COVID vaccine information for APS patients
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. The Janssen vaccine was approved by the MHRA at the end of May 2021 and should be available later in the year; we will provide information about this new vaccine and its suitability for APS as it becomes available.
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.
However, on 7th April 2021, the government released new guidance based on the analysis of a small number of people who had suffered very rare adverse events of clots and low platelets in patients who received the first dose of the Astra Zeneca vaccine.
This updated guidance from the MHRA 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”.
Unfortunately, this rather ambiguous guidance led to an alarming situation where APS patients were given conflicting advice by healthcare practitioners and vaccination centres. For example, among those APS patients who had had the first AstraZeneca (AZ) vaccine, some were told it was safe to have the second AZ vaccine; others were informed they could not have a second AZ vaccine at all; while others were offered an alternative vaccine (Pfizer and Moderna) if they were available. This, inevitably, led to some APS patients missing their important second vaccination jabs.
After nine weeks of persistently pressing for clear updated guidance, on 8th June 2021, the MHRA informed APS Support UK that the “Joint Committee on Vaccination and Immunisation (JCVI) are responsible for how vaccines should be used in clinical practice. The JCVI advise that that those who have received their first dose of AstraZeneca vaccine without suffering the rare side-effect of major blood clot occurring at the same time as having low levels of platelets should continue to be offered the second dose to complete the course.”
Following on from this statement, Public Health England have kindly produced this short summary of evidence which they hope will provide clarity to the community on this topic and reassure them that they can receive the vaccine if they are aged 40 years or older and do not have any of the contraindications".
There is also a specific section on the GOV.UK website for people with APS titled: ‘Can people with antiphospholipid syndrome have the vaccination?’
As ever, APS Support UK will continue to monitor the situation and update this information when necessary.
MHRA Yellow Card Scheme updates
The MHRA regularly review reports of suspected side effects of the UK-approved COVID vaccines. Any member of the public or health professional can submit suspected side effects through the Yellow Card scheme. The nature of Yellow Card reporting means that reported events are not always proven side effects. Some events may have happened anyway, regardless of vaccination. This is particularly the case when millions of people are vaccinated, and especially when most vaccines are being given to the most elderly people and people who have underlying illness.
According to the latest safety update report, based on detailed analysis of data from 9th December 2020 up to 5 May 2021, the MHRA had received Yellow Card reports of 262 cases of major thromboembolic events (blood clots) with concurrent thrombocytopenia (low platelet counts) in the UK following vaccination with COVID-19 Vaccine AstraZeneca. These events occurred in 149 women and 112 men aged from 18 to 93 years and the overall case fatality rate was 20% with 51 deaths. Eight cases have been reported after a second dose.
It is important to note that Yellow Card data cannot be used to derive side effect rates or compare the safety profile of COVID-19 vaccinations as many factors can influence adverse reaction reporting.
However, for your information. we will continue to update our APS and COVID information page with any relevant data from the latest weekly summary of Yellow Card reporting.
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.