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Staph vaccine to treat CFS??

Gondwanaland

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So I emailed and called IQB in Argentina and I can confirm that they are not the manufacturers of any vaccines or anything to do with Staph Vacs. So that is out. I've emailed and called the Brazilian entity with no reply. @Helen and @Gondwanaland I tried calling about 5 different "Drug Stores" which is where they would sell Estafiloide they all hung up on me after I tried to see if they spoke either Spanish or English. Still trying to find someone who knows Portuguese to give them a call.
You can PM me the phone numbers you have.
Last year I called and exchanged emails with labs and clinics, spoke with medical doctors and researchers and all I could find was closed doors (discontinued production/availability of the product). One dr told me that one research institute would make it under backorder for doctors only. This stuff is just not for sale to end consumers, and appears to have been discontinued even for backorder of drs, who now got used to work with abx only.
 

Hip

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I wasn't going to mention it until I had a few more details sorted out, but I have in fact been able to obtain the Russian Staphylococcus toxoid vaccine. It arrived three days ago, and the vaccine is now sitting in my fridge.

I administered my first subcutaneous injection of the Russian vaccine two days ago, as per the eight week introductory protocol detailed in Prof Gottfries clinical study. Nothing significant to report as yet, no changes in ME/CFS symptoms; but if I do respond to the vaccine, then I imagine I will perhaps start noticing the benefits in 2 to 4 weeks.

The details I wanted to sort out are whether my contact, who bought the vaccine in his country and had it shipped to me, is willing to do this again for other ME/CFS patients who might be interested in experimenting with this vaccine.

The way I found this contact was by posting up details of the job I wanted done — ie, buying the vaccine and shipping by courier to me in the UK — on the website fiverr.com. Fiverr allows you to cheaply hire people anywhere in the world to do short jobs. There are also lots of similar websites to Fiverr that serve the same purpose.

It took a lot of organizing, especially with figuring out the international couriers, refrigerated transportation, and the Russian and Ukrainian customs rules and requirements. I took me about 6 weeks in fact (you know what it is like trying do these sort of tasks under brain fog conditions).

I want to be able to give other interested ME/CFS patients details of my contact, who now, like me, understands the whole shipping process, so that patients can easily get hold of the vaccine, and not go through all the difficulties and learning curve that I did over 6 weeks. However, I need to clear this with my contact first, and also with the moderators of this forum, just in case there are some issues with this.
 
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I assume it may help in the same way as Staphypan injections as this was used as a substitute according to one of the well-informed patients at the clinic. She wasn´t a candidate for Staphypan (with the preservative Timerosal/mercury) as she had reacted badly to mercury before.
I spoke with a pharmacy in New Zealand about it and they basically could only tell me what was written on the box. They were just looking at the box and reading it to me. They did say that it was made in Italy which was new info to me. Big question here, does this work the same? Helen, is there any way for you to confirm this since you seem to be close?

If this is a good replacement this looks to be a fairly easy drug to get. The pharmacy I spoke with was nice and they ship worldwide.
 

Hip

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@Hip, amazing work! Please update us on the progression!
I certainly will do. As soon as I feel any improvements or changes to my symptoms, I will report them here.

Though it should be pointed out that not everyone responded to the Swiss Staphylococcus toxoid vaccine used by Prof Gottfries, so if I don't experience any benefits from this Russian vaccine, that is not an indication that the Russian vaccine does not work. It may just mean I am a non-responder. The Russian vaccine would really need to be tested on several ME/CFS patients in order to gauge whether it has efficacy.
 

Hip

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Can you advise what the total cost has been to you, including courier, shipping and the vaccine itself? (and other costs, if any)
The vaccine costs $20 for a box of 10 x 1 ml ampoules in Russia; but it is more expensive, at $45 a box, in the Ukraine, where I got mine. I bought two boxes, totaling $90, plus $5 for domestic shipping.

The advantage of the Ukraine is that it does not have any customs restrictions on exporting medicines, which makes it a little easier; whereas if you buy in Russia, it needs some customs forms filled out and ratified before you can ship your medicine (nothing too difficult though, and the Russian DHL are very helpful with explaining things in English and providing the right customs forms, and telling you where the forms must be emailed to get ratified). Ukrainian customs do however require the receipt or sales invoice from the pharmacy where the vaccine was bought, and will not ship without this. I am not sure if the same is required in Russia.

