Research on the Vaccine and immune suppressed people

[Sue]

Sorry to be the bearer of bad news, but I have just read this. I have put the bold font into the text.

Although the research was with patients who had had organ transplants, it seems that the findings may also apply to people with auto-immune conditions:

https://www.medpagetoday.com/infectiousdisease/vaccines/91631?xid=nl_mpt_DHE_2021-03-16&eun=g1781883d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%20Top%20Cat%20HeC%20%202021-03-16&utm_term=NL_Daily_DHE_dual-gmail-definition

Taking care of a lot of immunosuppressed patients, one big question my Johns Hopkins colleagues and I have had throughout the pandemic has been: Will vaccines rescue them from the COVID-19 threat? Based on a new study we published today in JAMA, the answer appears to be: only for some.

The day that the FDA granted the Pfizer COVID-19 vaccine an emergency use authorization, we launched a national study of vaccine immune responses in immunosuppressed solid organ transplant recipients. Among 436 COVID-na?ve participants who received a first dose of mRNA vaccine, only 17% mounted detectable antibodies to SARS-CoV-2. This is in stark contrast to immunocompetent people who were vaccinated, of whom 100% mounted detectable antibody; that was true for people who had received either the Pfizer-BioNTech or Moderna vaccine. We also found that those taking anti-metabolites, such as mycophenolate or azathioprine, were about five times less likely to develop antibody responses (8.75% detectable antibody in those taking anti-metabolites versus 41.4% in those not taking them).

Naturally, we were disappointed to see these findings, as we were hoping to be able to tell our immunosuppressed patients that the vaccines seemed to work well for them. Given this observation, the CDC should update their new guidelines for vaccinated individuals to warn immunosuppressed people that they still may be susceptible to COVID-19 after vaccination. As the CDC guidelines are currently written, they assume that vaccination means immunity. Our study shows that this is unlikely for most transplant recipients, and one could guess that our findings (especially those concerning anti-metabolites) could also apply to other immunosuppressed patients, such as those with autoimmune conditions.

Of note, our previous research has not found that immunosuppressed transplant patients are at increased risk of COVID-19 mortality as we thought might be the case. But regardless, the vaccine does not seem to work as well in this same population.

As a transplant surgeon, there are a few implications for my patients. First, it seems pretty clear that immunosuppressed individuals need (at least) their second vaccine dose; proposals to stop at one dose until the rest of the population is vaccinated apply to immunocompetent people, but not to my patients. Second, it is critically important for immunosuppressed individuals to realize that they are not necessarily immune after receiving the vaccine, and to talk to their providers about antibody testing before relaxing protective behaviors. Fortunately, semiquantitative antibody tests like the ones used in our study are widely available, and correlate well with neutralizing immunity.

Our study is ongoing, and soon we will have data from the second dose, as well as deeper studies of T-cell and B-cell responses, which can confer immunity even when antibodies are not present. We are also studying other vulnerable populations. Enrollment is open, we welcome new participants, and we hope to share more information soon.

Dorry Segev, MD, PhD, is a professor of surgery and epidemiology and associate vice chair of surgery at Johns Hopkins University School of Medicine and Bloomberg School of Public Health.

[Penguin68]

Sue -

1. The extrapolation made by the commercial publisher medpagetoday has not been made by the original researchers. It is therefore a guess - at best (as the study looked specifically at those with hard tissue transplants only - not even at those with bone-marrow transplants).

2. The study looked for detectable anti-bodies, but these are not the only protection offered by the vaccine - which includes e.g. T-Cells and B-Cells, as recognised in the report summary. The fact that, for those who had the vaccine, but without anti-bodies (or almost without) Of note, our previous research has not found that immunosuppressed transplant patients are at increased risk of COVID-19 mortality as we thought might be the case suggests that T- Cells and B-Cells may still be offering protection.

3. The Zoe people specifically touched on issues to do with immuno-suppressed and auto-immune diseases - they suggest that they should certainly take the vaccine, which at worst might suppress the extremes of Covid-19 if not fully protect.

But the study looked at, and is relevant to, a single group (and an unusual one, statistically) of those who have had organ transplants. And it is not complete.

I don't think that this, except for a small group of people, is actually 'bad news' as the more general extrapolation made by the US publisher is not one backed by clinical research. And even for the group which displays lower or no levels of antibodies following the first vaccination there may be other aspects of protection which are present for them.

