Safety and Efficacy of the NVX-CoV2373 Coronavirus Disease 2019 Vaccine at Completion of the Placebo-Controlled Phase of a Randomized Controlled Trial Article Swipe
Paul T. Heath
,
Eva Galiza
,
D. N. Baxter
,
Marta Boffito
,
Duncan L. Browne
,
Fiona Burns
,
David Chadwick
,
Rebecca A. Clark
,
Catherine A. Cosgrove
,
James Galloway
,
Anna L. Goodman
,
Amardeep Heer
,
Andrew Higham
,
Shalini Iyengar
,
Christopher Jeanes
,
Philip A. Kalra
,
Christina Kyriakidou
,
Judy Bradley
,
Chigomezgo Munthali
,
Angela M. Minassian
,
Fiona McGill
,
Patrick Moore
,
Imrozia Munsoor
,
Helen Nicholls
,
Orod Osanlou
,
Jonathan Packham
,
Carol Pretswell
,
Alberto San Francisco Ramos
,
Dinesh Saralaya
,
Ray Sheridan
,
Richard Smith
,
Roy L. Soiza
,
Pauline A. Swift
,
Emma C. Thomson
,
Jeremy Turner
,
Marianne Elizabeth Viljoen
,
Louis Fries
,
Iksung Cho
,
Irene McKnight
,
Greg Glenn
,
Elizabeth Rivers
,
Andreana Robertson
,
Katia Alves
,
Kathy Smith
,
Seth Toback
·
YOU?
·
· 2022
· Open Access
·
· DOI: https://doi.org/10.1093/cid/ciac803
YOU?
·
· 2022
· Open Access
·
· DOI: https://doi.org/10.1093/cid/ciac803
Background The recombinant protein-based vaccine, NVX-CoV2373, demonstrated 89.7% efficacy against coronavirus disease 2019 (COVID-19) in a phase 3, randomized, observer-blinded, placebo-controlled trial in the United Kingdom. The protocol was amended to include a blinded crossover. Data to the end of the placebo-controlled phase are reported. Methods Adults aged 18–84 years received 2 doses of NVX-CoV2373 or placebo (1:1) and were monitored for virologically confirmed mild, moderate, or severe COVID-19 (onset from 7 days after second vaccination). Participants who developed immunoglobulin G (IgG) against nucleocapsid protein but did not show symptomatic COVID-19 were considered asymptomatic. Secondary outcomes included anti-spike (S) IgG responses, wild-type virus neutralization, and T-cell responses. Results Of 15 185 participants, 13 989 remained in the per-protocol efficacy population (6989 NVX-CoV2373, 7000 placebo). At a maximum of 7.5 months (median, 4.5) postvaccination, there were 24 cases of COVID-19 among NVX-CoV2373 recipients and 134 cases among placebo recipients, a vaccine efficacy of 82.7% (95% confidence interval [CI], 73.3%–88.8%). Vaccine efficacy was 100% (95% CI, 17.9%–100.0%) against severe disease and 76.3% (95% CI, 57.4%–86.8%) against asymptomatic disease. High anti-S and neutralization responses to vaccination were evident, together with S-protein–specific induction of interferon-γ secretion in peripheral blood T cells. Incidence of serious adverse events and adverse events of special interest were similar between groups. Conclusions A 2-dose regimen of NVX-CoV2373 conferred a high level of ongoing protection against asymptomatic, symptomatic, and severe COVID-19 through >6 months postvaccination. A gradual decrease of protection suggests that a booster may be indicated. Clinical Trials Registration EudraCT, 2020-004123-16.
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1093/cid/ciac803
- https://academic.oup.com/cid/article-pdf/76/3/398/49125106/ciac803.pdf
- OA Status
- bronze
- Cited By
- 70
- References
- 28
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4303982806
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4303982806Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1093/cid/ciac803Digital Object Identifier
- Title
-
Safety and Efficacy of the NVX-CoV2373 Coronavirus Disease 2019 Vaccine at Completion of the Placebo-Controlled Phase of a Randomized Controlled TrialWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2022Year of publication
- Publication date
-
2022-10-10Full publication date if available
- Authors
-
Paul T. Heath, Eva Galiza, D. N. Baxter, Marta Boffito, Duncan L. Browne, Fiona Burns, David Chadwick, Rebecca A. Clark, Catherine A. Cosgrove, James Galloway, Anna L. Goodman, Amardeep Heer, Andrew Higham, Shalini Iyengar, Christopher Jeanes, Philip A. Kalra, Christina Kyriakidou, Judy Bradley, Chigomezgo Munthali, Angela M. Minassian, Fiona McGill, Patrick Moore, Imrozia Munsoor, Helen Nicholls, Orod Osanlou, Jonathan Packham, Carol Pretswell, Alberto San Francisco Ramos, Dinesh Saralaya, Ray Sheridan, Richard Smith, Roy L. Soiza, Pauline A. Swift, Emma C. Thomson, Jeremy Turner, Marianne Elizabeth Viljoen, Louis Fries, Iksung Cho, Irene McKnight, Greg Glenn, Elizabeth Rivers, Andreana Robertson, Katia Alves, Kathy Smith, Seth TobackList of authors in order
- Landing page
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https://doi.org/10.1093/cid/ciac803Publisher landing page
- PDF URL
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https://academic.oup.com/cid/article-pdf/76/3/398/49125106/ciac803.pdfDirect link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
-
bronzeOpen access status per OpenAlex
- OA URL
-
https://academic.oup.com/cid/article-pdf/76/3/398/49125106/ciac803.pdfDirect OA link when available