It is legal to import medical products for personal use into the UK, US and Australia (though unfortunately it is not legal to do this in Canada — unless you personally take the medical product across the Canadian border). DHL seem to be pretty strict with following rules, so I don't think they will ship medicines to any country like Canada that has import restrictions on medicines.

Fast 2-day DHL international express shipping from Russia or the Ukraine to Europe or the US costs around $55 - $60. That price includes DHL pickup from the sender's address. It's about 25% cheaper if the sender brings the parcel themselves to the DHL office.

You need fast 2-day shipping, because the vaccine should be kept refrigerated between 2ºC to 8ºC, so you want to minimize the time the vaccine spends out of the fridge and exposed to higher temperatures. You can ship using an ice block, placing that block and the vaccine inside an inch or two of expanded polystyrene packing, for good thermal insulation; but even then the cold from the ice block will not last more than around 1 or 2 days. However, it's probably not that essential to keep the vaccine cold during shipping, and you could probably get away with shipping the vaccine at normal room temperature. Mine was shipped with an ice block, though.

I then paid my contact $35 to do this job. So that's a total cost of around $190 to get two boxes of vaccine.

You could also get away with buying just one box of vaccine. In normal use for ME/CFS, you would only use one ampoule every 4 weeks, so a box of 10 ampoules would last quite a while. Though when first starting the protocol, for the first 8 weeks, you get through a few more ampoules than you would normally.
 
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Mary

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Thanks, @Hip - You are being a guinea pig for all of us and I would be happy to chip in a little to help defray your expenses, if you like (I'm sure others would too!) Just let me know, you could PM me contact info to do this --
 

Hip

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You are being a guinea pig for all of us and I would be happy to chip in a little to help defray your expenses, if you like (I'm sure others would too!)
Thanks very much Mary for your thoughtfulness. But I am OK at the moment as a self-funding guinea pig!

If this vaccine treatment turns out to be effective, it will in fact be an extremely cheap treatment, if one $20 box of vaccine lasts for nearly a year.

I should mention that I informed Professor Gottfries in Sweden about this Russian Staphylococcus toxoid vaccine, and he seems very interested. He is currently getting permission to import the Russian vaccine into Sweden (Swedish customs unfortunately normally prohibit importation of medicines for personal use), and wants to test it.

He is the ideal person to test the Russian vaccine, as he still takes the original discontinued Swiss Staphylococcus toxoid vaccine made by Berna Biotech one every month (from his stockpile), in order to keep his ME/CFS at bay. So he is an ME/CFS patient for whom the original Swiss works, and is thus in a good position to test the Russian one.



If you look at the Wikipedia page on ME/CFS medical treatments with known efficacy (ignoring the nonsense about CBT/GET), you see that the Staphylococcus toxoid treatment is listed, along with other treatments that are much, much more expensive, such as Ampligen, interferon, immunoglobulins, rituximab, Valcyte. These are mostly treatments whose yearly costs are in the tens of thousands. Yet ME/CFS treatment using Staphylococcus toxoid vaccine is just around $20 per year. That would make the Staphylococcus toxoid vaccine treatment very accessible.
 
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Mary

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Yet ME/CFS treatment using Staphylococcus toxoid vaccine is just around $20 per year. That would make the Staphylococcus toxoid vaccine treatment very accessible.
That's amazing. And I know if it were manufactured in or for the U.S. by Big Pharma, the cost would be in the thousands.

What I really like, potentially, about this vaccine is it's lack of side effects compared to interferon, rituximab, valcyte, etc. and it's proposed method of action in modulating the immune system, potentially getting to the root of the problem. I'll be following your progress with great interest!
 

Hip

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What I really like, potentially, about this vaccine is it's lack of side effects
In Professor Gottfries's clinical trial (full paper here) using the original Staphypan® Swiss vaccine to treat ME/CFS and fibromyalgia patients, the side effects were low (the vaccine treated group did not have significantly more side effects than the control group who received a placebo).

However, the Russian version of this vaccine may be a slightly different formulation to the original tried and tested Swiss one, so technically trying the Russian vaccine for ME/CFS may involve some risk. So anyone thinking of trying the Russian vaccine should be aware of this.
 
