Pregnant Women Absent from Zika Vaccine Trials

Some vaccine developers are taking steps to include them, in line with bioethicists' urging, but it will likely take years before any expectant mothers are enrolled.

Written byAggie Mika
| 8 min read

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ISTOCK, JOVANMANDICWhen it comes to Zika infection, pregnant women have the most to lose. If the virus is passed from mother to baby, the debilitating effects on fetal health are irrevocable or fatal. While there are no known treatments or countermeasures against an infection, there are a handful of vaccines currently in early phases of human testing that are reportedly demonstrating promising results.

But not in pregnant women. At least, not yet.

Researchers leading current vaccine trials say that in the initial stages of testing, including pregnant women would be risky, premature, and difficult to justify to regulatory authorities. For some vaccines, however, their eventual inclusion could be on the horizon.

The inactivated Zika virus vaccine (ZPIV) is among those currently in Phase 1 clinical trials. In this initial stage of testing, researchers are evaluating whether the vaccine is safe and can prompt an immune response.

Women do indeed get vaccinated while pregnant—against the flu or tetanus, diphtheria, and pertussis (Tdap), for example.

From the trial’s conception, “all of us were mindful of [Zika’s] risks to pregnant women,” says Nelson Michael, director of the US Military HIV Research ...

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