban, Marta Rosiek-Biegus, Berenika Jankowiak, Gracjan Iwanek, Marat Fudim, Piotr Ponikowski
The safety of simultaneous vaccination for Respiratory Syncytial Virus (RSV) and influenza in vulnerable high-risk heart failure (HF) patients remains unclear. In an open-label, prospective study, 105 patients received concurrent influenza (Vaxigrip Tetra, season 2023/2024, Sanofi) and RSV (Arexvy, GSK) vaccinations from September 15th to November 17th, 2023. Adverse events were collected on the fourth-day post-vaccination. Overall, the vaccination was well tolerated, with the most common reaction being injection site pain (63 %). General symptoms occurred in 33 % of patients, predominantly fatigue (23 %), myalgia (12 %), and headache (9 %). Grade 3 reactions were observed in 6 % of patients, and a few experienced temperature elevation or flu-like symptoms, managing them with antipyretics. Notably, there were no exacerbations of HF, hospitalizations, or deaths within a week post-vaccination. This study indicates the safety of simultaneous influenza and RSV vaccination in high-risk HF patients, with a low incidence of mild adverse events.
{"title":"The early safety profile of simultaneous vaccination against influenza and Respiratory Syncytial Virus (RSV) in patients with high-risk heart failure.","authors":"Jan Biegus, Leszek Szenborn, Robert Zymliński, Michał Zakliczyński, Krzysztof Reczuch, Mateusz Guzik, Szymon Urban, Marta Rosiek-Biegus, Berenika Jankowiak, Gracjan Iwanek, Marat Fudim, Piotr Ponikowski","doi":"10.1016/j.vaccine.2024.03.060","DOIUrl":"https://doi.org/10.1016/j.vaccine.2024.03.060","url":null,"abstract":"<p><p>The safety of simultaneous vaccination for Respiratory Syncytial Virus (RSV) and influenza in vulnerable high-risk heart failure (HF) patients remains unclear. In an open-label, prospective study, 105 patients received concurrent influenza (Vaxigrip Tetra, season 2023/2024, Sanofi) and RSV (Arexvy, GSK) vaccinations from September 15th to November 17th, 2023. Adverse events were collected on the fourth-day post-vaccination. Overall, the vaccination was well tolerated, with the most common reaction being injection site pain (63 %). General symptoms occurred in 33 % of patients, predominantly fatigue (23 %), myalgia (12 %), and headache (9 %). Grade 3 reactions were observed in 6 % of patients, and a few experienced temperature elevation or flu-like symptoms, managing them with antipyretics. Notably, there were no exacerbations of HF, hospitalizations, or deaths within a week post-vaccination. This study indicates the safety of simultaneous influenza and RSV vaccination in high-risk HF patients, with a low incidence of mild adverse events.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140295773","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-23DOI: 10.1016/j.vaccine.2024.03.054
Benjamin A Dahl, Beth Tritter, Deena Butryn, Melissa Dahlke, Sean Browning, Richard Gelting, Monica Fleming, Nancy Ortiz, Jacqueline Labrador, Ryan Novak, David Fitter, Elizabeth Bell, Megan McGuire, Robert Rosenbaum, Robert Pulwer, Jolene Wun, Anna McCaffrey, Maisoon Chowdhury, Nida Parks, Marc Cunningham, Anthony Mounts, Dora Curry, Dominique Richardson, Gavin Grant
In December 2021 the U.S. Government announced a new, whole-of-government $1.8 billion effort, the Initiative for Global Vaccine Access (Global VAX) in response to the global COVID-19 pandemic. Using the foundation of decades of U.S. government investments in global health and working in close partnership with local governments and key global and multilateral organizations, Global VAX enabled the rapid acceleration of the global COVID-19 vaccine rollout in selected countries, contributing to increased COVID-19 vaccine coverage in some of the world's most vulnerable communities. Through Global VAX, the U.S. Government has supported 125 countries to scale up COVID-19 vaccine delivery and administration while strengthening primary health care systems to respond to future health crises. The progress made by Global VAX has paved the way for a stronger global recovery and improved global health security.
