COVID-19 vaccines and MDS: Approvals and Advice – Updated 07/01/2022

Treatment for patients with COVID-19

MDS UK Note (12th January 2022): We have now received confirmation that CMML patients on treatment are also eligible to receive the treatments below.

Updated 7th January 2022

The Department of Health and Social Care (DHSC) has issued a ‘Rapid Policy Statement’ regarding ‘Neutralising monoclonal antibodies or antivirals for patients with COVID-19’, for both hospitalised and non-hospitalised settings.

The eligibility criteria for these drugs was revised on the 24th December.

The most important change being that MDS patients are now eligible to receive these treatments.

Below is a summary of the most main information.

You can find a link to the full document below this article – and as a downloadable PDF – in case you need to take the information to your GP.

Non-hospitalised patients

Commissioning position by DHSC

The proposal is: Sotrovimab is recommended to be available as a treatment option through routine commissioning for non-hospitalised adults and children (aged 12 years and above) with COVID-19 treated in accordance with the criteria set out in this document. Where treatment with sotrovimab is contraindicated or not possible, eligible patients may be offered an antiviral as an alternative.

Background

nMABs are synthetic monoclonal antibodies that bind to the spike protein of SARS-CoV-2, preventing subsequent entry of the virus into the host cell and its replication. This effectively ‘neutralises’ the virus particle.

The following nMAB has conditional marketing authorisation (or regulation 174 emergency use authorisation in Northern Ireland) for use in the treatment of COVID-19 in the UK:

  • Sotrovimab (Xevudy®): a dual-action nMAB that both blocks viral entry into healthy cells and clears cells infected with SARS-CoV-2

Eligibility criteria

Patients must meet all of the eligibility criteria and none of the exclusion criteria.

Pre-hospitalised patients are eligible for treatment if:

  • SARS-CoV-2 infection is confirmed by polymerase chain reaction (PCR) testing within the last 5 days

AND

  • Onset of symptoms of COVID-19 within the last 5 days

AND

  • A member of a ‘highest’ risk group (as defined in Appendix 1).

The eligible patients as outlined in this policy should initially be considered for treatment with an nMAB (sotrovimab).

Where an nMAB is contraindicated or the administration of an nMAB is not possible, patients may be treated with a five-day course of molnupiravir if the onset of symptoms is in the last 5 days.

Patients who have received an nMAB within a post-exposure prophylaxis (PEP) or pre-exposure prophylaxis (PrEP) trial (such as the PROTECT-V trial) who meet the eligibility criteria of this policy can still receive treatment with an nMAB.

Exclusion criteria

Patients are not eligible for nMAB treatment in the community if they meet any of the following:

  • The pattern of clinical presentation indicates that there is recovery rather than risk of deterioration from infection
  • Require hospitalisation for COVID-19
  • New supplemental oxygen requirement specifically for the management of COVID-19 symptoms
  • Children weighing less than 40kg
  • Children aged under 12 years
  • Known hypersensitivity reaction to the active substances or to any of the excipients of sotrovimab as listed in the respective Summary of Product Characteristics

Hospitalised patients

Commissioning position by DHSC

Neutralising monoclonal antibodies or intravenous antivirals are recommended to be available as a treatment option for COVID-19 through routine commissioning for adults and children (aged 12 years and above) patients in hospital with COVID-19 infection in accordance with the criteria set out in this document.

Background

nMABs are synthetic monoclonal antibodies that bind to the spike protein of SARS-CoV-2, preventing subsequent entry of the virus into the host cell and its replication. This effectively ‘neutralises’ the virus particle. The following nMABs have conditional marketing authorisation (or Regulation 174 emergency use authorisation in Northern Ireland) for use in the treatment of COVID-19 in the UK:

  • Casirivimab and imdevimab (Ronapreve): an nMAB combination that binds specifically to two different sites on the spike protein of the SARS-CoV-2 virus particle
  • Sotrovimab (Xevudy): an nMAB that both blocks viral entry into healthy cells and clears cells infected with SARS-CoV-2

The following intravenous antiviral has conditional marketing authorisation in the UK:

  • Remdesivir: an adenosine nucleotide prodrug that is metabolised intracellularly to form the pharmacologically active substrate remdesivir triphosphate which inhibits SARS-CoV-2 RNA polymerase and perturbs viral replication Results from the RECOVERY trial indicate that casirivimab and imdevimab reduced the relative risk of mortality by 20% (24% in the treatment group vs 30% in those who received standard care alone) in hospitalised patients with COVID-19 who had not mounted an antibody response of their own to the virus (were seronegative) at the time of treatment.

