Loosening regulatory landscape in the USA?


I received the following question below that I thought was important enough, it deserved a blog post.  I provide the question below in its original form, and I provide my response below the question.

I think that this question, perhaps, most closely gets at the heart of the matter under consideration……what is the most appropriate (most rational) balance to strike between (1) the safety of vaccine candidates under testing versus (2) the burden of human disease that is being caused because we lack an effective vaccine?  If the USA was a competitive market to rapidly and efficiently bring live HSV vaccines to market, it would be my first choice.  But, it’s really pathetically bad to the point where I anticipate it will take the USA a decade to get the FDA to back off their uber-authoritarian stance and become as competitive as many other countries in the world who have already, TODAY, streamlined their paths to advance safe and effective biologics & vaccines  to market.

Great question from Terri, but there is a lot more to consider here than meets the eye.

  • Bill H.

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Dr. Halford,
Do you think the 21st Century Cures bill that has been passed by the Senate and is expected to be signed by the President will help move your vaccine along in the US? Even if you plan to do work in other countries, the evidence that you collect as to the efficacy of your product should count as evidence to help progress the approval of the product in the US.
https://energycommerce.house.gov/cures

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Hi Terri,

This is a great question, but like many great questions, the answer is complicated.  I try my best to answer it, as follows.

Am I optimistic that the 21st Century Cures bill or the Trump Presidency (i.e., let’s challenge the assumptions of every gov’t agency) will change the regulatory landscape for HSV-2 vaccine development in my lifetime?  My answer is an unequivocal “No.”  However, this does not mean that I don’t agree with your general sentiment, it’s just that I have cancer that most likely reduces my remaining lifetime to something less than five years.  And both my parents were attorneys, and so I know the other reality that whenever you are talking about either changing or interpreting laws, the devil is in the details and it takes time. The Clintons pushed for broader medical coverage in the U.S. in the 1990s, and ObamaCare has only been around for a few years (i.e. post-2010).

So, does anything happening in the U.S. change Halford’s personal calculus? No.  Do the things happening in the U.S. affect RVx’s calculus…..absolutely.  My business partners in RVx are my successors, as are the members of RVx’s Scientific Advisory Board with whom we just met on Saturday December 10.  So, the possibility that the U.S. FDA will likely undergo reform over the next decade does change the timeline by which RVx may advance its live HSV-1 and HSV-2 vaccines into routine clinical practice by the USA.

So, I come to Part 2.  Before I shuffle off this mortal coil, I want to see herpes sufferers provided with access to potentially life-changing (hope-restoring) medicine so that they do not feel like they are slaves to the whims of their herpes symptoms.  That is something we can start doing in 2017 if we simply expand the jurisdictions where we offer the vaccine to all 190-odd countries around the world.  The science I have done with HSV ICP0- mutant viruses for 20 years now establishes the idea of injecting a person in the skin of the calf with a live HSV-2 ICP0- virus as something that is clearly safe.  If the approach is safe and creates a new opportunity to (1) prevent herpes in vulnerable HSV-seronegative persons and (2) better treat herpes patients who are not well treated with acylovir-based antiviral drugs, then that is something that we should do ASAP.  Period. End of sentence.

I have been listening to scientists tell me for a decade…..”Whoa Halford, we have to slow down, and you have to convince me that (1) not only is a live HSV-2 ICP0- virus vaccine safe, but I also want to know (2) that a live HSV-2 ICP0- virus works better than a gD subunit vaccine, and then (3) you need to prove to me why it works better, and then (4) you need prove this is not only true in mice, but you also need to prove this is true in guinea pigs, rabbits, monkeys, cats, dogs, squirrels, llamas, etc.

