What is the Safety of COVID-19 Vaccines in Immunocompromised Patients? Results from the European “Covid Vaccine Monitor” Active Surveillance Study
Drug Safety,
Год журнала:
2024,
Номер
47(10), С. 1011 - 1023
Опубликована: Июнь 22, 2024
The
safety
profile
of
COVID-19
vaccines
in
immunocompromised
patients
has
not
been
comprehensively
evaluated.
Язык: Английский
Events supposedly attributable to vaccination or immunization of COVID-19 vaccines in Brazil: a cross-sectional study
Deleted Journal,
Год журнала:
2025,
Номер
22(1)
Опубликована: Янв. 2, 2025
Abstract
COVID-19
vaccines
effectively
reduce
morbidity
and
mortality
but
are
associated
with
Events
Supposedly
Attributable
to
Vaccination
or
Immunization
(ESAVI).
This
cross-sectional
study
examined
the
incidence
characteristics
of
ESAVI
in
Brazil
during
2021,
using
data
from
e-SUS
Notifica
Vacivida.
Among
109,424
reports,
rates
were
30.82
83.08
symptoms
per
100,000
doses.
Most
reports
involved
women
(70.83%),
individuals
aged
30–39,
residents
southern
region.
Common
included
headache,
fever,
myalgia.
AstraZeneca
accounted
for
56.79%
cases.
Non-severe
cases
predominated
(95.03%),
78.7%
classified
as
“product-related
according
literature.”
Mortality
was
rare
(0.03%),
a
significant
association
identified
between
DNA
deaths
(χ
2
=
4.333;
p
0.037;
OR
2.673;
95%
CI
1.020–7.007).
Regional
disparities
evident,
higher
incidences
South
Southeast.
Underreporting
non-severe
remains
challenge.
Logistic
regression
showed
lower
odds
severe
among
adults
Black/Brown
individuals,
while
Pfizer
initial
doses
linked
odds.
These
results
highlight
safety
emphasizing
need
strengthened
post-vaccination
surveillance
address
regional
disparities,
health
inequities,
vaccine
hesitancy.
Язык: Английский
Real-Time Pharmacovigilance: Transforming Population-Based Monitoring of Post-Approval Vaccine Safety Through Rapid Cycle Analysis (RCA)—A Review of the Published Literature
Pharmaceuticals,
Год журнала:
2025,
Номер
18(1), С. 80 - 80
Опубликована: Янв. 10, 2025
Background/Objectives:
Rapid
cycle
analysis
(RCA)
is
an
established
and
efficient
methodology
that
has
been
traditionally
utilized
by
United
States
health
authorities
to
monitor
post-approval
vaccine
safety.
Initially
developed
in
the
Vaccine
Safety
Datalink
(VSD)
early
2000s,
RCA
evolved
into
a
valuable
approach
for
timely
signal
detection.
Due
availability
of
additional
near
real-time
data
sources
enhanced
analytic
approaches,
use
expanded.
This
narrative
review
provides
in-depth
assessment
studies
safety
surveillance
detect
evaluate
signals
monitoring.
Methods:
Embase
Medline
were
searched
on
8
August
2024
identify
non-interventional
using
or
other
methods
published
from
1
January
2018
31
July
2024.
Data
study
characteristics
(e.g.,
population,
source,
outcomes)
methodological
type
comparator,
sequential
testing
method,
confounding
control
method)
extracted
eligible
studies.
Results:
Of
1128
articles
screened,
18
included,
which
17
(94.4%)
conducted
(US).
Twelve
(67%)
aimed
at
detection
six
(33%)
further
evaluation.
Over
60%
examined
COVID-19
safety,
with
half
VSD.
80%
weekly
monthly
about
78%
used
database-specific
historical
comparator
group.
Conclusions:
indicates
most
application
are
based
research
US.
With
increasing
advanced
capabilities,
expected
be
more
widely
deployed
as
active
tool
complement
traditional
pharmacovigilance.
