What follows is a transcript of the Q&A session which took place on World MAP Day, 15th March 2021. This was a Facebook event which remains accessible on our main Facebook page. We are placing it here to reach a wider audience. Sincere thanks to Dr Tom Merritt for answering some very difficult questions.
Crohn’s MAP Vaccine
Good evening everyone and welcome to our World MAP Day 2021 event. We will be quizzing Dr Tom Merritt about viral vector vaccines and hope that our followers will find it informative. Thank you so much, Tom, for agreeing to do this! Members of the Crohn’s MAP Vaccine team, including Dr Amy Hermon-Taylor, will be commenting along the way. So, let’s get started with a general question for Tom.
Could you please give us a general overview of how Viral Vector Vaccines work?
Tom Merritt
Crohn’s MAP Vaccine Hi All!
Wow first let me say- thanks for inviting me. Lots of great things happening. I’ll do my best to answer questions- but my specialty is vaccines, gene therapy, and genetics. I have direct experience with viral vectors and will focus on that first. So please excuse me if I can’t answer all your questions directly on MAP as my knowledge is limited. I promise to do my best.
Paula Winzar
Hi Tom, thanks for answering our questions later. I’ve got a couple for you:
Please can you tell me a bit more about the evidence that MAP might cause Crohn’s? E.g. is it the case that the diagnostic test developed picks up more MAP in Crohnies than people without Crohn’s?
Also—I hope you don’t mind answering questions about the Covid vaccine— any insight on whether Oxford’s viral vector vaccine for Covid helps prevent long Covid, particularly from the S African variant? Due to Crohn’s, I have respiratory issues and exhaustion so I really don’t want long Covid on top of that.
Finally, if we wanted to take part in the MAP vaccine trial, how long after having had the Oxford vaccine would we have to wait, and would we experience any symptoms from ‘bacterial die off’ do you know?
Thanks for all your amazing work 🙂
Tom Merritt
Paula, let me try to answer the MAP question- there were MANY studies done in the years between 2000-2015 on this. Over and over again they were able to prove MAP when removed allowed healing to begin in animals and yes even some people. There have been people who were treated with an extreme regime of antibiotics that destroyed MAP and up to 20+ years later those people feel they are Crohn’s free.
I highly suggest watching this well-made presentation:
Tom Merritt
Well, Facebook is not letting me link to the presentation- apologies- it’s on the front of the Crohn’s MAP page today.
Crohn’s MAP Vaccine
https://crohnsmapvaccine.com/media/ The Phil Nicholson video is here. It is brilliant on AMAT.
Tom Merritt
Paula – as for the CoVID question- the AZ/Oxford vaccine shows that it should prevent any severe infection of CoVID. But obviously as it’s only been in people for a few months, no official idea of long-term Covid. It likely will prevent you getting severe Covid, so HOPEFULLY it can decrease long-term effects for those who may still get infected after being vaccinated.
Tom Merritt
Paula – Finally as for the last Question – simple instantly. They are two different viral vectors. So, no issues there at all.
Amy Hermon-Taylor
One of the strongest arguments for MAP as a cause of CD also comes from the genetic data. This paper is key. The study looked at the genes of 75,000 people with IBD and asked ‘which genes make people susceptible to IBD and what do those genes do?’ They found that the most common/important ‘susceptibility genes’ for IBD confer that person with a susceptibility to mycobacterial infections… and although MAP isn’t mentioned in the paper, MAP is the only mycobacteria which has repeatedly been found to be associated with CD https://pubmed.ncbi.nlm.nih.gov/23128233/
Paula Winzar
Thanks Tom—much appreciated
Sean Young
I’m sure there will be a few people who will want to know about the similarities and differences between the viral vectors of the MAP vaccine and the Covid-19 vaccine, as well as the ongoing study into using the same viral vector twice.
Tom Merritt
Okay now that all said- let me answer this– it’s long so my apologies:
Hopefully you’ve gotten to learn about this via many news networks and websites, so hopefully as I describe this you can have a decent idea of what I mean. But warning this will be one of my longer answers, but I’ll give you a quicker answer then explain it in a bit more detail [that you are very welcome to skip].
The Too Long Didn’t Read (TLDR) version is this:
Viral vectors are a live, but non-replicating, virus that infects cells and delivers a DNA encoded message to make those cells produce a protein and express it on that cell and induce an immune response. That immune response will build antibodies against that protein, but also produce memory B-cells that will keep producing antibodies that will help protect against the virus/bacteria it is designed against.
[Skip to the next question if you are happy with that].
