Near real-time surveillance of safety outcomes in US COVID-19 vaccine recipients aged 12 to 64 years.

Autor: Lloyd PC; US Food and Drug Administration, Silver Spring, MD, USA., Hu M; Acumen LLC, Burlingame, CA, USA., Wong HL; US Food and Drug Administration, Silver Spring, MD, USA., Shoaibi A; US Food and Drug Administration, Silver Spring, MD, USA., Ke Zhou C; US Food and Drug Administration, Silver Spring, MD, USA., Lo AC; Acumen LLC, Burlingame, CA, USA., Amend K; Optum Epidemiology, Boston, MA, USA., Beachler DC; HealthCore, Inc, Wilmington, DE, USA., McMahill-Walraven CN; CVS Health Clinical Trial Services, Blue Bell, PA , USA., Smith ER; Acumen LLC, Burlingame, CA, USA., Seeger J; Optum Epidemiology, Boston, MA, USA., Secora A; IQVIA, Falls Church, VA, USA., Audrey Djibo D; CVS Health Clinical Trial Services, Blue Bell, PA , USA., Obidi J; US Food and Drug Administration, Silver Spring, MD, USA., Feng Y; Acumen LLC, Burlingame, CA, USA., Song J; Optum Epidemiology, Boston, MA, USA., Reich C; IQVIA, Falls Church, VA, USA., Harris C; CVS Health Clinical Trial Services, Blue Bell, PA , USA., Akhtar S; Acumen LLC, Burlingame, CA, USA., Clifford R; Optum Epidemiology, Boston, MA, USA., Selvam N; IQVIA, Falls Church, VA, USA., Pigoga JL; CVS Health Clinical Trial Services, Blue Bell, PA , USA., Jiao Y; Acumen LLC, Burlingame, CA, USA., Chillarige Y; Acumen LLC, Burlingame, CA, USA., MaCurdy T; Acumen LLC, Burlingame, CA, USA., Forshee R; US Food and Drug Administration, Silver Spring, MD, USA., Anderson SA; US Food and Drug Administration, Silver Spring, MD, USA. Electronic address: steven.anderson@fda.hhs.gov.
Jazyk: angličtina
Zdroj: Vaccine [Vaccine] 2022 Oct 26; Vol. 40 (45), pp. 6481-6488. Date of Electronic Publication: 2022 Sep 27.
DOI: 10.1016/j.vaccine.2022.09.060
Abstrakt: Background: Active monitoring of safety outcomes following COVID-19 vaccination is critical to understand vaccine safety and can provide early detection of rare outcomes not identified in pre-licensure trials. We present findings from an early warning rapid surveillance system in three large commercial insurance databases including more than 16 million vaccinated individuals.
Methods: We evaluated 17 outcomes of interest following COVID-19 vaccination among individuals aged 12-64 years in Optum, HealthCore, and CVS Health databases from December 11, 2020, through January 22, 2022, January 7, 2022, and December 31, 2021, respectively. We conducted biweekly or monthly sequential testing and generated rate ratios (RR) of observed outcome rates compared to historical (or expected) rates prior to COVID-19 vaccination.
Findings: Among 17 outcomes evaluated, 15 did not meet the threshold for statistical signal in any of the three databases. Myocarditis/pericarditis met the statistical threshold for a signal following BNT162b2 in two of three databases (RRs: 1.83-2.47). Anaphylaxis met the statistical threshold for a signal in all three databases following BNT162b2 vaccination (RRs: 4.48-10.86) and mRNA-1273 vaccination (RRs: 7.64-12.40).
Discussion: Consistent with published literature, our near-real time monitoring of 17 adverse outcomes following COVID-19 vaccinations identified signals for myocarditis/pericarditis and anaphylaxis following mRNA COVID-19 vaccinations. The method is intended for early detection of safety signals, and results do not imply a causal effect. Results of this study should be interpreted in the context of the method's utility and limitations, and the validity of detected signals must be evaluated in fully adjusted epidemiologic studies.
Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: John Seeger reports a relationship with Optum Inc that includes: employment and equity or stocks. Kandace Amend reports a relationship with Optum Inc that includes: employment and equity or stocks. Jennifer Song reports a relationship with Optum Inc that includes: employment and equity or stocks. Robin Clifford reports a relationship with Optum Inc that includes: equity or stocks. Cheryl N. McMahill-Walraven reports a relationship with CVS Health Clinical Trial Services LLS that includes: employment. Djenaba Audrey Djibo reports a relationship with CVS Health Clinical Trial Services LLS that includes: employment. Charlalynn Harris reports a relationship with CVS Health Clinical Trial Services LLS that includes: employment. Jennifer L. Pigoga reports a relationship with CVS Health Clinical Trial Services LLS that includes: employment.
(Published by Elsevier Ltd.)
Databáze: MEDLINE
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