But bad news sells papers.

[Sue]

Thanks Penguin, but I didn't get it from a paper, it's apparently a medical news site for people working in the medical profession?

And the article I posted appears to have been written by one of the researchers? He says "our study is ongoing"?

He does stress that the study is not complete and that they were looking at a very specific group or people.

Also the Zoe suggestion to take the vaccine was clearly made with very little research to back it up at the time (not that I'm in any way suggesting that immune suppressed people should not have the jab!)

But - it's not the US publisher who has made any extrapolation, so far as I can see, it's a professor who was directly involved in the research. I may be wrong, but that's how I read it.

ETA: Just read this post from someone on the forum I got the article I posted above from (grammar) (it's a forum for people with a particular auto-immune condition):

"BETTER NEWS!I contacted Prof Segev for some clarity (the author of the article)He just replied and said that they don't have evidence that 'steroids are blunting the vaccine response' but results are preliminary."

[Guest]

Thank you Sue, that is interesting but not alarming. I do not think is a matter of good or bad news. It is a fact that the vaccines are all been approved as a matter of public health emergency (and they have not been tested on people with those "previous underlying conditions" we often hear quoted as cause of death of severe Covid)... Another fact is that the lower effectiveness of the vaccines among people with compromised immune systems is something that has already transpired... As you may remember this is the point I wanted to raise few weeks ago...

Anyhow, you got it and it might have in any case increased a little bit your probability of NOT developing a sever form of Covid in case you get infected - but you should keep on wearing your mask and go ahead with all the other precautions... I know lot of people with one or two autoimmune conditions, over 70 and over 80, that are doing very well: they got the vaccine and pretty much with no side effect at all.

As far as I am concerned I do not want the vaccine now, I need to concentrate on other aspects of my autoimmune disease and on my circumstances and I will reconsider this decision in one year time approximately.

[muffins78]

A little while ago I read that immune compromised people may need a third dose of vaccine for example.

Nonetheless the article is a good reminder not to be complacent just because you?ve had the vaccine. In my mind I was beginning to think that it will be all okay after the second dose, but perhaps not. I wouldn?t not take the vaccine. Either way we?ve to be careful and mindful of others still. There are many good reasons to take it, and for some there are real reasons not to have it.

[Soylent Green]

I would want to see a wider choice of results before taking this as gospel. I am immunosuppressed and my consultant was keen for me to take the vaccine, which I have done. I was told that it might take a little longer for my resistance to build, but it has never been suggested to me that the vaccine would not work. Admittedly, I only skimmed through the post, but I did not see any time scales - perhaps if these people had been retested two or three weeks later, their immunity to Covid would have increased? There is a huge range of drugs for immune-suppression and doses vary widely, so I would trust the doctors who treat you rather than Dr Google.

[Guest]

Good luck with trusting your doctors! I have just had today the results of the blood test that should have helped me understanding if I have or not have a certain condition, in addition to my diagnosed autoimmune disease.

Plus, I also tested for Covid antibodies to see if I had or not the infection.

Well... my GP clearly said on the request I should be tested for excluding a certain condition but unfortunately the lab at the hospital did what they wanted to do ... they tested me for something else, completely useless...

What can we say? Back to the starting point. It is not the first time that this happens. My GP trusts that specialists can help but this does not happen. Rheumathologist trusts that GP knows what to do next but this does not happen. Ophtalmologists, kidney specialists, dentists, all the consultants trust that other colleagues know what to do next and that does not happen.

The only one who really knows what to do next is me. I now need to make a research again (as I cannot remember what I had already discussed with specialist and GP almost two months ago and I lost traces of the clinical advice or articles as in the meantime I have moved house and I still have lot of things upside down), I have to find exactly what type of antibodies tests need to be done AGAIN, find out if such tests are done through the NHS in the UK (surely they are) and how precisely are they named or coded in the UK so that labs specialists do not get confused reading the request, speak AGAIN with my GP and tell him precisely what needs to be made explicit for the lab if we really want to test the condition, and go for another blood test. And finger crossed next time somebody will listen and I will be luckier.

