The Journal of Toxicological Sciences,
Год журнала:
2024,
Номер
49(3), С. 79 - 94
Опубликована: Янв. 1, 2024
The
development
and
regulatory
review
of
BNT162b2,
a
COVID-19
vaccine,
PaxlovidTM
(nirmatrelvir
tablets/ritonavir
tablets),
therapeutic,
are
benchmarks
for
accelerated
innovation
during
global
pandemic.
Rapid
choice
the
SARS-CoV-2
spike
protein
main
protease
(Mpro)
as
targets
vaccine
respectively,
leveraged
available
knowledge
biology
related
viruses.
nonclinical
immunogenicity
safety
BNT162b2
was
rigorously
assessed.
Likewise,
comprehensive
assessment
conducted
therapeutic
candidates,
lufotrelvir
(PF-07304814)
nirmatrelvir
(PF-07321332).
Paxlovid
enabled
through
close
collaboration
pharmaceutical
industry
with
agencies
public
health
organizations.
This
experience
highlights
approaches
that
could
be
adopted
pandemic
preparedness
including
risk-based
investment
strategies,
conduct
activities
in
parallel
normally
sequentially,
quick
kill
decisions,
simultaneous
evaluation
multiple
use
flexible,
established
platforms.
JAMA Pediatrics,
Год журнала:
2024,
Номер
178(3), С. 258 - 258
Опубликована: Янв. 22, 2024
Importance
Uptake
of
COVID-19
vaccines
among
pregnant
individuals
was
hampered
by
safety
concerns
around
potential
risks
to
unborn
children.
Data
clarifying
early
neurodevelopmental
outcomes
offspring
exposed
vaccination
in
utero
are
lacking.
Objective
To
determine
whether
exposure
maternal
associated
with
differences
scores
on
the
Ages
and
Stages
Questionnaire,
third
edition
(ASQ-3),
at
12
18
months
age.
Design,
Setting,
Participants
This
prospective
cohort
study,
Assessing
Safety
Pregnancy
During
Coronavirus
Pandemic
(ASPIRE),
enrolled
participants
from
May
2020
August
2021;
follow-up
children
these
pregnancies
is
ongoing.
Participants,
which
included
their
all
50
states,
self-enrolled
online.
Study
activities
were
performed
remotely.
Exposure
In
fetus
during
pregnancy
compared
those
unexposed.
Main
Outcomes
Measures
Neurodevelopmental
validated
ASQ-3,
completed
birth
mothers
months.
A
score
below
established
cutoff
any
5
subdomains
(communication,
gross
motor,
fine
problem
solving,
social
skills)
constituted
an
abnormal
screen
for
developmental
delay.
Results
total
2487
(mean
[SD]
age,
33.3
[4.2]
years)
less
than
10
weeks’
gestation
research
activities,
yielding
a
2261
1940
infants
aged
months,
respectively,
assessments.
crude
analyses,
471
1541
(30.6%)
screened
abnormally
delay
vs
203
720
unexposed
(28.2%;
χ
2
=
1.32;
P
.25);
corresponding
prevalences
262
1301
(20.1%)
148
639
(23.2%),
respectively
(χ
2.35;
.13).
multivariable
mixed-effects
logistic
regression
models
adjusting
race,
ethnicity,
education,
income,
depression,
anxiety,
no
difference
risk
ASQ-3
screens
observed
either
time
point
(12
months:
adjusted
ratio
[aRR],
1.14;
95%
CI,
0.97-1.33;
aRR,
0.88;
0.72-1.07).
Further
adjustment
preterm
infant
sex
did
not
affect
results
1.16;
0.98-1.36;
0.87;
0.71-1.07).
Conclusions
Relevance
this
study
suggest
that
safe
perspective
neurodevelopment
Additional
longer-term
should
be
conducted
corroborate
findings
buttress
clinical
guidance
strong
evidence
base.
Scientific Reports,
Год журнала:
2025,
Номер
15(1)
Опубликована: Фев. 22, 2025
Low
birth
weight
and
anemia
are
significant
public
health
challenges
in
developing
countries.
