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Lyme Disease Webcast- Stanley Plotkin
Slide Show by Stanley Plotkin
Notes Provided By A Lyme Patient
I just tortured myself for several hours listening and re-listening to the December 2016 slide program (about 1 hour and 20 minutes long) about the new vaccine and taking notes and screen shots of slides. It was presented by Stanley Plotkin of Global Vaccine and those involved with the company making the vaccine, Valneva.
Below are my notes. I had to paraphrase those not in quote marks due to heavy accents and my inability to type quickly. Some of you had questions and some are answered in this presentation which may not be in my notes.
Plotkin- start his slide show at 16 minutes unless you want to know what Lyme disease is and hear Plotkins blah blah blah stories. Ends at 23 minutes for Plotkin’s original presentation. Not much.
NOTE- At the end of the time slot, after all speakers, there was time for a lot of questions- probably more answers there than in actual presentations.
New vaccine doesn’t have the product protein putative epitote that is in the OSp A. Plotkins slides more telling than his drone voice. Here are his conclusions.
Then Valneva speaks on vaccine
$500 million annually is what they expect to get from sales.
31:30 new speaker
Tried to get as close as possible in mouse studies as to what humans will experience. Children under 5 should be fine.
We believe the old vaccine was safe. We want to offer it to children in as low an age as possible. (The younger the better, even 1-2 year olds.)
38 minutes (=/-) for info on giving it to those with Lyme disease. They plan to market it to people who already had/have Lyme.
Safety and the perception of safety is "important for the activists sake".
84 minutes- safety data info- they jumped thru this section like a frog with his tail on fire.
38 minutes (=/-) for info on giving it to those already with Lyme disease. They plan to market it to people who already had/have Lyme. It contains aluminum.
Trials in US are out of Lincoln Nebraska Center (low incidence of Lyme there). One trial also being conducted in Holland.
Questions & Answers- start at 42 minutes
Patents is 1st question asked about- need to hear it- couldn't translate well. But, rest assured, they are right on top of it.
Does not protect against any other TBD’s
They claim there is only 1 serotype in US, Borrelia burgdorferi. B. miyamotio was mentioned on slide, but they didn’t talk much, if at all about it. About 6 or so more serotypes (strains) were listed on slide. Those in Europe will be covered.
Plotkin says he has NO financial ties to vaccine.
How to educate other areas of the country? One of the mistakes made originally was not to educate physicians. When people want to know if they should be vaccinated they ask their physician. Plotkin told Valneva to go to scientific meetings, write to press, speak to doctors.
Costs to devlop- depends on cost from licensures. If they can agree with authorities they can license thru small efficacy trial instead of large trial. $200- 300 million it costs to license. $100 million additional in post vaccine expenditures given safety concerns (does this mean law suit money?).
Cost per vaccine? For Europe- beginning out of pocket then catch up campaigns- then to local market, then to public market. 2-3 years post licensure it will be non-reimburseabler. Depends on recommendations. That is what drives the costs.
Plotkin said… "Hope they (CDC) have learned their lesson"- vaccine should be given in certain areas. Once made ok for children by CDC, all kids covered by insurance will have the “right" to be vaccinated.
"Very few ticks in Trump Tower." Comment at 55:28 minutes
Ball park- compared to vaccines costs based on last 5 years- $400-500 for new Lyme vaccine.
They will try to accelerate process to phase 2 before done with phase one. Don’t want to wait.
Plotkin recommends the C6 test for Lyme. Slides may tell what tests they are basing the new vaccines on?
How is your vaccine better than Lyme Rix? LR was developed only against one serotype. Theirs is covering current existing serotypes. "This is good enough for protecting the population."
AGAIN they stated… There was no safety concerns with last vaccine.
LymeRix never had any proven side effects- and they have reengineered that part of vaccine to make it safe.
They have state of the art improvements.
Improved efficacy found in mice now- they hope it goes with humans too.
AGAIN- Over 1 million doses of LymeRix used with no problems with safety.
Minute 1:10:00- Plotkin- The point of removing cross reactive epitote- was mainly (hahaha he laughs) to avoid reaction from LD groups, the people who suffer from chronic LD and are very sensitive to something that might make situation worse.
Plotkin- Anything that removes safety concerns, not a real safety concern before though, we need to do because groups were “exercised about it.” It is a real important “psychological advance”.
We have to make sure this is a vaccine for the “smallest” (meaning children). (For profit considerations.)
Need to agree with authorities to get it widely accepted- adults first, then children.
When will it be available? He said most optimistic- if we get levels of acceleration- the fastest maybe 7 years to market if we don’t cut corners.
Plotkin- "We KNOW how to make the vaccine.” It wouldn’t be wrong to say 4-5 projects never make it to the end. "But here we KNOW it will work!” There is a real advantage here.
HLA DR2- autoimmune phenomenon question. As we tried to explain- the vaccine that was previously used until 2002 in US, due to molectulor changes made this will be ok. C terminal of antigen. The old vaccine was only “assumed” to cause problems. Steere dismissed his own conclusions about that.
AGAIN- Plotkin- No data to suggest the 1st vaccine caused any problems. This is the SAME vaccine, but tailored to retain safety.
They are excited to be pioneers in the field. "You will hopefully see this baby growing up."
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