COVID vaccine information for APS patients
While the vast majority of people are still vulnerable to COVID-19, a vaccine could help teach our bodies to fight the virus by stopping us from being infected or, at least, make COVID-19 less deadly.
There are now three different vaccines available in the UK: the Pfizer/BioNTech, the Oxford AstraZeneca and Moderna.
APS Support UK directly contacted the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) when the first vaccine was made available in the UK in December 2020. The MHRA replied very promptly to say that the Pfizer/BioNTech is suitable for anyone with antiphospholipid syndrome (APS).
In December 2020 and January 2021, the MHRA approved two new COVID-19 vaccines: the Oxford/AstraZenaca and Moderna respectively.
APS Support UK immediately contacted the MHRA for guidance about the suitability of these new vaccines for people with APS and asked which one of the three injections would be the best for APS patients.
We were contacted again by the MHRA in January 2021 who informed us that, although there is no published safety data specifically for APS patients, “all three authorised vaccines may be administered to these patients”.
So the main message is: there is no reason for concern that any of the COVID-19 vaccines will be less safe in people with APS and there is no information to say that any vaccine is preferred in this group of patients.
If you are worried about which vaccine to have, please talk to your doctor otherwise all three are considered safe.
COVID-19 vaccine and anticoagulation
Thank you to Thrombosis UK and Professor Beverley Hunt (OBE) for providing this update:
The COVID-19 vaccine is given as an injection into your upper arm (intramuscular).
Individuals receiving direct oral anticoagulant (apixaban, dabigatran, edoxaban & rivaroxaban) or warfarin in therapeutic INR range, on full dose heparin or fondaparinux injections or antiplatelet medications such as aspirin and clopidogrel can all receive the COVID-19 vaccination.
Please beware of the following issues:
- There is a risk of bruising at the injection site, but we do not anticipate any serious effects related to anticoagulation
- We suggest that after the injection prolonged pressure (at least 5 minutes) should be applied to the injection site to reduce bruising
- Patients on warfarin with supra-therapeutic INR should wait until their INR is <4.0
- We encourage patients to have vaccinations and they should not be avoided on the basis of being on anticoagulation treatment
Please click here: https://www.versusarthritis.org/covid-19-updates/vaccines-for-covid-19-your-questions-answered/ if you would like to learn more about the vaccine programme and current advice for patients.
Current guidelines for ‘clinically vulnerable people’
When the national lockdown began on 23rd March 2020, the UK government originally recommended that anyone who qualified for a ‘flu vaccination on medical grounds, was over the age of 70 and/or had certain medical conditions would be considered to be in the 'high risk group', but this guidance was withdrawn on 11th May 2020.
Since then, there have been many guideline changes within England, Scotland, Wales and Northern Ireland so it has been difficult to know how exactly to advise APS patients in a meaningful way; however from the 14th September 2020, the four governments implemented changes to “simplify restrictions and ensure the virus is controlled”.
These changed again to reflect the second lockdown until the Tier System was introduced on 2nd December 2020 and there are now are new guidelines for ‘clinically vulnerable people’ - (please see point 9), and also specific guidelines for those people who are ‘clinically extremely vulnerable’.
Am I at risk because I have APS?
Currently, there is little known about the virus in APS and there is no evidence, yet, that patients with pre-existing diagnosed antiphospholipid syndrome are at higher risk of contracting the virus.
Several research papers have recently been published linking the presence of antiphospholipid antibodies (aPL) to thrombosis in COVID-19. It does seem that thrombosis in severe COVID-19 is immune mediated and related to the severity of the inflammatory response and the so-called ‘cytokine storm’. However, it is not yet clear that antiphospholipid antibodies contribute directly to thrombosis in COVID-19 or are just transient as they often are in other infections, so it’s important that a cautious interpretation of positive aPL in patients with COVID-19 is maintained.
Should I be shielding?
At present, antiphospholipid syndrome (APS), along with many other rare diseases, is not specified in either of the above guidelines, but the NHS Digital website states “if you have been identified as at high risk of complications from coronavirus (COVID-19) you will receive a letter from your GP, hospital or (if identified nationally) from our national service. If you are unclear why you have received a letter, please contact your GP or hospital consultant.”
APS Support UK is very much aware that there has been uncertainty about guidance on shielding and some patients with APS, with no other underlying medical conditions, did receive shielding letters at the beginning of the pandemic. It appears these patients were identified by an algorithm depending on the severity of their condition and clotting events.
From 1st August 2020, the government ‘paused’ shielding for the clinically extremely vulnerable and new guidelines can be found on their website. The UK government states the advice was relaxed because the chances of encountering the virus in the community had fallen compared to when shielding began.
Understandably, many APS patients are still concerned that they should be shielding and we can now direct you to certain resources that help make that decision such as the Royal College of GPs and the British Society for Rheumatology but, currently, these are aimed at health professionals rather than patients and do not refer specifically to APS.
On 13th October 2020, the government stated that shielding will not be introduced in England as, unlike in March, there are other protective measures in place to help reduce the spread of the virus.
Those who were on the shielding list will receive a letter about with government advice with tips on how they should take precautions to avoid getting Covid.
As knowledge of the virus increases, it is likely that the medical profession and governments will be able to produce guidelines more informed by evidence.
What should I do about my medication?
It is very important that all patients with APS keep taking their prescribed medication. If you are taking anticoagulants such as aspirin, clopidogrel, heparin, rivaroxaban and warfarin you will not be considered more vulnerable as these drugs do not suppress the immune system.
Many APS patients also take hydroxychloroquine to control the fatigue and joint pain caused by this autoimmune condition. Unlike immunosuppressants, hydroxychloroquine is an immunomodulatory drug and is unlikely to limit the body’s response to infection. There has been a lot of media attention about this medication as a possible treatment for the coronavirus but, so far, there has been no evidence to support this theory. For more information, please read the in-depth article by our friends at LUPUS UK.
- Keep taking your normal APS medications.
- If your only medical problem is APS, there is no current evidence saying that you should shield.
- However, if you are told you do need to shield, you should be informed by your GP or hospital specialist team.
- The decision about whether an individual patient with APS needs to shield depends on what other risk factors they have. If you have not been told to shield, but remain in any doubt about your individual situation you should contact your GP.