Future
should
explore
extension
non-vaccine
medicinal
products.
Язык: Английский
Timing Matters: Exploring the Role of the Time to Onset in Recall Bias for Adverse Events Following Immunization (AEFIs) of COVID-19 Vaccines from Spontaneous Reports
Pharmacoepidemiology,
Год журнала:
2025,
Номер
4(2), С. 8 - 8
Опубликована: Апрель 7, 2025
Objective:
The
aim
of
this
study
was
to
investigate
a
possible
relationship
between
the
time
onset
(TTO)
adverse
events
following
immunization
(AEFIs)
and
recall
bias
compare
it
AEFIs
COVID-19
vaccines
reported
though
spontaneous
reporting
system
(SRS)
those
from
cohort
event
monitoring
(CEM)
study.
Methods:
A
retrospective
comparing
TTO
patterns
four
SRS
CEM
performed.
Reports
concerning
related
vaccination
were
used
for
stratified
dose
number,
perceived
burden
AEFI,
being
pre-defined.
Additionally,
since
menstrual
disorders
received
much
media
attention,
their
effect
on
pattern
investigated
reports
only.
Results:
total
160,613
19,979
CEM,
containing
755,647
103,703
AEFIs,
respectively,
included.
For
with
short
TTO,
no
differences
in
observed.
However,
median
lower
increasing
duration.
There
both
before
during
episodes
but
correlation
two
could
be
found.
Conclusions:
Based
performed
analyses,
does
not
seem
more
evident
compared
studies
TTO.
longer
may
pronounced.
Язык: Английский
Anti-science case study: COVID-19 vaccines’ effectiveness and safety exaggerated
Public Health in Practice,
Год журнала:
2024,
Номер
7, С. 100517 - 100517
Опубликована: Май 23, 2024
Язык: Английский
Case Report: The Rehabilitation of a Patient with Acute Transverse Myelitis after COVID-19 Vaccination
Clinics and Practice,
Год журнала:
2024,
Номер
14(3), С. 1076 - 1084
Опубликована: Июнь 6, 2024
We
report
the
case
of
a
55-year-old
man
with
multi-symptomatic
transverse
myelitis
after
vaccination
against
coronavirus
disease
2019
(COVID-19).
The
patient
was
diagnosed
based
on
course
and
results
imaging
laboratory
tests.
excluded
other
most
probable
causes
disease.
quick
start
diagnosis
allowed
for
early
treatment
intravenous
steroids
then
plasmapheresis
implementation
modern
rehabilitation
methods
using
biofeedback
platforms,
among
others,
an
exoskeleton.
returned
to
work,
but
process
continues
this
day
due
persistent
symptoms
that
impair
patient's
quality
life.
Язык: Английский
Safety of COVID-19 Vaccines among People with History of Allergy: A European Active Surveillance Study
Vaccines,
Год журнала:
2024,
Номер
12(9), С. 1059 - 1059
Опубликована: Сен. 17, 2024
Conventional
vaccines
rarely
cause
severe
allergic
reactions.
However,
the
rapid
development
and
approval
of
COVID-19
left
limited
initial
data
on
their
adverse
reactions,
particularly
in
individuals
with
a
history
allergy.
The
aim
this
study
was
to
assess
compare
safety
profile
different
doses
brands
subjects
allergy
vs.
those
without
Язык: Английский
Scientific views around mRNA based covid vaccines are changing, but to what end?
Polish Annals of Medicine,
Год журнала:
2024,
Номер
unknown, С. 1 - 4
Опубликована: Окт. 3, 2024
Язык: Английский
Cohort event monitoring of safety of COVID-19 vaccines: the Italian experience of the “ilmiovaccinoCOVID19 collaborating group”
Frontiers in Drug Safety and Regulation,
Год журнала:
2024,
Номер
4
Опубликована: Авг. 12, 2024
Introduction:
In
2021,
the
European
Medicines
Agency
supported
“Covid
Vaccine
Monitor
(CVM),”
an
active
surveillance
project
spanning
13
countries
aimed
at
monitoring
safety
of
COVID-19
vaccines
in
general
and
special
populations
(i.e.,
pregnant/breastfeeding
women,
children/adolescents,
immunocompromised
people,
people
with
a
history
allergies
or
previous
SARS-CoV-2
infection).
