Experts Discuss Use Of Experimental Ebola Vaccine Among Pregnant Women In Healio Opinion Pieces

Healio: Point/Counter: Should pregnant women receive an Ebola vaccine despite WHO recommendations?Point: Inclusion of pregnant women in live vaccine trials is an ethical imperative
W. Christopher Golden, medical director of the newborn nursery at Johns Hopkins Hospital and assistant professor of pediatrics at Johns Hopkins University School of Medicine, and Jeanne S. Sheffield, director of the division of maternal-fetal medicine at Johns Hopkins Hospital and professor of gynecology and obstetrics at Johns Hopkins University School of Medicine

“…Although there has been a pervasive presumption of exclusion of pregnant women in live vaccine trials and clinical initiatives, inclusion of these women is an ethical imperative in the setting of this devastating disease. … In Ebola-endemic regions, immunization should be offered (with informed consent) to pregnant women to reduce perinatal mortality, coordinated with prospective monitoring of maternal and neonatal outcomes. … Additionally, future clinical trials of immunotherapy against Ebola designed to delineate further potential benefits should include pregnant women and women of childbearing age. Respectful engagement and collaboration between international organizations (such as WHO), clinical researchers, and governmental leaders will facilitate improved outcomes in these vulnerable populations” (October 2018).

Counter: An unlicensed Ebola vaccine could be given to pregnant women now only if both DRC and WHO agree
Daniel R. Lucey, senior scholar with the O’Neill Institute for National and Global Health Law and adjunct professor of medicine and infectious diseases at Georgetown University Medical Center

“…For the benefit of patients now and in the future — pregnant and nonpregnant — no unlicensed Ebola vaccine should be given ‘despite WHO recommendations.’ To do so would jeopardize the collaborative efforts between the [Democratic Republic of the Congo (DRC)] and WHO in gaining the trust of the patients, their contacts, and their communities. This trust is essential to stop Ebola epidemics. Instead, the DRC and WHO should agree to convene an international meeting as soon as possible this October to address all aspects of this issue, including ethical, medical, risk communication, regulatory, and more. … Truly informed consent must be obtained, and comprehensive monitoring for safety and efficacy must be carried out, if the decision is made to offer this unlicensed vaccine to pregnant women…” (October 2018).

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