COVID vaccine information for APS patients

[Updated 14/05/2021]

While COVID-19 is still circulating in the human population, 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.

The NHS COVID-19 vaccination programme is now well underway and, currently, there are three different COVID vaccines available in the UK: the Pfizer/BioNTech, the Oxford AstraZeneca and Moderna.

Until 7th April 2021, the government advice from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the Joint Committee on Vaccination and Immunisation (JCVI) has been that each of the available COVID vaccines can be used in any patient group.

There was no evidence to suggest that patients with APS were at increased risk of complications from any of the available COVID vaccines.

On 7th April 2021, the government released new guidance based on the analysis of a small number of people who have suffered very rare adverse events of clots and low platelets in patients who received the first dose of the Astra Zeneca vaccine. Adverse events have not been reported after the second dose.

According to the data on the government website which was updated on 15th April 2021, there have been 79 cases of this adverse event, whereas over 20 million people have been given the Astra Zeneca vaccine in the UK. So, for every one million people receiving the vaccine, four could develop this adverse event. This is an extremely low risk. 

This updated guidance states that is that as “a precautionary measure, administration of the COVID-19 Vaccine AstraZeneca in patients with a history of cerebral venous sinus thrombosis or antiphospholipid syndrome should only be considered when the benefit outweighs any potential risks”.

It is not clear whether this means that they and their healthcare practitioners will be able to choose one of the other two vaccines (Pfizer or Moderna) instead. As the MHRA has been in touch with our charity directly since December 2020, when the vaccines were first approved, and has provided our charity with guidance for people with antiphospholipid syndrome, we asked for clarification on this point on 10th April 2021.

We received the following response on 11th May 2021:

The MHRA has undertaken a thorough review into UK reports of an extremely rare specific type of blood clot in the brain, known as cerebral venous sinus thrombosis (CVST) occurring together with low levels of platelets (thrombocytopenia) following vaccination with the COVID-19 Vaccine AstraZeneca. It is also considering other blood clotting cases (thromboembolic events) alongside low platelet levels. On the basis of this ongoing scientific review, it has concluded that the evidence of a link with COVID-19 Vaccine AstraZeneca is stronger, but more work is still needed. The most recent MHRA press release on this issue can be found here.

Following this review, the information for UK healthcare professionals for COVID-19 AstraZeneca has been updated to advise that, as a precautionary measure, administration of the COVID-19 Vaccine AstraZeneca in patients with a history of cerebral venous sinus thrombosis or antiphospholipid syndrome should only be considered when the benefit outweighs any potential risks.

The information for the recipient of COVID-19 Vaccine AstraZeneca has also been updated in line with this advice and advise people to tell their doctor, pharmacist or nurse before vaccination if they have ever had a blood clot in the sinus veins in the brain, or the autoimmune condition called antiphospholipid syndrome.

The updated information for healthcare professionals and the public about the COVID-19 Vaccine AstraZeneca is available at: https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca.”

While we were waiting for this response, the: Information for healthcare professionals on blood clotting following COVID-19 vaccination was updated by Public Health England and published on GOV.UK on 7th May 2021.

Although this document provides new advice about the second dose of the AstraZeneca vaccine for the condition “characterised by thromboembolic events (blood clots) accompanied by thrombocytopenia (low platelets) following the first dose of the AstraZeneca (AZ) COVID-19 vaccination”, it does not provide guidance or specifically mention antiphospholipid syndrome.

From listening to the APS community, we understand that the patients are extremely concerned as to whether it is safe to have the second shot of the AstraZeneca vaccine following their first one. This is compounded by the fact that patients are being given confused and conflicting advice by different authorities.

For example, among those APS patients who have had the first AstraZeneca vaccine, some have been told it is safe to have the second AZ vaccine compared to contracting COVID-19; others have been informed they cannot have a second AZ vaccine at all; while others are being offered a different type (Pfizer and Moderna) if they are available.

APS Support UK has pressed the MHRA for clarification in this matter urgently as we are aware that some APS patients are now missing the timing slot for their second vaccination.

We completely understand that the COVID-19 pandemic is a unique and emerging medical situation and appreciate all the work the MHRA is doing in reviewing this situation. We hope to hear from them shortly so we can help guide the APS patient community.

 

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.