Italy
participated
this
as
large
multidisciplinary
network
called
“ilmiovaccinoCOVID19
collaborating
group.”
Methods:
The
study
to
describe
experience
Italian
group”
CVM
context
from
June
2021
February
2023.
Comprising
about
30
partners,
facilitate
vaccinee
recruitment.
Participants
completed
baseline
follow-up
questionnaires
within
48
h
vaccination
over
6-month
period.
Analyses
focused
on
those
who
both
first
questionnaire
(Q1),
exploring
temporal
trends,
campaign
correlation,
loss
follow-up.
Characteristics
recruited
vaccinees
vaccinee-reported
adverse
drug
reactions
(ADRs)
were
compared
passive
data
Italy.
Results:
From
November
2022,
22,384,663
doses
38,207,452
booster
administered
Simultaneously,
enrolled
1,229
2,707
participants
for
doses,
respectively.
Of
these,
829
1,879
vaccinees,
respectively,
least
Q1
included
analyses,
significant
proportion
them
(57.8%/34.3%)
belonging
cohorts.
Most
analyses
women.
Comirnaty
®
(69%)
Spikevax
(29%)
most
frequently
vaccines.
ADR
rates
following
higher
after
second
dose,
particularly
.
Serious
ADRs
infrequent.
Differences
observed
characteristics
between
surveillance.
Conclusion:
This
confirmed
favorable
profile
vaccines,
findings
consistent
pivotal
clinical
trials
although
different
proportions
serious
spontaneous
reporting
observed.
Continuous
evaluation
through
cohort
event
studies
provides
real-time
insights
crucial
regulatory
responses.
Strengthening
infrastructure
implementing
early
strategies
are
essential
enhance
vaccine
assessment
prepare
future
pandemics.
Язык: Английский
Post-COVID-19 Vaccination and Long COVID: Insights from Patient-Reported Data
Vaccines,
Год журнала:
2024,
Номер
12(12), С. 1427 - 1427
Опубликована: Дек. 18, 2024
COVID-19
vaccinations
reduce
the
severity
and
number
of
symptoms
for
acute
SARS-CoV-2
infections
may
risk
developing
Long
COVID,
also
known
as
post-acute
sequelae
(PASC).
Limited
heterogenous
data
exist
on
how
these
received
after
infection
might
impact
trajectory
PASC,
once
persistent
have
developed.
We
investigated
association
post-COVID-19
vaccination
with
any
vaccine(s)
PASC
in
two
independent
cohorts:
a
retrospective
chart
review
self-reported
from
patients
(n
=
128)
seen
Stanford
Clinic
between
May
2021
2022
2023
multinational
survey
assessment
individuals
484).
Within
patient
cohort
128),
58.6%
75)
were
female,
41.4%
53)
male;
50%
64)
white,
38.3%
49)
non-white.
A
total
60.2%
77)
reported
no
change
their
vaccination,
17.2%
22)
improved
symptoms,
22.7%
29)
worsened
symptoms.
In
484),
380
U.S.,
104
outside
U.S.;
88.4%
428)
11.6%
56)
88.8%
430)
11.2%
54)
The
distribution
vaccine
effects
was
20.2%
98),
60.5%
effect
293),
19.2%
93).
both
cohorts,
demographic
features,
including
age,
sex,
race/ethnicity,
not
significantly
associated
post-vaccination
symptom
changes.
There
non-significant
difference
median
dates
among
different
outcomes.
BMI
significant
improvement
(p
0.026)
cohort,
while
history
booster
doses
<
0.001)
cohort.
Most
did
report
changes
overall
following
onset.
Further
research
is
needed
to
better
understand
relationship
PASC.
Язык: Английский