PMID- 34709664
OWN - NLM
STAT- MEDLINE
DCOM- 20220603
LR  - 20221005
IS  - 1096-9071 (Electronic)
IS  - 0146-6615 (Print)
IS  - 0146-6615 (Linking)
VI  - 94
IP  - 3
DP  - 2022 Mar
TI  - Comparative safety of mRNA COVID-19 vaccines to influenza vaccines: A 
      pharmacovigilance analysis using WHO international database.
PG  - 1085-1095
LID - 10.1002/jmv.27424 [doi]
AB  - Two messenger RNA (mRNA) vaccines developed by Pfizer-BioNTech and Moderna are 
      being rolled out. Despite the high volume of emerging evidence regarding adverse 
      events (AEs) associated with the COVID-19 mRNA vaccines, previous studies have 
      thus far been largely based on the comparison between vaccinated and unvaccinated 
      control, possibly highlighting the AE risks with COVID-19 mRNA vaccination. 
      Comparing the safety profile of mRNA vaccinated individuals with otherwise 
      vaccinated individuals would enable a more relevant assessment for the safety of 
      mRNA vaccination. We designed a comparative safety study between 18 755 and 
      27 895 individuals who reported to VigiBase for adverse events following 
      immunization (AEFI) with mRNA COVID-19 and influenza vaccines, respectively, from 
      January 1, 2020, to January 17, 2021. We employed disproportionality analysis to 
      rapidly detect relevant safety signals and compared comparative risks of a 
      diverse span of AEFIs for the vaccines. The safety profile of novel mRNA vaccines 
      was divergent from that of influenza vaccines. The overall pattern suggested that 
      systematic reactions like chill, myalgia, fatigue were more noticeable with the 
      mRNA COVID-19 vaccine, while injection site reactogenicity events were more 
      prevalent with the influenza vaccine. Compared to the influenza vaccine, mRNA 
      COVID-19 vaccines demonstrated a significantly higher risk for a few manageable 
      cardiovascular complications, such as hypertensive crisis (adjusted reporting 
      odds ratio [ROR], 12.72; 95% confidence interval [CI], 2.47-65.54), and 
      supraventricular tachycardia (adjusted ROR, 7.94; 95% CI, 2.62-24.00), but lower 
      risk of neurological complications such as syncope, neuralgia, loss of 
      consciousness, Guillain-Barre syndrome, gait disturbance, visual impairment, and 
      dyskinesia. This study has not identified significant safety concerns regarding 
      mRNA vaccination in real-world settings. The overall safety profile patterned a 
      lower risk of serious AEFI following mRNA vaccines compared to influenza 
      vaccines.
CI  - (c) 2021 Wiley Periodicals LLC.
FAU - Kim, Min Seo
AU  - Kim MS
AUID- ORCID: 0000-0003-2115-7835
AD  - College of Medicine, Korea University, Seoul, Republic of Korea.
AD  - Samsung Advanced Institute for Health Sciences and Technology (SAIHST), 
      Sungkyunkwan University, Samsung Medical Center, Seoul, Republic of Korea.
FAU - Jung, Se Yong
AU  - Jung SY
AUID- ORCID: 0000-0003-1337-563X
AD  - Department of Pediatrics, Yonsei University College of Medicine, Seoul, Republic 
      of Korea.
FAU - Ahn, Jong Gyun
AU  - Ahn JG
AD  - Department of Pediatrics, Severance Children's Hospital, Yonsei University 
      College of Medicine, South Korea.
FAU - Park, Se Jin
AU  - Park SJ
AD  - Department of Pediatrics, Eulji University School of Medicine, Daejeon, Republic 
      of Korea.
FAU - Shoenfeld, Yehuda
AU  - Shoenfeld Y
AD  - Laboratory of the Mosaics of Autoimmunity, Saint Petersburg State University, 
      Saint-Petersburg, Russian Federation.
AD  - Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Affiliated to 
      Tel-Aviv University School of Medicine, Tel-Hashomer, Israel.
FAU - Kronbichler, Andreas
AU  - Kronbichler A
AD  - Department of Internal Medicine IV, Medical University Innsbruck, Innsbruck, 
      Austria.
