Zika Virus: Experimental Vaccine Human Trials Approved By FDA

The U.S. FDA has approved human trials of an experimental vaccine for the Zika virus, according to reports. The news comes as the Zika virus, which causes devastating birth defects in fetuses of infected mothers, continues to ravage the world and its impacts continue to grow and become more profound. The Zika virus is mosquito-borne and has also been determined to be sexually transmittable. The human trials of the new experimental Zika vaccine mark a milestone and hopefully a turning point as scientists and healthcare professionals continue to struggle to combat the Zika virus.


As RT reports, the human trials of the experimental Zika virus vaccine will be carried out by Inovio Pharmaceuticals, which is based in Pennsylvania. The announcement that experimental human trials of the vaccine had been approved by the U.S. FDA was made on Monday. Following the newly-attained FDA approval of the Zika vaccine, human trials are expected to begin within the next few weeks.

“We are proud to have attained the approval to initiate the first Zika vaccine study in human volunteers. As of May 2016, 58 countries and territories reported continuing mosquito-borne transmission of the Zika virus; the incidences of viral infection and medical conditions caused by the virus are expanding, not contracting.”

The new, experimental vaccine for the Zika virus is known as GLS-5700, and human trials will begin with a limited number of human volunteers. Currently, it is expected that 40 people will participate in the voluntary human trials of the experimental Zika vaccine. The goal of the upcoming trial for the Zika virus vaccine is to determine whether or not the experimental vaccine is both effective at preventing Zika and safe to use on healthy humans.

Reportedly, preliminary Zika vaccine results should be available as soon as the end of 2016, presuming that all goes according to plan.

The new, experimental Zika virus vaccine works in the same method as all vaccines. Namely, GLS-5700 exposes the body’s immune system to “genetic material similar enough to the virus” so that the individual’s body is able to develop an immune response to the virus.


The new Zika vaccine, soon to be tested on humans, has already gone through an animal testing phase. According to representatives from the pharmaceutical company, it has proven to provide valuable immune protection against the Zika virus in animals. During the upcoming Phase I human trials of the vaccine, scientists will try to determine an “appropriate dosage level” for human beings.

If this first phase of human clinical trials of the experimental Zika virus vaccine go well and demonstrate a safe and effective human immune potential, subsequent trials will take place. The secondary human trials of the experimental Zika virus vaccine are slated to utilize human volunteers who already have the Zika virus.

The announcement of the experimental Zika virus vaccine trials comes at a time when scientists and the medical community have really begun to panic about the spread of the Zika virus, which currently has no vaccine or effective drug treatment. According to the National Institutes of Health, Zika has already reached “pandemic” status in the Americas, and more and more “Zika babies” are being born every day.


The Zika virus is primarily spread by the bite of the mosquito Aedes aegypti, which is widespread in the tropics. In most cases, the symptoms of the Zika virus are relatively mild and are generally limited to a rash and fever. However, in fetuses, the impact of the Zika virus is profound and debilitating. Serious birth defects that have suddenly reached epidemic proportions in South and Central America are attributed to the Zika virus.

The most common birth defect associated with exposure to the Zika virus in utero is microcephaly; however it is believed that Zika is also responsible for additional birth defects such as vision problems, impaired growth, and hearing loss.


In some cases, exposure to the Zika virus causes fetal death, miscarriage, and stillbirth.

The new experimental Zika vaccine’s human trials were approved only days after the CDC released its initial report on “Zika pregnancies” in the United States. That report, which was released last Thursday, indicates that six babies/fetuses in the U.S. are known to have been impacted by Zika-related birth defects.

Three of those impacted were born with severe birth defects related to the Zika virus but survived. The other three impacted fetuses were miscarried.

Scientists and the medical community are hopeful that the experimental new Zika virus vaccine may help prevent future birth defects caused by the virus.

[Photo by Mario Tama/Getty Images]