PMID- 37891051
OWN - NLM
STAT- MEDLINE
DCOM- 20231103
LR  - 20231103
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 41
IP  - 47
DP  - 2023 Nov 13
TI  - Background rates for severe cutaneous reactions in the US: Contextual support for 
      safety assessment of COVID-19 vaccines and novel biologics.
PG  - 6922-6929
LID - S0264-410X(23)01208-2 [pii]
LID - 10.1016/j.vaccine.2023.10.025 [doi]
AB  - The global COVID-19 public health crisis has resulted in extraordinary 
      collaboration to expeditiously develop vaccines and therapeutics. The safety of 
      these biologics is closely monitored by the US Food and Drug Administration (FDA) 
      and the Centers for Disease Control and Prevention (CDC). Novel products may have 
      limited safety data, and although serious medical outcomes associated with 
      vaccination are rare, knowledge of background incidence rates of medical 
      conditions in the US population puts reported adverse events (AEs) in perspective 
      for further study. Although relatively minor vaccination skin reactions are 
      common, rare instances of severe delayed hypersensitivity reactions such as 
      erythema multiforme (EM), Stevens-Johnson syndrome (SJS), toxic epidermal 
      necrolysis (TEN), and SJS/TEN overlap syndrome may occur. To aid in the 
      assessment of these events, we performed a literature search in PubMed and Web of 
      Science on the background incidence of EM, SJS, SJS/TEN, and TEN in the US 
      population and on published reports of these conditions occurring 
      post-vaccination. The US background annual incidence rates per million 
      individuals of all ages ranged from 5.3 to 63.0 for SJS, from 0.4 to 5.0 for TEN, 
      and from 0.8 to 1.6 for SJS/TEN. Since these conditions may overlap, some studies 
      reported rates for EM/SJS/TEN combined, however we did not find studies with 
      exclusive EM incidence rates. The published literature, including studies of 
      reports submitted to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS), 
      describes post-vaccination EM, SJS, SJS/TEN and/or TEN as rare occurrences. The 
      vaccines most frequently associated with these conditions were measles, mumps, 
      and rubella; diphtheria, tetanus, and pertussis; and varicella. The majority of 
      VAERS reports of EM, SJS, SJS/TEN, or TEN occurred in children within 30 days of 
      vaccination. This review summarizes background rates of these disorders in the 
      general population and published AEs among vaccine recipients, to support safety 
      surveillance of COVID-19 vaccines and other biologics.
CI  - Published by Elsevier Ltd.
FAU - Gubernot, Diane
AU  - Gubernot D
AD  - U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, 
      10903 New Hampshire Avenue, Silver Spring, MD 20993, United States. Electronic 
      address: Diane.Gubernot@fda.hhs.gov.
FAU - Menis, Mikhail
AU  - Menis M
AD  - U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, 
      10903 New Hampshire Avenue, Silver Spring, MD 20993, United States. Electronic 
      address: Mikhail.Menis@fda.hhs.gov.
FAU - Whitaker, Barbee
AU  - Whitaker B
AD  - U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, 
      10903 New Hampshire Avenue, Silver Spring, MD 20993, United States. Electronic 
      address: Barbee.Whitaker@fda.hhs.gov.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20231025
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Biological Products)
RN  - 0 (COVID-19 Vaccines)
SB  - IM
MH  - Child
MH  - Humans
MH  - *Biological Products/adverse effects
MH  - COVID-19/prevention & control
MH  - *COVID-19 Vaccines/adverse effects
MH  - Erythema Multiforme/epidemiology
MH  - Skin
MH  - Stevens-Johnson Syndrome/epidemiology/etiology
OTO - NOTNLM
OT  - Background incidence rates
OT  - COVID-19 surveillance
OT  - Erythema multiforme (EM)
OT  - Stevens-Johnson syndrome (SJS)
OT  - Toxic epidermal necrolysis (TEN)
OT  - Vaccine safety
COIS- Declaration of Competing Interest 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- 2023/10/28 11:42
MHDA- 2023/11/03 06:44
CRDT- 2023/10/27 22:56
PHST- 2023/04/19 00:00 [received]
PHST- 2023/09/11 00:00 [revised]
PHST- 2023/10/11 00:00 [accepted]
PHST- 2023/11/03 06:44 [medline]
PHST- 2023/10/28 11:42 [pubmed]
PHST- 2023/10/27 22:56 [entrez]
AID - S0264-410X(23)01208-2 [pii]
AID - 10.1016/j.vaccine.2023.10.025 [doi]
PST - ppublish
SO  - Vaccine. 2023 Nov 13;41(47):6922-6929. doi: 10.1016/j.vaccine.2023.10.025. Epub 
      2023 Oct 25.