PMID- 34802491
OWN - NLM
STAT- MEDLINE
DCOM- 20211125
LR  - 20231107
IS  - 1815-7920 (Electronic)
IS  - 1027-3719 (Print)
IS  - 1027-3719 (Linking)
VI  - 25
IP  - 9
DP  - 2021 Sep 1
TI  - Thrombotic events and COVID-19 vaccines.
PG  - 701-707
LID - 10.5588/ijtld.21.0298 [doi]
AB  - COVID-19 vaccines are considered promising agents in the control of the pandemic. 
      Although their safety was assessed in randomised clinical trials, severe adverse 
      events (AEs) have been reported after large-scale administration. This study aims 
      to evaluate thromboembolic AEs reported after vaccination in a real-world context 
      and how they led to the interruption of vaccination campaigns. We also review the 
      benefits and risks of the vaccines approved in the European Union and provide 
      recommendations. A review of the literature was performed using Medline/PubMed 
      electronic database as well as institutional and pharmacovigilance official 
      reports. Our findings show that vaccine-induced prothrombotic immune 
      thrombocytopenia has been suggested as a very rare AE associated with viral 
      vector vaccines. Unusual thrombotic events combined with moderate-to-severe 
      thrombocytopenia were reported mainly in women under 60 years of age. As safety 
      signals emerged, Vaxzevria and Janssen s COVID-19 vaccine campaigns have been 
      paused while investigations proceed. On the other hand, the number of deep vein 
      thrombosis and pulmonary embolism reports have not increased. Post-marketing 
      surveillance indicated that mRNA vaccines are safe and should continue to be 
      used. The thrombotic events report rate is not increased in people over 60 years. 
      As they are at greater risk for COVID-19 complications and death, no vaccine 
      restrictions are recommended in this group. Risk factors for vaccine-induced 
      prothrombotic immune thrombocytopenia should be established so that 
      evidence-based decisions can be made. Systematic monitoring of COVID-19 vaccine 
      safety is essential to ensure that the benefits of vaccination outweigh the 
      risks.
FAU - Brazete, C
AU  - Brazete C
AD  - Instituto de Saude Publica da Universidade do Porto, Porto, Portugal, Unidade de 
      Saude Publica do Alto Minho, Viana do Castelo, Portugal.
FAU - Aguiar, A
AU  - Aguiar A
AD  - EPIUnit, Instituto de Saude Publica da Universidade do Porto, Porto, Portugal, 
      Laboratorio para a Investigacao Integrativa e Translacional em Saude Populacional 
      (ITR), Porto, Portugal.
FAU - Furtado, I
AU  - Furtado I
AD  - Servico de Infeciologia, Centro Hospitalar e Universitario do Porto, Porto, 
      Portugal.
FAU - Duarte, R
AU  - Duarte R
AD  - EPIUnit, Instituto de Saude Publica da Universidade do Porto, Porto, Portugal, 
      Laboratorio para a Investigacao Integrativa e Translacional em Saude Populacional 
      (ITR), Porto, Portugal, Unidade de Investigacao Clinica da Administracao Regional 
      de Saude do Norte, Porto, Portugal, Departamento de Ciencias da Saude Publica, 
      Ciencias Forenses e Educacao Medica, Universidade do Porto, Porto, Portugal, 
      Servico de Pneumologia, Centro Hospitalar de Vila Nova de Gaia/Espinho, Vila Nova 
      de Gaia, Portugal.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
PL  - France
TA  - Int J Tuberc Lung Dis
JT  - The international journal of tuberculosis and lung disease : the official journal 
      of the International Union against Tuberculosis and Lung Disease
JID - 9706389
RN  - 0 (COVID-19 Vaccines)
RN  - 0 (Vaccines)
SB  - IM
CIN - Int J Tuberc Lung Dis. 2021 Sep 1;25(9):691-692. PMID: 34802488
MH  - *COVID-19
MH  - COVID-19 Vaccines
MH  - Female
MH  - Humans
MH  - SARS-CoV-2
MH  - Vaccination
MH  - *Vaccines/adverse effects
PMC - PMC8412105
COIS- Conflict of interests: none declared.
EDAT- 2021/11/23 06:00
MHDA- 2021/11/26 06:00
PMCR- 2021/09/01
CRDT- 2021/11/22 05:42
PHST- 2021/11/22 05:42 [entrez]
PHST- 2021/11/23 06:00 [pubmed]
PHST- 2021/11/26 06:00 [medline]
PHST- 2021/09/01 00:00 [pmc-release]
AID - 10.5588/ijtld.21.0298 [doi]
PST - ppublish
SO  - Int J Tuberc Lung Dis. 2021 Sep 1;25(9):701-707. doi: 10.5588/ijtld.21.0298.