This
study
seeks
to
evaluate
the
relationship
between
hemoglobin
levels
during
first
second
trimesters
of
pregnancy
occurrence
low
weight,
while
accounting
for
potential
confounding
factors.
multi-center
cross-sectional
was
conducted
among
all
pregnant
women
with
COVID-19
no
history
receiving
vaccine
who
delivered
private
hospitals
three
counties,
Mahabad,
Miandoab,
Bukan
Iran,
using
routinely
collected
maternity
data
on
pregnancies.
Hemoglobulin
were
measured
(6–10th
weeks)
(24–28th
pregnancy,
outcomes
recorded
information
system.
Hb
categorized
into
four
groups
as
follows:
≥110
g/L,
100–109
90–99
<
90
g/L
trimester
≥
105
100–104
trimester.
Multivariable
logistic
regression
analysis
determined
association
weight.
P-values
0.05
considered
statistically
significant.
A
total
385
mothers
included.
The
mean
age
30.01
±
6.24
years.
After
multivariable
adjustment,
110
had
a
[OR,
4.13;
(95%
CI
2.11–8.10)].
Morevoer,
[OR:3.91;
CI:1.98–7.75)].
Maternal
including
trimesters,
even
after
adjusting
common
confounders.
Effective
management
monitoring
women,
particularly
low-
middle-income
countries,
crucial
preventing
Vaccine,
Год журнала:
2024,
Номер
42, С. 125549 - 125549
Опубликована: Фев. 9, 2024
During
the
COVID-19
pandemic,
candidate
vaccines
were
being
developed
for
potential
use
in
United
States
on
an
unprecedented,
accelerated
schedule.
It
was
anticipated
that
once
available,
under
U.S.
Food
and
Drug
Administration
(FDA)
Emergency
Use
Authorization
(EUA)
or
FDA
approval,
would
be
broadly
used
potentially
administered
to
millions
of
individuals
a
short
period
time.
Intensive
monitoring
post-EUA/licensure
necessary
timely
detection
assessment
safety
concerns.
To
address
this,
Centers
Disease
Control
Prevention
(CDC)
convened
Advisory
Committee
Immunization
Practices
(ACIP)
work
group
focused
solely
vaccine
safety,
consisting
independent
experts
representatives
from
federal
agencies
-
ACIP
Vaccine
Safety
Technical
Work
Group
(VaST).
This
report
provides
overview
organization
activities
VaST,
summarizes
data
reviewed
as
part
comprehensive
effort
monitor
during
highlights
selected
actions
taken
by
CDC,
ACIP,
response
accumulating
post-authorization
data.
VaST
regular
meetings
over
course
29
months,
November
2020
through
April
2023;
March
2023
issued
EUAs
six
four
different
manufacturers
subsequently
licensed
two
these
vaccines.
The
collaborated
with
ensure
this
worked
closely
Vaccines
Group;
VaST's
assessments
benefit-risk
guidance
vaccination
policy.
topics
included
those
identified
systems
other
scientific
public
interest.
provided
CDC's
efforts,
forum
review
several
government
systems,
assured
diverse
scientists
clinicians,
external
government,
promptly
In
event
future
pandemic
biological
health
emergency,
model
could
strengthen
monitoring,
enhance
confidence,
increase
transparency
incorporation
independent,
non-government
into
process,
strong
collaboration
among
partners.
Drug Safety,
Год журнала:
2024,
Номер
47(10), С. 991 - 1010
Опубликована: Июль 15, 2024
Pregnant
persons
are
susceptible
to
significant
complications
following
COVID-19,
even
death.
However,
worldwide
COVID-19
vaccination
coverage
during
pregnancy
remains
suboptimal.
Abstract
Vaccines
against
COVID-19
and
influenza
can
reduce
the
adverse
outcomes
caused
by
infections
during
pregnancy,
but
vaccine
uptake
among
pregnant
women
has
been
suboptimal.
