Next Steps….

stairs

Several blog followers have asked me via comments or by email, “What next?”

I very briefly highlight the plan of attack, and will then be reducing my presence on the blog for a while, so that I can focus my attention on the goals I highlight below.

————————

First and foremost, there is quite a bit of data from the clinical trial (i.e., blood antibody responses to HSV-2) that I and other members of Team RVx’s science team will have to finish analyzing.  As this data becomes available, I will be making it public on RVx’s website.

Second, Team RVx will be working on finding host countries where we can offer the therapeutic HSV-2 vaccine to sufferers ASAP.  Without question, there is still a lot of science that remains to be done to figure out why the therapeutic HSV-2 vaccine works far better than any herpes immunologist would expect.  However, in the absence of herpes treatments that effectively alleviate the suffering of millions of people living with chronic and unrelenting herpetic disease for years to decades, the first priority should not be to answer the endless question of science dweebs (of whom I am certainly one), but rather should be on alleviating chronic pain and human suffering.  Therefore, RVx’s highest priority is getting better herpes treatments to those who suffer with symptoms that are simply not addressed by the current standard of care for herpes sufferers in the USA and elsewhere; namely, prophylactic acyclovir-like antiviral drugs.  I cannot offer specifics yet, but such negotiations and navigation of the political landscape in many potential countries takes time.  This is Team RVx’s highest priority.

Third, Team RVx has every intention of bringing safe and effective HSV vaccines to the global market.  While we will not rule out the U.S. and the FDA, there are 200 other countries on Earth, and many of those countries are known to offer a far more efficient process for vetting new biotechnologies such that (1) the science is done right but (2) the time spent talking to regulatory oversight bodies is more on the order of months rather than decades.  Whichever countries serve as host to this activity, such a venue would be the place for dozens of small clinical trials to address a myriad of questions about the therapeutic and preventative potential of live-attenuated HSV vaccines.  This is where most of the basic science would transpire to better understand the properties of live HSV ICP0- mutant vaccines in human recipients and the durability of the protective immune response they elicit.

Fourth, I personally will spend my time focused on getting the message on this blog into newspapers, magazines, and potentially on television interviews.  This is time that I would have spent on the blog, but instead I will focus on disseminating the message to a broader audience.  That, and I might attend a scientific conference or twenty.

Against this background, while followers of the blog may be personally disappointed that my presence in this particular forum is decreased, I believe that most of you will understand that my focus should be on the four goals I outline above, and no longer on the blog answering each individual question as it arises.   I will try to stop in on the blog and answer a question here and a question there as time allows.  However, for the next few months, my attention will have to focus on the steps I outline above so that I can move beyond words, and focus more on the actions required to advance this new class of live-attenuated HSV vaccines to the clinics where they may help doctors begin to (1) better control / reduce herpetic disease severity in sufferers and (2) prevent HSV transmission within discordant couples.


A second question followers of the blog have been asking is, “How can we help?”

Two ways.

First, when RVx makes our vaccines available in a country outside of the USA, those of you who can afford to do so, please consider traveling to receive this treatment.

Second, for those of you who cannot afford to travel to another country, please consider contacting your senators or representatives in the U.S. Congress and ask them the following series of questions, or questions that follow this line of reasoning:

“Why is the best HSV treatment in the world, developed in the USA, not more readily available for Americans to benefit from at home?”

“Why is a live-attenuated HSV vaccine that was developed with dollars provided by U.S. taxpayers not more readily accessible to Americans?”

“Why does an American vaccine developed by an American scientist have to leave the USA to be offered to Americans who then have to travel outside their own country to receive a treatment that they need?”

I am happy to help bring the technology forward to the world.  However, it is up to Americans who suffer with chronic herpetic disease to lean on their representatives in the U.S. Congress and ask them to re-evaluate whether current U.S. laws and regulations in the space of vaccine development really serve the interests of the American people.

I would suggest that “The road to hell is paved with good intentions.”  More specifically, the status quo of how vaccines are developed in the USA today came to be through a combination of (1) inertia and neglect by lawmakers and the FDA and (2) Big Pharma companies who exploited these rules to reinforce their monopoly on the sale & development of biologics in the USA.  As we all know, the U.S. pharmaceutical industry has gotten quite comfortable in the past 20 years with extorting fabulous sums of money out of the U.S. government and private citizens in the USA, who pay far more per capita for their drugs / biologics than the citizens of any other country on the face of the Earth.

