Since New, Promising Herpes Vaccine: Interview With Dr. William Halford was posted on October 17 many people have asked for more specific information about Theravax. The availability of the vaccine in the US (and in other countries) is a hot topic as well as Rational Vaccines' strategy for running clinical trials outside of the US.
Dr. Halford was kind enough to take the time to address these questions by making the following statement.
I do not believe that I said anything about making Rational Vaccines' Theravax HSV-2 vaccine available in the United States any time soon. This is certainly not where the clinical trial of this live HSV-2 vaccine was conducted. 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. I would suggest that misguided is probably a more apt term, as the way to correctly assess a vaccine's risk is in terms of the "relative risk" of (1) the downside of not having an effective vaccine versus the (2) risk of running small clinical trials based on years of pre-clinical studies.
Over one million people per week are newly infected with HSV-1 or HSV-2, and under the FDA's watch, the U.S. has invested all of our time and effort into herpes subunit vaccines (while ignoring live HSV-2 vaccines) for the past 30 years. During that time, over 1.5 billion people have been newly infected with HSV-1 and HSV-2 while the U.S. government has, never once, considered the possibility that a live HSV-2 vaccine would almost certainly yield a herpes vaccine that actually works (unlike the herpes subunit vaccine trash they have pushed for 30 years). Personally, I am done talking to the American government about their regressive positions in the space of herpes vaccine development. I would prefer to help the other 95% of the world, and work with a more cooperative and forward-looking government that actually understands the value of mathematics (probability) and science.