Traditional vaccines before used dead viruses/bacteria, a live but chemically weakened viruses/bacteria, or proteins made by pharmaceutical companies to trigger an immune response. In addition to that they would also use some adjuvants [molecules like egg proteins] that would help induce an immune response to the area that this virus/bacteria vaccine was injected into to make sure the body built up an immune response to it.
Viral vectors though are different because they do use a live virus, but not to derive an immune response. Instead, they are using a replication deficient virus. Meaning the virus that is used is missing very important parts that would allow it to be able to replicate and function like a normal virus would. This virus is no more than a delivery mechanism to get a gene of interest into a cell and tell the cell how to produce that gene. Basically, you can think of it like the envelope with an address and a stamp on it. Inside that envelope is what scientist put in it, not what the virus normally puts in it.
In the case of the AstraZeneca Vaccine and the Crohn’s MAP vaccine, they are using a type of Chimp Adenovirus. Which is a common cold virus. Why did they use a Chimp version and not a human version, like Johnson & Johnson? Because by using a virus that does not, by nature’s design, infect humans it has a few positive aspects for this type of science:
1) We are very unlikely to have been exposed to it before and have any natural immune response to a Chimp Adenovirus, yes even those in chimp regions of Africa or Asia.
2) By using this you can expose a person to this viral vector multiple times and not get an immune response to viral vector. Meaning you can even use it multiple times with DIFFERENT genes, making different vaccines using the same variant.
Now after all that, let’s describe what actually happens…
The viral vector vaccine is an intra-muscular vaccine, in normal terms, this means a shot into your arm muscle. Once in body the virus will infect cells.
Now this is a DNA virus. DNA is a long-term message molecule, it is robust and very stable at various temperature ranges, and almost all organisms use it for their storage of genes. But for the cell to produce proteins, it needs that DNA message in a slightly different form so it can be read and translated into useable proteins. That different form is RNA, and even more specifically, something called messenger RNA or as you’ve heard in the news a lot mRNA. While DNA can be a long-term molecule, RNA is short term and gets broken down in a very short time period after being made [think hours later, not days]. So, the virus gets inside the cell, releases its DNA. That DNA gets translated into mRNA and that mRNA gets translated in amino acids that make up the protein of interest- in the case of the AZ vaccine that Spike protein. Well once start being made that protein gets displayed on the cell so it can be noticed and consumed by a set of our immune cells known as Natural Killer cells and macrophages. These cells break down these cells displaying this protein, and in simplified terms keep only the bits it doesn’t recognise and shows it to other immune cells, better known as T-cells. This begins a whole cascade of events that in the long run produce antibodies that will keep finding viruses and leading the bodies immunity cells to help destroy the virus/bacteria. And will also lead to memory immune cells called B-cells that remain to help produce antibodies to recognise and flag the protein it was taught was bad.
But what about those viral vectors and its DNA? Well, it delivered its message and produced those proteins which got all those cells producing it destroyed by those immune cells. And because it can’t replicate either it is no longer in the body. And if infected the cells properly and quick enough, the viral vector wasn’t seen by the immune system as a problem and no antibodies would be created against it.
Sean Young
Tom Merritt Think I’m going to have to sit down with a cuppa for that one. Great info, though.
Amy Hermon-Taylor
Tom Merritt, thanks so much for this really clear explanation. As well as the memory B cells remaining to give longer lasting immunity, does the T-cell immunity last?… and is it possible to measure the duration of T-cell immunity as well as measuring antibodies after vaccination?
Tom Merritt
Amy Hermon-Taylor, oh this is a really good question that I wish I had a proper answer for, but as my immunology knowledge is not great for this area, I will give you an answer from my memory, but know I’m not sure on it.
T-cells don’t last long. They are a short-term fighting cell for those activated to destroy a virus/bacteria/etc. They are constantly regenerated when needed, but for the body to not wipe itself out doing that they die off ‘quickly’ [I no longer remember how long that is].
As for is it possible? Oh, there is an assay somewhere with some research groups. But is it readily available, I doubt it. This is getting down to fine levels of distinction that I’m not sure our cheap assays can do yet.
James Robertson
Hi Tom, my question is: are attitudes changing towards the use of AMAT treatment? I have carefully approached the subject with my consultant in the past but was met with a very definite “no”. It feels like a lot of specialists have quite closed minds on the subject unfortunately.
Amy Hermon-Taylor
James Robertson Hi there, Tom’s expertise is in vaccines (incl our MAP vaccine) but not specifically in Crohn’s disease or other treatments for CD (although he knows a lot more about it than most as his brother is unfortunately a sufferer). So, I will answer some of the questions that relate to CD rather than vaccines…
James Robertson
Apologies, thank you 🙂
Amy Hermon-Taylor
I think the answer to your question is, unfortunately not yet. I think there is generally more open-mindedness to the MAP hypothesis (from speaking to Prof Sanderson and Dr Agrawal about their conversations with colleagues). I think it will take more big trial data on AMAT to convince specialists more widely… and as Redhill haven’t published their trial data yet, this is still not available. Also, approval by organisations like MHRA/FDA will also bring about a sea change… because many doctors worry about prescribing without guidelines.
