Barts-MS rose-tinted-odometer: ★★
In response to a comment from one of our readers. We have not directly addressed the thrombosis AstraZeneca vaccine issue as we are not vaccinologists or haematologists. But as there seems to a lot of anxiety around this issue a short blog post about the potential risks may allay your fears.
I received the following email, from Professor Marcel Levy (Consultant Haematologist and CEO, UCLH), on the 19th of March that suggests the underlying thrombotic disorder that has been recognised in patients who have received the Oxford-AstraZenca COVID-19 vaccine may be quite specific and identifiable.
19th March
Dear Colleagues
I am taking a rather peculiar step but I think it is important to get this premature information out in the open for the potential benefit of patients.
We have found a strong clue about what is causing the rare thrombosis and thrombocytopenia in patients who received the COVID-19 vaccination. We have to be extremely careful because it is pending some more confirmation but there may be immediate implications for patients we cannot ignore. I know some others may be thinking in the same direction but are awaiting to publish the findings in a journal but we feel it takes too long and I think it is not responsible not sharing this with others as soon as possible.
We have identified three UK cases who developed rare (cerebral sinus vein) thrombosis in London after COVID-19 vaccination and Marie Scully of UCLH has identified a very strong anti-platelet factor 4 antibody response in those patients. They were not exposed to heparin before but you may realise Ted Warkentin has described incidental cases a few years ago (Warkentin TE, Basciano PA, Knopman J, Bernstein RA. Spontaneous heparin-induced thrombocytopenia syndrome: 2 new cases and a proposal for defining this disorder. Blood. 2014 Jun 5;123(23):3651-4.). We feel it may be a good idea if others are confronted with these patients to do a HIT-ELISA and to withhold heparin until we know whether this is real or a false lead and awaiting further confirmation.
Just want to emphasise that we all realise this is extremely rare and should not be a reason to stop vaccination whatsoever. However, when confronted with a case, this may have consequences for their optimal treatment.
Please feel free to share this information within your communities as you may seem fit, as it might have implications for patients (once again, I think we need to be very careful of course before jumping to conclusions). I know we all want to be the first to publish, but we also have a responsibility for our patients.
All credits to Marie Scully who has done this test in these patients and is happy to share with everyone.
Best wishes, Marcel Levi
Prof. Marcel Levi MD PhD FRCP
Professor of Medicine, University College London
Professor of Medicine, University of Amsterdam
Consultant in Acute & Vascular Medicine and Haematology
Although we can’t be sure these thromboses are due to the AstraZenca vaccine it seems increasingly likely that they are as these sorts of thromboses have not been seen (yet) or described with the Pfizer-BionTech and other COVID-19 vaccines. According to the latest figures from the MHRA, there have been 22 reports of a blood clot or thrombosis in the brain called cerebral venous sinus thrombosis (CVST) accompanied by a low platelet count (as described in the letter above) as well as eight reports of other blood clotting problems with low platelets, among recipients of the AstraZeneca COVID-19 vaccine. Of these 30 reported cases, seven people have died. The denominator is over 18 million people who have received the vaccine. At the moment the rate of this complication is 1.7 people per million vaccinated and one death for every 2.6M people vaccinated. These estimates are likely to be under-estimates because of a reporting lag, but even if the risk increase by a factor of 2 or 3 they will still be relatively low. This risk needs to be compared to 1 in 1000 chance of dying from COVID-19 if you are aged between 40 and 50 years of age.
You have to realise that when you are vaccinating the whole adult population shit is still happening in the background; i.e. people will be getting DVTs, pulmonary emboli, myocardial infarctions, pneumonia, Bell’s palsy, strokes, CVSTs, etc. Life and biology continue as normal and all that has changed is that a vaccine is added to the mix. So when the EMA and MHRA say the benefits of these vaccines, including the AstraZeneca vaccine, outway the risks they mean it and their advice is based on safety data from tens of millions of vaccinated adults and a risk:benefit analysis. The latter is a judgment call they make on the impact of COVID-19 at a population level vs. the population benefits of vaccination. Their message can’t be any clearer: #GetVaccinatedASAP and these #VaccinesAreSafe. I think these figures speak for themselves and I fear we are literally throwing the baby out with the bathwater by dismissing the AstraZeneca vaccine as being too risky to use in certain population groups.
If you have any doubts about the benefits of being vaccinated or not being vaccinated just look at what is happening in France and Germany at the moment compared to the UK. My question is how many extra deaths are going to have happened because of delayed vaccinations in these countries? I suspect orders of magnitude more people will die from COVID-19 than from the rare complications of the COVID-19 vaccines. Do you agree?
CoI: multiple
Twitter: @gavinGiovannoni Medium: @gavin_24211
I agree that we should all get vaccinated but if these cases happen most often among women under 60, as is being reported, should that group not have their blood tested before getting the AZ vaccine?
No. The adverse event if confirmed to be real is too rare and baseline blood tests are unlikely to detect or predict it.
