Health

Zika Vaccine Can’t Save Our Summer

In long term it may help, maybe — but not now, not soon, says drug expert

A new Zika vaccine is in the works, but as an investigational medicine scientist, I am not terribly optimistic about this vaccine and don’t see it as something to get excited about, to be blunt.

The National Institutes of Health announced Wednesday that Inovio Pharmaceuticals has a candidate vaccine that it will test on humans for the Zika virus. These first Phase 1 trials will be tested on about 40 healthy volunteers, and that count of 40 people includes the placebo group — meaning that approximately 20 individuals will receive the drug and 20 more people will receive an inert drug.

Vaccines are a great goal for the future control of Zika virus — but having any hope for the near future would be a mistake.

I wrote about the Zika virus a few weeks ago: I predicted this virus will ravage the United States as Congress remains on vacation and the Obama administration seemingly ignores the threat the Zika virus poses to Americans, including those not yet born. We’re seeing just the beginning of transmission — Florida is only a start.

States across the South, much like Texas today, should be on high alert. We know this is coming.

Generally speaking, a vaccine or any drug this early in development has much to prove. As someone who has worked in drug development for nearly 20 years, I know that the failure rates for Phase 1 drugs are very high — around 95 percent. Math and statistics do not favor Inovio’s drug making it through all three Food and Drug Administration investigational phases.

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Even if it does, the six to 10 years it would take would allow the Zika virus to spread to almost every state in the U.S. well before that.

Additionally, even when investigational medications are approved by the FDA, they are approved based on limited testing in a small representative population. In other words, if a drug is tested and found to be safe in 2,000 or so individuals during a clinical trial over two to three years, then that safety wouldn’t necessarily be extrapolated to the 350 million Americans living in the United States.

We are over 99 percent similar genetically, but that very small difference can result in devastating side effects. For instance: If there was a one-percent allergic fatality rate from administering this drug to people during clinical trials, that could translate to a higher percentage — or millions upon millions of people when they administer the vaccine to the general public.

Secondly, the long-term safety of the drug would be unknown. Patients are typically only followed for a short period during the Phase 3 clinical testing period, usually just a few months to one year. Therefore, it wouldn’t be possible to know whether or not the drug might cause some delayed adverse event several years later on.

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The bottom line is that vaccines are a great goal for the distant and future control of Zika virus — yet having any hope for this vaccine to help any of us in the near future would be a mistake.

Our elected representatives and the Obama administration need to act immediately on this matter. The hot and wet monsoon season, already underway for the month of August, will provide a hospitable habitat for Zika-carrying mosquitoes to thrive.

Dr. David Gortler is a former FDA senior medical officer who is now a pharmacology expert and drug safety expert with FormerFDA.com.

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