No matter how many scientific questions you answer for Dr. Studies-Widgets-Dude #1, the answer you provide that person will beget 10 more questions from Dr. Studies-light flares, Dr. Studies-MHC, Dr. Studies-Lymphocytes, Dr. Studies-gD epitopes, etc.  And while academic scientists sit around in their little closed circles talking to themselves (e.g., NIH study sections; scientific talks), all of their little conversations (and little is a deliberate word choice) have no impact on the 1,000,000-fold BIGGER PROBLEM THAT 4 BILLION PEOPLE ARE INFECTED WITH HSV-1 OR HSV-2, AND 100,000,000 OF THOSE PEOPLE PERIODICALLY FEEL LIKE  BATTERY ACID IS BEING POURED ON THEIR CLITORIS, LABIA, SHAFT, GLANS, ANUS, BUTTOCKS, EYES, MOUTH, FACE, ETC.  Academic scientists treat the problem, well, academically.  It is not an academic problem for the MILLIONS AND MILLIONS of people who live with a disease that destroys their lives.

Call me crazy,  but I don’t think that the established community of herpes researchers has taken a particularly noble or enlightened path to alleviate the human suffering caused by the human herpesviruses that they allegedly study.  All of the scientists who take the approach I describe above (which is easily >95%) sit in their ivory towers for decades studying aspects of “herpes virus molecular genetics, or immunology, or latency, or vaccines, or novel antiviral therapies,” but rarely do they ever talk to an actual patient suffering with recurrent genital herpes; the most common human disease that any of the 8 human herpesviruses inflicts upon patients.  The T-shirt at the top of the post…..yeah, that’s for you guys.

I have a news flash for all my pointy-headed science colleagues (of which I consider myself one)……..pick a nice restaurant or bar and meet 4 people who have genital herpes and let them unload………it’s a lot more entertaining than most scientific activities, you might actually make some new friends, and most importantly YOU WILL learn something new that rocks you to the core in terms of understanding how this topic  you have studied for decades intersects with and torments people’s live.  ACTUAL PATIENTS are the natural system that counts, and in the case of genital herpes, scientists missed a LOT in the 1970s and noone double-checked their work.   I would recommend to my fellow scientists that you seriously reconsider studying herpes patients in a one-on-one conversational fashion as (1) I don’t think the medical textbooks do the topic justice and (2) there is ample room for improvement in how we diagnose, prevent, and treat recurrent genital herpes.

During the last decade I have been answering a myriad of scientific questions to UNEQUIVOCALLY PROVE that the live HSV-2 0deltaNLS virus vaccine is head and shoulders better than the HSV-2 subunit vaccine approach, which is all we have tested in the USA for the past 30 years.  Scientifically, this is a slam dunk.  We put all of our eggs in the HSV-2 subunit vaccine approach and it did not pan out.  NEVER ONCE did anyone push to seriously test the logical alternative; a live HSV-2 vaccine, which works about 100 times better.  Regarding the zero US trials of live HSV vaccines, I generally find that it is difficult to make new discoveries in areas that one systematically avoids exploring.

Herpes sufferers (all 100 million of them) should be at the center of the equation.  What do they want?  They want a treatment, ANY TREATMENT, that better controls their herpes symptoms and allows them to protect their loved ones from the risk of transmission by virtue of a preventative HSV vaccine.  The new treatments that HERPES SUFFERERS want to see tested, those should be the ones that advance to Phase I Clinical Trials first. And, it should not be one treatment, but 10 treatments that simultaneously advance to small Phase I trials on a timeline of less than one year.

Aside from getting more trials of live HSV vaccines going ASAP, a second issue is building scientific consensus that this is a reasonable approach that deserves the scientific community’s full attention.  So, this requires that I engage scientists year-in and year-out in talks and papers that generally sound like this……”There are a lot of good reasons that a live HSV-2 ICP0- virus vaccine should actually solve the herpes problem.”  The established group of herpes vaccine scientists in the room either (1) don’t let me give a talk (bury the body) or if I manage to get some public air time, (2) well let’s just say the leaders who have been failing at this task for 30 years don’t applaud and cheer that I am claiming to have a live HSV-2 vaccine that works 100 times better than their lame HSV subunit vaccine approach.

I once heard a scientist state, “You know, scientists would much rather wear each other’s underwear than use each other’s nomenclature.”  The negative reaction is far stronger when you lead with, “Hi, my name is Bill, I grew up in Louisiana, and all of you Ivy-League trained scientists are very, very smart, but I think you missed the line where God was handing out the common sense.  You should check it out….I find it to be extraordinarily helpful.”  Generally, the words I choose are softer, but the meaning is similar, and all of the scientists who have worked on, studied, and published on HSV subunit vaccines that have a long history of failure do not appreciate it when I pile on with words like “inferior,” “garbage,” and “waste of time and money.”  These are the only final conclusions that I may offer, because they are the only truth (explanation) that remains after a decade of studying this topic.  Sometimes in science, you have to choose between pleasing the group or telling the truth. I opted for the latter.

