Auto Immune disease and Vaccine

[ihearttc]

Can someone more knowledgeable than me point me in the direct of where I would find information about the effects of the vaccine on people with auto immune disease? I have googled but a bit overwhelmed with information and not entirely sure what I should be looking at.
I have Rheumatoid Arthritis and only take Hydroxychloriquine (incidentally the wonder drug as suggested by Trump back in April!) but I also work in a school so I’m very keen to have the Vaccine if at all possible. I’m interested in the effects of the Vaccine on my body (I don’t have the flu vaccine as it has made me really poorly in the past) but I feel this is vital to have. Is there a specific one which is better for people with auto immune conditions and if so are we likely to be able to choose which one we have? I’m way way down the list in terms of when I will get it anyway, I’m early 40’s and I’m not the medications for immuno suppressed group.

Thank you @BungeleandGeorge that's really helpful.

The guidelines are a bit contradictory though. So immune suppressed people can have the vaccine. But it may not work and they have to continue to shield anyway.....hopefully they will gather more data on this as it doesn't sound like there is a way out for the vulnerable otherwise.

I've been reading about the issue today. From what I can find, autoimmune disease, including things like thyroid, are exclusion criteria from trials I have read so far.

I want to know why?

clinicaltrials.gov/ct2/show/NCT04283461

DM has an autoimmune condition her consultant won't allow her to have flu or pneumonia vaccines so I'm assuming he will say the same re Covid vaccine but we will take advice.

@CrunchyCarrot

So I found this letter to the editor in the BMJ, a well-respected medical journal, re the possibility of the Covid mRNA vaccine potentially triggering autoimmunity in recipients.

www.bmj.com/content/371/bmj.m4347/rr-6

As far as I understand it, having Covid-19 can result in triggering autoimmunity, and this may be via the spike protein invoking some kind of molecular mimicry (think of what gluten can do in coeliac disease). That would mean any vaccine using the spike protein could potentially do the same thing:

antibodies to SARS-CoV-2 spike glycoproteins cross-reacting with structurally similar host heptapeptide protein sequences

This could result in an inflammatory reaction leading to autoimmunity developing. I presume it could also depend on one's genetics as to how susceptible one may be, but for those of us who have existing autoimmunity, it's not something we need re-triggering!

This could presumably then also happen if you are infected with SARS-COV-2 (as the letter suggests). So it wouldn't be unique to the vaccine. It seems from reading various posts that people with autoimmune conditions definitely wouldn't want covid-19 and there may be a slightly increased risk to a vaccine than the general public. So high uptake of the vaccine in the general public would be the best way to protect you to reduce the likelihood of contracting covid-19?

[quote catonmylapcantmove]I've been reading about the issue today. From what I can find, autoimmune disease, including things like thyroid, are exclusion criteria from trials I have read so far.

I want to know why?

clinicaltrials.gov/ct2/show/NCT04283461[/quote]
In the Pfizer vaccine trial those people were only excluded from Phase 1, so they will have been included in the later ones after initial safety had been established. However I can't find any info on how many people in the Pfizer test group actually had autoimmune diseases, which would be useful to know.

If you want more info I am referencing page 42 of the clinical protocol document found here www.pfizer.com/science/coronavirus

Presumably they will shortly update the green book with the Pfizer info to show who can and cannot have the vaccine, so I'm keeping an eye on that link posted further up thread to check the date of amendment. Its really not clear at this stage if people with autoimmune diseases will be offered the jab or not, let alone the logic behind the decision. I wonder when they will release the full trial data....presumably after all the regulators have reviewed it first so that won't be until January as the EU are dragging their feet a bit and not meeting until the end of December.

@MrsMigginsMate

Presumably they will shortly update the green book with the Pfizer info to show who can and cannot have the vaccine, so I'm keeping an eye on that link posted further up thread to check the date of amendment. Its really not clear at this stage if people with autoimmune diseases will be offered the jab or not, let alone the logic behind the decision. I wonder when they will release the full trial data....presumably after all the regulators have reviewed it first so that won't be until January as the EU are dragging their feet a bit and not meeting until the end of December.

