Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults

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Harold Saive

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Sep 2, 2022, 2:16:10 PMSep 2
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Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults

https://www.sciencedirect.com/science/article/pii/S0264410X22010283

Author links open overlay panelJosephFraimanaJuanErvitibMarkJonescSanderGreenlanddPatrickWhelaneRobert M.KaplanfPeterDoshig
a
Thibodaux Regional Health System, Thibodaux, LA, USA
b
Unit of Innovation and Organization, Navarre Health Service, Spain
c
Institute of Evidence-Based Healthcare, Bond University, Gold Coast, QLD, Australia
d
Fielding School of Public Health and College of Letters and Science, University of California, Los Angeles, CA, USA
e
Geffen School of Medicine, University of California, Los Angeles, CA, USA
f
Clinical Excellence Research Center, School of Medicine, Stanford University, CA, USA
g
School of Pharmacy, University of Maryland, Baltimore, MD, USA

Received 31 May 2022, Revised 21 July 2022, Accepted 1 August 2022, Available online 31 August 2022.

Key portion:

“Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI −0.4 to 20.6 and −3.6 to 33.8), respectively. Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9); risk ratio 1.43 (95 % CI 1.07 to 1.92). The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group; risk difference 18.0 per 10,000 vaccinated (95 % CI 1.2 to 34.9); risk ratio 1.36 (95 % CI 1.02 to 1.83). The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI –23.2 to 37.4); risk ratio 1.06 (95 % CI 0.84 to 1.33). Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI −3.2 to 29.6); risk ratio 1.16 (95 % CI 0.97 to 1.39).”

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