{"title":"Global VAX: A U.S. contribution to global COVID-19 vaccination efforts, 2021-2023.","authors":"Benjamin A Dahl, Beth Tritter, Deena Butryn, Melissa Dahlke, Sean Browning, Richard Gelting, Monica Fleming, Nancy Ortiz, Jacqueline Labrador, Ryan Novak, David Fitter, Elizabeth Bell, Megan McGuire, Robert Rosenbaum, Robert Pulwer, Jolene Wun, Anna McCaffrey, Maisoon Chowdhury, Nida Parks, Marc Cunningham, Anthony Mounts, Dora Curry, Dominique Richardson, Gavin Grant","doi":"10.1016/j.vaccine.2024.03.054","DOIUrl":"https://doi.org/10.1016/j.vaccine.2024.03.054","url":null,"abstract":"<p><p>In December 2021 the U.S. Government announced a new, whole-of-government $1.8 billion effort, the Initiative for Global Vaccine Access (Global VAX) in response to the global COVID-19 pandemic. Using the foundation of decades of U.S. government investments in global health and working in close partnership with local governments and key global and multilateral organizations, Global VAX enabled the rapid acceleration of the global COVID-19 vaccine rollout in selected countries, contributing to increased COVID-19 vaccine coverage in some of the world's most vulnerable communities. Through Global VAX, the U.S. Government has supported 125 countries to scale up COVID-19 vaccine delivery and administration while strengthening primary health care systems to respond to future health crises. The progress made by Global VAX has paved the way for a stronger global recovery and improved global health security.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140208768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-19DOI: 10.1016/j.vaccine.2024.03.026
Lise Gehrt, Hélène Englund, Ida Laake, Heta Nieminen, Sören Möller, Berit Feiring, Mika Lahdenkari, Lill Trogstad, Christine Stabell Benn, Signe Sørup
Objectives: Previous studies have shown that vaccination against measles, mumps, and rubella (MMR) may have beneficial non-specific effects, reducing the risk of infections not targeted by the vaccine. We investigated if MMR vaccine given after the third dose of diphtheria-tetanus-acellular pertussis vaccine (DTaP3), was associated with reduced rates of antibiotic treatments.
Methods: Register-based cohort study following children from the age of recommended MMR vaccination until age 2 years. We included 831,287 children born in Denmark, Finland, Norway, and Sweden who had received DTaP3 but not yet MMR vaccine. Cox proportional hazards regression with age as the underlying timescale and vaccination status as a time-varying exposure was used to estimate covariate-adjusted Hazard Ratios (aHRs) and inverse probability of treatment weighted (IPTW) HRs of antibiotic treatments. Summary estimates were calculated using random-effects meta-analysis.
Results: Compared with only having received DTaP3, receipt of MMR vaccine after DTaP3 was associated with reduced rates of antibiotic treatments in all countries: the aHR was 0.92 (0.91-0.93) in Denmark, 0.92 (0.90-0.94) in Finland, 0.84 (0.82-0.85) in Norway, and 0.87 (0.85-0.90) in Sweden, yielding a summary estimate of 0.89 (0.85-0.93). A stronger beneficial association was seen in a negative control exposure analysis comparing children vaccinated with DTaP3 vs two doses of DTaP.
Conclusions: Across the Nordic countries, receipt of MMR vaccine after DTaP3 was associated with an 11% lower rate of antibiotic treatments. The negative control analysis suggests that the findings are affected by residual confounding. Findings suggest that potential non-specific effects of MMR vaccine are of limited clinical and public health importance for the milder infections treated out-of-hospital in the Nordic setting.