Perhaps if you are on biologics (immunosuppressant drugs) you are looked after with much more accuracy and precision and you can have the privilege of trusting your doctors, full stop. I am the villain that trust all the doctors but keeps healthy going back and forth for useless blood tests coz they do not have the humility to simply say alright we do not know what the others specialists are talking about so perhaps it is better if we learn before doing the first thing that comes to mind - that usually it is the wrong one.

Ah, and as far as the Covid antibodies test is concerned they tested me for Covid infection and said I do not have the infection at the moment, not mentioning at all the antibodies test (that may have other functions and meanings in the context of a patient that wants to understand the behaviour of the compromised immune system in a certain period of time).

Sorry for the bitterness of this post, I am really tired tonight. All this emphasis on the vaccination and the pandemic is obviously important but for many people there is more than Covid-19 to be worried about.

[Penguin68]

What can we say? Back to the starting point. It is not the first time that this happens. My GP trusts that specialists can help but this does not happen. Rheumathologist trusts that GP knows what to do next but this does not happen. Ophtalmologists, kidney specialists, dentists, all the consultants trust that other colleagues know what to do next and that does not happen.

Sadly, most specialists work in silos - so whilst they may liaise through GPs (actually dentists and ophthalmologists sit outside that loop, normally, unless they involve hospital specialists) they rarely talk together about a particular patient. If you present with multiple conditions, more likely as you age, this is problematic. An elderly relative of mine had both a respiratory and a heart condition where the standard treatment for one actually exacerbated the other - it was only when both specialists could be brought together in a room that a complementary treatment regime could be sorted out.

And I have noted that ordering tests effectively seems to have worsened. As everything is now hands-off no one gets to review what's actually printed out on forms (except the patient, not medically trained to know what the abbreviations are). And at least one local practice is sending all patients who need blood tests to have an HIV test in addition (part of a survey) without discussing this with the patient. As even having an HIV test can impact life insurance adversely (as most people only request a test if they think their behaviour has put them at risk) I think this is entirely reprehensible. [some insurance forms ask 'whether you have been tested for HIV'].

[Sue]

I have a vague memory that there was a big sign up when I went for a blood test saying something about an HIV test.

I have a vague memory that it was completely optional.

I'm pretty sure that a GP would not request an HIV test directly unless there was a clinical reason for it which would have been discussed with the patient.

I may be wrong, in which case surely this should be taken up with the GP and the relevant authorities as a matter of urgency?

[Penguin68]

It is optional but it is automatically being added to blood test request forms. you can cross it out but the phebotomist won't.

[Sue]

I'm pretty sure it wasn't added to mine!

[Penguin68]

Depends which surgery, I'm guessing. Some will be in the study, some not.

[Siduhe]

UK insurance industry guidelines (in place since 2004) only allow insurers to ask about your HIV status, about whether you have had a sexually transmitted infection in the last five years, whether you have lived or travelled abroad, had blood transfusions or surgery abroad or whether you inject drugs. The guidelines make clear that other questions - like whether you have ever been tested for HIV or whether you are gay - are not permitted.

I don't disagree that people should be aware and should consent to HIV testing but I don't think it's particularly unusual to be given a test. Anyone who gives blood is regularly tested for HIV (first donation and random checks afterwards but at least once every two years).

[Guest]

Penguin68 Wrote:

> Sadly, most specialists work in silos - so whilst

> they may liaise through GPs (actually dentists and

> ophthalmologists sit outside that loop, normally,

> unless they involve hospital specialists) they

> rarely talk together about a particular patient.

That is exactly what I think is happened in the circumstances I described. But it is not just a matter of communication between specialists, that surely lacks, there is also something more subtle "in the system".

GP asks to make an antibodies test to ascertain / exclude I have a certain rare condition.

The hospital's lab just follows a protocol that very likely says that particular antibodies test must be done only for patients with other autoimmune diseases (and that is my case!!!) under the case of rheumatologists (that is, again, my case but my rheumatologist is at a different hospital).

Instead of performing a circa 90? value test as required by my GP, or to pick up the phone and ask more info about the patient, they made an entire array of tests to exclude other conditions that could have justified my GP request from the perspective of their protocol, totally unnecessary and not pertinent from my perspective, the commercial value of which was around ?500.

Anyhow, I have now recollected / researched again the whole matter and will ask GP to make a precise request for only the test we wanted.