Thank you. I was reading this, which seemed to have such a long exclusion list I wondered who was included!

clinicaltrials.gov/ct2/show/NCT04283461

I hope they have proper data on autoimmune outcomes and not just that it doesn't cause 'major' complications. I don't fancy a flare.

So we don't even know what the other ingredients are in the Pfizer vaccine, Jonathan Van Tam said this morning in an interview on the BBC, when asked about what should one do if one has allergies, he said that as yet they 'haven't been given the list of ingredients' in the vaccine. I am quite surprised that the MHRA have passed a vaccine without knowing all the contents?

Also I noticed at the press conference with Pfizer the other day, that one of the slides said they used 'healthy participants'. So that means not people who are currently under the weather with their condition. Perhaps those who are well-managed and 'well' were included, but for the rest of us, it again raises a question mark about how we might be affected.

So we don't even know what the other ingredients are in the Pfizer vaccine, Jonathan Van Tam said this morning in an interview on the BBC, when asked about what should one do if one has allergies, he said that as yet they 'haven't been given the list of ingredients' in the vaccine

I can't account for why he said that, but the pack info insert is now available online and includes the ingredients:

assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/940566/Information_for_UK_recipients_on_Pfizer_BioNTech_COVID-19_vaccine.pdf

@StopGo

DM has an autoimmune condition her consultant won't allow her to have flu or pneumonia vaccines so I'm assuming he will say the same re Covid vaccine but we will take advice.

must be particular to her disease as some of the common ones such as RA which the OP has you are strongly recommended to get flu and other vaccinations, the live ones only in the windows you may be off immune suppressing meds.

Best to keep watching NRAS or similar site for updates about your condition and the vacine OP. This was last month so a new one probably be out soon www.nras.org.uk/news/nras-statement-on-the-breaking-news-regarding-the-pfizer-vaccine

I'm definitely going to speak to my consultant. Had the pneumonia vaccine and have the flu one with no issues but I have
Autoimmune neutropenia (shielding)
Hashimotos
Cholinergic urticaria (body overreacts to histamine)
And some other autoimmune conditions
Plus I'm about to start on Xolair...

Thanks for that info @scaevola, very helpful.

I also have Ra and other complex medical issues. Very worried, about reacting to it.
I seem to react to a lot of antibiotics and medication.
However, if it's similar to flu vaccine as I have read and heard from people, I don't react to the flu jab, so maybe I might get away with it???

I too have RA and other conditions.
I don't react to much though I did to chemotherapy.
TBH I will risk a reaction / flare if it frees me.

@scaevola

^What COVID-19 mRNA Vaccine BNT162b2 contains

The active substance is BNT162b2 RNA.After dilution, the vial contains 5 doses, of 0.3 mL with 30 micrograms mRNA each.

The other ingredients are:

• ALC-0315 = (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate),
• ALC-0159 = 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide,
• 1,2-Distearoyl-sn-glycero-3-phosphocholine,
• cholesterol,
• potassium chloride,
• potassium dihydrogen phosphate,
• sodium chloride,
• disodium hydrogen phosphate dihydrate,
• sucrose ^

Not sure if I'm asking the correct question, but would we know at some point the sub components of the BNT162b2 RNA ingredient in order to assess any allergic reaction for instance?

@scaevola and @CrunchyCarrot

Again, for instance in the case of Valneva (that is developing an inactivated whole virus Covid vaccine adjuvated with Dynavax's CpG 1018 adjuvant which the UK has pre-ordered)

If the adjuvant is proprietary, would there be any information on the underlying components?

