Friday February 05, 2016

Concerns over clinical trials with pregnant women could delay a Zika vaccine

Mothers with their children, who have microcephaly, await medical care at the Hospital Oswaldo Cruz, in Recife, Brazil, January 26, 2016. Health authorities in the Brazilian state at the center of a rapidly spreading Zika outbreak have been overwhelmed by the alarming surge in cases of babies born with microcephaly, a neurological disorder associated to the mosquito-borne virus.

Mothers with their children, who have microcephaly, await medical care at the Hospital Oswaldo Cruz, in Recife, Brazil, January 26, 2016. Health authorities in the Brazilian state at the center of a rapidly spreading Zika outbreak have been overwhelmed by the alarming surge in cases of babies born with microcephaly, a neurological disorder associated to the mosquito-borne virus. (Ueslei Marcelino/Reuters)

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In early Feb. 2016, the World Health Organization declared a global health emergency with the Zika virus "spreading,explosively" across Latin and South America. And its apparent link to microcephaly, a serious birth defect that leaves babies with smaller heads and brains, means pregnant women have the most to fear from Zika.

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A pregnant woman waits at the Maternal and Children's Hospital in Tegucigalpa, Jan. 21, 2016. The medical school at the National Autonomous University of Honduras (UNAH) recommended women in the country avoid getting pregnant for the time being due to the presence of the Zika virus. (Orlanda Sierra/AFP/Getty Images)

But even though the race is on in the scientific community to find a Zika vaccine, the prospect of clinical tests involving pregnant women raises some serious concerns. 

Dr. Peter Hotez, one of the world's leading experts on the Zika virus and dean of the National School of Tropical Medicine Baylor College of Medicine, says safety concerns for drug tests on pregnant women will prolong the search for Zika vaccine. He estimates it is possible a vaccine could be created in about two years but not in time to be used for this round of infection.

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Clinical tests involving pregnant women raise some important ethical issues. 

Françoise Baylis, a Canada research chair in bioethics and philosophy at Dalhouse University, is calling for pregnant women to be included in clinical trials at a later stage in the clinical testing process and thinks the pharmaceutical needs of pregnant women are not addressed thanks to the current industry standard of excluding them from testing.


This segment was produced by The Current's Howard Goldenthal.