It is time for today’s lawmakers in the USA to reconsider the current rules that would lead an American scientist, funded by the American taxpayers, to take his invention to a nation outside the USA because the U.S. landscape for vaccine development is simply that regressive and prohibitively expensive in terms of dollars and time.   The fact that there is now overwhelming evidence in support of the safety and effectiveness of a live HSV ICP0- mutant vaccine apparently is irrelevant;  there is simply no viable path forward for an effective herpes vaccine in the USA.  The U.S. Congress, and the U.S. Congress alone, has the power to change the legal landscape and restore the USA to its former status as a country capable of developing life-saving and/or live-improving vaccines.  It is up to Americans who have suffered with chronic herpetic disease to demand a change, and demand that this disease finally be addressed (1) at home in the USA and (2) friggin’ ASAP.

–  Bill H.

35 thoughts on “Next Steps….

  1. CA says:

    Great achievement Dr.Halford to get to where you are regarding this revolutionary medical discovery for HSV, I have followed your work for the last 9 years, it has to be on your agenda to move this discovery to Africa because of the great AIDS pandemic there and how this can save millions of lives, the hub and gateway and powerhouse for Africa is South Africa a country with first world infrastructure in the medical area.

    Like

  2. David says:

    This is so exciting. Thank you. Through Internet sleuthing and your comments/talk it seems at least 2 – 3 chronically affected people are now symptom free. I have no idea if one of your constraints is financial – but I know you accept donations and are seeking investors. If it would help bring things to market faster, why not allow those individuals who will fly wherever in 2017 to prepay for the vaccinations? Perhaps offer a discount as an incentive and a refund if they don’t end up qualifying. In addition to providing any needed funds, the prepaid individuals would also demonstrate clear demand to potential investors.

    Like

  3. crazyhorse says:

    why not just charter or rent a large vessel, sail it into international waters and drop anchor…that ship would be for all intents and purposes another country…then contract another boat to act as a shuttle…seems plausible to me

    Like

    • AccountKiller says:

      Mr. Halford is probably still not going rogue all the way. Vaccination is still probably happening in some kind or form of clinics/hospital/physicians offices by trained medical professionals.

      Do not forget that not only western countries have quality medical personnel.

      Like

  4. TCBH says:

    Thank you Dr. Halford for tireless efforts and for focusing on the people who are suffering and not only the almighty dollar, which is important too. 🙂 I have so much respect for you. I’m so proud of my fellow Gen Xer! May your success continue and absolutely skyrocket. Thank you so much! And as soon as your vaccine is available, I’ll be on the next flight out. Cheers!

    Like

    • AGLFH says:

      Hi Dr. Halford,
      I was wondering if your vaccine would offer any relief to patients with compromised immune systems (i.e., someone who has cancer, lupus, etc.)?

      Like

      • Herpes Vaccine Research says:

        Hi AGLFH,

        This is a great question. There are a lot of different ways that the immune system may be compromised, so it is impossible to offer a blanket YES or NO response to your question. However, I understand what you are asking, and the simplistic and correct answer is, “Yes, for the most part, RVx’s live-attenuated HSV-1 and HSV-2 vaccines could be offered to people who are partially immunosuppressed.” As a specific example, yes, it would almost certainly be fine to give these live HSV-1 or HSV-2 vaccines to a patient with lupus (an autoimmune disease) whose condition was being managed with prednisone, which is a common immunosupressive drug.

        The live HSV ICP0- mutant vaccine approach was discovered because I spent from 1997 to 2006 trying to fully understand how it was possible that (1) I could establish an infection of a HSV-1 ICP0- mutant virus in the eyes of SCID mice (which are profoundly immunocompromised by virtue of having no functional B or T lymphocytes) and yet (2) the HSV-1 ICP0- mutant virus infection would only sustain detectable virus replication in the mice’s eyes for 3 days. Thereafter, these HSV-1 mutant-infected SCID mice would run around happily in their cages for 100 (ONE HUNDRED) days showing no signs of viral replication or disease. This was very puzzling when I first observed the phenomenon in 1997. In contrast, wild-type HSV-1 uniformly kills 100% of the same SCID mice in 10 to 20 days, and the animals start to show overt / obvious signs of severe herpetic disease by 5 days after the inoculation.

        Fast forward to 2006, it turns out HSV-1 ICP0- mutant viruses are sensitive to (and effectively controlled by) the innate interferon system which is intact in SCID mice. The publication is here: https://www.ncbi.nlm.nih.gov/pubmed/16764725

        So, bottom line, RVx’s live HSV-1 and HSV-2 ICP0 are far safer than past generations of live viral vaccines because they are, for the first time in the history of medicine, based on rationally-engineered live viruses that achieve a 1,000-fold higher level of safety due to (1) genetic engineering that introduces a defined mutation and yields (2) a live-and-appropriately attenuated virus where we can simply and rationally explain why the live vaccine is uber-safe……because it is hypersensitive to the host’s innate interferon system.

