Many avid readers of the blog will remember the guest post from Sita a few weeks ago. As part of her elective placement I asked her to look at some of the early data from people taking part in the COVID blood spot study, and she has written a blog post below talking about what she found.
This is very timely, as in a BartsMS advisory group meeting this morning I was reminded of the importance of feeding back to people taking part in research regularly – not just at the start and end, but with progress reports along the way as well. As a researchers, when you’re in the midst of paddling madly trying to get results out, or understand some of what you have found, it doesn’t always feel like the “right” time to feedback. However, there is never really a wrong time! At the moment we are working hard on the lab side analysing blood spots and making sure that all of the results that we get are accurate, alongside sending out more packs to those that are due them. But in the meantime, here is some data from the first c200 people who have returned packs – we are hugely grateful to every one of you.
As I mentioned in my previous blog post, my name is Sita and I am a final year medical student. For the past month I have been spending time with the neurology and Multiple Sclerosis (MS) team. In this time, I have been helping to recruit people for our blood spot study, which looks at Covid-19 antibodies in people with MS.
I have also been analysing some of the data from the first 211 participants who have completed and returned questionnaires, so I thought it would be nice to discuss some of the things I have been looking at.
I found that the average age of people taking part in this study was around 42 years old and the average time since diagnosis was 8.6 years. Most people had relatively stable MS, with around 30% having had a relapse in the past year. Over 90% of people in the study were on treatment, of which Ocrelizumab (Ocrevus) was the commonest, followed by Natalizumab. This reflects the fact that the first people that we recruited to the study were those who were coming to the hospital for their infusions. Over 80% of those on Ocrelizumab received both their vaccine doses within 5 weeks or less – compared to only 33% of those on Natalizumab.
In terms of vaccinations, it was twice as common for people to have received the AstraZeneca vaccine compared to the Pfizer vaccine. Our data showed that of those who had received both vaccine doses, around 2/3 of you received both vaccine doses within five weeks. At this time, this is most likely because we would be more likely to have complete vaccination data for those of you who had received both doses. We were able to obtain a blood spot sample prior to vaccination in 129 people taking part in this study, and the purpose of this is to find out how many people living with MS had Covid-19 antibodies prior to vaccination.
Our data also revealed that 53 participants were shielding during the pandemic, with an additional 90 participants following strict social isolation. Over 100 participants reported having had covid symptoms, which lasted on average 15 days. The symptom length did not appear to be affected by MS treatments. Interestingly, around 1/3 of people who were shielding developed Covid-19 symptoms; however, this was not observed in those with a strict social isolation status – only 13% of those isolating developed symptoms. It is possible that this finding could be coincidental and may indeed change as we analyse more participants, but at the moment we can’t explain it.
But what does this all mean for you?
At the moment, not a huge amount. We did this kind of analysis to get a general idea about what the cohort of participants is like. Our current steps are analysing the samples you have sent in to find out how many people produce a sufficient antibody response to the vaccine. For those of you taking part in the study, please remember to email us when you have had your second vaccine dose so we know when to send out your blood test kit! For anyone who isn’t taking part but is keen (and under the care of BartsMS) please let us know. We are particularly interested in hearing from people who are taking oral (tablet) medications for their MS.
Isn’t 30% quite a high relapse rate for people on treatment?
“Isn’t 30% quite a high relapse rate”
For Ocrevus and Tysabri…yes.
Remember this study includes everyone. There are quite a lot of people in the study who are (relatively) newly diagnosed and just starting treatment – all of them will have had a relapse in the past 12 months (at the time of diagnosis and prior to treatment).
So yes, at first glance high, but when I paused and thought I feel a bit better about it 🙂
“There are quite a lot of people in the study who are (relatively) newly diagnosed ”
No..not really the case.
“I found that the average age of people taking part in this study was around 42 years old and the average time since diagnosis was 8.6 years. Most people had relatively stable MS, with around 30% having had a relapse in the past year. “
Fair point! This is the average – but the range was from 0 years (and looking at the numbers there is a “hump” at 0-1 years, the distribution is not even around the average). And there are also a proportion of patients who will have switched treatment in the last year because of relapses. Bearing this in mind, I think the relapse rate is ok..
