Mary Wilson
Well-known member
Published:October 21, 2021
DOI:https://doi.org/10.1016/S0140-6736(21)02282-0
Kushalinii Hillson, Sue Costa Clemens, Shabir A Madhi, Merryn Voysey, Andrew J Pollard, Angela M Minassian, et al.
Fears of adverse effects of COVID-19 vaccination on fertility have affected vaccine uptake in some communities. Despite the absence of supporting evidence for such a risk, low biological plausibility, and preliminary data supporting the safety of mRNA vaccines in pregnancy,[SUP]1[/SUP][SUP], [/SUP] [SUP]2[/SUP][SUP], [/SUP] [SUP]3[/SUP] this claim has become widespread, and it has been challenged by WHO.[SUP]4[/SUP] Vaccine hesitancy during pregnancy, or among women of childbearing age, could have substantial public health consequences because infection with SARS-CoV-2 during pregnancy is a risk factor for severe maternal illness and complications.[SUP]5[/SUP][SUP], [/SUP] [SUP]6[/SUP]
We have analysed pregnancies that have occurred in four ongoing phase 1, phase 2, and phase 3 clinical trials of ChAdOx1 nCoV-19 (AZD1222)[SUP]7[/SUP] in three countries (NCT04324606 and NCT04400838 in the UK; NCT04536051 in Brazil; and NCT04444674in South Africa). Participants of childbearing age (defined as 49 years or younger) were randomly assigned to receive ChAdOx1 nCoV-19 or the control vaccine. Pregnancy was an exclusion criterion in all four trials, and all female volunteers tested negative for urine β-hCG before vaccination. Any pregnancies that occurred after vaccination were recorded and followed up until 3 months after birth. Pregnancy outcomes were reviewed by the independent data and safety monitoring board.
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https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02282-0/fulltext#tables
DOI:https://doi.org/10.1016/S0140-6736(21)02282-0
Kushalinii Hillson, Sue Costa Clemens, Shabir A Madhi, Merryn Voysey, Andrew J Pollard, Angela M Minassian, et al.
Fears of adverse effects of COVID-19 vaccination on fertility have affected vaccine uptake in some communities. Despite the absence of supporting evidence for such a risk, low biological plausibility, and preliminary data supporting the safety of mRNA vaccines in pregnancy,[SUP]1[/SUP][SUP], [/SUP] [SUP]2[/SUP][SUP], [/SUP] [SUP]3[/SUP] this claim has become widespread, and it has been challenged by WHO.[SUP]4[/SUP] Vaccine hesitancy during pregnancy, or among women of childbearing age, could have substantial public health consequences because infection with SARS-CoV-2 during pregnancy is a risk factor for severe maternal illness and complications.[SUP]5[/SUP][SUP], [/SUP] [SUP]6[/SUP]
We have analysed pregnancies that have occurred in four ongoing phase 1, phase 2, and phase 3 clinical trials of ChAdOx1 nCoV-19 (AZD1222)[SUP]7[/SUP] in three countries (NCT04324606 and NCT04400838 in the UK; NCT04536051 in Brazil; and NCT04444674in South Africa). Participants of childbearing age (defined as 49 years or younger) were randomly assigned to receive ChAdOx1 nCoV-19 or the control vaccine. Pregnancy was an exclusion criterion in all four trials, and all female volunteers tested negative for urine β-hCG before vaccination. Any pregnancies that occurred after vaccination were recorded and followed up until 3 months after birth. Pregnancy outcomes were reviewed by the independent data and safety monitoring board.
...
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02282-0/fulltext#tables