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

• Main Authors: Omar M. Albalawi (Author), Maha I. Alomran (Author), Ghada M. Alsagri (Author), Turki A. Althunian (Author), Thamir M. Alshammari (Author)
• Format: Book
• Published: Elsevier, 2022-02-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.
• Notes: 1319-0164; 10.1016/j.jsps.2021.12.008
• Keywords: Adverse events following immunization; COVID-19; Vaccine safety; Pfizer-BioNTech; Moderna; Janssen Ad26.COV2.S; Therapeutics. Pharmacology; RM1-950
• Source: Saudi Pharmaceutical Journal, Vol 30, Iss 2, Pp 180-184 (2022)

Introduction: 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.