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Guidance for design and analysis of observational studies of fetal and newborn outcomes following COVID-19 vaccination during pregnancy
by
Ortiz, Justin R.
, Savitz, David A.
, Fell, Deshayne B.
, Dimitris, Michelle C.
, Platt, Robert W.
, Hutcheon, Jennifer A.
, Regan, Annette K.
in
Allergy and Immunology
/ Bias
/ Calendars
/ Clinical decision making
/ Coronaviruses
/ COVID-19
/ COVID-19 - prevention & control
/ COVID-19 infection
/ COVID-19 vaccination
/ COVID-19 vaccines
/ COVID-19 Vaccines - administration & dosage
/ COVID-19 Vaccines - adverse effects
/ Data collection
/ Decision making
/ Design analysis
/ Disease transmission
/ Epidemiology
/ Estimates
/ experimental design
/ Female
/ Fetus
/ Fetuses
/ Humans
/ Immunization
/ Infant, Newborn
/ Maternal Exposure
/ neonates
/ Observational studies
/ Observational Studies as Topic
/ pandemic
/ Pandemics
/ Pharmacovigilance
/ Population studies
/ Pregnancy
/ Premature birth
/ Public health
/ Research Design
/ risk
/ Severe acute respiratory syndrome coronavirus 2
/ Short Communication
/ Subgroups
/ Swine flu
/ vaccination
/ Vaccination - adverse effects
/ Vaccine safety
/ Vaccines
2021
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Guidance for design and analysis of observational studies of fetal and newborn outcomes following COVID-19 vaccination during pregnancy
by
Ortiz, Justin R.
, Savitz, David A.
, Fell, Deshayne B.
, Dimitris, Michelle C.
, Platt, Robert W.
, Hutcheon, Jennifer A.
, Regan, Annette K.
in
Allergy and Immunology
/ Bias
/ Calendars
/ Clinical decision making
/ Coronaviruses
/ COVID-19
/ COVID-19 - prevention & control
/ COVID-19 infection
/ COVID-19 vaccination
/ COVID-19 vaccines
/ COVID-19 Vaccines - administration & dosage
/ COVID-19 Vaccines - adverse effects
/ Data collection
/ Decision making
/ Design analysis
/ Disease transmission
/ Epidemiology
/ Estimates
/ experimental design
/ Female
/ Fetus
/ Fetuses
/ Humans
/ Immunization
/ Infant, Newborn
/ Maternal Exposure
/ neonates
/ Observational studies
/ Observational Studies as Topic
/ pandemic
/ Pandemics
/ Pharmacovigilance
/ Population studies
/ Pregnancy
/ Premature birth
/ Public health
/ Research Design
/ risk
/ Severe acute respiratory syndrome coronavirus 2
/ Short Communication
/ Subgroups
/ Swine flu
/ vaccination
/ Vaccination - adverse effects
/ Vaccine safety
/ Vaccines
2021
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Guidance for design and analysis of observational studies of fetal and newborn outcomes following COVID-19 vaccination during pregnancy
by
Ortiz, Justin R.
, Savitz, David A.
, Fell, Deshayne B.
, Dimitris, Michelle C.
, Platt, Robert W.
, Hutcheon, Jennifer A.
, Regan, Annette K.
in
Allergy and Immunology
/ Bias
/ Calendars
/ Clinical decision making
/ Coronaviruses
/ COVID-19
/ COVID-19 - prevention & control
/ COVID-19 infection
/ COVID-19 vaccination
/ COVID-19 vaccines
/ COVID-19 Vaccines - administration & dosage
/ COVID-19 Vaccines - adverse effects
/ Data collection
/ Decision making
/ Design analysis
/ Disease transmission
/ Epidemiology
/ Estimates
/ experimental design
/ Female
/ Fetus
/ Fetuses
/ Humans
/ Immunization
/ Infant, Newborn
/ Maternal Exposure
/ neonates
/ Observational studies
/ Observational Studies as Topic
/ pandemic
/ Pandemics
/ Pharmacovigilance
/ Population studies
/ Pregnancy
/ Premature birth
/ Public health
/ Research Design
/ risk
/ Severe acute respiratory syndrome coronavirus 2
/ Short Communication
/ Subgroups
/ Swine flu
/ vaccination
/ Vaccination - adverse effects
/ Vaccine safety
/ Vaccines
2021
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Guidance for design and analysis of observational studies of fetal and newborn outcomes following COVID-19 vaccination during pregnancy
Journal Article
Guidance for design and analysis of observational studies of fetal and newborn outcomes following COVID-19 vaccination during pregnancy
2021
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Overview
COVID-19 vaccines are now being deployed as essential tools in the public health response to the global SARS-CoV-2 pandemic. Pregnant individuals are a unique subgroup of the population with distinctive considerations regarding risk and benefit that extend beyond themselves to their fetus/newborn. As a complement to traditional pharmacovigilance and clinical studies, evidence to comprehensively assess COVID-19 vaccine safety in pregnancy will need to be generated through observational epidemiologic studies in large populations. However, there are several unique methodological challenges that face observational assessments of vaccination during pregnancy, some of which may be more pronounced for COVID-19 studies. In this contribution, we discuss the most critical study design, data collection, and analytical issues likely to arise. We offer brief guidance to optimize the quality of such studies to ensure their maximum value for informing public health decision-making.
Publisher
Elsevier Ltd,Elsevier Limited,The Author(s). Published by Elsevier Ltd
Subject
/ Bias
/ COVID-19
/ COVID-19 - prevention & control
/ COVID-19 Vaccines - administration & dosage
/ COVID-19 Vaccines - adverse effects
/ Female
/ Fetus
/ Fetuses
/ Humans
/ neonates
/ Observational Studies as Topic
/ pandemic
/ risk
/ Severe acute respiratory syndrome coronavirus 2
/ Vaccination - adverse effects
/ Vaccines
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