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In Professor Gottfries's clinical trial (full paper here) using the original Staphypan® Swiss vaccine to treat ME/CFS and fibromyalgia patients, the side effects were low (the vaccine treated group did not have significantly more side effects than the control group who received a placebo).

However, the Russian version of this vaccine may be a slightly different formulation to the original tried and tested Swiss one, so technically trying the Russian vaccine for ME/CFS may involve some risk. So anyone thinking of trying the Russian vaccine should be aware of this.
Again, just want to say great work finding a source @Hip. Is there anyone close to Dr Gottfries that can update us on his thoughts and if he is able to get the Russian Staph Toxoid Vac and test it?
 
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You can PM me the phone numbers you have.
Last year I called and exchanged emails with labs and clinics, spoke with medical doctors and researchers and all I could find was closed doors (discontinued production/availability of the product). One dr told me that one research institute would make it under backorder for doctors only. This stuff is just not for sale to end consumers, and appears to have been discontinued even for backorder of drs, who now got used to work with abx only.
Thanks so much for the help! Now that @Hip has successfully been able to get the Russian version I'm thinking we should focus on getting it that route. As soon as I can get the info on the helper that he used I will be doing it the same route.
 

Hip

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Is there anyone close to Dr Gottfries that can update us on his thoughts and if he is able to get the Russian Staph Toxoid Vac and test it?
Prof Gottfries said he will keep me updated regarding his efforts to import the Russian vaccine into Sweden and test it, so I will post this info when I get it. I am guessing it will be some months, as bureaucracy is involved.


@Ninan kindly put me in touch with an ME/CFS patient in Sweden who did very well on the original Staphypan® Staphylococcus toxoid vaccine. This patient said she started to feel the first inklings of improvements after 2 weeks taking the vaccine, with the full benefits taking 3 or 4 months to manifest. I heard a similar story from another patient in Sweden.

So if I am a responder, I expect I may begin to feel some improvements in ME/CFS symptoms after around 2 weeks taking the vaccine, but will not see the full benefits until 3 or 4 months from now.

In rare cases, it can take up to 6 months before the benefits appear.

It has been around one week since I started taking the Russian vaccine, and I have been feeling a little more tired than normal, and needing more sleep than normal. I also had some increased levels of the ME/CFS emotional sensitivity symptom for two days after my first vaccine injection, but this passed (and may have just been coincidence). Other than that, I have not observed any other changes as yet.



Getting Hold of the Russian Staphylococcus Toxoid Vaccine

I got confirmation from the PR forum moderators that it is OK to give to members details of my contact in the Ukraine who bought and sent me this Russian vaccine.

So for anyone who wants to get hold of the Russian Staphylococcus toxoid vaccine via my acquaintance in the Ukraine, I think the best way may be to set up private Conversation that includes the forum members interested in buying it. That's just to keep my acquaintance's details private. So if you are interested, let me know on this thread, and I will include you in a private Conversation I set up shortly. @CaptainA, I know you are interested, so I will automatically include you.

If there are say 3 people interested in buying the vaccine, it may be easier for my contact to process these 3 jobs all at once. So if you are interested in getting this Russian vaccine, now's the time to mention it.

My contact is a very reliable, competent and honest person, and I have every confidence in him.

Having said that, if anything unforeseen happens, and due to some disaster you don't get your vaccine (eg, because customs confiscate it, or the vaccine gets hit by a stroke of lightening) and you lose all the money, that is a risk you would have to bear. I obviously can't guarantee that it will work out, and my contact in the Ukraine cannot either, although I have no doubt that he will do his utmost.

So keep in mind that this is not as if you are buying from an online retailer or online pharmacy, and they will send you a replacement if you did not receive the item. This more like a friend doing you favor by buying and shipping the vaccine. I don't anticipate any problems, but I feel it is important to point out that ultimately, even though you put up the money, there are no guarantees you will get the vaccine. If you are not happy with taking that risk, then don't proceed.


UPDATE (May 2016): This vaccine is now available to buy at an online international Russian pharmacy: adsorbed version here (recommended), non-adsorbed version here (not recommended, as it is weaker than the absorbed).