We
examined
disparities
in
pandemic
to
inform
vaccination
interventions.
used
data
from
Oxford-Royal
College
of
General
Practitioners
Research
Surveillance
Centre
database
England
Secure
Anonymised
Information
Linkage
Databank
Wales.
The
at
least
one
dose
was
40.2%
for
41.8%
eligible
women.
observed
uptake,
with
socioeconomically
deprived
ethnic
minority
groups
showing
lower
rates.
suboptimal
vaccines,
especially
those
backgrounds
Black,
mixed
or
other
groups,
underscores
necessity
interventions
hesitancy
enhance
acceptance
bioRxiv (Cold Spring Harbor Laboratory),
Год журнала:
2025,
Номер
unknown
Опубликована: Янв. 16, 2025
ABSTRACT
Sequestration
of
Plasmodium
parasites
in
the
placental
vasculature
causes
increased
morbidity
and
mortality
pregnant
compared
to
non-pregnant
patients
malaria-
endemic
regions.
In
this
study,
outbred
CD1
mice
with
semi
allogeneic
fetuses
were
infected
transgenic
berghei
or
mock-inoculated
by
mosquito
bite
at
either
embryonic
day
(E)
6
(first
trimester-equivalent)
10
(second
trimester-
equivalent)
females.
P.
-infected
mosquitoes
had
greater
biting
avidity
for
E10
dams
than
uninfected
mosquitoes,
which
was
not
apparent
E6
nor
Infected
numbers
uterus
spleen,
but
blood
liver.
While
found
placentas,
no
present
fetuses.
Maternal
infection
caused
maternal
morbidity,
rates
fetal
reabsorption
stillbirths
E10.
Infection
adverse
offspring
outcomes,
including
growth
restriction.
To
identify
possible
mechanisms
euthanized
during
peak
parasitemia
(8
days
post
infection),
outcomes
mock-infected
dams.
significant
systemic
immune
activation
elevated
circulating
lymphocytes,
eosinophils,
neutrophils
splenic
cytokine
concentrations.
corticosterone
decreased
progesterone
concentrations,
could
contribute
perinatal
through
immunomodulation.
There
limited
changes
fecal
microbiome
after
infection.
Mosquito
malaria
provides
a
novel,
tractable
model
investigate
therapeutic
treatments.
The Obstetrician & Gynaecologist,
Год журнала:
2025,
Номер
27(1), С. 43 - 56
Опубликована: Янв. 1, 2025
Key
content
COVID‐19
is
known
to
be
associated
with
significant
morbidity
for
pregnant
women
and
their
babies.
This
susceptibility
adverse
clinical
outcomes
may
the
unique
physiological
characteristics
of
host.
Public
health
measures
recommended
management
prevention
critical
in
pregnancy
lactation
evolved
during
2020
pandemic;
some
decisions
were
controversial.
We
highlight
lessons
learnt
considerations
future
pandemic
preparedness.
Learning
objectives
To
outline
pathology
pregnancy,
including
placental
involvement.
summarise
current
evidence‐based
signpost
resources
updates.
discuss
role
vaccines
reduce
mortality
existing
novel
SARS‐CoV‐2
viral
strains.
Ethical
issues
Sustained
international
collaborative
strategies
are
crucial
ensure
global
equity
access
treatment
communicable
diseases.
The Pediatric Infectious Disease Journal,
Год журнала:
2025,
Номер
44(2S), С. S13 - S15
Опубликована: Фев. 1, 2025
Background:
The
maternal
immunization
platform
has
multiple
vaccines
already
being
utilized
with
more
considered.
Methods:
We
describe
areas
knowledge
gaps
regarding
including
(1)
pathogen,
(2)
vaccine
product,
(3)
strategy,
(4)
implementation
research
and
(5)
Regulatory
Public
Health
Policy.
Results:
Despite
advances
in
clinical
during
pregnancy,
many
questions
remain
administration,
products,
coadministration
of
acceptance.
Issues
antibody
transfer
high-risk
pregnancies
need
further
study.
Conclusions:
Moving
new
forward
will
take
support
from
a
broad
array
experts.