The last time I wrote about one of the two most advanced experimental herpes vaccines— Rational Vaccines' (RVx) Rotavax, which performed well in one very small clinical trial, I noted that all clues about the continued development of the vaccine were pointed in the same direction—Mexico. (See: Herpes Vaccine Heads South ... Of The Border?", November 13, 2006.
Although the first (and only) trial so far consisted of only 20 patients, the results were encouraging, and it was clear that the company was planning on more advanced trials, which would be held outside to the US to circumvent the FDA—an agency that Dr. William Halford, the inventor of the vaccine and CSO of RVx, has little regard for (1).
But despite the fact that conducting trials in Mexico makes sense on many levels, this remains no more than an educated guess. Since November-- nothing. Not a word. Until today.
A new report by CBS medical correspondent Dr. Max Gomez offers some additional clues, as well as some hope that Americans may have access to the vaccine sooner than we thought. Dr. Gomez wrote about the beginning of Phase II studies, during which dose-ranging studies, those designed to determine the optimal dose for the vaccine, are beginning. Better still, Americans may be able to try it.
The following segment from the CBS report should be seen as very hopeful for the millions of patients who are awaiting a breakthrough therapy to treat their infections:
"The company is now starting a phase 2 efficacy and dosage trial, but FDA approval for vaccines is a long process, so they expect the vaccine to first be available in the Caribbean and Mexico where Americans may be able to get it."
Dr. Max Gomez- January 6, 2017
I spoke with Dr. Halford this morning, and he is not yet able to reveal additional details at this time. But my sense is that it will not be long before this changes. When it does, you will be able to read it here right away. Although it is impossible to predict the possibility of success of any drug or vaccine at such an early stage, this one looks promising.
Keep 'em crossed.
(1) "My aim is to make the live HSV-2 vaccine available in some of the other 95% of the world that is not under the FDA's jurisdiction. I am American, and I have nothing against my fellow Americans, but I am afraid in the arena of vaccine development, the United States policies are regressive at best." Dr. Bill Halord, October, 2016.