The reaction that comes from the scientific establishment in these situations is generally not pretty.  The phenomenon is called “Scientific Suppression” and is nothing new.  Rumor has it, the Catholic Church and the thought-establishment of the middle ages were not fans of the idea that the Earth was not the dead-center of the universe.  Thus, several “heretics” were burned at the stake for claiming the Earth was rotating around the sun (https://en.wikipedia.org/wiki/Giordano_Bruno).  Similar story for a German physician who was laughed out of the profession when he suggested to his colleagues at a hospital that they should  consider washing their hands with soap and water in between perforrming autopsies and delivering babies (https://en.wikipedia.org/wiki/Ignaz_Semmelweis).

So, Terri, returning to your original question, “Yes RVx is very interested in seeing the FDA become less regressive and more interested in eradicating herpes by advancing live HSV-1 and HSV-2 vaccines that actually work to American clinics and citizens.”

However, my experience informs me that the key to success is to (1) hope for the best (and exploit new opportunities as they arise), but (2) plan for the worst so that the project advances regardless of whether or not the ideal situation arises.  Nearly all of the NIH grants I have submitted over the past 15 years were not funded, and yet I am one of the more influential thinkers in HSV vaccine development today.  How can this be the case?   Because my research always moved forward with the MODEST MONEY I HAD IN HAND rather than going on hold while I waited for the ideal situation when I reached the pot of gold at the end of the rainbow of a NIH-funded grant.  If I had lived in fantasy and waited for the NIH to fund my science, I would not have gotten far.  However, I did keep applying and received a single 2-year NIH R21 grant (by accident), and that helped.

Likewise, I take a similar view to advancing RVx’s live HSV-1 and HSV-2 vaccines in the USA to the FDA. Fortunately, it’s not the middle ages, and so a good Halford-burning-at-the-stake seems unlikely.  But that same emotional vitreol does, and will always, exist in science, when (1) the established group of scientist made miscalculations that led them to a conclusion that was diametrically opposed to the truth, and (2) then 20 to 200 years later the Established Group is forced to react to the one newcomer who  has the audacity to wear the shirt at the top of this post and say, “You fellas are real smart, but did you ever hear of common sense and double-checking your work to figure out what you missed during the first few passes?”   That takes balls (courage and self-assuredness), and that is what a lot of the scientists we remember today had….. because they dared to think and say something different.

So, I would love to move things forward in the USA tomorrow.  However, in my experience, 95% of academic scientists suffer from the conditions of arrogance, ignorance, and often a profound disconnect / inability to differentiate bullshit from reality.  The USA just isn’t all that.  Adolf Hitler made the USA a scientific powerhouse between 1950 and 1980…because a LOT of German scientists fled war-time Germany en masse, and post WWII the USA wisely (at that point in time) invested a truckload of money into infrastructure.  German was the international language of science at the dawn of the 20th century, and English became the international language of science in the wake of WWI and WWII.  In 2017, I see science moving to China and India or other countries who actually understand how to use logic, reason, and mathematics to figure out how natural systems work.  The American people (and my fellow New Orleans natives) have many wonderful attributes, but I am definitely the freak in the group who thought it was worthwhile to seriously study science and mathematics.  It’s lonely being a freak, and I think I am not alone in that regard.  So other freaks like me often choose to go to countries where a higher percentage of the group understand what a cell is, or who perhaps invested a year of their lives studying chemistry, physics, and biology so they could spend the rest of their lives understanding the basic rules that describe how the natural systems (in which they live) work.

So, the real question is, “Do I hate Americans?”  No I do not. But, I do believe that, as a group, Americans suffer from an overly high opinion of themselves and they are demonstrably less educated than about 30 other countries in the world.  From a business viewpoint, 95% of herpes sufferers do not live in the USA, many of them live in far-better educated countries who are doing better financially, and many of them are not run by the 800-pound gorilla of the FDA that passionately hates live virus vaccines.  The FDA folks won’t admit that, but the last live virus vaccine developed in the USA with the FDA’s blessing, well, that happened before I was born.  So in my lifetime, the jokers at the FDA have offered no demonstrable support for a live virus vaccine to be developed.

Does this annoy me in the arena of live HSV vaccines.  To quote Sarah Palin, “You betcha.”

But where it really deeply upsets me is in the realm of live-attenuated HIV vaccines that could save over 1 million lives per year in Africa alone.  The FDA would never allow a live HIV vaccine to be tested in 10 people because it could be dangerous.  But, it’s OK that >30 million people have died of AIDS, and >10,000 people will die of AIDS this weekend.

I am from New Orleans originally, and I met a gentleman from the Northeast who had lived in New Orleans for 8 years.  One night over drinks (which rarely happens in that city), we were discussing why most people who hail from the Northeastern U.S. do not care for New Orleans in the long term, and often choose to leave.  When I asked him his thoughts on why this was the case, he responded very simply and in a very matter-of-fact tone; “It’s not the heat.  It’s the stupidity.”

So, why do I believe that RVx’s mission to eradicate herpes should start outside the USA?  Well, I will give you a hint…it’s not the heat.

Black, white, brown, tan, Japanese, Chinese, Indian, Brazilian, Belgian, Turkish, Iranian, Egyptian, Chilean, Christian, Muslim, Buddhist…..it really makes no difference to me.  Herpes affects every nationality, race, and creed on Earth.  I don’t think anyone should have to suffer with this needless affliction.  If the American establishment want to cling to HSV subunit vaccines and lame antiviral drugs as the only biotechnologies they will throw at the herpes problem, then I say, “Good luck fellas.  Maybe you will find something new in the next 30 years that you missed in the first 30 years you were testing those same approaches.”

RVx is a company with a global perspective.  Our website is available in English and Spanish, and will soon be available in Russian.  We don’t need the USA’s inward-looking stupidity, which is most obviously manifest in the FDA….the very agency charged with protecting the health of Americans that will be the last to consider a live HSV vaccine capable of eradicating herpes.

RVx believe that it is time to put patients (and their treating physicians) first!  No more needless infections, and let’s see if therapeutic HSV vaccines dial back herpes sufferers symptoms.  So far, the results have been pretty impressive.  Down with the pure academic scientists who have been talking about “curing herpes” since 1983, and who have delivered jack.  Over the time I was in high school, college, grad school, a postdoc, and three University professor jobs, and started my own company, these bozos offered failed herpes subunit vaccine concepts from 1985 – 2000, and have been doing little more than CYA science for the past 15 years to save face and not admit that their approach is diametrically opposed to the truth….a live HSV-2 vaccine was always the most viable option from the start, and the subunit vaccines just proved to be hopelessly ineffective.

Let’s do something real and eradicate herpes once for all. Outside of the USA mostly (where 95% of the Earth’s population lives), but if Americans want to eradicate herpes in their own country, well I am all for that too.  To my fellow Americans, I offer you a simple message if you want to see viable HSV vaccines at home……..get your so-called leaders to get their shit together and create a landscape where an American company with live HSV-1 and HSV-2 vaccines has a real path forward in this decade.   It should take a year of trials and science to figure this out if these vaccines works……not 30 years.

For myself, I am going to go where my passion takes me, which is wherever I can best use my science to help improve people’s lives.

– Bill H.

18 thoughts on “Loosening regulatory landscape in the USA?

  1. Dave says:

    Dr. Halford,

    Thank you for your hard work and urgency around this topic. You mention that your vaccine is the first live attenuated HSV-2 vaccine to be tested. I am am interested to learn how your attenuation compares to Cantab Pharmacuticals’ HSV-2 DISC vaccine that failed to elicit enough immunogenicity to combat flair ups in Ph II trials (https://www.theguardian.com/business/2001/oct/11/4, https://www.ncbi.nlm.nih.gov/books/NBK47451/#_c69zzk-z4l-gp7-rs0_). What gives you confidence that your iteration will have enough of a reaction to combat flare ups?