I completely agree. I live in Berlin and the allowing, subsequent suspending, then re-allowing, then suspending for the under-60s of the OAZ vaccine is causing a lot of mistrust and confusion. I have a colleague in a medical priority group who chose to wait longer for an appointment for Pfizer than to get the OAZ within a few days and a friend that has had the first shot of OAZ now being advised to have Pfizer or Modena for his second shot. The head of the vaccine commission here has said that he doesn’t view these measures as damaging the image of vaccines but instead that they demonstrate that the
safety system in Germany works. I can’t speak for everyone but that’s definitely not the impression that I’m getting.
Most don’t think that most people read the full reports or blogs like this one and have just concluded that OAZ is unsafe – I’ve heard several people say in casual conversation that they wouldn’t have that vaccine. Although I’m delighted and relieved that my family and friends in the UK have almost all received their first shot, it’s hard to take when we are heading into harder measures (a negative test result for that day if you want to go to any shop other than a supermarket / drugstore, curfew between 21.00 and 5.00 etc) with no idea of the timescale for getting our vaccines.
So while we wait for further studies and decisions, I’m trying to stay safe. On the plus side the sun is shining and I have sausages and last night’s Gogglebox to look forward to.
As a 40 something female who had my 1st AstraZeneca this week…
If I that one doesn’t precipitate thrombosis, are my chances of the 2nd dose also being okay even better?
I suspect not. However, most of the cases reported so far are after the first dose. Time will tell. I don’t see why you shouldn’t go ahead with the second or booster dose.
Thanks Prof G.
It occurs to me that few make such a fuss about the oral contraceptive pill, with a far higher thrombosis risk? I’ve been on it myself in the past, I never thought about it.
This suspending and restarting is not how you do pharmacovigilance, it’s wrecking public trust in what is a very safe vaccine.
There are steps they should be taking – close monitoring post-delivery, a protocol for suspected cases, trying to make sure any potential thromboembolism is proactively prevented rather than having to treat them. Maybe they are. If so why aren’t we being told? “There’s a potential problem and we are already sorting it out” – would help.
The numbers for risk-benefit speak for themselves (and don’t take into account morbidity and mortality from long Covid which makes the numbers even more compelling). But it’s not just enough for the government to say, “it’s safe” – give people the numbers as ProfG has done. And explain that “you” getting vaccinated also protects the people you come into contact with. Cos as PwMS we know only too well that you don’t have to “look” ill…
By the way, numbers above are slightly out of date, these things move so fast. Link below for updated numbers, they’re still well as within the “minuscule risk” range.
https://www.bbc.com/news/health-56620646
We also need balance we here the figures for AZ but need to hear them for the other…as for the BBC as the information source…I have a friend who works in a COVID testing and there was stuff about the sloppyiness of the testing but they showed video of the training set up with people in training.
In my opinion, the benefits of vaccination outweigh the risks. so we should go on with vaccination as fast as possible. But, dear Prof. G., I think you have to be very open with the numbers and differentiate for different age groups: In Germany, until 29.03. with 2.7 million vaccinations (AstraZeneca) 31 cases of unusual thrombosis have occured. 29 of those affected are women between the ages of 20 and 63. 19 patients had thromobocytopenia at the same time, 9 patients died. The Paul-Erhlich-Institut in D (PEI) gives the risk of a sinus vein thrombosis at AstraZeneca with approx. 1: 100,000 (with ALL age groups (also> 60)included). The risk for young women for SVT is therefore likely to be higher.
And thus the risk for an 18-year-old or 25-year-old woman (e.g. whether with or without MS) is higher to suffer severe complications from the vaccination or to die, i.e. to die from COVID19. According to the Federal Statistical Office (https://de.statista.com/statistik/daten/studie/1104173/umfrage/todesfaelle-aufgrund-des-coronavirus-in-deutschland-nach-geschlecht/) there is no single death from COVID for women betwenn 10-19 years (after A12months of pandemia), in the group 20-29 years 21 women died from COVID. The fact that we already have several seriously ill or deceased young women in connection with the vaccination after a few weeks of AstraZeneca in Germany is therefore alarming. I can see no reason to vaccinate a 20 year old woman when I consider the possible benefit vs. riks!
We are still on the 50 to 59 year old cohort.
I wonder why the figures between the UK and Germany are so different. I wonder if it is a manufacturing issue; Belgium vs. the UK plants. It will be interesting to see what happens over the next few weeks. If the German figures are right then we will see many more cases in the UK.
I guess this will be seen as an issue as the younger sections of society get offered vaccines, particularly when prevalence here is falling. I only saw one case of CVST in my career, associated with the combined pill, and the big plus of all this is that the condition might be recognised, diagnosed and treated earlier. The mortality rate in Germany seems higher than it might be given that its is so treatable. Here’s my crack at education. https://drbannonsblog.aprendo.co.uk/drbannonsblog_wp/2021/04/03/aztra-zenecas-clotting-problems/
Thanks for this, Colin.