Eligibility criteria

Patients must meet all of the eligibility criteria and none of the exclusion criteria under one of the following pathways:

Patients hospitalised for acute COVID-19 illness

Hospitalised patients are eligible to be considered for treatment with casirivimab and imdevimab if:

  • SARS-CoV-2 infection is confirmed by polymerase chain reaction (PCR) test or where a multidisciplinary team (MDT) has a high level of confidence that the clinical and/or radiological features suggest that COVID-19 is the most likely diagnosis

AND

  • Hospitalised specifically for the management of acute symptoms of COVID-196

AND

  • Negative for baseline serum anti-spike (anti-S) antibodies against SARS-CoV-2 (see section on ‘Serum antibody status’ below)

AND

  • Genotyping confirms the patient is infected with a non-Omicron variant.

For patients hospitalised with acute COVID-19 illness there are no available nMABs for the Omicron variant.

Please see access policies to dexamethasone (CAS alert), remdesivir and IL-6 inhibitors for these patients.

Clinicians are encouraged to enter all other patients admitted to hospital due to COVID-19 infection (including those infected with the Omicron variant, regardless of antibody status) into the RECOVERY trial, which is studying sotrovimab vs standard of care.

The following patients are NOT eligible for treatment in Group 1:

  • Children weighing less than 40kg
  • Children aged under 12 years
  • Known hypersensitivity reaction to the active substances or to any of the excipients of casirivimab and imdevimab as listed in the Summary of Product Characteristics

MDS UK note – please consult the full document for more precise information and various hospital situations, including COVID-19 acquired in hospital.

 These policies will be effective - from the date of publication (24th December 2021)

Appendix 1: Patient cohorts considered at highest risk from COVID-19 and to be prioritised for treatment with nMABs

MDS UK note: this is just the section of Appendix 1 detailing the list of eligible blood cancers, including MDS.

For the full list of conditions, please check the link or PDFs.

Please note – we are checking eligibility for CMML – as this condition does not seem to be included specifically.

The following patient cohorts were determined by an independent advisory group commissioned by the Department of Health and Social Care (DHSC).

Cohort

DescriptionPatients with a haematological diseases and stem cell transplant recipients• Allogeneic haematopoietic stem cell transplant (HSCT) recipients in the last 12 months or active graft vs host disease (GVHD) regardless of time from transplant (including HSCT for non-malignant diseases)

• Autologous HSCT recipients in the last 12 months (including HSCT for non-malignant diseases)

• Individuals with haematological malignancies who have

o received chimaeric antigen receptor (CAR)-T cell therapy in the last 24 months, or

o radiotherapy in the last 6 months

• Individuals with haematological malignancies receiving systemic anti-cancer treatment (SACT) within the last 12 months except patients with chronic phase chronic myeloid leukaemia (CML) in molecular response or first or second line tyrosine kinase inhibitors (TKI).

• All patients with myeloma (excluding MGUS) or chronic B-cell lymphoproliferative disorders (e.g. chronic lymphocytic leukaemia, follicular lymphoma) or myelodysplastic syndrome (MDS) who do not fit the criteria above.

• All patients with sickle cell disease.

• Individuals with non-malignant haematological disorder (e.g. aplastic anaemia or paroxysmal nocturnal haemoglobinuria) receiving B-cell depleting systemic treatment (e.g. anti-CD20, anti-thymocyte globulin [ATG] and alemtzumab) within the last 12 months.