    Thank you,

    Dave

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    • Herpes Vaccine Research says:

      Hi Dave,

      There are two questions that you put forth in your query, which relate to two common misconceptions that I hear experts, and interested laypeople, get wrong all the time. One of the biggest barriers to getting the academic scientific community re-engaged and working towards actually (productively) solving the herpes problem is to identify the simple errors in logic that have derailed herpes vaccine development efforts. In my estimation, the current field of “leading herpes vaccine scientists” have produced, over the past 20 years, little more than a stagnant quagmire of failed concepts and bad ideas, and are now paralyzed by their inability to admit their past mistakes. In science, it is exceedingly difficult to make progress towards new and useful knowledge if one is unwilling to admit the shortcomings of past ideas that have well and truly failed to yield a useful solution. I would characterize the herpes vaccine science community of the past 15 years as a group of lost and confused people whose hypotheses are simply not well aligned with reality of how immunity to herpes simplex virus naturally develops and is maintained over time.

      Stated differently, what is required to eradicate herpes with a vaccine is very simple, has been done time and time again over the past 220 years, and it is human beings (in their arrogance and stupidity) who have made this complicated. The natural system “created by God” (i.e., that which simply exists around us) is far simpler than the so-called “herpes vaccine experts” have made it out to be. Once everyone is willing to quit listening to these clowns, then solving the world’s herpes problem will be simple because the underlying principles that scientists have uncovered over the past 200 years tell us everything we need to know to solve the problem.

      Stated yet differently again, if a live varicella-zoster virus vaccine (Oka strain) is adequate to reduce the burden of disease associated with chickenpox (which is now a well-established fact), then there is not a single reason on God’s green Earth that we cannot do the same with a live herpes simplex virus vaccine that shares ~65 of 75 genes in common with HSV-1 and HSV-2. From my viewpoint, this is self-evident and it is moronic to not explore this self-evident possibility. Yet, this is precisely what the so-called herpes vaccine experts do not want to do; they passionately hate the idea of a live-attenuated HSV-2 vaccine, they have refused for a decade to listen to my arguments of why we should explore this possibility, and it is for one simple reason. They don’t want to admit that the HSV-2 subunit vaccine strategies they have been backing for the past 30 years might be as pathetically bad as my research suggests they are. So, better to save face and let hundreds of millions of people continue to contract oral, ocular, genital, and neonatal herpes as opposed to running a high-caliber clinical trial directly comparing the safety and efficacy of (1) a HSV-2 subunit vaccine versus (2) a live HSV-2 vaccine in a side-by-side fashion in n=20 human clinical trial participants per arm (n=40 participants total).

      Against that backdrop, I address your questions.
      =========================
      Question 1. “You mention that your vaccine is the first live-attenuated HSV-2 vaccine to be tested. I am am interested to learn how your attenuation compares to Cantab Pharmacuticals’ HSV-2 DISC vaccine.”

      Here is a link to a post in the blog answers the general question in depth: https://liveherpesvaccine.com/2016/04/10/on-the-einstein-vaccine/

      Here is yet another way of stating the answer. First, you (and all the so-called experts) should take the time to understand what the term “DISC HSV-2 vaccine” actually means….”disabled infectious single cycle HSV-2 vaccine.” So, here is what you and experts are asking me all the time….”How is RVx’s live HSV-2 vaccine different from a “live-disabled” (note the contradiction in terms) infectious single cycle HSV-2 vaccine?

      This is like asking a rancher, “Hey, I know you have that bull that you are using to impregnate all of the female cattle in your herd, but why not use Farmer Brown’s “fertile-castrated” bull to impregnate your herd? I hear that castrated bull is a lot less ornery.”

      Do you understand the contradiction in terms between “fertile” and “castrated” in the context of a bull? A castrated bull is incapable of pro-creation. Likewise, it is equally idiotic when so-called HSV-2 vaccine experts (Sanofi Pasteur HSV-529 or Cantab’s HSV-2 DISC vaccine) suggest that a “live-disabled” HSV-2 vaccine is a real thing. This term makes as much sense to me as a “zen assassin” or a “peaceful explosion.” A virus can no more be “live” and “replication-disabled” than a bull can be “fertile” and “castrated.” In both cases,”replication-defective” and “castrated” eliminate the ability for pro-creation of the virus and the bull, respectively.