But again MHRA/FDA approval will need more trial data. If our trial shows efficacy of the vaccine, this will also lend weight in terms of proof of causation
Amy Hermon-Taylor
James Robertson no problem at all! Thanks for joining the discussion -all support much appreciated 💜
Natalie Maria
Hi Dr. Merritt, thank you for taking questions. My question is how could a vaccine treat or attenuate Crohn’s Disease. I am only familiar with vaccines preventing disease. Is there a precedent for this novel approach? Is there any risk with introducing MAP to someone with CD, could it make it worse? Again, thank you for all of your work and research.
Tom Merritt
Natalie I have been asked similar version of this question before hand and have answer for that- So let me post that here now….
Yes- in the case of MAP it might be better to describe this as a molecular therapy, not a vaccine in the traditional sense [though it is very much a vaccine]. When we think of vaccines usually, we think of getting a shot to prevent a disease or lessen a disease if you do end up getting infected with it. And that is exactly what the MAP vaccine is going to do for those not suffering already from Crohn’s. Meaning for the vast majority of the population if they got this vaccine it will help in preventing those bacteria [Mycobacterium avium ssp paratuberculosis (MAP)] that help cause Crohn’s from taking hold, just like traditional vaccine would. But for those suffering from Crohn’s, it’s going to train the immune system to attack something that had found a way to avoid detection and cause the body harm. The important part is that it is using the body’s immune system to do it, instead of an outside set of antibiotics, which can cause lots of unforeseen issues.
So, the viral vector vaccine works in a very similar fashion as the AZ CoVID-19 vaccine. It is a variant of the ChAdOx virus which will deliver a set of genes [instead of just one] to the cells it infects. Those cells will produce the proteins these genes encode for and those proteins will get displayed for the body’s immune system to find. After finding these proteins the body will then begin to build a defence against each one. This is really important as MAP needs to be attacked at multiple points to give the best chance of making sure all of the bacteria are removed from the body and don’t’ have a chance to recover. And this is why I like to think of this more of a molecular drug therapy than a vaccine. Those who this is most important for are already battling, and sadly losing that battle, against the disease. This means instead of preventing it, it’s getting rid of an already established problem. And the most brilliant part is that it’s utilising the body’s defences and creating a new long-term defence that remains- thus why it is a vaccine.
And yes, this concept can potentially be used for cancer treatments too, if the correct genes are found and can be expressed safely to induce an immune response.
It’s also important to know this is close to gene therapy, but that is does not act upon, change, or destroy any cellular DNA/Genome. Nor can it. It does not integrate into your genome. It does not change your DNA. It strictly borrows the machinery in the cells it infects and then goes away. But leaves a lasting impression like a great teacher.
Natalie Maria
Tom Merritt Crohn’s MAP Vaccine Thank you for such a detailed answer! Very helpful!
António Torres
Tom Merritt thank you Dr. Merritt
Nicola Price
Tom Merritt it is interesting that I am reading a lot about the Covid vaccines targeting the spike protein only (hence may be not so good at dealing with mutations) whereas the CMVaccine will target four pieces of DNA, so it should provide excellent coverage for us!
Sean Young
Sorry, I know you are getting blasted with questions, something I’d be interested to know is if there is something about MAP that lends itself to being treated with a viral vector vaccine? Was a viral vector vaccine chosen specifically for a reason? Is it simply that it could be used to both treat and create immunity?
Tom Merritt
Sean Good question. I think I sorta answered that above in Natalie’s question.
So, a viral vector vaccine lends to being a bit like a gene therapy treatment without affecting the genome. Hence why I like to call it a molecular therapy treatment.
If you don’t think the answer above fits for what you want to know, please let me know. I do my best to answer your question then.
Amy Hermon-Taylor
Sean Young I think in addition, viral vector vaccines are particularly good at generating T-cell immunity (is that correct Tom?) and T-cells are the part of the immune system which is best at tackling intracellular infections (where the bacteria or virus is inside the cell) like MAP… whereas antibodies (which are proteins in the serum outside cells) can’t get to the MAP inside cells.
Tom Merritt
Amy Hermon-Taylor Yes, they do generate T-cell immunity. It’s the best immune response. The general immune response is Natural Killer and Macrophages. The antibodies are more of a tag. As for the DNA vs antibodies it’s going to vary per therapy. But as I don’t know specifically what segments they are targeting, I am assuming these DNA bits produce specific segments, if not whole proteins that the researchers know are good solid targets that can be found by antibodies.