LINKS to NHS England pages:

https://www.england.nhs.uk/coronavirus/publication/interim-clinical-commissioning-policy-neutralising-monoclonal-antibodies-or-antivirals-for-non-hospitalised-patients-with-covid-19/

https://www.england.nhs.uk/coronavirus/publication/neutralising-monoclonal-antibodies-and-intravenous-antivirals-in-the-treatment-of-covid-19-in-hospitalised-patients/

Latest update re Covid-19 treatments – 7th January 2022

Covid-19 treatments for some severely immune-compromised patients are now available.
However – the list of eligible patients is still fairly restricted, and we are waiting for more clarity on whether MDS and CMML patients are included – or will be included in a further review.

Stem Cell Transplant patients seem to be included, as we had reports from MDS transplant patients who have received the NHS letter.

On the 21st January, all cancer patient charities will have their regular monthly meeting with NHS England, and seek further updates and clarity on this topic.
In the meantime – please remain extra vigilant to avoid getting COVID-19 and make sure you obtain your 3rd and 4th vaccine dose.

You can download the document here:

Prioritising and protecting cancer services during the Omicron COVID-19 wave FAQs

Date: 21 December 2021

Overview
On 12 December the Prime Minister announced a rapid expansion of the booster programme to seek to mitigate the swiftly-growing wave of Omicron-variant Covid-19 cases.
The following day, the NHS confirmed in a letter from Amanda Pritchard (chief executive, NHS England) and Stephen Powis (chief executive, NHS Improvement) to the system that it is moving back into level 4 and incident response measures are being implemented. This document provides answers to frequently asked questions on the implications of these and other recent developments for cancer pathways and cancer patients.

Key message to patients

  • The NHS is taking the necessary action to ensure cancer diagnosis and treatment continues throughout any wave of coronavirus – GPs and hospitals have been told they must continue to prioritise and protect cancer services.
  • If you have symptoms you’re worried could be cancer, contact your GP without delay  they will want to see you.

FAQs

Impact of incident response and booster drive

Q: What is the impact of the response to the Omicron variant on people worried they have symptoms that could be cancer?
A: If you have symptoms that you’re worried could be cancer, contact your GP practice without delay. They will want to see you – while fewer routine appointments may be available, as practices free up more time to deliver coronavirus vaccines, people with possible cancer symptoms count as urgent and you will still be seen and, if necessary, referred for urgent checks.

Q: What is the impact on cancer services of the NHS initiating ‘level 4’ incident response measures?

A: The Chief Executives of NHS England and NHS Improvement, Amanda Pritchard and Stephen Powis, wrote to NHS organisations on 14 December. In their letter, they made clear that cancer must remain a priority and services must be protected, asking that:

  • people should continue to have rapid access to tests for suspected cancer
  • all cancer screening should continue
  • urgent cancer surgery is prioritised, and cancer surgery hubs are set up if needed
  • cancer treatment is delivered in COVID-secure sites wherever possible
  • local systems maximise the use they make of independent sector capacity
  • effective communications with patients and safety netting are in place, and patients are involved in decisions around their care.

Q: GPs are being told to deprioritise some other work to free up time to deliver more coronavirus vaccines. What does this mean for people who have symptoms that could be cancer?
A: Anyone who has symptoms they’re worried about that could be cancer should contact their GP without delay – people in this position are treated as urgent by GPs who will want to see you.

Q: My GP practice won’t offer me a face-to-face appointment, what do I do?
A: There has been an increased use of phone and video appointments by GPs through the pandemic. If you’re offered a phone or video appointment in the first instance, you should take it up and your GP will then either follow this up with a face-to-face appointment or may refer you for tests if they feel it’s appropriate.

