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The inclusion of pregnant women in live vaccine trials is an ethical imperative.
Almost universal fetal, neonatal and maternal mortality associated with Ebola virus infections during pregnancy requires the development of a strategy to improve perinatal outcomes. Immunization of pregnant women with live attenuated vaccines is usually contraindicated because of theoretical concerns about the damage to the fetus from transplacental acquisition of the virus. Although there is a general presumption of exclusion of pregnant women in live vaccine trials and clinical initiatives, the inclusion of these women is an ethical imperative in the context of this devastating disease.
W. Christopher Golden
Data on pregnant women receiving live attenuated rubella vaccine (including those vaccinated inadvertently) did not show any adverse effects (ie, congenital rubella syndrome). In addition, the deaths of pregnant women infected with Ebola and their newborns during the 2014 outbreak in Sierra Leone, as well as reported safety and immunogenicity of anti-AIDS vaccines. -Ebola attenuated in the course of clinical trials, suggest that the risk of vaccination of the mother and fetus will be significantly lower than natural. infection.
Jeanne S. Sheffield
In areas where Ebola is endemic, immunization should be offered (with informed consent) to pregnant women to reduce perinatal mortality, in coordination with prospective surveillance of maternal and newborn outcomes. This strategy is in line with the longstanding principle, "Do not penalize a woman for her pregnancy". In addition, future clinical trials of Ebola immunotherapy to identify other potential benefits should include pregnant women and women of childbearing potential. Respectful engagement and collaboration from international organizations (such as WHO), clinical researchers, and government leaders will facilitate improved outcomes for these vulnerable populations.
References:
Bar-Oz B et al. Follow J Med Genet A. 2004; doi: 10.1002 / ajmg.a.30225.
Levy Y et al. Lancet. 2018; doi: 10.1016 / S0140-6736 (18) 31710-0.
Lyman M, et al. Int J Gynaecol Obstet. 2018; doi: 10.1002 / ijgo.12490.
W. Christopher Golden, MD, is a neonatologist, medical director of the Newborn Nursery at Johns Hopkins Hospital and an assistant professor of pediatrics at the Johns Hopkins University School of Medicine. Jeanne S. Sheffield, MD, is director of the Division of Maternal and Fetal Medicine at Johns Hopkins Hospital and Professor of Gynecology and Obstetrics at the Johns Hopkins University School of Medicine. Disclosures: Golden and Sheffield do not report any relevant financial information.
An unlicensed Ebola vaccine could be given to pregnant women now only if the DRC and the WHO are in agreement.
There is a clear and collaborative answer to this question. Realistically, the way forward should first involve stakeholders in the DRC who are battling this Ebola outbreak. It's their country. In the interest of patients today and tomorrow – pregnant and nonpregnant – no unlicensed Ebola vaccine should be administered "despite WHO recommendations". Otherwise, collaborative efforts between the DRC and WHO to gain the trust of patients would be compromised. contacts and their communities. This trust is essential to ending Ebola outbreaks.
Instead, the DRC and WHO should agree to convene an international meeting as soon as possible in October to consider all aspects of this issue, including ethics, medicine, risk communication, regulation, etc. . All safety data should be shared regarding pregnant women who received this vaccine in West Africa and among the 13,000 vaccines in the DRC registered to date in 2018.
Daniel R. Lucey
A truly informed consent must be obtained and a complete monitoring of the safety and effectiveness must be carried out if the decision is made to offer this vaccine without a license to pregnant women. This timely meeting would follow the recent example of the meeting of 27 August 2018, convened by the DRC and WHO to update opinions on five experimental Ebola treatments. (posted on the WHO website on 7 September).
My point of view is influenced by the care of many patients with Ebola in 2014 in West Africa. In an Ebola treatment unit at Médecins Sans Frontières, two of our patients were pregnant. Our best efforts have failed to help them survive. During the 2016 yellow fever epidemic in the DRC, I met with Congolese colleagues who are currently fighting the Ebola virus for the third time since 2017.
Daniel R. Lucey, MD, MPH, is Principal Investigator at the O'Neill Institute for Global and National Health Law, Adjunct Professor of Medicine and Infectious Diseases at the Georgetown University Medical Center and Associate Researcher in Anthropology at the Smithsonian National Museum of Natural History . Disclosure: Lucey does not report any relevant financial information.
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