Law On Importing Medications For Personal Use

Also, before you go ahead, PLEASE CHECK THAT IT IS LEGAL TO IMPORT MEDICINES FOR PERSONAL USE IN YOUR OWN COUNTRY. It is legal(ish) to import medicines for personal use in the UK, US and Australia, but not in Canada (unless you personally carry the medicine across the border).

Though the US law on medicine importation for personal use is a bit of gray area; the FDA statement is somewhat confusing: strictly speaking it is illegal to import medications for personal use into the US, but the FDA generally don't mind you importing medications for serious illnesses where there is no effective treatment available in the US.

However, I have heard that the US Customs and Border Protection may take a different view to the FDA, and still confiscate your medications! So there is a risk your vaccine might be confiscated when it arrives in the US. It might an idea to contact the US DHL and ask them how likely confiscation is, and if there is anything your can do in advance to prevent it.

Australian regulations on importing medicines for personal are detailed here.

At the moment I cannot find any online details of the UK law on importing prescription drugs into the UK, but in 10 years of buying numerous prescription drugs from overseas pharmacies, I have never had any packages stopped and confiscated by UK customs.

In Sweden, it is only legal to import medicines for personal use from European Economic Area (EEA) countries, and unfortunately the Ukraine is not in the EEA. Swedish regulations are here.

As well as checking the medication importation rules in your country, I would also advise you to contact the DHL office in your country, and ask them about importing medications for personal use. From what I can gather, DHL will not ship medicinal products to countries where importation for personal use is against the regulations.



Cost Of Importing The Russian Vaccine

To get hold of this vaccine, you will need to pay my Ukrainian contact upfront $45 for each a box of vaccine you require, plus $5 for domestic mail in the Ukraine (my contact orders the vaccine by mail, as he could not find a pharmacy in his city that stocks it). This is the cost of the vaccine in the Ukraine. Money can be transferred to my contact by Paypal.

If my contact takes the parcels of vaccine to the DHL office himself, then it will cost around $40 for fast 2-day DHL Worldwide Express international shipping from the Ukraine to your home address in Europe or the US. Otherwise, if DHL collect the parcel from my contact's home, the total DHL shipping cost is around $60. You can check DHL shipping prices on the DHL Ukraine website (click on "Get Time and Rate Quote").

My contact's fee for sourcing, buying, packaging and shipping the vaccine to you is $35.

It's probably a good idea pay in two stages: send the money to buy the vaccine first, and once my contact has confirmed that he obtained the vaccine, and that it is safely in his fridge, then you can send the second part of the money to pay for the DHL shipping and his fee. That is what I did, as I was not sure if he would be able to obtain the vaccine in the first place.

I am happy to help facilitate the whole process, as I have a working relationship with my contact, and know a bit about the shipping requirements. I won't get involved in the money side, though; you need to send the money directly to my contact.




How Many Boxes of Vaccine Are Required?

You probably just need one box of vaccine, if you just want to initially test whether the vaccine works for you or not. One box will last for 5 to 8 months, depending on your methods of administration (more details on these methods below). Five months should be enough time to see whether the vaccine works for you or not; and eight months is definitely enough time.



Vaccine Dosage Protocol

When you take the Staphylococcus toxoid vaccine on a regular basis, one 1 ml ampoule of the vaccine is injected subcutaneously every 4 weeks. So one box of the Russian Staphylococcus toxoid vaccine, which contains 10 x 1 ml ampoules, will last for roughly 10 months.

However, in the first introductory 8 weeks of taking the vaccine, slightly more vaccine is used. Here is the introductory protocol used by Prof Gottfries in his clinical trial of the Staphypan® Staphylococcus toxoid vaccine for ME/CFS and fibromyalgia patients:

Gottfries's protocol: Doses for Staphypan vaccine injection in the introductory first eight weeks:

Week 1: one injection of 0.1 ml of vaccine
Week 2: one injection of 0.2 ml of vaccine
Week 3: one injection of 0.3 ml of vaccine
Week 4: one injection of 0.4 ml of vaccine
Week 5: one injection of 0.6 ml of vaccine
Week 6: one injection of 0.8 ml of vaccine
Week 7: one injection of 0.9 ml of vaccine
Week 8: one injection of 1.0 ml of vaccine

When the introductory first eight weeks are complete, thereafter one injection of 1.0 ml of vaccine is given every 4 weeks on an indefinite basis (if this vaccine works for you, then you need to take it indefinitely, else your ME/CFS symptoms will return).​

Note that each ampoule of the Staphypan® vaccine contains 1 ml, as does each ampoule of the Russian vaccine.