Hello from Germany… I am still not eligible for Covid-19 vaccination, but maybe I could speed up things if I decide to have the AstraZeneca vaccine even though I am a female under 60. It is possible based on an individual risk analysis and if the vaccinating doctor agrees. Regarding my talk to the doctor – I am on Ocrevus, is there really any risk I produce antibodies against platelet factor 4?? My last Ocrevus infusion was 4 months ago and my B cell count 1 cell/µL… Thank you!
Wow.. absolutely nothing to do with this post but you just hit something’s in my head! My daughter who is just turning 17 is scheduled for Pfizer next week at her Children’s Hospital. Between her health issue, grocery store worker 6 days a week, High School & in school for Clinical Medical Assisting in which they are going out on Co-op, She needs this vaccine. But I just remembered she had a reaction to aspirin last year where skin turned all shades of dark red, burning. Hives. Her eyelids swelled beyond crazy. Gave her only allergy pill I had Zyrtec & brought her to Drs stat. They gave her Benedryl & she was fine. Later we find her paternal grandfather has aspirin allergy too. Do you know if any articles out advising against the vaccine with an allergy to aspirin?
Asperin is not part of the vaccines or the vaccination period
Hi – I have a particular concern/question about the Astra Zeneca vaccination and my MS treatment – I am a 48 year old male diagnosed with RRMS in 2010 but have been doing well with Gilenya (Fingolimod) for the last 3 years and my last scan in Jan 2020 showed NEDA which was amazing. I have had my first dose of the AZ vaccine with seemingly no adverse reaction and am due to have my second in about a month’s time. I understand that my “COVID age” is 57, as anyone living with MS should add 10 years to their actual age irrespective of how well they are doing. So on that basis, and despite the comment elsewhere that no adverse reaction after one dose is no guarantee of no reaction after the second, I would be very inclined to go ahead and get my second dose and I am generally taking the view that I have another month to see what further data emerges. HOWEVER – my real hesitation is that according to the study completed in Israel that I read about on this blog, it would appear that Fingolimod patients did unexpectedly and quite spectacularly badly in terms of producing COVID antibodies having had two doses of vaccine. The equation for the general population is simple – the benefits of vaccination outweigh the risks and the likelihood of having severe or even fatal COVID is higher than the likelihood of a blood clot for someone with a COVID age of 57. But for me is that equation redundant? Does the probable failure of seroconversion (not sure what that means) and therefore the ineffectiveness of the vaccine mean that the risk/benefit analysis changes and perhaps I should consider the German model of requesting a different second dose? I think there was mention of further results about T cell response coming through soon but presumably not in the next month? Any guidance would be much appreciated. P.S slightly separately are reports of herd immunity in the paper today something that we can rely on? I.e. even if I don’t produce a good response after the vaccine I will be protected by herd immunity in the near future?
Hi – I have a particular concern/question about the Astra Zeneca vaccination and my MS treatment – I am a 48 year old male diagnosed with RRMS in 2010 but have been doing well with Gilenya (Fingolimod) for the last 3 years and my last scan in Jan 2020 showed NEDA which was amazing. I have had my first dose of the AZ vaccine with seemingly no adverse reaction and am due to have my second in about a month’s time. I understand that my “COVID age” is 58, as anyone living with MS should add 10 years to their actual age irrespective of how well they are doing. So on that basis, and despite the comment elsewhere that no adverse reaction after one dose is no guarantee of no reaction after the second, I would be very inclined to go ahead and get my second dose and I am generally taking the view that I have another month to see what further data emerges. HOWEVER – my real hesitation is that according to the study completed in Israel that I read about on this blog, it would appear that Fingolimod patients did unexpectedly and quite spectacularly badly in terms of producing COVID antibodies having had two doses of vaccine. The equation for the general population is simple – the benefits of vaccination outweigh the risks and the likelihood of having severe or even fatal COVID is higher than the likelihood of a blood clot for someone with a COVID age of 58. But for me is that equation redundant? Does the probable failure of seroconversion (not sure what that means) and therefore the ineffectiveness of the vaccine mean that the risk/benefit analysis changes and perhaps I should consider the German model of requesting a different second dose? I think there was mention of further results about T cell response coming through soon but presumably not in the next month? Any guidance would be much appreciated. P.S slightly separately are reports of herd immunity in the paper today something that we can rely on? I.e. even if I don’t produce a good response after the vaccine I will be protected by herd immunity in the near future?
The Australian TGA has now stated the preferred vaccine for people under the age of 50 is the Pfizer vaccination. The problem is we have limited stock down under and we are now having to import our stock (we are manufacturing the AZ vaccine locally). To say this has derailed our immunisation schedule is an understatement.
I’m under 50 and will be going to my GP to discuss receiving the AZ jab with an understanding of the risk (sign the consent form etc). I have no qualms about receiving this vaccine, especially if it means keeping my wife (who has MS) safe while she waits for her jab.