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Medicine, Placebo, Asymptomatic, Adverse effect, Internal medicine, Vaccination, Randomized controlled trial, Regimen, Population, Immunology, Vaccine efficacy, Pathology, Alternative medicine, Environmental healthTop concepts (fields/topics) attached by OpenAlex
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70Total citation count in OpenAlex
- Citations by year (recent)
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2025: 22, 2024: 25, 2023: 22, 2022: 1Per-year citation counts (last 5 years)
- References (count)
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28Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.COVID-19 | 69, 91, 139, 231 |
| abstract_inverted_index.Clinical | 248 |
| abstract_inverted_index.EudraCT, | 251 |
| abstract_inverted_index.Kingdom. | 26 |
| abstract_inverted_index.decrease | 238 |
| abstract_inverted_index.disease. | 176 |
| abstract_inverted_index.efficacy | 9, 119, 151, 160 |
| abstract_inverted_index.evident, | 185 |
| abstract_inverted_index.included | 97 |
| abstract_inverted_index.interest | 208 |
| abstract_inverted_index.interval | 156 |
| abstract_inverted_index.outcomes | 96 |
| abstract_inverted_index.protocol | 28 |
| abstract_inverted_index.received | 51 |
| abstract_inverted_index.remained | 115 |
| abstract_inverted_index.suggests | 241 |
| abstract_inverted_index.together | 186 |
| abstract_inverted_index.vaccine, | 5 |
| abstract_inverted_index.>6 | 233 |
| abstract_inverted_index.Incidence | 198 |
| abstract_inverted_index.Secondary | 95 |
| abstract_inverted_index.conferred | 219 |
| abstract_inverted_index.confirmed | 64 |
| abstract_inverted_index.developed | 79 |
| abstract_inverted_index.induction | 189 |
| abstract_inverted_index.moderate, | 66 |
| abstract_inverted_index.monitored | 61 |
| abstract_inverted_index.placebo). | 124 |
| abstract_inverted_index.reported. | 45 |
| abstract_inverted_index.responses | 181 |
| abstract_inverted_index.secretion | 192 |
| abstract_inverted_index.wild-type | 102 |
| abstract_inverted_index.(COVID-19) | 14 |
| abstract_inverted_index.Background | 1 |
| abstract_inverted_index.anti-spike | 98 |
| abstract_inverted_index.confidence | 155 |
| abstract_inverted_index.considered | 93 |
| abstract_inverted_index.crossover. | 35 |
| abstract_inverted_index.indicated. | 247 |
| abstract_inverted_index.peripheral | 194 |
| abstract_inverted_index.population | 120 |
| abstract_inverted_index.protection | 225, 240 |
| abstract_inverted_index.recipients | 142 |
| abstract_inverted_index.responses, | 101 |
| abstract_inverted_index.responses. | 107 |
| abstract_inverted_index.Conclusions | 213 |
| abstract_inverted_index.NVX-CoV2373 | 55, 141, 218 |
| abstract_inverted_index.coronavirus | 11 |
| abstract_inverted_index.randomized, | 19 |
| abstract_inverted_index.recipients, | 148 |
| abstract_inverted_index.recombinant | 3 |
| abstract_inverted_index.symptomatic | 90 |
| abstract_inverted_index.vaccination | 183 |
| abstract_inverted_index.NVX-CoV2373, | 6, 122 |
| abstract_inverted_index.Participants | 77 |
| abstract_inverted_index.Registration | 250 |
| abstract_inverted_index.asymptomatic | 175 |
| abstract_inverted_index.demonstrated | 7 |
| abstract_inverted_index.nucleocapsid | 84 |
| abstract_inverted_index.per-protocol | 118 |
| abstract_inverted_index.symptomatic, | 228 |
| abstract_inverted_index.asymptomatic, | 227 |
| abstract_inverted_index.asymptomatic. | 94 |
| abstract_inverted_index.interferon-γ | 191 |
| abstract_inverted_index.participants, | 112 |
| abstract_inverted_index.protein-based | 4 |
| abstract_inverted_index.vaccination). | 76 |
| abstract_inverted_index.virologically | 63 |
| abstract_inverted_index.57.4%–86.8%) | 173 |
| abstract_inverted_index.immunoglobulin | 80 |
| abstract_inverted_index.neutralization | 180 |
| abstract_inverted_index.17.9%–100.0%) | 165 |
| abstract_inverted_index.2020-004123-16. | 252 |
| abstract_inverted_index.73.3%–88.8%). | 158 |
| abstract_inverted_index.neutralization, | 104 |
| abstract_inverted_index.postvaccination, | 133 |
| abstract_inverted_index.postvaccination. | 235 |
| abstract_inverted_index.observer-blinded, | 20 |
| abstract_inverted_index.placebo-controlled | 21, 42 |
| abstract_inverted_index.S-protein–specific | 188 |
| cited_by_percentile_year.max | 100 |
| cited_by_percentile_year.min | 89 |
| corresponding_author_ids | https://openalex.org/A5017567807 |
| countries_distinct_count | 2 |
| institutions_distinct_count | 45 |
| corresponding_institution_ids | https://openalex.org/I4210100774 |
| sustainable_development_goals[0].id | https://metadata.un.org/sdg/3 |
| sustainable_development_goals[0].score | 0.800000011920929 |
| sustainable_development_goals[0].display_name | Good health and well-being |
| citation_normalized_percentile.value | 0.98178539 |
| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | True |