PMID- 34729549
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220429
IS  - 2666-7762 (Electronic)
IS  - 2666-7762 (Linking)
VI  - 12
DP  - 2022 Jan
TI  - Adverse events of active and placebo groups in SARS-CoV-2 vaccine randomized 
      trials: A systematic review.
PG  - 100253
LID - 10.1016/j.lanepe.2021.100253 [doi]
LID - 100253
AB  - BACKGROUND: For safety assessment in clinical trials, adverse events (AEs) are 
      reported for the drug under evaluation and compared with AEs in the placebo 
      group. Little is known about the nature of the AEs associated with clinical 
      trials of SARS-CoV-2 vaccines and the extent to which these can be traced to 
      nocebo effects, where negative treatment-related expectations favor their 
      occurrence. METHODS: In our systematic review, we compared the rates of solicited 
      AEs in the active and placebo groups of SARS-CoV-2 vaccines approved by the 
      Western pharmaceutical regulatory agencies.We implemented a search strategy to 
      identify trial-III studies of SARS-CoV-2 vaccines through the PubMed database. We 
      adopted the PRISMA Statement to perform the study selection and the data 
      collection and identified three trial: two mRNA-based (38403 participants) and 
      one adenovirus type (6736 participants). FINDINGS: Relative risks showed that the 
      occurrence of AEs reported in the vaccine groups was higher compared with the 
      placebo groups. The most frequently AEs in both groups were fatigue, headache, 
      local pain, as injection site reactions, and myalgia. In particular, for first 
      doses in placebo recipients, fatigue was reported in 29% and 27% in BNT162b2 and 
      mRNA-1273 groups, respectively, and in 21% of Ad26.COV2.S participants. Headache 
      was reported in 27% in both mRNA groups and in 24% of Ad26.COV2.S recipients. 
      Myalgia was reported in 10% and 14% in mRNA groups (BNT162b2 and mRNA-1273, 
      respectively) and in 13% of Ad26.COV2.S participants. Local pain was reported in 
      12% and 17% in mRNA groups (BNT162b2 and mRNA-1273, respectively), and in 17% of 
      Ad26.COV2.S recipients. These AEs are more common in the younger population and 
      in the first dose of placebo recipients of the mRNA vaccines. INTERPRETATION: Our 
      results are in agreement with the expectancy theory of nocebo effects and suggest 
      that the AEs associated with COVID-19 vaccines may be related to the nocebo 
      effect. FUNDING: Fondazione CRT - Cassa di Risparmio di Torino, IT (grant number 
      66346, "GAIA-MENTE" 2019).
CI  - (c) 2021 The Authors.
FAU - Amanzio, Martina
AU  - Amanzio M
AD  - Department of Psychology, University of Turin, Via Verdi 10, 10124 Turin, Italy.
FAU - Mitsikostas, Dimos D
AU  - Mitsikostas DD
AD  - First Department of Neurology, Aeginition Hospital, National and Kapodistrian 
      University of Athens, 72-74 V. Sofia's Avenue, Athens 11528, Hellas, Greece.
FAU - Giovannelli, Fabio
AU  - Giovannelli F
AD  - Section of Psychology - Department of Neuroscience, Psychology, Drug Research and 
      Child's Health (NEUROFARBA), University of Florence, Via di San Salvi 12, 50135 
      Florence, Italy.
FAU - Bartoli, Massimo
AU  - Bartoli M
AD  - Department of Psychology, University of Turin, Via Verdi 10, 10124 Turin, Italy.
FAU - Cipriani, Giuseppina Elena
AU  - Cipriani GE
AD  - Department of Psychology, University of Turin, Via Verdi 10, 10124 Turin, Italy.
FAU - Brown, Walter A
AU  - Brown WA
AD  - Department of Psychiatry and Human Behavior, Brown University, 69 Brown Street 
      Providence, RI 02912, USA.
LA  - eng
PT  - Journal Article
DEP - 20211028
PL  - England
TA  - Lancet Reg Health Eur
JT  - The Lancet regional health. Europe
JID - 101777707
PMC - PMC8553263
OTO - NOTNLM
OT  - SARS-CoV-2 vaccines
OT  - adverse events
OT  - nocebo effect
OT  - placebo
OT  - randomized control trials
COIS- All authors declare no conflict of interest.
EDAT- 2021/11/04 06:00
MHDA- 2021/11/04 06:01
PMCR- 2021/10/28
CRDT- 2021/11/03 07:01
PHST- 2021/11/04 06:00 [pubmed]
PHST- 2021/11/04 06:01 [medline]
PHST- 2021/11/03 07:01 [entrez]
PHST- 2021/10/28 00:00 [pmc-release]
AID - S2666-7762(21)00239-8 [pii]
AID - 100253 [pii]
AID - 10.1016/j.lanepe.2021.100253 [doi]
PST - ppublish
SO  - Lancet Reg Health Eur. 2022 Jan;12:100253. doi: 10.1016/j.lanepe.2021.100253. 
      Epub 2021 Oct 28.