{"title":"Is vaccination against measles, mumps, and rubella associated with reduced rates of antibiotic treatments among children below the age of 2 years? Nationwide register-based study from Denmark, Finland, Norway, and Sweden.","authors":"Lise Gehrt, Hélène Englund, Ida Laake, Heta Nieminen, Sören Möller, Berit Feiring, Mika Lahdenkari, Lill Trogstad, Christine Stabell Benn, Signe Sørup","doi":"10.1016/j.vaccine.2024.03.026","DOIUrl":"https://doi.org/10.1016/j.vaccine.2024.03.026","url":null,"abstract":"<p><strong>Objectives: </strong>Previous studies have shown that vaccination against measles, mumps, and rubella (MMR) may have beneficial non-specific effects, reducing the risk of infections not targeted by the vaccine. We investigated if MMR vaccine given after the third dose of diphtheria-tetanus-acellular pertussis vaccine (DTaP3), was associated with reduced rates of antibiotic treatments.</p><p><strong>Methods: </strong>Register-based cohort study following children from the age of recommended MMR vaccination until age 2 years. We included 831,287 children born in Denmark, Finland, Norway, and Sweden who had received DTaP3 but not yet MMR vaccine. Cox proportional hazards regression with age as the underlying timescale and vaccination status as a time-varying exposure was used to estimate covariate-adjusted Hazard Ratios (aHRs) and inverse probability of treatment weighted (IPTW) HRs of antibiotic treatments. Summary estimates were calculated using random-effects meta-analysis.</p><p><strong>Results: </strong>Compared with only having received DTaP3, receipt of MMR vaccine after DTaP3 was associated with reduced rates of antibiotic treatments in all countries: the aHR was 0.92 (0.91-0.93) in Denmark, 0.92 (0.90-0.94) in Finland, 0.84 (0.82-0.85) in Norway, and 0.87 (0.85-0.90) in Sweden, yielding a summary estimate of 0.89 (0.85-0.93). A stronger beneficial association was seen in a negative control exposure analysis comparing children vaccinated with DTaP3 vs two doses of DTaP.</p><p><strong>Conclusions: </strong>Across the Nordic countries, receipt of MMR vaccine after DTaP3 was associated with an 11% lower rate of antibiotic treatments. The negative control analysis suggests that the findings are affected by residual confounding. Findings suggest that potential non-specific effects of MMR vaccine are of limited clinical and public health importance for the milder infections treated out-of-hospital in the Nordic setting.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140178492","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-07DOI: 10.1016/j.vaccine.2024.02.050
Sana Ghasemifar, Omid Chabak, Tohid Piri-Gharaghie, Abbas Doosti
This article has been withdrawn at the request of the Editor. The Publisher apologizes for any inconvenience this may cause. The full Elsevier Policy on Article Withdrawal can be found at https://www.elsevier.com/about/policies/article-withdrawal. The data presented in the manuscript was deemed severely flawed after appearing online as an Article in Press. The scientific community raised concerns about the methodology (including but not limited to major technical issues) used in the study and the subsequent conclusions drawn from the presented experiments. After careful investigation, the Vaccine editorial office concluded that the data in the publication was indeed severely flawed and that the concerns raised by the scientific community were valid. Therefore, the journal editors decided to withdraw the article and sincerely apologize for any inconvenience caused.