      In more practical terms, I would suggest (and history supports) the notion that “virus pro-creation” is essential for a live virus vaccine to successfully elicit the most protective immune response possible.

      Finally, I close this portion of my answer with a paragraph from a review I recently authored, as follows:

      “Herpetic disease represents a major challenge that is too often underestimated in terms of its human toll. An essential step towards a viable herpes solution is to first understand why past solutions have failed to slow the pandemic spread of herpes. Only three strategies have been proposed that have an established track record of clinical success in preventing viral disease, and these are 1. antiviral drugs [34]; 2. viral protein subunit vaccines [35]; and 3. live-attenuated virus (LAV) vaccines [15, 36-42].
      Acyclovir-based drugs are effective at preventing HSV replication in cultured cells, but have limited bioavailability in vivo. Famciclovir and valacyclovir partially address this limitation [43, 44], but have not slowed the pandemic spread of herpes [45, 46]. Herpes glycoprotein subunit vaccines have been investigated in six U.S. clinical trials, but have not curbed the symptoms of recurrent genital herpes [12, 13] nor protected naïve recipients from contracting genital herpes [9-11, 14]. Bona fide live-attenuated HSV-2 virus vaccines have the potential to stop the spread of herpes, but have not been tested in a single U.S. clinical trial (reviewed in Ref. [47]).

      Bona fide live-attenuated HSV-2 virus vaccines should not be confused with replication-defective viruses that deliver a cargo of foreign antigens to a recipient [48-50]. Such replication-defective, antigen-delivery vehicles have yet to yield a single viable vaccine, and one such HIV vaccine candidate made recipients more susceptible to HIV infection [51]. In the current article, the term “live HSV-2 vaccine” is reserved for live viruses that undergo limited replication and spread in vaccine recipients, as is true of all LAV vaccines that have succeeded in clinical practice.”

      Key References that speak to Dave’s query:
      48. Delagrave, S., et al., Immunogenicity and Efficacy of Intramuscular Replication-Defective and Subunit Vaccines against Herpes Simplex Virus Type 2 in the Mouse Genital Model. PLoS One, 2012. 7(10): p. e46714.
      49. Boursnell, M.E., et al., A genetically inactivated herpes simplex virus type 2 (HSV-2) vaccine provides effective protection against primary and recurrent HSV-2 disease. J Infect Dis, 1997. 175(1): p. 16-25.
      50. Petro, C., et al., Herpes simplex type 2 virus deleted in glycoprotein D protects against vaginal, skin and neural disease. Elife, 2015. 4.
      51. Cohen, J., AIDS research. Did Merck’s failed HIV vaccine cause harm? Science, 2007. 318(5853): p. 1048-9.
      ===================================================

      Question 2. “What gives you confidence that your iteration will have enough of a reaction to combat flare ups?”

      Dave, the end-game here is eradicating herpes, not combating flare-ups (stopping recurrent herpes outbreaks). I have presented data that RVx’s live HSV-2 0NLS vaccine (Theravax^HSV-2) does combat / reduce the frequency and duration of outbreaks in the first 4 to 6 months post-vaccination and this is an area my company is interested in studying. However, it is an area of exploration whose final answer remains to be determined, so my confidence has nothing to do with this active area of ongoing exploration. I usually reserve judgment and refrain from offering conclusions until a study is complete. The study that I refer to above is “in progress,” and data collection will not be complete until June 2017.

      What my confidence lies is in our ability to eradicate all herpetic diseases by deploying an effective PREVENTATIVE HSV-2 vaccine. The goal is not to help current herpes sufferers reduce their symptoms, but is to render our children and grandchildren fully immune to (incapable of) contracting herpetic diseases such as genital herpes…..ever. If we deployed an effective live HSV-2 vaccine to the human population en masse today, then 20 years from now, kids entering college would have at least a 10-fold smaller risk of contracting herpes than 17-year-olds today. That is what I am confident we can do. Here is the reason why I am confident we can achieve this goal (per the RVx website):

      “Over One Million Individuals Will Contract HSV this Week. Should We Just Stand By and Watch?

