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Immunosuppressed Patients Respond to Booster Shots: Hope for a COVID Booster Vaccine for Lupus and Other Autoimmune Disease Patients? [Updated 8/12/21]

posted in All on August 11, 2021 by

Donald Thomas

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Will a COVID Booster Vaccine for Lupus Patients Increase Response Rates?

We do not know, yet. However, the August 12, 2021 edition of the New England Journal of Medicine reported significant responses in immunosuppressed organ transplant patients. This gives lupus patients, and other immunosuppressed autoimmune disease patients, hope that they may also respond well to a COVID booster vaccine.

The Problem: Early reports from COVID vaccine studies suggest that patients on immunosuppressants have lower response rates. The Johns Hopkins Hospital study has already suggested that patients on mycophenolate mofetil, rituximab, and steroids (when combined with another immunosuppressants) have high rates of nonresponse.

This leaves immunosuppressed patients, such as lupus patients, unsure of how well they responded to their COVID vaccines and they must remain vigilant with social distancing, mask wearing, etc. Unfortunately, the usual COVID antibody tests available to most doctors do not test for antibodies to the SARS-Cov-2 spike protein, which is essential to test for vaccine responses, so few patients know if they responded or not.

The COVID Booster Vaccine Study in Immunosuppressed Patients:

Who were tested?

-101 organ transplant patients who were immunosuppressed

-Toulouse University Hospital, Toulouse, France

What immunosuppressant drugs were they on?

– 63% were on mycophenolate mofetil (CellCept)

– 87% were on steroids (like prednisone)

– 79% were on calcineurin inhibitors (such as tacrolimus and cyclosporin)

– Others were on others such as mammalian target of rapamycin inhibitors, and belatacept

How were they vaccinated against COVID-19?

– All received the Pfizer-BioNTech RNA vaccine

– The 2nd dose was given 1 month after the first dose

– The booster vaccine (shot #3) was given around 2 months after dose #2

 

What Were The Results of the COVID Booster Vaccine Study?

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Only 40% of the patients had an antibody response after the typical 2nd Pfizer dose

68% had a COVID-19 spike protein antibody response 1 month after the booster shot (the 3rd dose)

Antibody levels increased from just 36 +/- 12 before the booster shot to 2676 +/- 350 after the booster shot!! That is amazing!!

None of the patients had any serious side effects to the vaccines

None of the patients developed COVID-19 after all 3 shots

Those less likely to respond = elderly, those with decreased kidney function, and those on the most immunosuppressants

 

Take-Aways from This Study

  • Many of these organ transplant patients were immunosuppressed on drugs commonly used in lupus patients (mycophenolate and steroids)
  • It appears from other preliminary study results that too many immunosuppressed patients are not responding to the current dosing of COVID-19 vaccines
  • It is very impressive how antibody levels went from 36 before the booster shot to 2676 after the booster shot!
  • My prediction: A COVID booster vaccine for lupus patients and other autoimmune disease patients has a high chance of increasing immunity against COVID-19
  • However, we do not know for sure. This study was not a study of lupus patients.
  • Even though a significantly higher number of immunosuppressed patients responded, 32% had still not responded.
  • All immunosuppressed patients should get vaccinated. Thus far they appear to be safe and significant numbers of patients do respond.
  • We need COVID booster vaccine for lupus patient studies performed as soon as possible to answer these questions.

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Update from 8/12/21:

Moderna Booster Study also showed increased responsiveness

The NEJM also reported that a similar study performed on 120 organ transplant patients using the Moderna COVID-19 booster shot (a 3rd shot) resulted in much better response rates. This study was done in Toronto, Canada by VG Hall et al. This is even more evidence that there is hope for the need of a COVID booster vaccine for lupus patients in the future!

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PLEASE COMMENT ON THESE STUDIES > WHAT ARE YOUR THOUGHTS, CONCERNS regarding the possibility of a COVID booster vaccine for lupus patients?

AUTHOR: Donald Thomas, MD

Reference:

Kamar N, Abravanel F, Marion O, Couat C, Izopet J, Del Bello A. Three Doses of an mRNA Covid-19 Vaccine in Solid-Organ Transplant Recipients. N Engl J Med. 2https://www.nejm.org/doi/10.1056/NEJMc2108861021 Aug 12;385(7):661-662. doi: 10.1056/NEJMc2108861. Epub 2021 Jun 23. PMID: 34161700; PMCID: PMC8262620.

Hall VG, et al “Randomized trial of a third dose of mRNA-1273 vaccine in transplant recipients” N Engl J Med 2021; DOI: 10.1056/NEJMc2111462.

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32 Comments

  1. This is great news. I am hoping this booster will be available for lupus patients and other immunocompromised patients soon. I am already 4 months out from my second shot and am now pregnant as well. With cases rising, I am definitely hoping to get a booster shot soon.

    • Britt: I’m so happy to hear about your pregnancy! I sure hope all goes well… Dr. T

    • This is awesome news to me since I have about seven autoimmune illnesses. I already contracted COVID but this gives me hope.