{"title":"WITHDRAWN: PIRES2-EGFP/CTB-UreI vaccination activated a mixed Th1/Th2/Th17 immune system defense towards Helicobacter pylori infection in the BALB/c mice model.","authors":"Sana Ghasemifar, Omid Chabak, Tohid Piri-Gharaghie, Abbas Doosti","doi":"10.1016/j.vaccine.2024.02.050","DOIUrl":"10.1016/j.vaccine.2024.02.050","url":null,"abstract":"<p><p>This article has been withdrawn at the request of the Editor. The Publisher apologizes for any inconvenience this may cause. The full Elsevier Policy on Article Withdrawal can be found at https://www.elsevier.com/about/policies/article-withdrawal. The data presented in the manuscript was deemed severely flawed after appearing online as an Article in Press. The scientific community raised concerns about the methodology (including but not limited to major technical issues) used in the study and the subsequent conclusions drawn from the presented experiments. After careful investigation, the Vaccine editorial office concluded that the data in the publication was indeed severely flawed and that the concerns raised by the scientific community were valid. Therefore, the journal editors decided to withdraw the article and sincerely apologize for any inconvenience caused.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140061679","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-29DOI: 10.1016/j.vaccine.2024.02.019
Kevin Chatham-Stephens, Rosalind J Carter, Chris Duggar, Kate R Woodworth, Catherine Amanda Carnes, Achal Bhatt, Christina Ottis, Chris Voegeli, Shannon Stokley, Tara Vogt
COVID-19 vaccination decreases risk for COVID-19 illness and severe disease in children, including multisystem inflammatory syndrome (MIS-C) and death. On December 13, 2020, CDC recommended COVID-19 vaccination for persons ages ≥16 years, with expansion on May 12, 2021, to adolescents ages 12-15 years; to children ages 5-11 years on November 2, 2021; and to children ages 6 months-4 years on June 18, 2022. Following each age-specific recommendation, the U.S. government collaborated with state and local governments, vaccine manufacturers, and numerous other public and private entities, to ensure rapid, broad, and equitable COVID-19 vaccine distribution to strategic locations across the country to maximize access. However, vaccination coverage among children has been lower than among adults and lower among younger children than adolescents. As of May 10, 2023, COVID-19 primary series vaccination coverage was 61.8% among U.S. children ages 12-17 years, 32.9% among those ages 5-11 years, and 5.5% among those ages 6 months-4 years. This manuscript describes the planning and implementation of the U.S. COVID-19 pediatric vaccine program, including successes (e.g., the availability of pharmacy vaccination to extend access beyond more traditional pediatric vaccine providers) and challenges (e.g., multi-dose vaccine vials instead of single-dose vials, leading to concerns about wastage) to provide a historical record of the program and to help inform planning and implementation of future routine or pandemic-related pediatric vaccination campaigns.
{"title":"An overview of the COVID-19 pediatric vaccine program - The U.S. experience vaccinating children ages 6 months through 17 years.","authors":"Kevin Chatham-Stephens, Rosalind J Carter, Chris Duggar, Kate R Woodworth, Catherine Amanda Carnes, Achal Bhatt, Christina Ottis, Chris Voegeli, Shannon Stokley, Tara Vogt","doi":"10.1016/j.vaccine.2024.02.019","DOIUrl":"https://doi.org/10.1016/j.vaccine.2024.02.019","url":null,"abstract":"<p><p>COVID-19 vaccination decreases risk for COVID-19 illness and severe disease in children, including multisystem inflammatory syndrome (MIS-C) and death. On December 13, 2020, CDC recommended COVID-19 vaccination for persons ages ≥16 years, with expansion on May 12, 2021, to adolescents ages 12-15 years; to children ages 5-11 years on November 2, 2021; and to children ages 6 months-4 years on June 18, 2022. Following each age-specific recommendation, the U.S. government collaborated with state and local governments, vaccine manufacturers, and numerous other public and private entities, to ensure rapid, broad, and equitable COVID-19 vaccine distribution to strategic locations across the country to maximize access. However, vaccination coverage among children has been lower than among adults and lower among younger children than adolescents. As of May 10, 2023, COVID-19 primary series vaccination coverage was 61.8% among U.S. children ages 12-17 years, 32.9% among those ages 5-11 years, and 5.5% among those ages 6 months-4 years. This manuscript describes the planning and implementation of the U.S. COVID-19 pediatric vaccine program, including successes (e.g., the availability of pharmacy vaccination to extend access beyond more traditional pediatric vaccine providers) and challenges (e.g., multi-dose vaccine vials instead of single-dose vials, leading to concerns about wastage) to provide a historical record of the program and to help inform planning and implementation of future routine or pandemic-related pediatric vaccination campaigns.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140013887","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-28DOI: 10.1016/j.vaccine.2024.01.069
Dana Meaney-Delman, Sarah Carroll, Kara Polen, Tara C Jatlaoui, Sarah Meyer, Sara Oliver, Julianne Gee, Tom Shimabukuro, Hilda Razzaghi, Laura Riley, Romeo R Galang, Van Tong, Suzanne Gilboa, Sascha Ellington, Amanda Cohn
As the worldwide COVID-19 pandemic unfolded, the clinical and public health community raced to understand SARS-CoV-2 infection and develop life-saving vaccines. Pregnant persons were disproportionately impacted, experiencing more severe illness and adverse pregnancy outcomes. And yet, when COVID-19 vaccines became available in late 2020, safety and efficacy data were not available to inform their use during pregnancy because pregnant persons were excluded from pre-authorization clinical trials. Concerns about vaccine safety during pregnancy and misinformation linking vaccination and infertility circulated widely, creating a lack of vaccine confidence. Many pregnant people initially chose not to get vaccinated, and while vaccination rates rose after safety and effectiveness data became available, COVID-19 vaccine acceptance was suboptimal and varied across racial and ethnic distribution of the pregnant population. The COVID-19 pandemic experience provided valuable insights that can inform current and future approaches to maternal vaccination against.