      Never once, in the history of medicine, has a live-and-appropriately-attenuated viral vaccine failed to stop the spread of its corresponding disease in the human population.

      Over 60% of the world’s population has antibodies to herpes simplex virus 1 (HSV-1), and over 12% have antibodies to HSV-2. This means that 4 billion people are infected with HSV. This high frequency of infection is driven by an epidemic in which four billion chronic carriers transmit their HSV infections to more than one million uninfected people per week. The absence of a preventative vaccine ensures that 10% of our children will acquire genital HSV infections before they marry.
      Can we stop the spread of herpes? Rational Vaccines (RVx) was founded upon the belief that we can, we should, and the time to act is now.

      In recent years, biomedical researchers have attempted to develop “subunit vaccines” to prevent genital herpes, AIDS, tuberculosis, malaria, and other infectious diseases. Subunit vaccines are based on the premise that one small piece, or subunit, of an infectious agent may serve as an effective vaccine. Hundreds of such subunit vaccine concepts have been tested in clinical trials, and the approach has failed more than 98% of the time. RVx believes that our different approach, which uses rationally-engineered live vaccines that retain 99% of HSV’s potential antigens, will be sufficient to end the herpes epidemic.

      Live viral vaccines re-create every facet of a microbe’s life cycle, and fully prepare the human immune system to do battle with the natural pathogen. Live viral vaccines have been used to prevent the viral diseases of (1) smallpox, (2) yellow fever, (3) polio, (4) mumps, (5) measles, (6) rubella, and (7) chickenpox. Never once, in the history of medicine, has a live-and-appropriately-attenuated viral vaccine failed to stop the spread of its corresponding disease in the human population.

      The adjacent graph on measles incidence is representative of what happens when governments deploy an effective live viral vaccine into a vulnerable population. RVx’s Profavax^HSV-1 and Profavax^HSV-2 vaccines offer a similar opportunity to relegate all herpetic diseases, including genital herpes, to the dustbin of history. This long-term vision will require governments to implement vaccination programs. In the interim, RVx is committed to offering more immediate solutions to mitigate the risk of HSV transmission within discordant couples.”

      ————–
      This isn’t that complicated, and everyone needs to quit listening to the so-called herpes vaccine experts who have been failing at this task for the past 30 years (e.g., University of Washington). Yes, those people messed up and messed up spectacularly. In 2016, I question whether they are simply too arrogant to admit the error of their ways. The human population deserves a real answer to the herpes problem, and it is time for the failed herpes vaccine “experts” to quit playing CYA and get behind a real herpes solution.

      – Bill H.

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  2. Hope says:

    Dr. Halford,
    First, thank you! I’ve read your articles & appreciate all of your dedication & tenacity. It is exciting to have someone who is standing in the fight against herpes on behalf of all the sufferers. If so many more people understood that this condition is more than just a nuisance that affects one’s sexual life, they would support & advocate for more meaningful research.
    I wanted to inquire on the effectiveness of anticipated relief of some symptoms that occur as a result of having the herpes virus. I get intense neuralgia: sharp pains, tingles, & now meningitis. These issues, I think stem from also having a compromised immune system (rheumatoid arthritis) and HSV2. Do you foresee/hope that the vaccine would alleviate these symptoms for sufferers?

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  3. Dr. Hyder says:

    Dr. Halford can you please tell me if the rumours that the theravax vaccine will be developed in mexico are true ?? if so then when can we expect it in the market ? I know it is very early to comment on this but can u please throw some light on this ?

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  4. RealScience77 says:

    As you blog about this topic Dr. Halford, we get this in the news yesterday as that Trump considers staunch libertarian Jim O’Neill for FDA commissioner.

    I personally don’t know much about Mr. O’Neill but after reading up on him this might be a step in the right direction maybe? Politicians are politicians as we know but he appears to be on record with some quotes I can definitely get behind.

    Jim O’Neill’s quotes…

    ““Let people start using them, at their own risk,” the candidate, Jim O’Neill, said in a 2014 speech to a biotech group.