“Bearing this in mind, I think the relapse rate is ok..”
It’s ok for now….but over 20 years that relapse rate combined with the PIRA Ocrevus and Tysabri don’t affect…can cause them sp.
The writer Joan Didion is 86 and had ms for 50 years and still walks…I wonder will these patients be so lucky..?
I’m happy y to participate in the research but not eligible however what I really want to know is how can I get an antibody test to find out whether thee vaccine has worked for me given that I am on Fingolimod
This is so frustrating having spent the past few days getting my head around how fingolimod and the other mods may respond to the vaccine yours is a valuable sample, Are you sure you havent been seen at Barts
COVID19Ab@qmul.ac.uk
No I have never been to Barts
Thanks for the update Sita and Dr. Ruth, it is really interesting to see where you are at and findings so far 🙂 Good luck with the rest of the study!
Thanks for the update. I’m not under Barts care , but under ***** which is coincidentally also doing its own blood spot analysis. Not heard any feedback from them yet, but think they are still processing the spots. I found it interesting that 2/3 of your patients had their jabs approx 5 weeks apart. Certainly in my experience in wales is that you are talking a min of 11 weeks between the AZ jabs. Be interesting to see if the two studies have the same findings.
We started vaccinating in the beginning of Jan on Jan 26 it was recommemended that the interval be brought done to a minimum of interval so on 26th this is what we started to organise on 27th this was overruled and put back up to the twelve weeeks but BartsHealth overruled the Joint Vaccine committee and went for the short interval on about 30 Jan. I heard there was the talk of rebellion by some doctors if they didnt get jab more promptly.
For the AZ jab the longer the interval the higher the antibody response will be bigger but for pfizer no-one in any of the studies had gone on for longer than 6 weeks so the vaccine committee were being science cowboys and girls and this is why we are the only country to do this….What is the point of trials if you ignore what was done. With pfizer it has been shown that the antibody levels drop quickly after the first jab, it is really the second jab that does the business. Moderna gives a higher antibody levle based on trial data
I am not part of any study. I am on Ocrevus (since 2019) and was due to receive an infusion in April, 2021.
Per my neurologist’s advice I received a first dose of the Pfizer vaccine on 3/1/21, and the second dose on 3/22/21. Then received my regularly scheduled Ocrevus infusion on 4/20/21. Due to concerns re efficacy of the vaccine, my doc ordered an antibody blood test which was done on 5/24/21. It came back negative.
I would like to know what are the recommendations and/or options for me (and others like me) now? My doc and the physicians in practice with him don’t seem to know.
Dear Cindy
Thank you for your info.
I can’T give recommendations and not sure the neuros have enough data to make evidence based recommendations. However you are not alone…based on the data that is surfacing many people who have a vaccination before your standard six monthly dose do not make an antibody response if you are taking ocrellizumab. I predict this may be about 80% dont make an antibody response.I suspect however that a significant number of such people will make a T cell response, but it will not be in all people. This may give protection.
We are starting to see safety data from people were the ocrelizumab dosing was delayed at the start of the pandemic. In all instances I have seen so far this delay was not associated with reactivation of MS. How long can we delay, I think we need to see the data..I have seen two published studies, I know we are doing an audit and I know many other places have done one. When we see this data we know what is feasible
Why? It may be relevant because by delaying the infusion you may help get an antibody response. Why say this..There are examples. the MS margaret Keenan did this and they made an antibody response. Last friday there was a modelling study that suggests that by delaying the dose it allows time for more people to respond. Likewise the data is hinting that if the B cells are repopulating then you can make an antibody response. In the modelling study a B cell level of about 20-25% was as good as a 9 months wait. Data will emerge hopefully of the CD19 levels being measured and then if we can link a B cell level to a response maybe when vaccine round three happens and we are not in a desparate state then maybe we can personalise thisto optimize a response.