{"title":"Planning for the future of maternal immunization: Building on lessons learned from the COVID-19 pandemic.","authors":"Dana Meaney-Delman, Sarah Carroll, Kara Polen, Tara C Jatlaoui, Sarah Meyer, Sara Oliver, Julianne Gee, Tom Shimabukuro, Hilda Razzaghi, Laura Riley, Romeo R Galang, Van Tong, Suzanne Gilboa, Sascha Ellington, Amanda Cohn","doi":"10.1016/j.vaccine.2024.01.069","DOIUrl":"10.1016/j.vaccine.2024.01.069","url":null,"abstract":"<p><p>As the worldwide COVID-19 pandemic unfolded, the clinical and public health community raced to understand SARS-CoV-2 infection and develop life-saving vaccines. Pregnant persons were disproportionately impacted, experiencing more severe illness and adverse pregnancy outcomes. And yet, when COVID-19 vaccines became available in late 2020, safety and efficacy data were not available to inform their use during pregnancy because pregnant persons were excluded from pre-authorization clinical trials. Concerns about vaccine safety during pregnancy and misinformation linking vaccination and infertility circulated widely, creating a lack of vaccine confidence. Many pregnant people initially chose not to get vaccinated, and while vaccination rates rose after safety and effectiveness data became available, COVID-19 vaccine acceptance was suboptimal and varied across racial and ethnic distribution of the pregnant population. The COVID-19 pandemic experience provided valuable insights that can inform current and future approaches to maternal vaccination against.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11349930/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139998783","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-14DOI: 10.1016/j.vaccine.2024.02.020
Christopher Duggar, Jeanne M Santoli, Cameron Noblit, Lori B Moore, Roua El Kalach, Carolyn B Bridges
During December 2020 through May 2023, the Centers for Disease Control and Prevention's (CDC) Immunization Services Division supported and executed the largest vaccine distribution effort in U.S. history, delivering nearly one billion doses of COVID-19 vaccine to vaccine providers in all 50 states, District of Columbia, Puerto Rico, Virgin Islands, Guam, Federated States of Micronesia, American Samoa, Marshall Islands, Northern Mariana Islands, and Palau. While existing infrastructure, ordering, and distribution mechanisms were in place from the Vaccines for Children Program (VFC) and experience had been gained during the 2009 H1N1 pandemic and incorporated into influenza vaccination pandemic planning, the scale and complexity of the national mobilization against a novel coronavirus resulted in many previously unforeseen challenges, particularly related to transporting and storing the majority of the U.S. COVID-19 vaccine at frozen and ultra-cold temperatures. This article describes the infrastructure supporting the distribution of U.S. government-purchased COVID-19 vaccines that was in place pre-pandemic, and the infrastructure, processes, and communications efforts developed to support the heightened demands of the COVID-19 vaccination program, and describes lessons learned.
