First human trial of a potential Zika vaccine has received green light from the US Food and Drug Administration (FDA) on Monday. Inovio Pharmaceuticals and GeneOne Life Science will perform the study. They have already done promising animal trials. According to them, phase one with 40 healthy adults will start in the next coming weeks.
As per the Guardian, known as GLS-5700, the vaccine has been made on the basis of synthetic fragments of virus DNA that fuel antibodies.
It may deliver results this year, but researchers have warned that it still would have a long way, years, to hit the market.
Also, while speaking to the Guardian, Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College in Houston, said, “since the vaccine would likely be needed for pregnant women or women who are about to become pregnant, the FDA will want to see extensive safety data in these populations”.
In February, the WHO declared Zika a global public-health emergency. Primarily, it spreads through mosquito bites, but its transmission can also take place sexually. Over 1 million cases have been reported throughout 39 nations and territories.
The disease’s effects are mild in most of the cases, but it has been associated with Guillain-Barré syndrome and results into problems for expectant women. In Brazil, around 5,000 cases of newborns with the birth defect microcephaly have been reported. So far, there isn’t any treatment or vaccine for Zika virus.
"The Food and Drug Administration on Monday for the first time approved a clinical trial for an experimental vaccine for Zika virus, an early but significant step in the effort to combat a disease that has quickly emerged as a global health threat," according to a news report published by Boston Globe.
The first people could be injected within a few weeks, said Inovio President and CEO Dr. Joseph Kim. Inovio, of Plymouth Meeting, Pa., and GeneOne Life Science, of Seoul, South Korea, will make the vaccine.
Interim results from the trial, which will involve 40 healthy adults, are expected later this year. Testing in mice and monkeys has shown the vaccine triggered what Inovio called a robust antibody response.
According to a report in CNN by Jen Christensen, "Inovio, which is based in Plymouth Meeting, Pennsylvania, and GeneOne Life Science, which is based in Seoul, South Korea, worked together on the vaccine. They previously collaborated to create vaccines for Ebola and MERS, both of which are being tested."
In the animal testing stage, the vaccine caused a strong antibody response, the company said. It is still very early in the vaccine's development. Phase I of a vaccine trial ensures that it can be tolerated well in human subjects.
If successful in this first round of human testing, it will need additional approval for further testing. At the next stage, the vaccine would be tested on people who have Zika. Then there would be a stage to see how well it works on a larger group of people.
According to a deal announced by Microsoft, the company’s online store is offering a markdown on the Lumia 550 smartphone. The handset, which was originally priced at $139, is being sold by the Microsoft online store for $99 unlocked.
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