Safety, efficacy, and immunogenicity of the NVX-CoV2373 vaccine
Introduction The coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has resulted in significant morbidity and mortality worldwide. As SARS-CoV-2 moves into endemic status, vaccination remains a key element in protecting the health of...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2023-12-01
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| Series: | Expert Review of Vaccines |
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| Online Access: | http://dx.doi.org/10.1080/14760584.2023.2218913 |
| _version_ | 1797680360204533760 |
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| author | Eddie Underwood Lisa M. Dunkle Shabir A. Madhi Cynthia L. Gay Paul T. Heath Karen L. Kotloff Katherine Smith Gordon Chau Shirley Galbiati Alice McGarry Wayne Woo Iksung Cho Katia Alves Germán Áñez Chijioke Bennett Vivek Shinde Louis Fries Raburn M. Mallory Gregory M. Glenn Seth Toback |
| author_facet | Eddie Underwood Lisa M. Dunkle Shabir A. Madhi Cynthia L. Gay Paul T. Heath Karen L. Kotloff Katherine Smith Gordon Chau Shirley Galbiati Alice McGarry Wayne Woo Iksung Cho Katia Alves Germán Áñez Chijioke Bennett Vivek Shinde Louis Fries Raburn M. Mallory Gregory M. Glenn Seth Toback |
| author_sort | Eddie Underwood |
| collection | DOAJ |
| description | Introduction The coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has resulted in significant morbidity and mortality worldwide. As SARS-CoV-2 moves into endemic status, vaccination remains a key element in protecting the health of individuals, societies, and economies worldwide. Areas covered NVX-CoV2373 (Novavax, Gaithersburg, MD) is a recombinant protein vaccine composed of SARS-CoV-2 spike trimer nanoparticles formulated with saponin-based Matrix-M™ adjuvant (Novavax, Gaithersburg, MD). NVX-CoV2373 is authorized for emergency use in adults and adolescents aged ≥12 years in the United States and numerous other countries. Expert opinion In clinical trials, NVX-CoV2373 showed tolerable reactogenicity and favorable safety profiles characterized by mostly mild-to-moderate adverse events of short duration and by low rates of severe and serious adverse events comparable to those seen with placebo. The two-dose primary vaccination series resulted in robust increases in anti-spike protein immunoglobulin G, neutralizing antibody titers, and cellular immune responses. NVX-CoV2373 vaccination was associated with complete protection against severe disease and a high (90%) rate of protection against symptomatic disease in adults, including symptomatic disease caused by SARS-CoV-2 variants. Additionally, the NVX-CoV2373 adjuvanted recombinant protein platform offers a means to address issues of COVID-19 vaccination hesitancy and global vaccine equity. |
| first_indexed | 2024-03-11T23:28:52Z |
| format | Article |
| id | doaj.art-63a46f7f41f7419791219c14242672d7 |
| institution | Directory Open Access Journal |
| issn | 1476-0584 1744-8395 |
| language | English |
| last_indexed | 2024-03-11T23:28:52Z |
| publishDate | 2023-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Expert Review of Vaccines |
| spelling | doaj.art-63a46f7f41f7419791219c14242672d72023-09-20T10:33:44ZengTaylor & Francis GroupExpert Review of Vaccines1476-05841744-83952023-12-0122150151710.1080/14760584.2023.22189132218913Safety, efficacy, and immunogenicity of the NVX-CoV2373 vaccineEddie Underwood0Lisa M. Dunkle1Shabir A. Madhi2Cynthia L. Gay3Paul T. Heath4Karen L. Kotloff5Katherine Smith6Gordon Chau7Shirley Galbiati8Alice McGarry9Wayne Woo10Iksung Cho11Katia Alves12Germán Áñez13Chijioke Bennett14Vivek Shinde15Louis Fries16Raburn M. Mallory17Gregory M. Glenn18Seth Toback19Novavax, IncNovavax, IncUniversity of the WitwatersrandUniversity of North Carolina School of MedicineUniversity of London and St George’s University Hospitals NHS; Foundation TrustUniversity of Maryland School of MedicineNovavax, IncNovavax, IncNovavax, IncNovavax, IncNovavax, IncNovavax, IncNovavax, IncNovavax, IncNovavax, IncNovavax, IncNovavax, IncNovavax, IncNovavax, IncNovavax, IncIntroduction The coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has resulted in significant morbidity and mortality worldwide. As SARS-CoV-2 moves into endemic status, vaccination remains a key element in protecting the health of individuals, societies, and economies worldwide. Areas covered NVX-CoV2373 (Novavax, Gaithersburg, MD) is a recombinant protein vaccine composed of SARS-CoV-2 spike trimer nanoparticles formulated with saponin-based Matrix-M™ adjuvant (Novavax, Gaithersburg, MD). NVX-CoV2373 is authorized for emergency use in adults and adolescents aged ≥12 years in the United States and numerous other countries. Expert opinion In clinical trials, NVX-CoV2373 showed tolerable reactogenicity and favorable safety profiles characterized by mostly mild-to-moderate adverse events of short duration and by low rates of severe and serious adverse events comparable to those seen with placebo. The two-dose primary vaccination series resulted in robust increases in anti-spike protein immunoglobulin G, neutralizing antibody titers, and cellular immune responses. NVX-CoV2373 vaccination was associated with complete protection against severe disease and a high (90%) rate of protection against symptomatic disease in adults, including symptomatic disease caused by SARS-CoV-2 variants. Additionally, the NVX-CoV2373 adjuvanted recombinant protein platform offers a means to address issues of COVID-19 vaccination hesitancy and global vaccine equity.http://dx.doi.org/10.1080/14760584.2023.2218913clinical trialcoronaviruscovid-19, matrix-m adjuvantpreventionprotein-based vaccinesars-cov-2vaccinationnvx-cov2373 |
| spellingShingle | Eddie Underwood Lisa M. Dunkle Shabir A. Madhi Cynthia L. Gay Paul T. Heath Karen L. Kotloff Katherine Smith Gordon Chau Shirley Galbiati Alice McGarry Wayne Woo Iksung Cho Katia Alves Germán Áñez Chijioke Bennett Vivek Shinde Louis Fries Raburn M. Mallory Gregory M. Glenn Seth Toback Safety, efficacy, and immunogenicity of the NVX-CoV2373 vaccine Expert Review of Vaccines clinical trial coronavirus covid-19, matrix-m adjuvant prevention protein-based vaccine sars-cov-2 vaccination nvx-cov2373 |
| title | Safety, efficacy, and immunogenicity of the NVX-CoV2373 vaccine |
| title_full | Safety, efficacy, and immunogenicity of the NVX-CoV2373 vaccine |
| title_fullStr | Safety, efficacy, and immunogenicity of the NVX-CoV2373 vaccine |
| title_full_unstemmed | Safety, efficacy, and immunogenicity of the NVX-CoV2373 vaccine |
| title_short | Safety, efficacy, and immunogenicity of the NVX-CoV2373 vaccine |
| title_sort | safety efficacy and immunogenicity of the nvx cov2373 vaccine |
| topic | clinical trial coronavirus covid-19, matrix-m adjuvant prevention protein-based vaccine sars-cov-2 vaccination nvx-cov2373 |
| url | http://dx.doi.org/10.1080/14760584.2023.2218913 |
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