Comparability of clinical trials and spontaneous reporting data regarding COVID-19 vaccine safety.
Journal
Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288
Informations de publication
Date de publication:
29 06 2022
29 06 2022
Historique:
received:
08
02
2022
accepted:
27
05
2022
entrez:
29
6
2022
pubmed:
30
6
2022
medline:
2
7
2022
Statut:
epublish
Résumé
Severe adverse events (AEs) after COVID-19 vaccination are not well studied in randomized controlled trials (RCTs) due to rarity and short follow-up. To monitor the safety of COVID-19 vaccines ("Pfizer" vaccine dose 1 and 2, "Moderna" vaccine dose 1 and 2, and "Janssen" vaccine single dose) in the U.S., especially regarding severe AEs, we compare the relative rankings of these vaccines using both RCT and the Vaccine Adverse Event Reporting System (VAERS) data. The risks of local and systemic AEs were assessed from the three pivotal COVID-19 vaccine trials and also calculated in the VAERS cohort consisting of 559,717 reports between December 14, 2020 and September 17, 2021. AE rankings of the five vaccine groups calculated separately by RCT and VAERS were consistent, especially for systemic AEs. For severe AEs reported in VAERS, the reported risks of thrombosis and GBS after Janssen vaccine were highest. The reported risk of shingles after the first dose of Moderna vaccine was highest, followed by the second dose of the Moderna vaccine. The reported risk of myocarditis was higher after the second dose of Pfizer and Moderna vaccines. The reported risk of anaphylaxis was higher after the first dose of Pfizer vaccine. Limitations of this study are the inherent biases of the spontaneous reporting system data, and only including three pivotal RCTs and no comparison with other active vaccine safety surveillance systems.
Identifiants
pubmed: 35768434
doi: 10.1038/s41598-022-13809-7
pii: 10.1038/s41598-022-13809-7
pmc: PMC9243073
doi:
Substances chimiques
COVID-19 Vaccines
0
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
10946Subventions
Organisme : NIA NIH HHS
ID : R56 AG069880
Pays : United States
Organisme : NIA NIH HHS
ID : R56 AG074604
Pays : United States
Organisme : NIA NIH HHS
ID : R01 AG073435
Pays : United States
Organisme : NLM NIH HHS
ID : R01 LM013519
Pays : United States
Organisme : NIH HHS
ID : 1R01AI130460
Pays : United States
Informations de copyright
© 2022. The Author(s).
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