Tom Merritt, thanks! Yes the 4 MAP DNA segments are part of a gene called IS900 which is a key MAP gene (also found in a few other closely related mycobacteria) thought to be involved in the pathogenicity of MAP.
Sean Young
Also, what other viruses and bacteria are being looked at as being possible to treat with this technology?
Tom Merritt
Sean A number of things. Mostly bacterial at this point. As they aren’t likely to always be treated by antibiotics. But of course, this therapy needs to show it works well before many others follow suit. So right now, its mainly ‘normal’ vaccines lined up for the viral vector use. This right now is the only publicly known therapy/vaccine using this technology right now. But I doubt it will be the only soon.
Caroline Brocklehurst
Tom Merritt thank you. I think you’ve already provided reassurance on some of my questions which centre around the question of if you’ve had the Oxford Covid vaccine whether that would affect the MAP vaccine and also about the likely effect and protection ability of the MAP vaccine on patients being treated with anti-tnf biologics?
Tom Merritt
Caroline – I have in varying questions here. Again though- no it won’t affect as it’s a different viral vector- but even if the same unlikely to cause any problem. As for the other I have a more extensive answer – but there are studies looking into this [i.e. anti-tnf biologics].
Caroline Brocklehurst
Tom Merritt thank you!
Crohn’s MAP Vaccine
The first 2 of our pre-planned questions have been covered in the beautifully long answer by Tom above! So, let’s skip to Q 3 on our list: The Oxford-Astra-zeneca COVID vaccine uses the viral vector ChAdOx1 whilst MAP Vaccine uses the viral vector ChAdOx2 (i.e. related vectors but not the same). There has been some concern that use of the same viral vector in different vaccines might reduce the immunity generated in response to subsequent vaccines, because of the possibility of developing immunity to the vector itself. What is your view on this?
Tom Merritt
Crohns MAP Vaccine Haha! I promise I’m not ALWAYS long-winded [well most of the time] hopefully the next few will be less…
It should not be something to worry about. Currently there is a study going on to test this potential issue. There are people, like myself, who have had multiple vaccines using the viral vector system that Oxford created. It was originally worried that this would induce a normal immune response to the viral vector itself. But in most cases, this has not been true. Prof. Sarah Gilbert, who has been involved with the development of the ChAdOX viral vectors said during the early results of the ChAdOx1 CoVID-19 vaccine they saw little to no immune response to the viral vector, meaning they couldn’t find levels antibodies against the viral vector that would cause problems for future doses. This most likely means that other vaccines using the same viral vector would not have issues either.
On a personal note, I’ve had 3 viral vector vaccines, two with ChAdOx1 and one with ChAdOx2. I know my samples were studied closely because of this. But to my knowledge it never caused any issue for the vaccines to work [or not work if they didn’t produce an immune response for their intended target]. So, in my case, there was no issue.
Crohn’s MAP Vaccine
Great, that is reassuring. Next question…. The Oxford-Astra-zeneca COVID vaccine trial showed in a subset of people that when a half dose of the vaccine was given for the first shot, it actually produced better immunity levels than when a full dose was given. The same finding was shown in our Phase I trial MAP vaccine trial. Could you explain why this might be? Are there any trials currently looking at the half-dose vaccination protocol in more detail?
Amy Hermon-Taylor
Tom Merritt, I feel so reassured by this… especially as I have now had the Oxford AstraZeneca covid vaccine and hope to have the MAP vaccine one day too 😊
Tom Merritt
Crohn’s MAP Vaccine, officially my answer on this is no, science still does not know why half-a-dose then a full dose gives a better immune response. There is a trial going on to try and see if they can resolve this odd occurrence. But to this point, no information has been published.
Now do I have my own theories? Yes, but that is exactly what this is, and should be understood as- *** a best guess reason***- no empirical proof or physical research done by me on this specific subject. But I’ll give you my best guess…
My personal theory is it deals with how much we really need for a dose and how it localises in the injection area. You have read about how people get pain in an area and even these recent vaccine rashes. The injection is intramuscular. So, as it is not directed into blood vessels and veins, this injection stays in the general area of where it gets injected. So, this high amount of virus will infect just that small area. Meaning also that single cells will likely get infected with multiple viral vectors. And then those cells are producing X times more protein than cells with a single copy. With immunity cells [natural killer cells/macrophages] looking for cells not acting normally or displaying normal signals, these cells mass-producing the proteins that are needed to build an immune response against. Except they may produce too much and kill themselves, or cause these killer cells/macrophages to destroy them sooner than if they had less copies. Meaning that instead of getting a more controlled response to producing the protein that needs an immune response too, it gets wiped out quickly and the body does not build as many B-cells as one would expect. The ½ dose doesn’t over infect those same cells, thus producing a more controlled immune response and builds a more extensive immune response.
