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1/4 Professors Orkin and Modi recently wrote to the Vaccine Taskforce (VTF )on behalf of the MWF to draw attention to exclusion of pregnant women, young people, children and infants from COVID-19 vaccine trials
Exclusion of these groups is widespread in clinical trials
Exclusion of these groups is widespread in clinical trials
2/4 These groups have a right to benefit from research
WHO estimates 68% of COVID studies exclude women and children
Extrapolating research from men and non-pregnant women is dangerous. Many drugs come to market without in-human fetal safety data, posing risk to unborn fetus
WHO estimates 68% of COVID studies exclude women and children Extrapolating research from men and non-pregnant women is dangerous. Many drugs come to market without in-human fetal safety data, posing risk to unborn fetus
3/4 SARS-CoV2 vaccine development is a key opportunity to demonstrate proactive, intentional inclusion of pregnant women and children. Without appropriate efficacy& effectiveness studies, risks from under, over, inappropriate or ineffective treatment will continue
4/4 MWF recommends the following VTF actions:
1. Advice to pharma companies&other researchers: ensure studies have power to assess effects in pregnant women, young people, children and infants
2. Engagement with the HRA to request inclusion of these groups as the default
1. Advice to pharma companies&other researchers: ensure studies have power to assess effects in pregnant women, young people, children and infants
2. Engagement with the HRA to request inclusion of these groups as the default
