The Food and Drug Administration approved an experimental Zika vaccine called GLS-5700 for a clinical trial in humans earlier today, the first such treatment to get an official nod from the agency. Initial trials will start with 40 healthy subjects getting dosed in the coming weeks, and if all goes without a hitch, preliminary results should be available later this year.
As Stat News points out, the thing to remember here is that this trial is meant to determine the vaccine’s safety and proper dosage levels in humans. Assuming this first round yields valuable results, further trials will see the vaccine given to people actually infected with Zika. As such, there’s really no telling how effective the vaccine currently is. So far though, creators Inovio and GeneOne say the experimental treatment has produced “robust antibody a T cell responses” in small and large animals — a promising sign for its chances to combat Zika in humans.
The news comes just days after a CDC disclosure defined the scope of Zika-related birth defects in the US — so far, three mothers have delivered babies with brain damage, while three others have terminated their pregnancies because of brain damage caused by the disease. The FDA also recently granted emergency approval to a Zika test produced by a Hologix, a Massachusetts-based pharmaceutical company. No Zika test has received full FDA approval, but this emergency approval gives laboratories the latitude to run the test if (or when) an official Zika outbreak occurs. This now means there are two tests — the other comes from Quest Diagnostics — available for use in critical situations where faster diagnoses could mean all the difference.