A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for the Moderna COVID-19 Vaccine (mRNA-1273).
Benefit/Risk
COVID-19
SARS-CoV-2
Safety
Vaccine
mRNA
Journal
Vaccine
ISSN: 1873-2518
Titre abrégé: Vaccine
Pays: Netherlands
ID NLM: 8406899
Informations de publication
Date de publication:
19 08 2022
19 08 2022
Historique:
received:
24
05
2022
accepted:
02
06
2022
pubmed:
27
6
2022
medline:
24
8
2022
entrez:
26
6
2022
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 35753841
pii: S0264-410X(22)00752-6
doi: 10.1016/j.vaccine.2022.06.005
pmc: PMC9181264
pii:
doi:
Substances chimiques
Vaccines, Synthetic
0
Viral Vaccines
0
mRNA Vaccines
0
2019-nCoV Vaccine mRNA-1273
EPK39PL4R4
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, Non-P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
5275-5293Informations de copyright
Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
Références
Vaccine. 2022 Mar 1;40(10):1499-1511
pubmed: 35105494
MMWR Morb Mortal Wkly Rep. 2020 Sep 25;69(38):1347-1354
pubmed: 32970655
Nat Biotechnol. 2013 Jul;31(7):638-46
pubmed: 23792630
Science. 2022 Jan 07;375(6576):43-50
pubmed: 34812653
Vaccine. 2020 Jul 22;38(34):5556-5561
pubmed: 32571717
Vaccine. 2021 May 12;39(20):2791-2799
pubmed: 33707061
Science. 2020 Mar 13;367(6483):1260-1263
pubmed: 32075877
Immunity. 2005 Aug;23(2):165-75
pubmed: 16111635
Proc Natl Acad Sci U S A. 2017 Aug 29;114(35):E7348-E7357
pubmed: 28807998
Vaccine. 2015 Aug 26;33(36):4398-405
pubmed: 26209838
JAMA. 2021 Oct 12;326(14):1390-1399
pubmed: 34477808
N Engl J Med. 2020 Oct 15;383(16):1544-1555
pubmed: 32722908
Nat Commun. 2021 Jan 11;12(1):267
pubmed: 33431879
Arch Pathol Lab Med. 2020 Dec 1;144(12):1465-1474
pubmed: 32818235
Nano Today. 2021 Jun;38:101142
pubmed: 33815564
Mol Ther Nucleic Acids. 2019 Apr 15;15:1-11
pubmed: 30785039
Nature. 2020 Oct;586(7830):567-571
pubmed: 32756549
N Engl J Med. 2020 Nov 12;383(20):1920-1931
pubmed: 32663912
Nat Rev Immunol. 2012 Jun 22;12(7):479-91
pubmed: 22728526
JAMA Netw Open. 2021 Feb 1;4(2):e2037069
pubmed: 33533933
Lancet HIV. 2021 Jan;8(1):e24-e32
pubmed: 33316211
MMWR Morb Mortal Wkly Rep. 2021 Jul 09;70(27):977-982
pubmed: 34237049
Clin Infect Dis. 2020 Dec 31;71(11):2933-2938
pubmed: 32594164
MMWR Morb Mortal Wkly Rep. 2021 Jan 29;70(4):125-129
pubmed: 33507892
Clin Infect Dis. 2020 Nov 19;71(16):2276-2278
pubmed: 32407467
J Biol Chem. 1991 Oct 25;266(30):19867-70
pubmed: 1939050
J Infect Dis. 2020 May 11;221(11):1757-1761
pubmed: 32067043
J Control Release. 2021 May 10;333:511-520
pubmed: 33798667
Vaccine. 2002 Dec 13;21(3-4):298-302
pubmed: 12450705
Front Chem. 2020 Oct 23;8:589959
pubmed: 33195094
J Infect Dis. 2021 Jan 4;223(1):15-18
pubmed: 33020822
N Engl J Med. 2022 Mar 17;386(11):1088-1091
pubmed: 35081298
Mol Ther. 2018 Jun 6;26(6):1509-1519
pubmed: 29653760
JAMA Cardiol. 2021 Oct 1;6(10):1202-1206
pubmed: 34185045
Biomater Sci. 2021 Feb 21;9(4):1449-1463
pubmed: 33404020
N Engl J Med. 2022 Mar 17;386(11):1046-1057
pubmed: 35081293
Sci Adv. 2021 Feb 26;7(9):
pubmed: 33637537
J Virol. 2021 Nov 9;95(23):e0131321
pubmed: 34549975
N Engl J Med. 2021 Jun 17;384(24):2273-2282
pubmed: 33882218
Ther Deliv. 2016;7(5):319-34
pubmed: 27075952
Immunity. 2021 Aug 10;54(8):1869-1882.e6
pubmed: 34270939
J Gen Virol. 2005 May;86(Pt 5):1239-1249
pubmed: 15831934
AIDS. 2020 Oct 1;34(12):1775-1780
pubmed: 32773471
Lancet HIV. 2020 May;7(5):e314-e316
pubmed: 32304642
Cell. 2021 Mar 18;184(6):1589-1603
pubmed: 33740454
N Engl J Med. 2021 Feb 4;384(5):403-416
pubmed: 33378609
N Engl J Med. 2021 Jun 10;384(23):2259-2261
pubmed: 33822494
Mol Ther. 2017 Jul 5;25(7):1467-1475
pubmed: 28412170
Vaccine. 2015 Jan 1;33(1):73-5
pubmed: 25305565
J Control Release. 2005 Oct 3;107(2):276-87
pubmed: 16054724
Nucleic Acids Res. 1999 Jan 1;27(1):196-7
pubmed: 9847178
Nat Rev Drug Discov. 2018 Apr;17(4):261-279
pubmed: 29326426
Clin Infect Dis. 2021 May 4;72(9):e291-e295
pubmed: 32965474
Nat Med. 2021 Jul;27(7):1205-1211
pubmed: 34002089
N Engl J Med. 2020 Dec 17;383(25):2427-2438
pubmed: 32991794
Nat Rev Drug Discov. 2021 Nov;20(11):817-838
pubmed: 34433919
N Engl J Med. 2021 Nov 4;385(19):1774-1785
pubmed: 34551225
JAMA. 2020 Nov 3;324(17):1782-1785
pubmed: 32965467
N Engl J Med. 2021 Mar 17;384(15):1468-1470
pubmed: 33730471
Ann Intern Med. 2020 May 05;172(9):577-582
pubmed: 32150748
N Engl J Med. 2021 Dec 9;385(24):2241-2251
pubmed: 34379915
Ann Intern Med. 2021 Sep;174(9):1330-1332
pubmed: 34125572
Toxicol Rep. 2021;8:871-879
pubmed: 33898273
Nat Mater. 2021 May;20(5):701-710
pubmed: 33542471
Nat Rev Cardiol. 2021 Mar;18(3):169-193
pubmed: 33046850
MMWR Morb Mortal Wkly Rep. 2020 Jun 19;69(24):759-765
pubmed: 32555134
Mol Pharm. 2021 Jan 4;18(1):377-385
pubmed: 33295773
Nat Med. 2022 May;28(5):1042-1049
pubmed: 35241844
Ann Intern Med. 2020 Oct 6;173(7):536-541
pubmed: 32589451