The answer: These Things Take Time, is not entirely satisfying. But that is just what the National Institutes of Health and the Centers for Disease Control have been telling us since the news of an Ebola epidemic in Africa first hit the media. For instance, ABC, NPR, and the BBC have all run recent stories about the possibility of a new vaccine, and the impossibility of releasing it quickly to the public.
I suppose everyone knows that safety testing is the key issue, and the Food and Drug Administration is extremely strict in its guidelines for what it will and won’t allow in a clinical testing program for a new drug or vaccine. The FDA’s go-slow, be-safe attitude is the major rate limiting step in the process. But there are other issues as well.
Another criterion of the FDA is what they call “efficacy.” A new drug or vaccine isn’t deemed approvable if it just does no harm. It’s got to do some good, as well. And it’s this second criterion of efficacy that has everyone holding their collective breath about whether or not the Ebola vaccine now being tested will make the final cut. It’s already shown itself to be rather wimpy when put up against the virus.
There is a Catch 22 operating here. If you try to create a vaccine that causes a rip-roaring response in every vaccinated person, you are liable to create a vaccine that causes a lot of side-effects, up to and including death. So the choice is usually to tone the vaccine down somehow, and hope you haven’t killed its usefulness completely.
That’s what the first volunteers are getting: a heavily toned down vaccine. It’s already been shown in animal studies not to cause any detectable harm to vaccinees. On the other hand, it has been shown to wear off quickly, leaving them susceptible to the virus again after as little as 10 months. That’s a far cry from smallpox or polio vaccines, which usually give lifetime immunity.
However, smallpox and polio vaccines are made from whole viruses, either killed or mutated to less infectious forms in the lab. Even those sometimes revert to their deadly forms and cause the very disease they were intended to prevent. No wonder native populations are often afraid to allow themselves to be vaccinated.
The trend in modern vaccine research has been to try to split the difference and come up with an efficacious vaccine that has carefully been designed to be unable to cause any type of disease. But there is no guarantee the researchers can hit this mark exactly. Hence the present caution with the Ebola vaccine, combined with doubts it will be strong enough. I wish us all well, on this one.
If all this gets you interested in the workings of vaccine labs and the people who inhabit them, then may I suggest my medical thrillers, The Neah Virus, and The Jihad Virus? These books give you the opportunity to learn about this branch of science while being engaged in some heart-stopping fictional tales of Ebola-like outbreaks.
In The Neah Virus, my super-intelligent biomedical sleuth, Dr. Peyton McKean, develops a subunit vaccine much like the current Ebola vaccine, which contains just a portion of the virus–one of the knobs shown on the gnarly virus at right, above. The story has it all: special interest groups protesting for quicker vaccine development, defects in the vaccine that may make it deadlier than the disease itself, corporate greed operating behind the scenes, and infighting among the scientists who are developing the product. Prepare to be astonished. It’s not too far from the way things really are!
In The Jihad Virus, poor Dr. McKean is infected with the virus himself, and must try the most desperate measure of all. He and his lab helpers design, synthesize, and inject themselves with a vaccine created virtually overnight. They do this by a method called chemical peptide synthesis, for which my old buddy Bruce Merrifield won the Nobel Prize. In my fictionalization of this process, the illustrious Dr. McKean tries to save himself with a vaccine he creates with unprecedented speed.
What’s most interesting about this fictional concept is that it has a basis in real science that I published long ago, at the time I was a visiting scientist in Dr. Merrifield’s labs. Here’s the scientific literature reference, if you need too much detail. Even though the account of an overnight vaccine in The Jihad Virus is fictional, it could actually be accomplished in real life using my method.
Sometimes, late at night, I wonder why the FDA, CDC, and NIH haven’t contacted me to give it a try on Ebola. On darker nights, I sometimes wonder why the CIA, NSA, and the Army haven’t abducted me and forced me to make some for their clandestine purposes. Wait a minute! I feel another novel coming on…
Believe me, if I were infected with a new virus for which there was absolutely no vaccine available, I would most definitely go to a lab, use my method, make a vaccine overnight, and jab it in my arm. I am sure the FDA would look at this askance, but if my life were on the line… You get the picture.
For now, however, truth is slower then fiction.