{"title":"U.S. COVID-19 vaccine distribution strategies, systems, performance, and lessons learned, December 2020 - May 2023.","authors":"Christopher Duggar, Jeanne M Santoli, Cameron Noblit, Lori B Moore, Roua El Kalach, Carolyn B Bridges","doi":"10.1016/j.vaccine.2024.02.020","DOIUrl":"10.1016/j.vaccine.2024.02.020","url":null,"abstract":"<p><p>During December 2020 through May 2023, the Centers for Disease Control and Prevention's (CDC) Immunization Services Division supported and executed the largest vaccine distribution effort in U.S. history, delivering nearly one billion doses of COVID-19 vaccine to vaccine providers in all 50 states, District of Columbia, Puerto Rico, Virgin Islands, Guam, Federated States of Micronesia, American Samoa, Marshall Islands, Northern Mariana Islands, and Palau. While existing infrastructure, ordering, and distribution mechanisms were in place from the Vaccines for Children Program (VFC) and experience had been gained during the 2009 H1N1 pandemic and incorporated into influenza vaccination pandemic planning, the scale and complexity of the national mobilization against a novel coronavirus resulted in many previously unforeseen challenges, particularly related to transporting and storing the majority of the U.S. COVID-19 vaccine at frozen and ultra-cold temperatures. This article describes the infrastructure supporting the distribution of U.S. government-purchased COVID-19 vaccines that was in place pre-pandemic, and the infrastructure, processes, and communications efforts developed to support the heightened demands of the COVID-19 vaccination program, and describes lessons learned.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11366301/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139743090","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-12DOI: 10.1016/j.vaccine.2024.02.023
Philippe De Wals, Michaël Desjardins
{"title":"Minimal interval for the administration of a pneumococcal polysaccharide vaccine following the administration of a pneumococcal conjugate vaccine.","authors":"Philippe De Wals, Michaël Desjardins","doi":"10.1016/j.vaccine.2024.02.023","DOIUrl":"https://doi.org/10.1016/j.vaccine.2024.02.023","url":null,"abstract":"","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139725529","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-09DOI: 10.1016/j.vaccine.2023.12.059
Lauri E Markowitz, Robert H Hopkins, Karen R Broder, Grace M Lee, Kathryn M Edwards, Matthew F Daley, Lisa A Jackson, Jennifer C Nelson, Laura E Riley, Veronica V McNally, Robert Schechter, Patricia N Whitley-Williams, Francesca Cunningham, Matthew Clark, Margaret Ryan, Karen M Farizo, Hui-Lee Wong, Jeffery Kelman, Tatiana Beresnev, Valerie Marshall, David K Shay, Julianne Gee, Jared Woo, Michael M McNeil, John R Su, Tom T Shimabukuro, Melinda Wharton, H Keipp Talbot
During the COVID-19 pandemic, candidate COVID-19 vaccines were being developed for potential use in the United States on an unprecedented, accelerated schedule. It was anticipated that once available, under U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) or FDA approval, COVID-19 vaccines would be broadly used and potentially administered to millions of individuals in a short period of time. Intensive monitoring in the post-EUA/licensure period would be necessary for timely detection and assessment of potential safety concerns. To address this, the Centers for Disease Control and Prevention (CDC) convened an Advisory Committee on Immunization Practices (ACIP) work group focused solely on COVID-19 vaccine safety, consisting of independent vaccine safety experts and representatives from federal agencies - the ACIP COVID-19 Vaccine Safety Technical Work Group (VaST). This report provides an overview of the organization and activities of VaST, summarizes data reviewed as part of the comprehensive effort to monitor vaccine safety during the COVID-19 pandemic, and highlights selected actions taken by CDC, ACIP, and FDA in response to accumulating post-authorization safety data. VaST convened regular meetings over the course of 29 months, from November 2020 through April 2023; through March 2023 FDA issued EUAs for six COVID-19 vaccines from four different manufacturers and subsequently licensed two of these COVID-19 vaccines. The independent vaccine safety experts collaborated with federal agencies to ensure timely assessment of vaccine safety data during this time. VaST worked closely with the ACIP COVID-19 Vaccines Work Group; that work group used safety data and VaST's assessments for benefit-risk assessments and guidance for COVID-19 vaccination policy. Safety topics reviewed by VaST included those identified in safety monitoring systems and other topics of scientific or public interest. VaST provided guidance to CDC's COVID-19 vaccine safety monitoring efforts, provided a forum for review of data from several U.S. government vaccine safety systems, and assured that a diverse group of scientists and clinicians, external to the federal government, promptly reviewed vaccine safety data. In the event of a future pandemic or other biological public health emergency, the VaST model could be used to strengthen vaccine safety monitoring, enhance public confidence, and increase transparency through incorporation of independent, non-government safety experts into the monitoring process, and through strong collaboration among federal and other partners.