    “As a libertarian, I was inclined to believe that the regulatory costs that the FDA impose kill a lot of people and provide a lot of harm to the economy, and I don’t deny that… but one thing that surprised me is that the actual human beings at the Food and Drug Administration like science; they like curing disease and they actually like approving drugs and devices and biologics.”

    “The problem, O’Neill told the group, is the overall structure and incentives of the regulatory system.”

    “Every time the FDA commissioner approves something and someone gets sick who used it, the commissioner is summoned to a congressional committee that also controls his budget and forced to testify under oath, why he made this rash decision…It’s a miserable process,” O’Neill said.

    Thoughts on this consideration Dr. Halford?

    Reference.

    https://www.scientificamerican.com/article/trump-considers-fda-chief-who-says-people-should-use-medicines-ldquo-at-their-own-risk-rdquo/?WT.mc_id=SA_WR_20161214

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  5. Mark says:

    …(2) better treat herpes patients who are not well treated with acyclovir-based antiviral drugs, …
    What if some of us are well treated with Acyclovir-based antiviral drugs, will this vaccine still be better than us taking Acyclovir?

    …live HSV-2 vaccine, which works about 100 times better…

    30 percent of patients receiving GEN-003 were lesion-free at 12 months after dosing. 100 times better to me sounds like a functional cure. Can you comment on this?

    Thank you and appreciate your hard work!

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  6. Gar11 says:

    well written reply. you are doing an amazing thing right now that WILL help millions I am confident in that. you and your team keep up the good work, you are giving all the sufferers hope and something to keep peoples moods up.

    Like

  7. Marian Nicholson says:

    Hi Dr Halford
    We have members in the UK who would like to travel to wherever you have your next clinical trial of the vaccine (St Kitts/Dominican Rep)? How do I find out where/when this is happening? Best wishes, Marian Nicholson, Director Herpes Viruses Association

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    • Herpes Vaccine Research says:

      Hi Marian,

      RVx is preparing for such an event, but please appreciate that I have a backlog of 5 years of scientific data to write up, and there will be considerable planning that goes into the next trial. So, let’s think in terms of Summer 2017 for an announcement and a trial happening in Fall 2017. If we can pull off sooner, we will, but just trying to be realistic. I will of course be using the blog and the RVx website to advertise the trial, so you will know when it is happening.

      – Bill H.

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      • Dr. Hyder says:

        can you treat genital herpes with interferons and interleukins ? and can you use shingles vaccine for hsv1 or hsv2???

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  8. Juan says:

    Well said Bill, you are best! Some … don’t have the balls to stand for what they know.. they just go by the flow…

    Like

  9. D says:

    Have you tried a “call to action” to FDA MASS email campaign? I have participated in many to various senators and government committees to influence votes and opinions. Usually it’s a set letter from an attached link people get who support a cause. They log in and forward to that senator or action committee. If you need to demonstrate support, rally the troops.

    Sent from my iPhone

    >

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    • Herpes Vaccine Research says:

      Hi D,

      I have not considered a ‘call to action” letter, but I think this would be more powerful coming from those involved in Honeycomb and other support groups. Such letters are far more compelling coming from (1) past participants of the first Theravax trial and (2) other sufferers who want to participate in a similar trial. Sounds like a great idea, and I am happy to offer a paragraph in support, but those suffering with the disease are those who have the power to humanize this condition. Most people not in the know assume that the desire to better treat herpes is anchored in a desire to have sex more freely. What they don’t know is that having GH symptoms daily robs people of hope. Most GH sufferers just want the possibility of waking up one day and forgetting they have GH for a day, a week, or God forbid even 3 or 4 months. If government officials understood how hopeless how many GH sufferers felt, YES, that would be the single most powerful bullet in your arsenal to get more governments to not only approve live HSV-2 vaccine trials, but to actively support them as well. This is a WIN-WIN-WIN-WIN for patients, doctors, governments, and insurance providers (who would love a 3-shot preventative vaccine over a lifetime of antiviral drugs….helps their bottom line).

      GH sufferers have a lot more power than they realize. A call to action letter would be a great start.

      – Bill

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    • StayingUpbeat says:

      X2 on the Amen. I hope there is a cancer researcher out there with the passion for helping you that you have for us Dr. Bill.

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