As another angle you can give people an anti-SARCov2 antibody response. The makers of ocrelizumab also make on of these. In our blood spot study we have seen someone having this type of treatment and there antibody levels are way above many vaccinated peoplehis…They should do a study to see if this protects ocrelizumab-treated people. We are in wave 3 and people are being encourgage to go out and about. It would be good PR and it may help people to be more confident about ocrelizumab in the COVID-19 era…if there is to be one this could be a COVID-19 casualty. Another could be fingolimod
Thank you for update DrRuth! And thanks too mousedoctor. My story is much like Cindy C above, only I got Pfizer at 2 months post infusion and testing for antibodies is not available to me because testing vaccinated but immune compromised individuals is not recommended by U.S. CDC at this time. I shield as much as possible and social distance, however, it is becoming increasingly difficult to safely distance anywhere in my community as it catapults open. Although Only 33% of my area is vaccinated, most go unmasked, and ignore personal space, and quite a bit have become aggressively more hostile in recent weeks to anyone wearing a mask. People here are genuinely mystified that a vaccinated immune compromised person is still at high risk for disease. I blame the confusing CDC messaging. Life outside my home is so significantly altered now and I am grateful to get any info from you all to share with my neuro to help guide DMT decisions. Thank you.
I have a T shirt with little print on it which read “If you can read this” then in Big print…”Stop being an inconsiderate A hole, please get out of my Air Space”
Testing vaccinated but immune compromised individuals is not recommended by U.S. CDC at this time….Do they give reason why…I know in Arthritis there were concern about false positives do you have a link
Gladly.
Interim Guidelines for COVID-19 Antibody Testing in Clinical and Public Health Settings (Updated Mar. 17, 2021)
Simply, not recommended to get/give antibody test if patient vaccinated, period.
https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html
CDC stated reasoning : “[s]ince vaccines induce antibodies to specific viral protein targets, post-vaccination serologic test results will be negative in persons without history of previous natural infection if the test used does not detect antibodies induced by the vaccine.”
In Orwellian terms, ignorance is freedom.
Involved in public policy decision making in my pre ms life, I guess how this needle was threaded. Does it make you scream as a scientist? Deconstruct this statement for insight into what health gov’t leaders here in US appear to want the public at large to understand and, implicitly, what has been determined to not be a priority.
The US FDA has more tact, and apparently more confidence in the American public to take head out of sand and grasp basic scientific principles, but the recommendation is the same:
Antibody Testing Is Not Currently Recommended to Assess Immunity After COVID-19 Vaccination: FDA Safety (Date Issued: May 19, 2021)
https://www.fda.gov/medical-devices/safety-communications/antibody-testing-not-currently-recommended-assess-immunity-after-covid-19-vaccination-fda-safety. It advises health care providers ” At this time, do not interpret the results of qualitative, semi-quantitative, or quantitative SARS-CoV-2 antibody tests as an indication of a specific level of immunity or protection from SARS-CoV-2 infection after the person has received a COVID-19 vaccination.” And just in case a doctor might be tempted to check if a pwMS got an immune response of any kind, the FDA adds, “SARS-CoV-2 antibody tests should be ordered only by health care providers who are familiar with the use and limitations of the test”. And finally in a marvelous demonstration of bureaucratic CYA, “if you are considering antibody testing in vaccinated individuals, follow cdc guidelines”, (which, says don’t do it.)
Not surprisingly due to the masterful semantics Of the CDC recommendation and the hand tying of physicians by the FDA, there is lack of agreement among doctors on what to advise immune compromised patients.
Debate is flushed out by the press, here Antibody test won’t reveal if you gained immunity from your COVID vaccine, experts say, Miami Herald (JUNE 07, 2021)
https://www.miamiherald.com/news/coronavirus/article251950398.html. Another article by US National Public Radio article says don’t get antibody test if vaccinated. But a thorough reader will discover at end of article that a Dean of a respected US medical school opines a single exception MAY exist for the immune compromised. And The advice is telling, “work with your physician to try to find the spike protein antibody test”. Coronavirus FAQ: Should I Get My Antibodies Checked After I Get Vaccinated?, NPR (May 16, 2021) https://www.npr.org/sections/goatsandsoda/2021/05/16/995446986/coronavirus-faq-should-i-get-my-antibodies-checked-after-i-get-vaccinated.