FAU - Koyanagi, Ai
AU  - Koyanagi A
AD  - Research and Development Unit, Parc Sanitari Sant Joan de Deu, Universitat de 
      Barcelona, Fundacio Sant Joan de Deu, CIBERSAM, Barcelona, Spain.
AD  - ICREA, Pg. Lluis Companys 23, Barcelona, Spain.
AD  - Instituto de Salud Carlos III, Centro de Investigacion Biomedica en Red de Salud 
      Mental, CIBERSAM, Madrid, Spain.
FAU - Dragioti, Elena
AU  - Dragioti E
AD  - Pain and Rehabilitation Centre, and Department of Health, Medicine and Caring 
      Sciences, Linkoping University, Linkoping, Sweden.
FAU - Tizaoui, Kalthoum
AU  - Tizaoui K
AUID- ORCID: 0000-0001-8524-6058
AD  - Laboratory of Microorganismes and Active Biomolecules, Sciences Faculty of Tunis, 
      University Tunis El Manar, Tunis, Tunisia.
FAU - Hong, Sung Hwi
AU  - Hong SH
AD  - Yonsei University College of Medicine, Seoul, Republic of Korea.
FAU - Jacob, Louis
AU  - Jacob L
AUID- ORCID: 0000-0003-1071-1239
AD  - Research and Development Unit, Parc Sanitari Sant Joan de Deu, Universitat de 
      Barcelona, Fundacio Sant Joan de Deu, CIBERSAM, Barcelona, Spain.
AD  - Faculty of Medicine, University of Versailles Saint-Quentin-en-Yvelines, 
      Montigny-le-Bretonneux, France.
FAU - Salem, Joe-Elie
AU  - Salem JE
AD  - Sorbonne Universite, INSERM, CIC-1901 Paris-Est, CLIP(2) Galilee, UNICO-GRECO 
      Cardio-oncology Program, and Department of Pharmacology, Pitie-Salpetriere 
      Hospital, Assistance Publique-Hopitaux de Paris, Paris, France.
FAU - Yon, Dong Keon
AU  - Yon DK
AUID- ORCID: 0000-0003-1628-9948
AD  - Department of Pediatrics, Seoul National University Children's Hospital, Seoul 
      National University College of Medicine, Seoul, Republic of Korea.
FAU - Lee, Seung Won
AU  - Lee SW
AUID- ORCID: 0000-0001-5632-5208
AD  - Department of Data Science, Sejong University College of Software Convergence, 
      Seoul, Republic of Korea.
FAU - Ogino, Shuji
AU  - Ogino S
AUID- ORCID: 0000-0002-3909-2323
AD  - Cancer Immunology and Cancer Epidemiology Programs, Dana-Farber Harvard Cancer 
      Center, Boston, Massachusetts, USA.
AD  - Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, 
      Massachusetts, USA.
AD  - Program in MPE Molecular Pathological Epidemiology, Department of Pathology, 
      Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
AD  - Broad Institute of Massachusetts Institute of Technology and Harvard, Cambridge, 
      Massachusetts, USA.
FAU - Kim, Hanna
AU  - Kim H
AD  - College of Medicine, Ewha Womans University, Seoul, Republic of Korea.
FAU - Kim, Jerome H
AU  - Kim JH
AD  - International Vaccine Institute, Seoul, Republic of Korea.
FAU - Excler, Jean-Louis
AU  - Excler JL
AD  - International Vaccine Institute, Seoul, Republic of Korea.
FAU - Marks, Florian
AU  - Marks F
AD  - International Vaccine Institute, Seoul, Republic of Korea.
AD  - Cambridge Institute of Therapeutic Immunology and Infectious Disease, University 
      of Cambridge School of Clinical Medicine, Cambridge, UK.
AD  - University of Antananarivo, Antananarivo, Madagascar.
FAU - Clemens, John D
AU  - Clemens JD
AD  - International Vaccine Institute, Seoul, Republic of Korea.
AD  - International Centre for Diarrheal Diseases Research, Dhaka, Dhaka, Bangladesh.
AD  - UCLA Fielding School of Public Health, Los Angeles, California, USA.
FAU - Eisenhut, Michael
AU  - Eisenhut M
AD  - Luton & Dunstable University Hospital, Luton, United Kingdom.
FAU - Barnett, Yvonne
AU  - Barnett Y
AD  - Centre for Health, Performance, and Wellbeing, Anglia Ruskin University, 
      Cambridge, UK.