        Thats the long answer. The short answer is as follows: “Yes, can probably use HSV ICP0- mutant vacccines in the majority of immunocompromised patients…..just depends on the specifics of which of the scores of different flavors of ‘immunocompromised’ we are talking about.”

        – Bill H.

        Liked by 1 person

  5. StayingUpbeat says:

    Dr. Halford,
    Congratulations on the phase I trial results. Your team must be so proud of the accomplishment. I have to ask, how did you overcome the steep manufacturing cost associated with scaling up to a commercially viable vaccine? It seems like the $10 million price tag for commercial manufacturing was the major hurdle AuRx was never able to get over relative to releasing its ICP10 deletion mutant vaccine.

    SuB

    Like

    • Herpes Vaccine Research says:

      Hi Raf,

      We have had to slow down the deployment of the ABVIC test. At this point, vaccine deployment is front and center on RVx’s agenda. No promises on ABVIC timeline. Sorry I cannot give you a definitive answer at this point in time.

      – Bill H.

      Like

  6. Guess says:

    Try Nigeria if your looking for a host country with minimal regulations. I’m from there and would gladly return for a theraVax and orovaz shots.

    Liked by 1 person

      • Mark says:

        Hello Halford,

        Question; do you think we will be able to visit the country/countries of your choice and have the first shot done and bring the other two or maybe three vials back with us to have the rest of the vaccine administered here under our doctors supervision? Or do you think they will give us a hard time at the boarder?

        Thanks.

        Like

    • David says:

      I would suggest the Philippines too. They, along with Mexico, are the only countries that have approved the dengue vaccine.

      Like

  7. EvolveEducation says:

    I would fly anywhere for this. The US only cares about profit, not actually taking care of their citizens. Seriously, name the place and I’ll bring the Champaign (& drink it without fear of an OB). It will be GLORIOUS!!

    Liked by 1 person

    • Mark says:

      We’re all jumping on a plane together when this baby comes out! We will all celebrate together after our vaccination! Maybe we will get a great deal on flights plus somewhere to stay if we try to clump many together? 🙂 I havent felt this positive in a long time.. My friends and family are wondering why I have been acting so happy compared to my negative,hopeless and depressed state… Show the world Halford.. I doubted you before but I will never doubt you again.

      Liked by 2 people

  8. Gar11 says:

    Thanks for the write up and its good to see how well you have progressed. I Know your route is going to work out for us all. Im in a bad position , i suffer constant pain but no outbreaks since an intial one (one i couldnt get swabbed as I had no clue about hsv) but I know what it is, Iggs dont prove this though. Im hoping for the abvic so i can diagnose then id be willing to travel , this is the only block i have from applying for anything (if you find somewhere in europe id be willing to go asap to trail) any news on the testing side?

    Liked by 1 person

  9. crazyhorse says:

    screw the FDA…if I want a vaccine I will get it…the govt. (U.S. Army) had no problem with injecting me with every vaccine they had..here are some, but not all…smallpox,triple typhoid,tetanus,cholera,yellow fever,thePlague,(2 times), polio,anthrax…..all taken frm my medical records.Some ,even given the same time.So FDA don’t tell me what I can put in my own body,this time it will be my decision not the govt.

    Liked by 2 people

  10. Rylee Davis says:

    Dr. Halford,
    Words can’t express the hope that your perseverance is eliciting to so many people suffering in silence. Many like myself just desire to have peace of mind, our health back and to feel normal. I have a question and I apologize if it was answered else where: What are the possible side effects, if any king term of the vaccine? Trial participants have tolerated it well thus far, but what hurdles (if any )could take place or that you worry could take place as a result of obtaining the Theravax vaccine?
    Thank you again for your sincerity! No more blah blah.. “Game on”.. Still praying for complete success!!
    #TeamHalford

    Like

  11. richard says:

    When it is available in other countries will your company be able to provide info on how to get it? like I guess create some sort of list of participating hospitals that will carry it and facilitate a way for foreigners to get it easily?

    Like

  12. enceladus_ says:

    But I couldn’t agree more with how frustrating it is that bureaucracy is standing in the way of vaccine trials happening here in the US. If it is legal for healthy people to sign a waiver and jump out of an airplane just for fun, then why is there all of this red tape preventing people with a medical need from accessing treatment by a subdued version of the same microbes that we are already infected with in the first place.

    Like

    • enceladus_ says:

      Considering live attenuated vaccines are already being used for smallpox and polio, two diseases which generally have more severe and debilitating consequences than HSV 1 or 2, it seems that the risks associated with a vaccine like Theravax would be mild in comparison to what is already out there. All things considered, especially since things went so well with the first human trial, the FDA really can’t make a legitimate argument for barring Theravax trials in the US, nor should they drag their feet on approving its use if all goes well in future trials elsewhere.

      Like

Comments are closed.