It is important to follow these gradually increasing doses. @Andey also gave me the warning that in the instruction for the vaccine, it says you should never inject full 1 ml ampule initially, as if you have a significant Staphylococcus infection in your body, you could have a major problem if you did this, as your immune system could respond too fiercely too quickly.





Methods Of Administration: Bacteriostatic Water Method

The following details a method I devised myself to help reduce the number of vaccine ampoules used in the introductory first 8 weeks of taking the vaccine.

In principle, you would use up eight ampoules of the Russian vaccine in the introductory first 8 weeks, because even though you only use a fraction of the ampoule for each injection (for example, on the first week you only inject 0.1 ml out of the 1 ml in the ampoule), you have to throw away the rest of the ampoule after breaking it open, because it loses sterility.

But in order not to be so wasteful, what I did was buy a 10 ml bottle of Hospira bacteriostatic water, and I added one 1 ml ampoule of the vaccine into that bottle. Hospira bacteriostatic water contains a preservative which keeps the bottle contents sterile for around 28 days after first using the bottle (especially if stored in the fridge).

Then using a sterile needle and syringe I just draw out from this bottle of bacteriostatic water/vaccine mixture the appropriate dose for each week of the first 4 introductory weeks (drawing out 1.1 ml of the mixture gives me 0.1 ml of vaccine, drawing out 2.2 ml of mixture gives me 0.2 ml of vaccine, etc). That way I make one ampoule last for the first 4 weeks of the introductory protocol, and can thus save on 3 ampoules.

So using my bacteriostatic water method, you only need 5 ampoules of vaccine to cover the introductory 8 week protocol. Then the remaining 5 ampoules in the box will last you around 6 more months. That is more than enough time to test whether the vaccine is going to work for you or not.


I assume my bacteriostatic water method is safe, and will not be contaminated by bacteria (and that the bacteriostatic water will not affect the vaccine). Hospira say that their bacteriostatic water is good for 28 days once the bottle is first used. Bacteriostatic water is usually used by body-builders when they want to reconstitute dried (lyophilized) peptides or hormones for injection. In the US you can buy bacteriostatic water here; in the UK, here.

Note that bottles of bacteriostatic water are never physically opened; to add or take of liquid from the bottle, you use a sterile hypodermic needle and syringe which you push through the rubber top part of the bottle. To see how this is done, check this video. If you are drawing liquid from the bacteriostatic water bottle, it is a good idea to first inject some air into the bacteriostatic water bottle (as shown in the video), as this creates pressure inside the bottle, making it easier to draw out the liquid.

If you've had no previous experience using bacteriostatic water, this method may not be a good idea for you, unless you are prepared to go up the learning curve. I already learnt all about it previously, as I have experimented with a number of body-builder's injectable peptides and hormones that require use of bacteriostatic water.

Note that to be diligent, you want to sterilize the rubber top of the bacteriostatic water bottle with disinfectant alcohol (70% isopropyl alcohol + 30% water mix) before you push the needle through the rubber. This is not obligatory, but it is supposed to help keep the bacteriostatic water sterile.

Even if you don't use the bacteriostatic water method, and so will use 8 vaccine ampoules for the first 8 weeks, and then the remaining 2 ampoules cover the three months that follow, that still gives you a total of nearly 5 months on the vaccine. This should be enough time to gauge whether the vaccine is working for you or not.

So whether you use this bacteriostatic water method or not, one box of 10 ampoules should suffice to test to see whether the vaccine works.




How to Perform a Subcutaneous Injection

To open a vaccine ampoule, you snap it open by the dot on the neck, as shown in this video.

In order to give yourself a subcutaneous injection (the belly area is good, 1 or 2 inches left or right of you belly button), see the instructions in this article. Basically, pinch up some belly skin into a mound, and subcutaneously inject into the mound of skin.

