A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for the Moderna COVID-19 Vaccine (mRNA-1273)

A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for the Moderna COVID-19 Vaccine (mRNA-1273)

The Brighton Collaboration Benefit-Risk Assessment of VAccines by TechnolOgy (BRAVATO) Working Group has prepared standardized templates to describe the key considerations for the benefit-risk assessment of several vaccine platform technologies, including nucleic acid (RNA and DNA) vaccines. This pa...

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Bibliographic Details
Published in:Vaccine Vol. 40; no. 35; pp. 5275 - 5293
Main Authors: Leav, Brett, Straus, Walter, White, Phil, Leav, Alison, Gaines, Tashawnee, Maggiacomo, Grace, Kim, Denny, Smith, Emily R., Gurwith, Marc, Chen, Robert T.
Format: Journal Article
Language:English
Published: Netherlands Elsevier Ltd 19-08-2022
Elsevier Limited
The Author(s). Published by Elsevier Ltd
Subjects:
2019-nCoV Vaccine mRNA-1273
Acids
Adult
Antigens
Benefit/Risk
Collaboration
Coronaviruses
COVID-19
COVID-19 - prevention & control
COVID-19 vaccines
Disease prevention
DNA vaccines
Drug dosages
Effectiveness
Humans
Immune system
Lipids
mRNA
mRNA Vaccines
Nucleic acids
Pandemics
Pathogens
Proprietary
Proteins
Risk Assessment
Safety
SARS-CoV-2
SARS-CoV-2 - genetics
Severe acute respiratory syndrome coronavirus 2
Vaccine
Vaccines
Vaccines, Synthetic
Vectors (Biology)
Viral diseases
Viral Vaccines
Working groups
COVID-19
SARS-CoV-2
Vaccine
mRNA
Safety
Benefit/Risk
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Description
Summary:The Brighton Collaboration Benefit-Risk Assessment of VAccines by TechnolOgy (BRAVATO) Working Group has prepared standardized templates to describe the key considerations for the benefit-risk assessment of several vaccine platform technologies, including nucleic acid (RNA and DNA) vaccines. This paper uses the BRAVATO template to review the features of a vaccine employing a proprietary mRNA vaccine platform to develop Moderna COVID-19 Vaccine (mRNA-1273); a highly effective vaccine to prevent coronavirus disease 2019 (Covid-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In response to the pandemic the first in human studies began in March 2020 and the pivotal, placebo-controlled phase 3 efficacy study in over 30,000 adults began in July 2020. Based on demonstration of efficacy and safety at the time of interim analysis in November 2020 and at the time of trial unblinding in March 2021, the mRNA-1273 received Emergency Use Authorization in December 2020 and full FDA approval in January 2022.
Bibliography:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
See Acknowledgement for other BRAVATO members.
ISSN:0264-410X
1873-2518
1873-2518
DOI:10.1016/j.vaccine.2022.06.005