Article No. 411
16 January 2021
COVID 19 dominates healthcare throughout the world.
It dominates politics.
It is in the news, it is in the social media , it is everywhere.
Information is needed that applies to all or just to some.
How to find it is another matter with all the noise.
Particularly if the individual’s perspective is through the prism of aHUS.
Those affected by aHUS have special interests, not least because the disease involves a part of the innate immune system which will play a part in the immune response to fight COVID19. There is enough of the complement system activity left , even after eculizumab blocks C5, for it to interact with other innate immune systems to produce an acquired immunity to COVID19 from a vaccination
The aHUS alliance has passed on a lot of information about aHUS and COVID 19 in the past year.
Now further information is being sought as exemplified by a question posed on an international aHUS platform.
Basically the questioner speaks for a lot of people affected by aHUS .
The question is “ Is the COVID 19 vaccination safe for aHUS patients on Soliris ( eculizumab). Has anyone had it? What is the recommendation by your doctor?” Typical social media chat.
But why is it necessary for anyone to ask strangers. Why cannot health care providers give an answer to preempt that need.
“Doctors” cover a wide spectrum of health practitioners from generalists to specialists through to aHUS specialists. It is unlikely that generalists would have a position on the COVID 19 vaccination of aHUS patients on eculizumab, and would likely treat them as any other patient. Perhaps with some knowledge of general risks.
It unlikely that specialists will be involved in any vaccination roll out programme and it would an exceptional specialist who would proactively inform a patient about aHUS and COVID 19 vaccinations. They are unlikely to have any evidence based advice other than generic advice for any vaccination.
What the questioner is really asking for is there any evidence of harm done to an treated aHUS patient having had a COVID 19 vaccination. Evidence, if any, like that should have come from the vaccine trials. But as aHUS prevalence is so rare it is unlikely anyone potentially affected by aHUS would have been involved as vaccine trialists. If they had and it was uneventful there is no story.
Now that vaccines roll out is reaching millions of the general population, nearly 38 million to date according to Bloomberg today, it is possible that around 150 prevalent aHUS patients could have been vaccinated by now. Enough of a research cohort to draw conclusions from.
Enough, too, for nephrologists and haematologists to be aware of adverse incidents which were preceded by a COVID vaccination. That kind of news would unlikely be suppressed given the media interest. (Although It is unlikely that many of the possible 150 are visitors to this website, and reading this article, but if any do aHUS Global Action would be pleased to hear from them. The wider aHUS community is interested)
The questioner confines the issue to patients who are already being treated. If the vaccine attempted to trigger aHUS in them they are already on the best treatment there is, including ravulizumab, to stop it. But there are also those who are susceptible to aHUS but not onset and potentially the vaccine could trigger an aHUS in them.
Potentially they could be among fewer than 15 or so of the vaccinated population who might have onset with aHUS, for any reason, in these past couple of months. Again if they had onset, their incidence would be very newsworthy. Certainly among the clinical Twitter community. Nothing seen so far.
Whether it is eculizumab ,rather than the disease itself, that is the issue, then that brings in the manufacture, Alexion, as an the information provider. More so as the overall eculizumab treated ( and ravulizumab) patient cohort is much wider with other diseases. The drug has prescribing information leaflets, but any revision for COVID 19 has not been noticed yet. No warnings from Alexion have appeared. But it can only act on evidence coming in via its adverse events reporting system.
Which brings us to the aHUS specialists. aHUS Global Action has featured aHUS Centres of Excellence on its website in recent years.
To be an aHUS centre of expertise requires evidence not only of substantial research into aHUS, but also being part of global aHUS and Complement networks, receiving and passing on breaking news about aHUS. This would apply to adverse vaccination events too.
One such Centre of Excellence known to the author is the National aHUS Centre at Newcastle upon Tyne, England.
It has an advisory post on its website about the UK COVID 19 vaccination programme including specific advice for aHUS patients, those susceptible, whether adults or children. Children under 16 years currently are not eligible for COVID 19 vaccination due to no research yet on children
The post on the National Renal Complement Treatment Centre website home page can be seen clicking on the image below.
aHUS alliance Global Action’s Linda Burke visiting the Newcastle aHUS Expert Centre
An extract is provided below of some of the advice provided.
“Guidance from the National Renal Complement Therapeutics Centre regarding vaccination against Covid-19 for aHUS patients
Organisations across kidney medicine have welcomed the arrival of effective Covid-19 vaccines.
Whilst the Covid-19 vaccine trials were not performed on patients with aHUS specifically, given previous experience with other vaccinations, there is no evidence to suggest that any of the available vaccinations for Covid-19 would not be safe and protective for our patients.
Any small risk associated with the vaccination is likely to be significantly outweighed by the potential benefits against Covid-19
Key Points
- We would recommend that all aHUS patients including those with a kidney transplant on Eculizumab are vaccinated against Covid-19
- If you have been told that you are at risk of developing aHUS (due to a complement mutation) we would recommend that you are vaccinated against Covid-19 *
* In this situation, there is a theoretical risk of a vaccine precipitating aHUS, and if you develop symptoms lasting more than a few days after the vaccination, blood tests to include: U&E, FBC and LDH should be performed (this is the same information on the “at risk” cards we produce). We believe that the benefits of a vaccine outweigh any theoretical risk. If any of these results are abnormal, patients should refer to the National aHUS Service website for advice (www.atypicalhus.co.uk or telephone 0191 282 0385).
Children/young people under 16 years
The Covid-19 vaccine trials have not yet studied the vaccine in children under 16 years old and therefore the vaccine is not currently licensed for patients under the age of 16 years. Because of this, we cannot recommend that children with aHUS or receiving Eculizumab treatment receive a Covid-19 vaccination at this time. Reassuringly, serious complications of Covid-19 infection are very rare in children, even in those with underlying health conditions or those receiving treatments that affect the immune system such as Eculizumab.
The advice given in this document is general guidance for those with aHUS. We cannot advise regarding any other health conditions patients might have. For this, you would need to seek specialist advice where appropriate, or discuss with the healthcare professional giving the vaccine.”
So no adverse events reported or known. A recognition of the risks from getting COVID19 or from its vaccine falls in favour of having the vaccine as far as this aHUS Expert Centre is concerned. It strongly recommended that full advice is read via the link above.
aHUS Global Action recommends that aHUS patients check National aHUS Centres of Excellence websites in their own country too.
aHUS Global Action cannot have any position on whether to vaccinate or not.