      • Andrea: I sure hope you do well… have a Happy Thanksgiving! … Donald Thomas, MD

  2. I have Lupus and got the Johnson and Johnson covid vaccine. Any news about getting a booster with that or if it’s safe to get a booster of another vaccine?

    • Marianne: Unfortunately, no. I feel badly for my J and J patients. It seems to be less effective, and we don’t know about boosters yet. I hope the J and J booster shot clinical trial data becomes available quickly so that we know. They are also looking at mixed boosters (such as Moderna or Pfizer after J and J)… Donald Thomas, MD

  3. This is great news. at this. I am taking mycophenolate. I had antibodies for 3 weeks after 2nd shot, then they were gone. So glad someone is looking at this.

  4. The article states, “ Unfortunately, the usual COVID antibody tests available to most doctors do not test for antibodies to the SARS-Cov-2 spike protein, which is essential to test for vaccine responses, so few patients know if they responded or not.”

    What exactly do the antibody tests test for if not for antibodies to the spike protein?

    • Mac: The antibody tests that I have access to measure antibodies for the COVID-19 nucleocapsid. This is the virus’ protein that binds to RNA and is important in taking over the host’s (us) cells in order to replicate. I first learned how this test was not as helpful when one of my first patients who got the vaccine (someone on Orencia and has RA) got a negative antibody test and it was negative after his vaccines. The patient was freaking out (high risk patient)… I asked the patient to enter the NIH study for the spike protein antibody test (the correct one) and happily, he had high titers. … thanks for asking… Donald Thomas, MD

  5. What about people with SLE considered “serologically active” (i.e., positive ds-DNA antibodies, low C3 and C4 and WBC) who are not on immunosuppressants except for hydroxychloroquine… is a booster still needed/appropriate?

    • arw: sorry for the late response. “Yes”. I got my booster. Reason, SLE patients have an abnormal immune system. You need all the protection you can get. I wish you all the best… Donald Thomas, MD

  6. What about people with SLE considered “serologically active” (i.e., positive ds-DNA antibodies, low C3 and C4 and WBC) who are not on any immunosuppressants except for hydroxychloroquine. Would a booster still be needed/appropriate?

  7. Thanks for the posting! Two questions: if the studies test spike protein antibody title, why can the doctors order such test in lupus patients? Any data on compromising lupus control from the booster?

    • Rachel: We do not have any data yet on lupus patients. However, studies are being conducted. We are recommending they get boosters based upon these study results. As physicians, when I order a COVID antibody test, it is not for the spike protein. It is for other COVID-19 antibodies directed at other parts of the virus. My patients can get their spike protein antibodies checked only if they enter a research study in my area. Thanks for your questions… Don Thomas, MD

      • Rachel: Myself and many others who specialize in seeing lupus patients will be recommending it to our SLE patients even if they are only on hydroxychloroquine (which does not suppress the immune system). There is a lot of evidence that the abnormal immune system of SLE itself increases infections. This includes things such as infections were part of the cause of death in SLE patients in the vast majority of patients before any lupus meds were available, a Dutch study showed that SLE patients only on HCQ had higher rates of severe pneumococcal infections compared to the healthy Dutch population, and SLE patients have higher rates of HPV infection at the time of SLE diagnosis… this is just a few off the top of my head… good question… Donald Thomas, MD

  8. I have Lupus and take plaquenil snd 5 mg of prednisone- 2 months after 2nd Pfizer I had thetest for the SARS-Cov-2 . Result was 1857. I see that is lower than the result returned 2676 +/- 350. I am now 4 months out from the 2nd Pfizer. I have had a very bad, ongoing flare since then that is confined to musculoskeletal pain & requiring more prednisone. Should I be concerned level too low? I don’t think I could bear another dose due to effects on me.

    • Dear Ann-Marie: you have a positive result. I do not think we really know the clinical significance of what numbers lead to how much more protection. Does a result of 2200 really provide much more protection than 1857? I have not seen a study yet that addresses this (though with all the research going on today, it would be easy to miss). I would think you are probably OK, but please talk to your doctor, and I wish you the best … Donald Thomas, MD

  9. Dear Dr. Thomas, I am so happy to see your posts. Really grateful to have someone like you here. We were not aware of the ACR recommendation on stopping mycophenolate for a week after 2nd dose, and our rheumatologist did not tell us to do so (My daughter has lupus and is on 2g/day for a number of years). Do you have any data on the difference (infection rate, infection severity, antibodies titers etc.) with and without stopping mycophenolate? Any anecdotal experience on flare up of lupus induced by vaccine? Thanks again!

    • Rachel: What a wonderful mom looking out for your daughter. This is data that I keep hoping for. They are currently doing these studies, and preliminary data from Johns Hopkins does show decreased response rates in patients on MMF. I hope that they look at this scenario (the MMF holders vs the MMF continuers). I hope your daughter gets the 3rd booster shot if she has received Moderna or Pfizer. … Donald Thomas, MD

  10. I have an autoimmune disease / shogren syndrome , Fibromyalgia , cervical spondylosis , High Blood , Reflux , osteoarthritis , osteoporosis , 66 years and vaccinated with Sinovac . Do I need to have one more dose in able to be safe with covid ?

    • Rosita: Definitely ask your doctor if you should or not.

