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Abstract
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Introduction: The purpose of the study was to evaluate the systematic exclusion of pregnant, breastfeeding, and reproductive-aged females in COVID-19 vaccine and treatment clinical trials due to historic patterns of exclusion.
Methods: Data was extracted from all COVID-19 vaccine and treatment clinical trials from May 1 to October 31, 2020 using the U.S. National Library of Medicine database. Trials were categorized into vaccine and treatment modalities and compared to pregnancy and lactation exclusion and contraception requirement status via chi-square tests.
Results: Pregnant and lactating females were explicitly excluded from the majority of COVID-19 vaccine and treatment clinical trials. Of the 90 vaccine trials, 88 (97.8%) excluded based on pregnancy, 73 (81.1%) lactation, and 56 (62.2%) required contraception use. Of the 495 treatment trials, 350 (70.7%) excluded based on pregnancy, 269 (54.3%) lactation, and 91 (18.4%) required contraception use. Although vaccine modality was not associated with pregnancy exclusion, it was associated with lactation exclusion (p=0.01) and contraception requirement (p < 0.001). Treatment modality was associated with pregnancy exclusion, lactation exclusion, and contraception requirement (all p < 0.001).
Conclusion/Implications: COVID-19 vaccination and treatment clinical trials mirrored historical trends of exclusion among reproductive-aged females based on presumed or unknown risks. Females of reproductive age face barriers to research participation due to restrictions on pregnancy and lactation while imposing contraception requirements. These results emphasize the necessary action needed to address these patterns and grant autonomy to reproductive-aged females, especially in the setting of a global pandemic.
Methods: Data was extracted from all COVID-19 vaccine and treatment clinical trials from May 1 to October 31, 2020 using the U.S. National Library of Medicine database. Trials were categorized into vaccine and treatment modalities and compared to pregnancy and lactation exclusion and contraception requirement status via chi-square tests.
Results: Pregnant and lactating females were explicitly excluded from the majority of COVID-19 vaccine and treatment clinical trials. Of the 90 vaccine trials, 88 (97.8%) excluded based on pregnancy, 73 (81.1%) lactation, and 56 (62.2%) required contraception use. Of the 495 treatment trials, 350 (70.7%) excluded based on pregnancy, 269 (54.3%) lactation, and 91 (18.4%) required contraception use. Although vaccine modality was not associated with pregnancy exclusion, it was associated with lactation exclusion (p=0.01) and contraception requirement (p < 0.001). Treatment modality was associated with pregnancy exclusion, lactation exclusion, and contraception requirement (all p < 0.001).
Conclusion/Implications: COVID-19 vaccination and treatment clinical trials mirrored historical trends of exclusion among reproductive-aged females based on presumed or unknown risks. Females of reproductive age face barriers to research participation due to restrictions on pregnancy and lactation while imposing contraception requirements. These results emphasize the necessary action needed to address these patterns and grant autonomy to reproductive-aged females, especially in the setting of a global pandemic.
Introduction: The purpose of the study was to evaluate the systematic exclusion of pregnant, breastfeeding, and reproductive-aged females in COVID-19 vaccine and treatment clinical trials due to historic patterns of exclusion.
Methods: Data was extracted from all COVID-19 vaccine and treatment clinical trials from May 1 to October 31, 2020 using the U.S. National Library of Medicine database. Trials were categorized into vaccine and treatment modalities and compared to pregnancy and lactation exclusion and contraception requirement status via chi-square tests.
Results: Pregnant and lactating females were explicitly excluded from the majority of COVID-19 vaccine and treatment clinical trials. Of the 90 vaccine trials, 88 (97.8%) excluded based on pregnancy, 73 (81.1%) lactation, and 56 (62.2%) required contraception use. Of the 495 treatment trials, 350 (70.7%) excluded based on pregnancy, 269 (54.3%) lactation, and 91 (18.4%) required contraception use. Although vaccine modality was not associated with pregnancy exclusion, it was associated with lactation exclusion (p=0.01) and contraception requirement (p < 0.001). Treatment modality was associated with pregnancy exclusion, lactation exclusion, and contraception requirement (all p < 0.001).
Conclusion/Implications: COVID-19 vaccination and treatment clinical trials mirrored historical trends of exclusion among reproductive-aged females based on presumed or unknown risks. Females of reproductive age face barriers to research participation due to restrictions on pregnancy and lactation while imposing contraception requirements. These results emphasize the necessary action needed to address these patterns and grant autonomy to reproductive-aged females, especially in the setting of a global pandemic.
Methods: Data was extracted from all COVID-19 vaccine and treatment clinical trials from May 1 to October 31, 2020 using the U.S. National Library of Medicine database. Trials were categorized into vaccine and treatment modalities and compared to pregnancy and lactation exclusion and contraception requirement status via chi-square tests.
Results: Pregnant and lactating females were explicitly excluded from the majority of COVID-19 vaccine and treatment clinical trials. Of the 90 vaccine trials, 88 (97.8%) excluded based on pregnancy, 73 (81.1%) lactation, and 56 (62.2%) required contraception use. Of the 495 treatment trials, 350 (70.7%) excluded based on pregnancy, 269 (54.3%) lactation, and 91 (18.4%) required contraception use. Although vaccine modality was not associated with pregnancy exclusion, it was associated with lactation exclusion (p=0.01) and contraception requirement (p < 0.001). Treatment modality was associated with pregnancy exclusion, lactation exclusion, and contraception requirement (all p < 0.001).
Conclusion/Implications: COVID-19 vaccination and treatment clinical trials mirrored historical trends of exclusion among reproductive-aged females based on presumed or unknown risks. Females of reproductive age face barriers to research participation due to restrictions on pregnancy and lactation while imposing contraception requirements. These results emphasize the necessary action needed to address these patterns and grant autonomy to reproductive-aged females, especially in the setting of a global pandemic.
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