For injection, I use very thin 30 gauge needles (outer diameter 0.3 mm) which are ½ long, and 2 ml plastic syringes.

It's usually a good idea to inject a 1 ml volume of liquid slowly over a period of 60 seconds or so. What I do is squeeze in around 20% of the liquid, then wait for 15 seconds, and then squeeze in another 20%, etc, until the whole 1 ml is injected.



Checking Your Fridge Temperature

By the way, you may want to check your fridge temperature with a thermometer when storing the vaccine. You want to store at a nice low temperature of around 5ºC. Some parts of the fridge are colder than others. The vaccine instructions say it should be stored between 2ºC and 8ºC. Some fridges may be on a low power setting, and so will be at too high a temperature for safe storage of the vaccine. I was surprised to find that the temperature in the door shelves of my fridge was as high as 14ºC. But now I have turned my fridge up to max power, to keep it cool. Note that under no circumstances should you freeze the vaccine.
 
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Helen

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Again, just want to say great work finding a source @Hip. Is there anyone close to Dr Gottfries that can update us on his thoughts and if he is able to get the Russian Staph Toxoid Vac and test it?
I was contacted by the clinic today and offered to be a part of another study of ME/CFS patients. I was also told that they are working hard on getting a permission to import the Russian vaccine. I got convinced that they are doing all they can to investigate the content of the vaccine, and if it is a safe treatment that could be available to us.

Edit: please note that the actual study that I was invited to is not about the vaccine. Before any study can be conducted they have to have a permission to import the vaccine.
 
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Hip

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I was told by @Andey that in the Ukraine, due to the government's new polarized political alignment towards the West and against Russia, all Russian medicines are no longer having their licence renewed. So when the Ukrainian licence runs out for this Russian vaccine (I don't know when that will be), unfortunately the vaccine will be taken off the market in the Ukraine.

The vaccine should still be available in Russia though. I will try to find a Russian source, just as a backup.
 
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Mary

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@Hip - please add me to the conversation you start - I don't want to purchase the vaccine right now (I'm trying a new B1 protocol which will take some time to sort out), but I'm definitely interested in the vaccine, and would like to be kept in the loop, so that I could possibly purchase it at a later time, if your contact is still able to supply it then.

I am a little puzzled by your math - you say that after the initial 8 weeks, if you use one ampule per week, the remaining 2 ampules will cover the next 3 months - wouldn't that be 2 months at one ampule per month?

Actually I should contact DHL first about bringing medicines into the U.S. before I go any further and will do so on Monday. Are you in the U.S. or a different country?

Thanks again so much for all your work and information etc. etc. etc.!!!
 

Hip

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@Hip - please add me to the conversation you start - I don't want to purchase the vaccine right now (I'm trying a new B1 protocol which will take some time to sort out), but I'm definitely interested in the vaccine, and would like to be kept in the loop, so that I could possibly purchase it at a later time, if your contact is still able to supply it then.
Will do, but so far nobody has expressed interest in buying it. In a month or so, when I have ben able observe the effect of the vaccine on myself, I will start another thread on this, which will I think get a wider audience. I don't think many people read this thread.



I am a little puzzled by your math - you say that after the initial 8 weeks, if you use one ampule per week, the remaining 2 ampules will cover the next 3 months - wouldn't that be 2 months at one ampule per month?
I thought somebody would ask that! I know it does sound wrong, but remember that at the end of initial 8 weeks, on the last week, you take a full 1.0 ml dose (a full ampoule). So I think that dose will keep you going for whole month (well 28 days to be precise), and then the other two ampoules that you have left will last for another two months.



Actually I should contact DHL first about bringing medicines into the U.S. before I go any further and will do so on Monday. Are you in the U.S. or a different country?
I am in the UK.
 
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I was told by @Andey that in the Ukraine, due to the government's new polarized political alignment towards the West and against Russia, all Russian medicines are no longer having their licence renewed. So when the Ukrainian licence runs out for this Russian vaccine (I don't know when that will be), unfortunately the vaccine will be taken off the market in the Ukraine.

The vaccine should still be available in Russia though. I will try to find a Russian source, just as a backup.
Damn, that is disappointing considering the logistical issues. I've got two contacts in Lithuania looking for it now. Fingers crossed.