FDA Approves Human Trials For Controversial Zika Vaccine

Human trials will begin soon, despite controversy over the safety of the vaccine.

Credit: Your News Wire

Credit: Your News Wire

The U.S. Food and Drug Administration has officially approved testing of the Zika vaccine on humans, despite controversy over using DNA vaccines

Forty volunteers from Miami, Philadelphia, and Quebec City have been chosen as the first humans to have the vaccine injected, and its side effects and effectiveness tested.

The Zika virus became a huge epidemic in Central and South American countries last year, when it allegedly caused microcephaly in infants whose carrying mothers were infected with the virus through mosquitos. Whether the virus was actually to blame is hotly debated, but either way, pharmaceutical companies went to work to create a vaccine in a short period of time to prevent further cases of microcephaly.

Inovio Pharmaceuticals, the company that convened late last year and decided to pull out all the stops to develop a vaccine, used Canada’s National Microbiology Laboratory to do the initial testing on mice.

The response from the mice was positive, and Inovio said they had a “robust antibody response.” Gary Kobinger, a chief of special pathogens at the lab where the testing was conducted, said that it took only nine months from the time Inovio decided to develop the vaccine until the FDA gave the approval for human trials.

“I think that’s really phenomenal,” Kobinger said of the fast process.

However, despite this success, release of a working vaccine to the public is still years away. Many tests need to be run in order to determine that the vaccine is safe for widespread use, and changes to the vaccine will need to be made along the way.

Despite celebration over the quick development of a promising shot, skeptics point out that not much is known about the long-term effects of DNA vaccines. Past research has shown that injected DNA vaccines could cause insertional mutagenesis, which is when mutations occur after new genetic material is inserted into a normal gene.

Insertional mutagenesis could increase a person’s risk of getting cancer, and inserting the vaccine into a healthy person could have unknown effects on their body over time.

Though there is some skepticism surrounding these vaccines, companies were quick to act on the Zika virus hysteria, and profit from the fear of citizens that are at risk of contracting the virus. With the volunteers already chosen, the human trials should begin fairly soon, pushing the vaccine even closer to completion.

What are your thoughts on these human trials? Please share, like, and comment on this article!

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