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.
Anales de Pediatría (English Edition),
Год журнала:
2024,
Номер
100(4), С. 268 - 274
Опубликована: Апрель 1, 2024
During
pregnancy,
physiological
changes
in
the
immune
response
make
pregnant
women
more
susceptible
to
serious
infection,
increasing
risk
for
mother
as
well
foetus,
newborn
and
infant.
All
should
be
correctly
fully
vaccinated
they
enter
their
reproductive
years,
especially
against
diseases
such
tetanus,
hepatitis
B,
measles,
rubella
varicella.
In
addition
recommended
vaccines,
situations,
inactivated
vaccines
could
administered
who
were
not
before,
while
attenuated
are
contraindicated.
Despite
fact
that
vaccination
during
pregnancy
is
a
very
important
preventive
measure
existing
recommendations
from
public
health
authorities,
scientific
societies
professionals,
coverage
clearly
improved,
influenza
SARS-CoV-2,
so
any
professional
involved
care
of
proactively
recommend
these
vaccines.
The
Spanish
Association
Pediatrics
(AEP),
through
its
Advisory
Committee
on
Vaccines,
Society
Gynaecology
Obstetrics
(SEGO)
following
pregnancy:
COVID-19,
trimester
postpartum
period
(up
6
months
post
birth)
pregnancy;
pertussis,
with
Tdap
vaccine,
between
weeks
27
36
gestation
(in
CAV-AEP
recommendations,
preferably
28);
RSV,
RSVPreF,
24
gestation,
32
36.
Durante
el
embarazo,
los
cambios
fisiológicos
en
la
respuesta
inmunitaria
favorecen
que
las
gestantes
sean
más
susceptibles
infecciones
graves,
tanto
para
ellas
como
feto,
recién
nacido
y
lactante.
Todas
mujeres
deberían
entrar
período
reproductivo
con
su
calendario
vacunal
correctamente
cumplimentado,
sobre
todo
lo
respecta
enfermedades
tétanos,
sarampión,
rubeola
varicela.
Además
de
vacunas
recomendadas,
situaciones
riesgo
inactivadas
podrían
ser
administradas
aquellas
no
estuvieran
inmunizadas
anterioridad,
mientras
atenuadas
están
contraindicadas.
A
pesar
vacunación
durante
embarazo
es
una
medida
preventiva
muy
importante,
recomendaciones
autoridades
sanitarias,
sociedades
científicas
profesionales
sanitarios,
coberturas
vacunales
son
claramente
mejorables,
especialmente
gripe
por
profesional
sanitario
atienda
embarazada
debe
proactivo
aconsejarlas.
La
Asociación
Española
Pediatría,
través
Comité
Asesor
Vacunas,
Sociedad
Ginecología
Obstetricia
recomiendan
siguientes
vacunaciones
gestación:
frente
cualquier
trimestre
del
puerperio
(hasta
meses)
hubieran
sido
vacunadas
gestación;
tosferina
Tdpa,
entre
semanas
gestación
(el
da
preferencia
28
semanas);
al
VRS
gestación,
semanas.
Medicine,
Год журнала:
2023,
Номер
102(9), С. e32954 - e32954
Опубликована: Март 2, 2023
Introduction:
Numerous
vaccines
have
been
evaluated
and
approved
for
coronavirus
disease
2019
(COVID-19).
Since
pregnant
persons
excluded
from
most
clinical
trials
of
COVID-19
vaccines,
sufficient
data
regarding
the
safety
these
person
their
fetus
rarely
available
at
time
product
licensure.
However,
as
deployed,
on
safety,
reactogenicity,
immunogenicity,
efficacy
neonates
are
becoming
increasingly
available.
A
living
systematic
review
meta-analysis
effectiveness
newborns
could
provide
information
necessary
to
help
guide
vaccine
policy
decisions.
Methods
analysis:
We
aim
conduct
a
based
biweekly
searches
medical
databases
(e.g.,
MEDLINE,
EMBASE,
CENTRAL)
trial
registries
systematically
identify
relevant
studies
persons.
Pairs
reviewers
will
independently
select,
extract
data,
risk
bias
assessments.
include
randomized
trials,
quasi-experimental
studies,
cohort,
case-control,
cross-sectional
case
reports.
Primary
outcomes
be
efficacy,
in
persons,
including
neonatal
outcomes.
Secondary
immunogenicity
reactogenicity.
paired
meta-analyses,
prespecified
subgroup
sensitivity
analyses.
use
grading
recommendations
assessment,
development,
evaluation
approach
evaluate
certainty
evidence.
Journal of Korean Medical Science,
Год журнала:
2023,
Номер
38(41)
Опубликована: Янв. 1, 2023
We
aimed
to
assess
the
risk
of
maternal
severe
acute
respiratory
syndrome
coronavirus
2
(SARS-CoV-2)
infection
and
early
abortive
outcomes
after
association
between
disease
2019
(COVID-19)
vaccination
during
preconceptional
period
preclinical
pregnancy,
which
are
likely
be
inadvertent
vaccination.We
used
data
from
Korea
Disease
Control
Prevention
Agency-COVID19-National
Health
Insurance
Service
cohort
December
2020
2021.
The
vaccinated
pregnant
women
were
matched
unvaccinated
controls
at
a
1:4
ratio.
risks
SARS-CoV-2
intensive
care
unit
(ICU)
admission
within
14
days
analyzed
its
effectiveness.
For
safety
measures,
adjusted
relative
(aRRs)
for
first
COVID-19
periods
calculated
considering
covariates.
compared
abortion
mRNA
viral
vector
vaccines.The
overall
rates
pregnancy
3.1%
(6,662/215,211)
2.6%
(5,702/215,211),
respectively.
cumulative
incidence
ICU
was
6/100,000
in
group,
whereas
there
no
admissions
groups.
not
significantly
different
group
(aRR,
1.04;
95%
confidence
interval
[CI],0.99-1.10)
or
their
(1.02;
CI,
0.96-1.08).
vaccines
have
shown
similar
miscarriages.Our
findings
provided
compelling
evidence
regarding
effectiveness
prior
pregnancy.
Further
research
is
required
extend
efficacy
profiles
babies.
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.
