GLOBAL
COVID VACCINE SAFETY PROJECT - SCI & TECH
News:
Global study quantifies
rise in blood clots, heart inflammation following COVID-19 vaccination
What's
in the news?
●
One of the largest assessments of its
kind, spanning 99 million people and investigating reports of adverse reactions
following COVID-19 vaccination, found that instances of Guillain Barre Syndrome, myocarditis, pericarditis and cerebral venous
sinus thrombosis (CVST) were at least 1.5 times more than expected
following inoculation with mRNA and ChadOX1 vaccines.
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This is in line with previous observations
by the World Health Organization and the European Medicines Agency, and was
what led to these being classified as ‘rare’ side effects following the
vaccination for COVID-19.
Key
takeaways:
●
The data set spanning 99 million people
did not include patients from India.
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Majority of Indians were administered the ChAdOX1 or Covishield vaccines during
the pandemic.
Global
COVID Vaccine Safety (GCoVS):
●
The simultaneous development of so many
vaccines for COVID-19 and their anticipated deployment in both high and
low-middle income countries to meet the global need is unprecedented.
●
If a true rare safety issue with one of
these COVID-19 vaccine candidates exists, it is likely to only be detected
post-introduction, when millions of people (including at-risk subpopulations)
will have been vaccinated.
Objective:
●
To address the need for very large,
coordinated safety assessments of
COVID-19 vaccines in different populations around the world.
Funded
by:
●
The
U.S. Centers for Disease Control and Prevention (CDC) funded the Global Vaccine
Data Network for three-years to conduct a programme of activities.
●
The Global COVID Vaccine Safety (GCoVS)
project uses the GVDN and its Global Coordinating Centre to manage and work
with the global data partners that have experience in the analyses of vaccine
safety surveillance using electronic databases and vaccine safety evaluation to
evaluate and compare COVID-19 vaccine safety.
●
In August 2022, the U.S. Centers for
Disease Control and Prevention granted additional funding to extend the GCoVS
project by two years and expand the number of sites participating globally.
Activities
under the Project:
●
Develop background rates for adverse
events of special interest for each partner site and display these on a
publicly available dashboard.
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Develop a common data dictionary for all
studies.
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Conduct observed over expected assessments
for selected adverse events of special interest.
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Conduct association studies for events
that have been identified as likely associated with COVID-19 vaccines such as
○
Myocarditis and pericarditis and mRNA
vaccines.
○
Thrombosis with thrombocytopenia
syndrome/vaccine-induced immune thrombotic thrombocytopenia (TTS/VITT) and
viral vector vaccines.
○
Guillain-Barré syndrome (GBS) and viral
vector vaccines.
○
Assess risk of vaccine mediated enhanced
disease.
○
Assess safety in pregnancy.
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Conduct genomic assessments for cases and
controls for myocarditis, TTS/VITT and GBS.
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Develop communications to support vaccine
confidence.