PMID- 35002372
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231105
IS  - 1319-0164 (Print)
IS  - 2213-7475 (Electronic)
IS  - 1319-0164 (Linking)
VI  - 30
IP  - 2
DP  - 2022 Feb
TI  - Analyzing the U.S. Post-marketing safety surveillance of COVID-19 vaccines.
PG  - 180-184
LID - 10.1016/j.jsps.2021.12.008 [doi]
AB  - 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.
CI  - (c) 2021 The Author(s).
FAU - Albalawi, Omar M
AU  - Albalawi OM
AD  - Research and Studies, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
FAU - Alomran, Maha I
AU  - Alomran MI
AD  - Research and Studies, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
FAU - Alsagri, Ghada M
AU  - Alsagri GM
AD  - Research and Studies, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
FAU - Althunian, Turki A
AU  - Althunian TA
AD  - Research and Studies, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
FAU - Alshammari, Thamir M
AU  - Alshammari TM
AD  - Research and Studies, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
AD  - College of Pharmacy, Riyadh Elm University, Riyadh, Saudi Arabia.
AD  - Medication Safety Research Chair, King Saud University, Riyadh, Saudi Arabia.
LA  - eng
PT  - Journal Article
DEP - 20211231
PL  - Saudi Arabia
TA  - Saudi Pharm J
JT  - Saudi pharmaceutical journal : SPJ : the official publication of the Saudi 
      Pharmaceutical Society
JID - 9705695
PMC - PMC8719360
OTO - NOTNLM
OT  - Adverse events following immunization
OT  - COVID-19
OT  - Janssen Ad26.COV2.S
OT  - Moderna
OT  - Pfizer-BioNTech
OT  - Vaccine safety
COIS- The authors declare that they have no known competing financial interests or 
      personal relationships that could have appeared to influence the work reported in 
      this paper.
EDAT- 2022/01/11 06:00
MHDA- 2022/01/11 06:01
PMCR- 2021/12/31
CRDT- 2022/01/10 09:05
PHST- 2021/08/04 00:00 [received]
PHST- 2021/12/27 00:00 [accepted]
PHST- 2022/01/11 06:00 [pubmed]
PHST- 2022/01/11 06:01 [medline]
PHST- 2022/01/10 09:05 [entrez]
PHST- 2021/12/31 00:00 [pmc-release]
AID - S1319-0164(21)00257-7 [pii]
AID - 10.1016/j.jsps.2021.12.008 [doi]
PST - ppublish
SO  - Saudi Pharm J. 2022 Feb;30(2):180-184. doi: 10.1016/j.jsps.2021.12.008. Epub 2021 
      Dec 31.