PMID- 36560439
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20221227
IS  - 2076-393X (Print)
IS  - 2076-393X (Electronic)
IS  - 2076-393X (Linking)
VI  - 10
IP  - 12
DP  - 2022 Nov 27
TI  - Quantitative Benefit-Risk Assessment of COVID-19 Vaccines Using the 
      Multi-Criteria Decision Analysis.
LID - 10.3390/vaccines10122029 [doi]
LID - 2029
AB  - In the early SARS-CoV-2 (COVID-19) pandemic, four major vaccines were approved 
      despite limited efficacy and safety data through short regulatory review periods. 
      Thus, it is necessary to assess the benefit-risk (BR) profiles of the COVID-19 
      vaccines. We conducted a quantitative BR assessment for four COVID-19 vaccines 
      (mRNA-based: mRNA-1273 and BNT162b2; viral vector-based: Ad26.COV.2 and 
      ChAdOx1-S) using multi-criteria decision analysis. Three benefit criteria and two 
      risk criteria were considered: preventing COVID-19 infection for (1) adults aged 
      >/=18 years; (2) seniors aged 60 years or older; and (3) severe COVID-19, adverse 
      events (AEs), and serious AEs. Data were retrieved from clinical trials, 
      observational studies, and county-specific AE monitoring reports. Based on the 
      collected data, vaccines were scored for each criterion. 22 professionals 
      weighted each criterion. The overall BR score was calculated using scores and 
      weights. mRNA-1273 was the most preferred vaccine in pre-authorization and 
      BNT162b2 in post-authorization. We found that the mRNA vaccine had a good balance 
      between the benefits and risks. Using this BR assessment, the benefit-risk 
      profile of COVID-19 vaccines can be updated with cumulated data. It will 
      contribute to building evidence for decision making by policy makers and health 
      professionals.
FAU - Son, Kyung-Hwa
AU  - Son KH
AD  - School of Pharmacy, Sungkyunkwan University, Suwon 16419, Republic of Korea.
FAU - Kwon, Sun-Hong
AU  - Kwon SH
AUID- ORCID: 0000-0002-1058-8392
AD  - School of Pharmacy, Sungkyunkwan University, Suwon 16419, Republic of Korea.
FAU - Na, Hye-Jung
AU  - Na HJ
AD  - School of Pharmacy, Sungkyunkwan University, Suwon 16419, Republic of Korea.
FAU - Baek, Youngsuk
AU  - Baek Y
AD  - School of Pharmacy, Sungkyunkwan University, Suwon 16419, Republic of Korea.
FAU - Kim, Inok
AU  - Kim I
AD  - School of Pharmacy, Sungkyunkwan University, Suwon 16419, Republic of Korea.
FAU - Lee, Eui-Kyung
AU  - Lee EK
AUID- ORCID: 0000-0003-0601-7754
AD  - School of Pharmacy, Sungkyunkwan University, Suwon 16419, Republic of Korea.
LA  - eng
PT  - Journal Article
DEP - 20221127
PL  - Switzerland
TA  - Vaccines (Basel)
JT  - Vaccines
JID - 101629355
PMC - PMC9785565
OTO - NOTNLM
OT  - COVID-19 vaccine
OT  - SARS-CoV-2
OT  - multi-criteria decision analysis
OT  - quantitative benefit-risk assessment
COIS- The authors declare no conflict of interest.
EDAT- 2022/12/24 06:00
MHDA- 2022/12/24 06:01
PMCR- 2022/11/27
CRDT- 2022/12/23 02:04
PHST- 2022/10/17 00:00 [received]
PHST- 2022/11/21 00:00 [revised]
PHST- 2022/11/25 00:00 [accepted]
PHST- 2022/12/23 02:04 [entrez]
PHST- 2022/12/24 06:00 [pubmed]
PHST- 2022/12/24 06:01 [medline]
PHST- 2022/11/27 00:00 [pmc-release]
AID - vaccines10122029 [pii]
AID - vaccines-10-02029 [pii]
AID - 10.3390/vaccines10122029 [doi]
PST - epublish
SO  - Vaccines (Basel). 2022 Nov 27;10(12):2029. doi: 10.3390/vaccines10122029.