Again, that’s purely my theory. I’m looking forward to a better explanation from Oxford in the near future.
Amy Hermon-Taylor
Tom Merritt thanks, that’s really interesting and as a hypothesis it certainly makes sense to me. It will be interesting to see what the studies show. I did ask (nicely 😁) when I had my Oxford AstraZeneca vaccine whether it would be possible to have a half dose… sadly, the answer no although the doctor who gave it to me was very nice and said she’d have asked the same!
James Robertson
Hi Tom, in patients with a relatively high-level of MAP infection, is there a danger of an extreme immune response upon vaccination (cytokine storm perhaps)?
Nicola Price
James Robertson that is something I am very interested in too.
Tom Merritt
James & Nicola – Great question. One that I know this ‘cytokine storm’ that’s been pushed out there in the mainstream has scared many… And hits on a question I was asked beforehand so I’m going to give my answer about antibody-dependent enhancement (ADE)
My personal view is this is a misunderstanding as to what happens with ADE versus what these vaccines are designed to do.
I personally like to think we are in a new age of vaccine development. Most vaccines until very recently have gone with the method of killing/weakening a harmful virus/bacteria/parasite and introducing that into our body and relying on the body to pick the right thing to recognise it later.
Today’s new vaccine development method now is designed to look at the harmful pathogen at a protein level and try to figure out which protein will induce the best immune response and is unlikely to change. By doing this, it minimises the chance that the vaccine will target multiple spots but not focused — which is really important in making sure that the body can recognise the virus/bacteria no matter how the organism tries to avoid it.
ADE comes from the fact the body doesn’t always get its immune choice right and the organism can play against that.
But very importantly, ADE is RARE. Very rare. Does it happen? Yes. Does it happen enough to warrant concern at a worldwide level that we all need to be thinking about it? No. Let those who specialise in this do that. We’ve administered over 20+ million doses of the viral vector so far, and no cases to my knowledge have been reported. And it’s almost 360 million doses given of all the vaccines for Covid right now, again, no cases have been reported. So, this is something we should not worry about as a society.
Thus, inferring this cytokine storm for things like MAP without it being a proven issue is something natural to do, but not necessary.
Nicola Price
Tom Merritt I suppose my concern was more over the Coronavirus vaccine as regards ADE, because animal trials have all failed when the animals were later exposed to wild virus: https://www.sciencedirect.com/science/article/pii/S2589909020300186?via%3Dihub&fbclid=IwAR20ABVm5KXLz8ZIeyrDbvS4LaWK4ELsKFhduNrH5jpede3YYQaNVNDPNTs Would you say there is a distinction to be made here? That the CMVaccine would not elicit this response?
Tom Merritt
So, this is an odd one to answer in that the science as to what happened there is questionable. So one of the difficulties in animal research is how much of a dosage is truly equal to what a true wild dosage would be like. Usually in animal trials the animals are given a direct nasal spray. I’m not sure the last time you had someone sneeze directly into your nose, but for me it’s only happened when my boy was a baby. So, I’ve always argued against this type of testing as it isn’t ‘real world’ exposure. Also, those experiments are done to get the worst possible outcome. Which is needed in terms of knowledge, but again very hard to replicate in normal circumstances. Which is where practical knowledge versus lab knowledge has to come into play here.
As I said, ADE is real. It is very real and happens to people [Dengue fever is prime example of us really first learning about this problem]. But unless this is seen in the ‘wild’ in people over and over again, I wouldn’t put this into a fear we should be watching for.
Please remember at the beginning of Covid there was the big scare of Ibuprofen and ACE receptors. That was shown later on to be a lab thing, not a real-life problem.
And as I mentioned we are 360 million vaccines deep – and specifically about 40 million for this viral vector. So far not a single case of ADE. Could it still happen? Yes. Is it likely to? No.
James Robertson
Fantastic, thank you Tom 🙂
Sean Young
Is there any data yet to show how well viral vector vaccines work in those who are taking immune-suppressing medications?
Tom Merritt
Sean – another fab question. And a simple answer sadly is No.
But, that said, I was asked a similar question prior to this to prepare and it also wondered if there were studies upcoming. And yes, there is supposed to be a 5,000 person clinical trial looking into this. But as it is being run by AZ, I don’t know the full details. Including is it looking into the vaccine or use of antibody therapy as they are also producing this in hopes of helping those who a vaccine won’t work for.
