A Broad Safety Assessment of the Recombinant Herpes Zoster Vaccine.
data mining
epidemiologic research design
vaccination
vaccines
Journal
American journal of epidemiology
ISSN: 1476-6256
Titre abrégé: Am J Epidemiol
Pays: United States
ID NLM: 7910653
Informations de publication
Date de publication:
24 03 2022
24 03 2022
Historique:
received:
29
07
2021
revised:
25
01
2022
accepted:
08
02
2022
pubmed:
14
2
2022
medline:
10
5
2022
entrez:
13
2
2022
Statut:
ppublish
Résumé
The recombinant herpes zoster vaccine (RZV), approved as a 2-dose series in the United States in October 2017, has proven highly effective and generally safe. However, a small risk of Guillain-Barré syndrome after vaccination was identified after approval, and questions remain about other possible adverse events. This data-mining study assessed RZV safety in the United States using the self-controlled tree-temporal scan statistic, scanning data on thousands of diagnoses recorded during follow-up to detect any statistically unusual temporal clustering of cases within a large hierarchy of diagnoses. IBM MarketScan data on commercially insured persons at least 50 years of age receiving RZV between January 1, 2018, and May 5, 2020, were used, including 56 days of follow-up; 1,014,329 doses were included. Statistically significant clustering was found within a few days of vaccination for unspecified adverse effects, complications, or reactions to immunization or other medical substances/care; fever; unspecified allergy; syncope/collapse; cellulitis; myalgia; and dizziness/giddiness. These findings are consistent with the known safety profile of this and other injected vaccines. No cluster of Guillain-Barré syndrome was detected, possibly due to insufficient sample size. This signal-detection method has now been applied to 5 vaccines, with consistently plausible results, and seems a promising addition to vaccine-safety evaluation methods.
Identifiants
pubmed: 35152283
pii: 6527338
doi: 10.1093/aje/kwac030
pmc: PMC9071519
doi:
Substances chimiques
Herpes Zoster Vaccine
0
Vaccines, Synthetic
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
957-964Informations de copyright
© The Author(s) 2022. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health.
Références
JAMA. 2021 Oct 12;326(14):1390-1399
pubmed: 34477808
Stat Med. 2007 Apr 15;26(8):1824-33
pubmed: 17216592
Neurology. 2013 Sep 3;81(10):928-30
pubmed: 23999562
MMWR Suppl. 2004 Sep 24;53:144-51
pubmed: 15714644
Clin Infect Dis. 2021 Sep 15;73(6):941-948
pubmed: 33580242
MMWR Morb Mortal Wkly Rep. 2020 Jul 03;69(26):815-819
pubmed: 32614808
Vaccine. 2020 Apr 16;38(18):3489-3500
pubmed: 31818534
Pharmaceutics. 2013 Mar 14;5(1):179-200
pubmed: 24300404
Pharmacoepidemiol Drug Saf. 2018 Apr;27(4):391-397
pubmed: 29446176
Vaccine. 2021 Jan 3;39(1):6-10
pubmed: 33277059
Ther Innov Regul Sci. 2021 Jan;55(1):56-64
pubmed: 32572773
BMC Public Health. 2021 May 21;21(1):961
pubmed: 34016076
Pharmacoepidemiol Drug Saf. 2013 May;22(5):517-23
pubmed: 23512870
Am J Epidemiol. 2021 Jul 1;190(7):1253-1259
pubmed: 33558897
MMWR Surveill Summ. 2021 May 14;70(3):1-26
pubmed: 33983910
N Engl J Med. 2015 May 28;372(22):2087-96
pubmed: 25916341
Am J Epidemiol. 2018 Jun 1;187(6):1269-1276
pubmed: 29860470
Emerg Infect Dis. 2021 May;27(5):
pubmed: 33900181
MMWR Morb Mortal Wkly Rep. 2019 Feb 01;68(4):91-94
pubmed: 30703077
PLoS One. 2013;8(1):e54168
pubmed: 23342098
PLoS Negl Trop Dis. 2013 Dec 12;7(12):e2521
pubmed: 24349586
BMC Bioinformatics. 2011 May 26;12:205
pubmed: 21612662
Biometrics. 2007 Mar;63(1):109-18
pubmed: 17447935
Vaccine. 2019 Apr 24;37(18):2482-2493
pubmed: 30935742
Clin Geriatr Med. 2016 Aug;32(3):539-53
pubmed: 27394022
Emerg Infect Dis. 2016 Oct;22(10):1808-12
pubmed: 27648777
JAMA Intern Med. 2021 Dec 1;181(12):1623-1630
pubmed: 34724025
Biometrics. 2003 Jun;59(2):323-31
pubmed: 12926717
Stat Med. 2008 Nov 10;27(25):5111-42
pubmed: 18712778
Am J Epidemiol. 2019 Jul 1;188(7):1383-1388
pubmed: 31062840
Stat Med. 2020 Mar 30;39(7):845-874
pubmed: 31912927