{"title":"COVID-19 Vaccine Safety Technical (VaST) Work Group: Enhancing vaccine safety monitoring during the pandemic.","authors":"Lauri E Markowitz, Robert H Hopkins, Karen R Broder, Grace M Lee, Kathryn M Edwards, Matthew F Daley, Lisa A Jackson, Jennifer C Nelson, Laura E Riley, Veronica V McNally, Robert Schechter, Patricia N Whitley-Williams, Francesca Cunningham, Matthew Clark, Margaret Ryan, Karen M Farizo, Hui-Lee Wong, Jeffery Kelman, Tatiana Beresnev, Valerie Marshall, David K Shay, Julianne Gee, Jared Woo, Michael M McNeil, John R Su, Tom T Shimabukuro, Melinda Wharton, H Keipp Talbot","doi":"10.1016/j.vaccine.2023.12.059","DOIUrl":"10.1016/j.vaccine.2023.12.059","url":null,"abstract":"<p><p>During the COVID-19 pandemic, candidate COVID-19 vaccines were being developed for potential use in the United States on an unprecedented, accelerated schedule. It was anticipated that once available, under U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) or FDA approval, COVID-19 vaccines would be broadly used and potentially administered to millions of individuals in a short period of time. Intensive monitoring in the post-EUA/licensure period would be necessary for timely detection and assessment of potential safety concerns. To address this, the Centers for Disease Control and Prevention (CDC) convened an Advisory Committee on Immunization Practices (ACIP) work group focused solely on COVID-19 vaccine safety, consisting of independent vaccine safety experts and representatives from federal agencies - the ACIP COVID-19 Vaccine Safety Technical Work Group (VaST). This report provides an overview of the organization and activities of VaST, summarizes data reviewed as part of the comprehensive effort to monitor vaccine safety during the COVID-19 pandemic, and highlights selected actions taken by CDC, ACIP, and FDA in response to accumulating post-authorization safety data. VaST convened regular meetings over the course of 29 months, from November 2020 through April 2023; through March 2023 FDA issued EUAs for six COVID-19 vaccines from four different manufacturers and subsequently licensed two of these COVID-19 vaccines. The independent vaccine safety experts collaborated with federal agencies to ensure timely assessment of vaccine safety data during this time. VaST worked closely with the ACIP COVID-19 Vaccines Work Group; that work group used safety data and VaST's assessments for benefit-risk assessments and guidance for COVID-19 vaccination policy. Safety topics reviewed by VaST included those identified in safety monitoring systems and other topics of scientific or public interest. VaST provided guidance to CDC's COVID-19 vaccine safety monitoring efforts, provided a forum for review of data from several U.S. government vaccine safety systems, and assured that a diverse group of scientists and clinicians, external to the federal government, promptly reviewed vaccine safety data. In the event of a future pandemic or other biological public health emergency, the VaST model could be used to strengthen vaccine safety monitoring, enhance public confidence, and increase transparency through incorporation of independent, non-government safety experts into the monitoring process, and through strong collaboration among federal and other partners.</p>","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11310362/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139716802","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-26DOI: 10.1016/j.vaccine.2024.01.053
Elisha Hall, Barbara E Mahon, Georgina Peacock
{"title":"The U.S. COVID-19 vaccination program: A look back and future directions.","authors":"Elisha Hall, Barbara E Mahon, Georgina Peacock","doi":"10.1016/j.vaccine.2024.01.053","DOIUrl":"https://doi.org/10.1016/j.vaccine.2024.01.053","url":null,"abstract":"","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139571031","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}