But as noted, many of those with CD are using these immunotherapies and those making MAP vaccine obviously know this. I can’t tell you their strategy yet for MAP. But what I do know is that some of the immune-suppressants are not fully suppressing the immune system to where these vaccines won’t work. As to which ones, I won’t say since I am not a medical doctor.
One of the many things that will become really important is to see how everyone on these therapies react to the AZ vaccine for Covid. Consider it a trial run for MAP. I suspect you will end up seeing there will be trials testing folks who got the AZ vaccine with these immunotherapies specifically for antibody levels. It makes sense as it is a ‘freebie’ trial since everyone is going to try and get vaccinated. If it turns out enough antibodies are produced using this while still on those therapies, then there is less to worry about.
But if the opposite shows to be true, then I promise you, these darn smart people working on this MAP vaccine will start to figure out the best method of how to get people the vaccine and keep them safe.
Sarah Dawson
Sean Young Tom Merritt the CLARITY study is looking at this! https://www.clarityibd.org/ I was one of the final recruits to the study in December 2020 🙂
Liz Hanbury
Sarah Dawson Yes indeed, have a family member on the CLARITY study – he’s recently had his AZ vaccine. CLARITY wanted notification immediately he had received it, so guess they will be measuring levels of antibodies etc over next few months at each infusion.
Tom Merritt
Sarah Great to know- looks good. I knew someone had to take advantage of this. And I bet other groups for other disorders are doing the same. It’s really a HUGELY needed study that will help millions of people.
Amy Hermon-Taylor
Sarah Dawson, oh Yaay! Do you get to find out your results at some point? (or not because it’s double blind and they aren’t allowed to look at the data yet?)
Sarah Dawson
Amy Hermon-Taylor, they fed back results of the initial blood test which showed I had no antibodies to Covid-19. I’ve now had my Covid vaccination so at my next Infliximab infusion I think they’ll check for antibodies again. Hopefully they will share the results with me, I had very little side effects from my Covid vaccination so it will be interesting to see what kind of immunity I’ve built up!
António Torres
Dr. Tom Merritt will this vaccine work as one shot or it could be like influenza 1 shot per year? Based on data is it possible to predict? Thank you for your time!
Tom Merritt
António I’m going to assume you are referring to the MAP vaccine- and that’s a great question that only time will tell. But as I mentioned in a question above, I feel it should be long lasting. It hopefully will produce good amount of memory B-cells and they will stick around. But that said, I can’t promise that to be true. Anthrax is a bacterium and we have a vaccine for it. Sadly, it still has to be given every year. Of course, that vaccine is an OLD vaccine, not designed with genetics in mind like the MAP vaccine. Your question is one I’ve been wondering in my spare time. And if the MAP team gets funding, they will have the ability to test this as the trials continue bring back those from the Phase 1B trial and later trials to see. (I’d say the Phase 1A too, but they didn’t list that in the paperwork, so I don’t know if they’ll be able to find the folks].
António Torres
Tom Merritt Dr. Thanks and I appreciate your time and answers!
Sean Young
If possible, it would great to get these answers archived somewhere so we can come back and read in more detail.
Nicola Price
Sean Young will look into that. We can’t risk losing all this great information!
Amy Hermon-Taylor
If Tom is ok with it, perhaps we can do a transcript and put it on the website later?
Tom Merritt
Amy Hermon-Taylor, have it. I want knowledge out there. And maybe we’ll get some smarter people to come in a correct anything I may have misinformed on by accident.
Amy Hermon-Taylor
Tom Merritt, I think you’re pretty smart!! But it’s also the case that the smartest people aren’t always the ones who are best at explaining things in ordinary plain English, for the lay person. I like the way you explain things. There will always be different opinions in science of course.
Liz Hanbury
Tom, thanks for answering the questions in such detail! What is your best guess for how much the AZ Covid 19 vaccine development will speed up development, trials and roll-out of a MAP Vaccine? It has to have some effect given the huge leaps forward in a year? Thanks
Tom Merritt
Liz – well in terms of getting it approved due to the technology- massive leaps. One of the biggest things everyone has HAPPILY forgotten about is not a single Viral Vector Vaccine has ever been approved for human use in the general population before. By doing this and showing [after >30 million doses worldwide so far] no real bad effects, it’s going to speed up the approval process if the vaccine is functional.