      Studies for Sjogren’s are lacking regarding the risk of infection when not taking immunosuppressant drugs. The following is my opinion… I am not immunosuppressed. However, I wish I could get the booster shot myself for extra protection. In your case, you could argue that you have a weaker immune system due to your systemic autoimmune disease and your age (our immune system declines with age). If you were my patient and asked me, I’d say “yes.” However, there are no studies to support this recommendation (the studies supporting a booster shot were done in organ transplant patients who were taking immunosuppressants). Thank you for your important question, and have this important discussion with your healthcare provider … Donald Thomas, MD

  11. Thanks Dr. Thomas. My daughter is 20 years old, first diagnosed with lupus at age of 14. She is very stable maintained by mycophenolate 2g/day and hydroxycloriquine 200mg/day. I know nobody has crystal ball, but if you were my daughter’s doctor, would you have her hold off on mycophenolate after the 3rd does? If so, for how long? Thanks again.

    • In my own practice, if a patient is not at high risk of flaring, I ask them to stop mycophenolate for 1 week after their vaccine as per the American College of Rheumatology recommendations. I hope she does well… Donald Thomas, MD

  12. I have Sjogrens and low IGM and IGG immunoglobulins. I am curious as to how many antibodies I have developed. My docs say that I shouldn’t get tested for them because not recommended by CDC. I’ve been told that I can ask for the test myself with LabCorp. However, I can’t find anywhere what kind of numbers I should expect for the results of the spike protein. Can anyone enlighten me? I would be so appreciative. For various reasons, medical and otherwise, I have only completed my vaccine.

  13. I have already had my Pfizer booster. After my first and second dose, I didn’t really have horrible effects from the vaccine. After my third (booster), I definitely struggled for about a week of side effects. I feel as though I now would present antibodies if I was tested. It was a rough week of not feeling well, but worth the extra protection!

    • Jacki: Make sure to now get a 4th vaccine 6 months after your 3rd vaccine (new recommendation). btw, I recommend that my patients take 2 extra strength 500 mg Tylenol right after their shot, then 3-4 times a day for the next 3-7 days to decrease the flu like syndrome it can cause… I wish you all the best… Donald Thomas, MD

  14. I had both pfister covid vaccines with an extremely increased response of my liver enzymes. I have been diagnosed with SLE lupus since then. My liver enzymes have gone down gradually. I am seeing a liver specialist and a RA doctor now. I am now on HCQ. Both doctors have recommended that I do not take the booster. I continue to wear masks, socially distancing, wash my hands excessively. But I worry about covid.

    • Debbie: I agree. If a patient of mine has a reaction like you describe, I also do not repeat the vaccine. However, there are two other vaccines that could be used as a booster (Mix and Match as approved by the CDC). My biggest concern would be the J and J and blood clots (though rare), especially in antiphospholipid antibody-positive patients (though this has not been specifically ID’d as a risk factor, yet). Even though Pfizer and Moderna are mRNA vaccines, they are different. It is a tough decision, with no definitive answer. I hope all goes well for you… Donald Thomas, MD

      • Thank you for responding. I will ask about the moderna booster.

  15. Hi Dr Thomas
    Thank you for all your help! You are an amazing person.

    My daughter who has sle had pericarditis 6 days after her second Pfizer vaccine. She has recovered but now she is on both methotrexate and plaquenil. She wants to get her booster shot but was wondering if there is anything she can do to reduce the chances of getting pericarditis again from the vaccine. Should she take cochicinr re emptively to try to keep any inflammation down? Should she stop methotrexate for 1 or 2 weeks after or not at all? Thank you very much

    • Wow, what a tough situation. Whether the pericarditis was an idiosyncratic reaction to the vaccine or whether the vaccine flared her lupus can be difficult to sort out. If she were to get a booster, I’d personally recommend the Moderna instead (but realizing that this doesn’t 100% eliminate the possibility of a reaction). I like the colchicine suggestion, and it certainly is very safe for the vast majority of people to take it for a short period. We usually ask patients to stop methotrexate for 2 weeks after the vaccine so that it works better. However, could continuing methotrexate possibly reduce the risk of pericarditis?

      https://www.rheumatology.org/Portals/0/Files/COVID-19-Vaccine-Clinical-Guidance-Rheumatic-Diseases-Summary.pdf
      You’ll find that your rheumatologist has no sound stance to take as all of this is so new to all of us.
      I wish I had an easy answer.

      However, whenever I’m faced with this sort of question, I always ask myself, “what would I do in this situation?” It is hard to know for certain, however, I’ve seen so many horrible things from COVID (and death is as bad as it is… surviving but ending up with horrible fatigue/shortness of breath is a bad 2nd place) that I’d want as much protection from COVID as possible. I think I would go for a Moderna booster, prophylactically take an NSAID and colchicine around the clock for about a week after the vaccine (if no contraindications), stop MTX for two weeks, and continue hydroxychloroquine. Yet, I’d have to remind myself that it could still possibly happen again, and to call my doctor immediately if any symptoms of recurrence happen.

      I hope this is helpful, and I hope she does well.

      Donald Thomas, MD

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