Analyzing the U.S. Post-marketing safety surveillance of COVID-19 vaccines

  

View ORCID ProfileOmar M. Albalawi, Maha I. Alomran, Ghada M. Alsagri,  View ORCID ProfileTurki A. Althunian,  View ORCID ProfileThamir M. Alshammari

doi: https://doi.org/10.1101/2021.07.10.21260304

This article is a preprint and has not been peer-reviewed [what does this mean?]. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.

PDF: https://www.medrxiv.org/content/10.1101/2021.07.10.21260304v1.full.pdf

Abstract

Background Since December 2020, three COVID-19 vaccines have been authorized in the United States (U.S.) and were proceeded by large immunization programs. The aim of this study was to characterize the U.S. post-marketing safety (PMS) profiles of these vaccines with an in-depth analysis of mortality data.

Methods This was a retrospective database analysis study. Details of the U.S. PMS reports (15 December 2020 to 19 March 2021) of the three vaccines (Pfizer-BioNTech, Moderna, and Janssen Ad26.COV2.S) were retrieved from the U.S. Vaccine Adverse Event Reporting System (VAERS). A descriptive analysis was conducted to characterize the reported adverse events (AEs). A comparative (Pfizer-BioNTech vs. Moderna) analysis of mortality was conducted. The mean count ratio of death between the two vaccines was estimated using a negative binomial regression model adjusting for the measured confounders.

Results A total of 44,451 AE reports were retrieved (corresponding to 0.05% of the U.S. population who received at least one dose). The most commonly reported AEs were injection site reactions (30.4% of the reports), pain (reported in 26.7% of the reports), and headache (18.6% of the reports). Serious AEs were reported in only 14.6% of the reports with 4,108 hospitalizations. The total number of deaths was 1,919 with a mean count ratio of Moderna (n=997) vs. Pfizer-BioNTech (n=899) of 1.07 (95% confidence interval 0.86 to 1.33).

Conclusions The vast majority of PMS AEs in the U.S. were non-serious, and the number of serious AEs is very low given the total number of vaccinated U.S. population.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

No funding was allocated for this study.

https://www.medrxiv.org/content/10.1101/2021.07.10.21260304v1