Now how this will directly affect MAP? Well, it will probably mean more people will be willing to try this ‘new’ viral vector vaccine without worry. Meaning clinical trials for it will not suffer from the ‘new technology’ scare. Also, a big thing, which is what I did for the world [okay so I’m not so modest about this] is my design of how to grow a viral vector vaccine in large quantities was just a bit proven. Mind you my original goal was to get to maybe 20,000 doses at a time. Well, I had no idea we’d need 2 billion doses. So, my original plan, along with the brilliant people I worked with, were able to show it could scale and work at a production level unheard of before. And that matters because if the MAP vaccine is effective there will be places that will now happily mass produce it knowing they can. And it will be cheaper because all the groundwork has been laid. So, getting to everyone will be easier now. I could go on, but yes, this year is a boost for MAP and others to come.
Amy Hermon-Taylor
Tom Merritt this really is a massive deal! I certainly know on a local level in terms of setting up our MAP vaccine trial at GSTT (who were one of the trial sites for the Oxford-AstraZeneca covid vaccine) that pre-covid there was a lot of uncertainty and trepidation about this ‘new technology’ which definitely slowed things in terms of getting regulatory approvals. But now that they’ve given a gazillion Oxford covid vaccine doses, everyone is now expert in their administration/regulation etc and totally cool about it.
Liz Hanbury
Tom Merritt that’s fab news, a real boost to those of us hoping for the MAP vaccine. Some good things will come out of this awful pandemic and the vaccine response. And no need to be modest 😁 you and your brilliant colleagues have done incredible work!!
·
Crohn’s MAP Vaccine
Adding a few more questions here. No pressure Tom! Just making sure they are all here….
Crohn’s MAP Vaccine
In your opinion, are we in danger of suppressing broader innate immunity by targeting a very specific part of the SARsCOV2 virus with a vaccine? This question relates to Dr Geert Vanden Bossche’s theory of immune escape, which has gained momentum in parts of the media. Explanation for the layman….. GVB gives the simple analogy of inadequate dosing of antibiotics causing antibiotic resistance. If so, is this a concern for CMVaccine too?
Tom Merritt
Well by my explanation earlier for the ADE question, no I think it makes it better. I think we’ve relied a bit too much on the body to make the right decision when given the whole picture. Many viruses have shown this fails long term as we keep getting re-infected over the years and sometimes in the same season. So, if we help design vaccines so our body to see a specific region that can’t change enough to avoid recognition then we are better off. Is it perfect? Of course not. But is it better than we have been doing? Yes!
Crohn’s MAP Vaccine
Is it possible to predict from studying other similar vaccines how long the protection we receive from a viral vector Covid vaccination (or indeed MAP vaccination) will last?
Tom Merritt
That is generally what we try to do. Like right now we hope to be hearing about those vaccinated against MERS 2 years ago using this same viral vector and spike protein [well it’s the same protein just a different sequence]. If those people still show good antibody levels that gives us hope that this vaccine will also last at least 2 years.
Crohn’s MAP Vaccine
Is it likely that future Covid vaccines will use the same vectors or will different ones be used? Is there a finite number of vectors?
Tom Merritt
Currently they will use the same vectors. But I suspect because there is still no definitive answer yet to if we’ll build up an immune response to the viral vector itself, that Oxford or VacciTech [owners of the Patent for the ChAdOX vectors] are working on new variants for those vectors.
Crohn’s MAP Vaccine
Why are some people having bad reactions and some aren’t? Is it related to how badly you would react to Covid if you caught it – whereas some people are asymptomatic?
Tom Merritt
Crohn’s MAP Vaccine, ah bad reactions- depends on what you consider bad. The vast majority of reactions are the normal immune reactions- headache, fever, meh/blah feeling [malaise]. It’s how you feel when you are sick. Your immune system is putting a lot of energy in to create a response that will help prevent you from really getting sick that you don’t recover from. Now for those with allergic reactions likely would have had that reaction to other vaccines before. There are always folks who react worse than others to vaccines. And no, it doesn’t mean they’d be worse off for CoVID or any other disease the vaccine is designed for. But why?! Ahh now there’s a question I can’t fully answer. This is down to genetics and of course care for one’s health. It can vary due to unrecognised stress at the time. Maybe underlying health conditions. But just like good luck, there is bad luck too. It’s honestly still a mystery of science that we can’t predict. It’s really why we do such large clinical trials. Hoping to find out if there is something we are missing when we work hard on these vaccines.
As for the asymptomatic coronavirus infections, no that’s not a mystery. It’s likely based on your last exposure to a coronavirus and how well you made antibodies to that previous infection. I won’t go into details, but there was research in the 1980’s in the UK that showed when exposed to the same exact coronavirus 1 year later, those people were asymptomatic, but still shedding virus to infect other people. So, this is not ‘new’ just not well known to the general public.