FAU - Butler, Laurie
AU  - Butler L
AD  - Centre for Health, Performance, and Wellbeing, Anglia Ruskin University, 
      Cambridge, UK.
FAU - Ilie, Cristian Petre
AU  - Ilie CP
AD  - Queen Elizabeth Hospital Foundation Trust, King's Lynn, Norfolk, England.
FAU - Shin, Eui-Cheol
AU  - Shin EC
AUID- ORCID: 0000-0002-6308-9503
AD  - Laboratory of Immunology and Infectious Diseases, Graduate School of Medical 
      Science and Engineering, Korea Advanced Institute of Science and Technology, 
      Daejeon, Republic of Korea.
AD  - The Center for Epidemic Preparedness, Korea Advanced Institute of Science and 
      Technology, Daejeon, Republic of Korea.
FAU - Il Shin, Jae
AU  - Il Shin J
AUID- ORCID: 0000-0003-2326-1820
AD  - Department of Pediatrics, Yonsei University College of Medicine, Seoul, Republic 
      of Korea.
FAU - Smith, Lee
AU  - Smith L
AD  - Centre for Health, Performance, and Wellbeing, Anglia Ruskin University, 
      Cambridge, UK.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20211108
PL  - United States
TA  - J Med Virol
JT  - Journal of medical virology
JID - 7705876
RN  - 0 (COVID-19 Vaccines)
RN  - 0 (Influenza Vaccines)
RN  - 0 (RNA, Messenger)
RN  - 0 (mRNA Vaccines)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems
MH  - *COVID-19/prevention & control
MH  - COVID-19 Vaccines/adverse effects
MH  - Humans
MH  - *Influenza Vaccines/adverse effects
MH  - *Influenza, Human/prevention & control
MH  - Pharmacovigilance
MH  - RNA, Messenger/genetics
MH  - World Health Organization
MH  - mRNA Vaccines
PMC - PMC8662238
OTO - NOTNLM
OT  - COVID-19
OT  - VigiBase
OT  - influenza vaccine
OT  - mRNA vaccine
OT  - post-implementation surveillance
OT  - safety
COIS- The findings and conclusions in this article are those of the authors and do not 
      necessarily represent the official position of the World Health Organization 
      (WHO) and the International Vaccine Institute (IVI). The authors declare that 
      they have no known competing financial interests or personal relationships with 
      companies that could have influenced the work reported in this paper. Dr. 
      Jean-Louis Excler reports nonfinancial support from Brighton Collaboration, 
      personal fees from US Military HIV Research Program, personal fees from Johnson & 
      Johnson, outside the submitted work; Dr. Jerome H. Kim reports personal fees from 
      SK bioscience, personal fees from educational companies during the period covered 
      by this manuscript; Min Seo Kim, Se Yong Jung, Jong Gyun Ahn, Se Jin Park, Yehuda 
      Shoenfeld, Andreas Kronbichler, Ai Koyanagi, Elena Dragioti, Kalthoum Tizaoui, 
      Sung Hwi Hong, Louis Jacob, Joe-Elie Salem, Dong Keon Yon, Seung Won Lee, Shuji 
      Ogino, Hanna Kim, Florian Marks, John D. Clemens, Michael Eisenhut, Yvonne 
      Barnett, Laurie Butler, Cristian Petre Ilie, Eui-Cheol Shin, Jae Il Shin, and Lee 
      Smith have no commercial associations that may present a conflict of interest 
      regarding this manuscript.
EDAT- 2021/10/29 06:00
MHDA- 2022/06/07 06:00
PMCR- 2021/11/08
CRDT- 2021/10/28 12:37
PHST- 2021/09/17 00:00 [received]
PHST- 2021/10/26 00:00 [accepted]
PHST- 2021/10/29 06:00 [pubmed]
PHST- 2022/06/07 06:00 [medline]
PHST- 2021/10/28 12:37 [entrez]
PHST- 2021/11/08 00:00 [pmc-release]
AID - JMV27424 [pii]
AID - 10.1002/jmv.27424 [doi]
PST - ppublish
SO  - J Med Virol. 2022 Mar;94(3):1085-1095. doi: 10.1002/jmv.27424. Epub 2021 Nov 8.