I've found some concerns regarding this adjuvant for instance in the BMJ - again, not trying to scare anyone. They are just questions I'm trying to figure out

www.bmj.com/content/360/bmj.k1378/rr-10

we know at some point the sub components of the BNT162b2 RNA ingredient

I think that's just the name for the type of RNA in the vaccine. It doesn't have any sub components. It's a bit of virus

@SexTrainGlue

I think that's not correct. It's synthetic and it was explained in some of these threads that it is messenger RNA that delivers instructions, not a synthetic reproduction of part of the actual virus

RNA is made of four nucleic bases, adenine, cytosine, uracil and guanine.
The order of the 4 bases (A, C, U and G) determines what protein is synthesised from the code. DNA is made from A, C, G and T.

Nucleic acids (DNA and RNA) are found in all nucleated cells (including plant cells) so are found naturally in many food substances.

If you were allergic to mRNA you wouldn't be alive as it is vital for every single cell in your body (it is the intermediary between your DNA gene sequences and the proteins that the gene codes for) so I don't think that you need to worry about the BNT162b2 RNA ingredient.

The mRNA is packaged in lipid nanoparticles but I assume that they are in the other ingrediants (e.g. 1,2-Distearoyl-sn-glycero-3-phosphocholine and cholesterol as these are lipids).

@JS87

That's fine. But I think that's not relevant to what I'm saying

I've been wondering about whether any of the vaccines are suitable for those with autoimmune conditions too.

I have scleroderma.

I would love to have a vaccine BUT only if it's safe to do so and not because it wasn't clear I shouldn't! My GP will not be any use, I don't think she's even aware I have scleroderma as I see a consultant at the hospital and the GP really doesn't get involved.

[quote trulydelicious]@JS87

That's fine. But I think that's not relevant to what I'm saying[/quote]
I thought this was what you asked?

Not sure if I'm asking the correct question, but would we know at some point the sub components of the BNT162b2 RNA ingredient in order to assess any allergic reaction for instance?

I answered with what the sub components were.

@ForeverInADay

Best to check with the specialist consultant at the hospital I think. They should be able to advise regarding the specific condition (now or in due course as more is known regarding autoimmunity and each vaccine type/brand)

@JS87 If you were allergic to mRNA you wouldn't be alive as it is vital for every single cell in your body (it is the intermediary between your DNA gene sequences and the proteins that the gene codes for) so I don't think that you need to worry about the BNT162b2 RNA ingredient.

Agreed, we have millions of mRNAs in our body at any time, it's how proteins are made. Incredibly clever system! The BNT162b2 is what they've called the mRNA fragment that codes for the spike protein, that's all. What it isn't is 'a bit of the virus' (someone else's comment further up). It is not. There is NO viral genome in the vaccine. People shouldn't be concerned about that.

The one thing that should be noted is that there's PEG in there - polyethylene glycol (ALC-0159 = 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide). This will be part of the lipid that protects the fragile mRNA. PEG isn't particularly nice and unfortunately is in a lot of foodstuffs and cosmetics, etc, so a lot of people have anti-PEG antibodies. But you could argue if you're not sensitive to it at this point, you'll probably be OK with the vaccine.

@trulydelicious I hadn't heard of the Valneva vaccine! Sounds like it's behind the front runners. Yes adjuvants are potentially problematic to the immune system e.g. aluminium salts (alum), squalene. Frequently it's the older 65+ section of the population that gets them in vaccines as our immune systems are allegedly 'weaker'.

So this Dynavax CpG 1018 adjuvant, I had a look around for any further info. It appears it's been developed to replace alum and is used in a Hep B vaccine. It acts to stimulate the toll like receptor 9 (TLR9)

www.dynavax.com/science/cpg-1018/

Thing is, TLR9 is also involved in the autoimmune response. There's active research into synthetic TLR9 agonists and antagonists that help regulate autoimmune inflammation. Not sure I would want that injected into me. This study shows that levels of TLR9 (along with some other TLRs) is raised in thyroid autoimmune patients.

www.ncbi.nlm.nih.gov/pmc/articles/PMC5145898/

Having Hashimoto's, that's one vaccine I wouldn't touch with a barge pole!