So no advice from cdc or fda if you’re an immune compromised pwMS but you can get info from news articles and blogs ;). See this blog COVID-19 antibody test not necessarily an indicator of immunity, UT Physicians Blog (March 29, 2021) https://www.utphysicians.com/covid-19-antibody-test-not-necessarily-an-indicator-of-immunity/ which posts some sage advice under their official approved blog
“If you are determined to test your immunity… Seek out an anti-spike protein COVID-19 antibody test, which are the antibodies that vaccines create….
‘If you get tested for antibodies and the results come back low or with none at all, that does not mean that your vaccination didn’t work … You should talk to your doctor about your results.” Oh, Thank goodness for physician blogs focused on the health of patients!!! Not sure if this goes without saying, but two barriers to antibody testing by immune compromised in US is that a lab test of antibodies generally requires a lab order by a physician AND health insurers are not gonna pay for test if it’s not recommended by the CDC and FDa. But By far my favorite quote I found is from the Miami Herald from a non govt infectious disease expert to consider getting another vaccine dose —
“If an immunocompromised patient does not have antibodies, doctors may consider bolstering their protection with another dose of the vaccine, continued masking and other precautions.” I add for clarity, be sure to check with your doctor….
Cynical and grumpy from all my self isolation I self censor the rest of my Comment. Note, this represents only my ideas and ramblings from articles I found on the internet, no one else, and under no circumstances does it represent anything to rely on for anything but that I’m pissed off.
Thank you SueBee
CDC stated reasoning : “[s]ince vaccines induce antibodies to specific viral protein targets, post-vaccination serologic test results will be negative in persons without history of previous natural infection if the test used does not detect antibodies induced by the vaccine.”…….Duh..However you would be surprised by the idiots that have tested for nucleocapsid response after the vaccinaation that does not contain nucleocapsid. Likewise the number of papers thinking the tests are a measure of amount is another feature that makes me laugh/weep and yes they are published in Nature/Science ;-(.
Thank you for the thoughtful reply. Very helpful.
“As another angle you can give people an anti-SARCov2 antibody response. The makers of ocrelizumab also make on of these.” This angle is intriguing. How/where can I obtain more information about this?
DEAR ALL
REMEMBER IF YOU DID NOT GIVE A BASELINE BLOOD , IT DOESNT MATTER.
IT IS NOT TOO LATE.
WE KNOW WHAT A NEGATIVE BASELINE SAMPLE LOOKS LIKE, WE ARE INTERESTED TO SEE WHAT HAPPENS AFTER VACCINATION NOTABLY WHAT HAPPENS AFTER THE SECOND VACCINATION. IF YOU GET A CERTAIN LEVEL YOU HAVE RESPONDED
FINGOLIMOD HAS NOT DONE TOO WELL IN ISRAEL IN TERMS OF SEROCONVERSION. IN ISRAEL THEY DID NOT USE THE ASTRAZENECA VACCINE. COULD THERE BE A DIFFERENCE BETWEEN IT AND THE PFIZER…WE NEED TO KNOW
We (the team, Dr Ruth, MD, Nikki and Nazli) are working on all the DBS as they come in post 4 weeks after the 2nd jab irrespective of which vaccine, Pfizer/BionTech , Astra Zenec/Oxford or now J&J. Overtime a picture will emerge and we will share this overall picture with you. We have healthy individual (that are not taking DMT’s) and pwMS that are on DMT’s that have participated in this study. We have enough baseline samples to figure out a zero response. It just takes time. We can glimpse a trend for internal discusions, but not for general release. As MD says, “WE KNOW WHAT A NEGATIVE BASELINE SAMPLE LOOKS LIKE, WE ARE INTERESTED TO SEE WHAT HAPPENS AFTER VACCINATION NOTABLY WHAT HAPPENS AFTER THE SECOND VACCINATION. IF YOU GET A CERTAIN LEVEL YOU HAVE RESPONDED”
DrA….Too Hot Can’t Sleep?:-).
I will also say Dr Angry are doing this blinded so we have not got the codes
Happy to take part in trial. Where/how do I sign up?
Brilliant! Will send you over the details separately
mscovid19ab@qmul.ac.uk
Sorry I see DrRuth got there first
Is this still only for Barts patients? I had first dose Pfizer 11 months post HSCT (rituximab protocol) & second jab 12 weeks later