Tom Merritt
Also, I was asked by my own friends on my page and also in an earlier question the following as it is currently happening:
What is your opinion on the suspension of use of the Oxford AstraZeneca covid vaccine by Ireland, Denmark and Norway?
Okay, so I was originally going to say- this overreaction and worry. Personally, I still feel this way.
But let’s be honest, this is not a bad thing. Something has gone wrong, though it is with a VERY limited number of people. We have no idea about these individuals and their situation. But these countries are trying to make sure there is nothing wrong. Heck maybe something did happen in a batch that was made. But what we do know is 40+ millions of doses worldwide have been injected and NOTHING has happened to others. But now we have a situation where a few have had issues. Sure, you can put a pause on it, review things and prove that these issues are NOT related. Once that happens begin again.
But what if they find there is a real issue? then yeah, they prevented a bad situation. And that’s the point of good medical review and batch processing. Things happen.
Right now, at my work I’m in the process of figuring out what has changed in one of our processes that we do in growing cells. And it’s not for the whole process, just a very specific step, so I have to review everything. And hopefully, we’ll figure it out, resolve it and move on. Does this mean everything before this time period was bad? Nope, but something now is, but once resolved it will be back to normal or maybe even better.
Now likely what will come out of this? Bad luck for those people and the timing of whatever vaccine they got? Most likely. But if it’s not, best to prevent other situations of a similar outcome.
As for the UK- do we stop giving AZ? Nope, no incidents here and our production is from UK places [like some little company I know]. And therefore, likely don’t have the same issue.
To add to this a person with more experience wrote this:
“Blood clotting, or thrombosis, occurs for a variety of reasons, the lead up to and even can often be undetected in the general population, and venous thrombosis is relatively common affecting 1 to 2 in 1000. Reports of what has triggered Denmark to pause the use of the Oxford AstraZeneca vaccine is not clear, but I note that the EMA has identified 22 cases of thrombosis among the 3 million who have received the vaccine so far, which is much lower than our 1 to 2 in 1000. Therefore, if there is any association between the vaccine and clotting, the risk is likely to be very low indeed.” – Prof Jon Gibbins, Director of the Institute for Cardiovascular and Metabolic Research, University of Reading
Those numbers by the way work out to 1 in 150,000 people, much less than the 1 in 500 / 1 in 1000. And his numbers are off, as it is 40 cases in all 17+ million doses in the UK/EU. Which means about 1 in a 425,000. So really unlikely this is the cause. But as I mentioned if they all come from just 2 or 3 batches, then you need to check into it properly. Which is what is going on.
Christine Clifford
Tom Merritt, thanks for covering this important issue and putting it into perspective.
Sean Young
Thanks for doing this Q&A, Tom Merritt. It’s been really interesting
Tom Merritt
Sean, happy to help where I can!
António Torres
Dr. Tom Merritt we all know that this work is based (by now) with fundraising, goodwill of the professionals, and personal time… but despite all that (and I thank you all for your efforts) in your opinion and personal knowledge, what is a good and real time frame for this kind of vaccine (map) to be available for all? 2 years from now is a realistic aim?
Tom Merritt
António if only. Funding-wise, I personally don’t know. But time-wise it’s ugly for any all things not a pandemic.
A typical vaccine once it reaches the clinical trial phase will take between 5-7 years. Not an exaggeration. Usually, it’s about 1 year for each trial, you need typically 4 trials. That said, in Phase 3 it begins to reach out to patients in greater numbers, so if you are aware then you are likely to get in by that point. But that point is 3-4 years from now at best. And with the weirdness of this pandemic, I can’t even hold that to be true.
I hope everything speeds up, but the main delay is the paperwork and it getting read and approved by regulatory bodies.
Keep a close watch on clinical trials. They will need you or your family members dealing with this.
But as a vaccine anyone can get, expect that near the end of the decade as sadly they don’t consider a disease that isn’t killing people quickly a priority to fast track sadly.
Crohn’s MAP Vaccine
I think we can all agree that this has been an absolutely brilliant romp through viral vector vaccines and much more besides! Thank you so much, Tom for doing this for us. We’ll try to get the whole thing transcribed for the website if you are agreeable. I think we should let you go now. You have earned a big drink / lie down / whatever form of relaxation you desire! Thank you so much from all of us!
Sarah Dawson
Thanks, so much Tom Merritt, some really fascinating answers and discussions!
Amy Hermon-Taylor
Thank you so much Tom! 😃💜🙏🏻
Christine Clifford
Yes, thank you Tom well worth it for us.
Tom Merritt
Thank you all for letting me share my knowledge. I do hope it helped and maybe gave you an idea about how some of this works. I do check in now and then, so if you really need an answer get into touch with these amazing folks and I’ll do my best. Cheers!!!