Happy New Year!
Thank you to all who worked so hard over the holiday period and who continue to work now to keep our patients safe. Below is a round-up of the latest news on COVID-19 from the professional community.
The situation remains challenging across the UK with busy workloads and high rates of staff sickness. Omicron is now the major variant, having rapidly supplanted the Delta variant.
We need to be cautious as the current wave has not yet peaked in many parts of the country. However, at the time of writing, services are reporting that this wave feels very different to the previous ones.
There is a high incidence of asymptomatic COVID-19 and most patients with symptoms have mild symptoms only. A lower proportion of patients are requiring hospitalisation and very few patients are requiring transfer to ITU.
There are early indications that dialysis patients are doing much better in this current wave; we remain concerned that kidney transplant and other immunosuppressed renal patients are still at a very high, increased relative risk of poor outcomes.
Renal services are working hard to ensure that patients can access neutralising monoclonal antibodies and anti-virals through their COVID Medicines Delivery Units (CMDUs) and some services have now set up to deliver anti-viral therapy to outpatients such as COVID-19 dialysis cohorts.
NHSBT paper analysing data after two COVID-19 vaccines in transplant recipients
Last week Transplantation published a paper written by NHSBT colleagues analysing ‘real-world’ vaccine effectiveness after two doses of either AstraZeneca or Pfizer vaccines. The full paper can be found here.
This publication combined data from the UK Health Security Agency (UKHSA), which identifies patients testing positive for COVID-19, the National Immunisation Registry and NHS Blood and Transplant (NHSBT) Transplant Registry. It reported that in solid organ transplant patients (of whom the majority are recipients of kidney transplants), after a two-dose vaccine course, neither vaccine offered protection against catching the disease but in patients who had tested positive for COVID-19, Oxford AstraZeneca was 31% more effective in reducing the risk of dying from the disease compared to those who are unvaccinated.
The reason for the difference between two doses of AstraZeneca and Pfizer vaccine is currently unexplained but clinical studies on third and fourth dose vaccines in transplant patients will be available in early summer of 2022 and data collection is already in progress.
It is important to recognise that these data are from kidney transplant patients who have not completed a vaccine course. It is crucial that all kidney transplant patients have a four-vaccine course – three primary vaccines and then a booster.
The need for extended vaccination has been known for some time. Two vaccines do not produce enough neutralising antibodies against COVID-19 in most transplant patients. A three primary vaccine course followed by a booster is essential to provide the highest protection for kidney transplant patients. This is recommended by JCVI.
This paper suggests differences between vaccines after the first two of the vaccine course. These differences are not consistent with what is known about the immune responses to the vaccines. The authors of the study describe some of the shortfalls in the study that may explain this finding including that the study is underpowered, and the study may be overlooking other factors that influence outcomes.
Whilst further data is awaited, UKKA and NHSBT feel the most important messages from this paper to transplant patients remain:
- Get vaccinated because the benefit of vaccination still outweighs the risk of dying from the disease in those who are unvaccinated
- Where possible, get vaccinated before transplantation to avoid impact of immunosuppression on vaccine efficacy
- Evidence shows that a three-vaccine course followed by a booster vaccine is likely to provide the highest immunological protection against COVID-19 from vaccination for transplant patients. Patients should aim to complete third and fourth vaccine doses as soon as able
- Whilst further studies on the effectiveness of the third and fourth doses of vaccine are awaited, the best protection against COVID-19 for everyone is non-pharmaceutical interventions i.e., social distancing, wearing face coverings and regular hand washing
- Encourage close contacts of transplant patients to be fully vaccinated and boosted
- Transplant patients should get tested as soon as possible if they or anyone close to them has symptoms suggestive of COVID-19
- In the event of a positive test for COVID-19, contact their transplant team immediately so that appropriate treatment can be commenced early and to maximum effect
Access to 4th COVID 19 vaccine doses. Please remember to supply eligible patients with a renal unit letter confirming the need for 4th vaccine doses
As previously highlighted, the current national booking and recording system is not always able to allow patients to book fourth COVID-19 booster doses. To ensure all eligible patients can access their fourth vaccine dose, please supply your patients with a confirmatory letter that they can take to a vaccine centre. A generic template to this letter can be found here.
Currently, patients eligible for a fourth dose are:
- Organ transplant recipient patients (including those who have returned to dialysis but are within 6 months of taking immunosuppressive medication)
- Patients with immune-mediated kidney disease who are taking immunosuppression equivalent to transplant recipients.
Access to sotrovimab and other extended therapies
The following groups of patients are entitled to be considered for treatments with extended therapies such as sotrovimab and molnupiravir. Groups are given in priority order:
- Kidney patients who have received B cell depleting -therapies or equivalent immunosuppression
- Organ transplant recipient or patients with immune-mediated kidney disease requiring equivalent levels of immunosuppression.
- All CKD 4 and 5 patients (both those not receiving and those receiving dialysis treatment).
Please highlight this to patients (particularly the CKD 4 patients who have not previously been included in CEV listings for renal).
Please remember that Ronapreve is not effective against the dominant OMICRON variant of the virus.
The UKKA is currently escalating the following concerns with regards to extended therapies.
The current guidance that therapies should be offered only to symptomatic patients.
Clinical experience from renal units suggests that transplant recipients and autoimmune patients remain very vulnerable. These patients form the bulk of patients getting sick from this variant at renal centres. We remain concerned that these therapies may be most effective in these patients if given before any symptoms and we are therefore escalating this view. We would recommend that units remind patients that even minor symptoms may be relevant and that they advocate for our most vulnerable patients regardless of symptoms.
At present inpatient sotrovimab is available in most centres only for those renal patients not receiving oxygen who have acquired COVID-19 during their hospital stay.
We remain concerned that this may leave our most vulnerable transplant and autoimmune patients who are admitted after acquiring this infection in the community vulnerable. Once again, we are seeking widening of the sotrovimab criteria to include all eligible renal groups regardless of whether they acquired the infection in the hospital or the community.
UKKA-KRUK Scientific Webinar: COVID-19 vaccinations in kidney patients – immune responses and clinical efficacy: 3rd February 2022, 16-17.30
Following extensive new scientific data, UKKA and KRUK are hosting an update webinar on 3rd February. Whilst a detailed programme will follow, topics will include:
- Immunological responses to vaccines in kidney patients
- Clinical efficacy of vaccines in kidney patients
- Clinical trials update
This should be a great opportunity to review the latest evidence and we hope as many will join as possible. Register here.
Information for patients
Hardworking colleagues from the Kidney Charites Together group are currently planning a patient-facing update webinar in early February. Full details will soon follow.
In the meantime, their websites provide excellent and regularly updated information for patients: