TY - JOUR
T1 - COVID-19 vaccines
T2 - Considering sex differences in efficacy and safety
AU - Jensen, Adelaide
AU - Stromme, Masha
AU - Moyassari, Shayda
AU - Chadha, Antonella Santuccione
AU - Tartaglia, Maria Carmela
AU - Szoeke, Cassandra
AU - Ferretti, Maria Teresa
N1 - Publisher Copyright:
© 2022 Elsevier Inc.
PY - 2022/4
Y1 - 2022/4
N2 - The development of SARS-CoV-2 vaccines represents a significant breakthrough for managing the COVID-19 pandemic. However, their approval process has exposed a crucial limitation in clinical trial reports—that is, a disregard for sex differences in response to vaccines. Historically, males and females have shown different reactions to vaccines of many kinds, which have become apparent with the arrival of COVID-19 vaccines in late-2020. In this article, we review regulatory data from Phase III vaccine trials as well as peer-reviewed reports from vaccines administered to the general population, many of which failed to stratify results by sex. We also discuss the exclusion of pregnant and lactating persons in drug development and the regulatory guidelines for use of COVID-19 vaccines in such populations. We conclude by proposing some questions to stimulate discussion with the intent of advancing the field toward precision medicine.
AB - The development of SARS-CoV-2 vaccines represents a significant breakthrough for managing the COVID-19 pandemic. However, their approval process has exposed a crucial limitation in clinical trial reports—that is, a disregard for sex differences in response to vaccines. Historically, males and females have shown different reactions to vaccines of many kinds, which have become apparent with the arrival of COVID-19 vaccines in late-2020. In this article, we review regulatory data from Phase III vaccine trials as well as peer-reviewed reports from vaccines administered to the general population, many of which failed to stratify results by sex. We also discuss the exclusion of pregnant and lactating persons in drug development and the regulatory guidelines for use of COVID-19 vaccines in such populations. We conclude by proposing some questions to stimulate discussion with the intent of advancing the field toward precision medicine.
KW - COVID-19
KW - Pregnancy
KW - Sex differences
KW - Vaccines
UR - http://www.scopus.com/inward/record.url?scp=85124753318&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2022.106700
DO - 10.1016/j.cct.2022.106700
M3 - Review Article
C2 - 35149232
AN - SCOPUS:85124753318
SN - 1551-7144
VL - 115
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 106700
ER -