Q: This comes on top of the NHS announcing earlier this month that it is partially suspending the Quality and Outcomes Framework for GPs until April. What impact will that have on rates of cancer diagnosis and care for cancer patients?
A: This move is primarily about reducing paperwork for GP practices. It doesn’t change the way they deal with any patient who has symptoms that could be cancer – they’ll continue to be seen as urgent cases. If you have symptoms you’re worried about that could be cancer, get in touch with your GP practice without delay – they will want to see you.
The Quality and Outcomes Framework – or ‘QOF’ - is an incentive programme for GP practices. It is a reporting mechanism for some of the work GPs have to do.
The routine care and monitoring which GP practices provide to people with cancer will continue. GP practices are still required to maintain a register of cancer patients, and we expect that they will continue to provide full support for patients with cancer.
This is only a partial and temporary suspension, and several elements of QOF reporting requirements remain in place, including for cervical screening.

Q: Will treatments be changed or cancelled?
A: The NHS has been asked to maintain diagnostic and treatment services for cancer and to prioritise cancer care. As at any time, in some individual cases there could be some changes to treatment plans, which clinicians would discuss with patients, but these will be very much the exception.
Patients should be reassured that the NHS continues to prioritise cancer services and has put in place all the necessary measures to ensure diagnostics and treatment, including surgery, can be delivered in COVID-safe environments. The use of over 40 Covid-friendly treatments has been extended again until the end of March 2022.

Q: What guidance is available online to explain the measures in place to enable cancer services to safely continue through the pandemic?
A: There is guidance published on the following:
Cancer and COVID page: Coronavirus » Cancer (england.nhs.uk) (which includes links to NICE guidance)
Radiotherapy guidance: https://www.nice.org.uk/guidance/ng162/chapter/7-Prioritising-radiotherapy-treatments
Chemotherapy guidance: https://www.nice.org.uk/guidance/ng161
Surgical prioritisation guidance: Clinical guide to surgical prioritisation during the coronavirus pandemic — Royal College of Surgeons (rcseng.ac.uk)

Third and fourth doses of Covid-19 vaccinations

Q: What’s the position on third doses and boosters for severely immunosuppressed patients?
A: People in this group are entitled to three ‘primary’ doses of coronavirus vaccines and a ‘booster’, which for them will be a fourth dose, 12 weeks after their third.
It doesn’t matter whether these patients’ third dose was described as a “third primary dose” or a “booster” when they had it – the practical outcome is the same. They are still eligible for a fourth dose (their “booster”) 12 weeks after their third jab. While a small handful of patients are already eligible for their fourth coronavirus vaccination, the majority of this group will be due early in the New Year.

Q: How can I get my third dose of the COVID-19 vaccine?
A: If you are eligible for a third dose, your GP or hospital consultant should contact you to let you know. You may also have received a letter from the NHS advising that you may be eligible and to discuss this with your doctor. Your doctor will discuss with you how you can get your vaccine. You'll usually get vaccinated at your local hospital or a local NHS
service, such as a GP surgery.
If you are aged 18 or over and have a letter from a GP or hospital consultant confirming your eligibility for a third dose, you can also book your vaccination appointment online through the National Booking System or attend a walk-in vaccination site if you bring the letter with you to your appointment.
If you are eligible and you do not have a referral letter from your GP or hospital consultant, you can still opt for a walk-in vaccination appointment, but you will need to present relevant medical documentation confirming your condition and have an assessment on site by a qualified healthcare professional. It’s important to be aware that not every walk-in site is able to offer vaccination for people who are severely immunosuppressed, so please use our online walk-in site finder to make sure you choose the right site for you.
Examples of medical evidence that can be used to confirm your eligibility includes, but is not limited to:

  • A hospital letter describing your condition at the time of your 1st and/or 2nd dose
  • Evidence of prescribed medication at the time of your 1st/2nd dose – either in a hospital letter that describes the medication being prescribed, a prescription copy or a medication box with your name and the date on it.

Q: How can I get my COVID-19 booster (fourth dose)??
A: If you are aged 18 and over and have already received a third dose of the vaccine, you should get a booster three months after your third vaccination. If you are eligible for a booster, your GP or hospital consultant should contact you to let you know and invite you to book your appointment.

If it has been three months since your third dose and you haven’t heard from your doctor yet, you should contact them to discuss your vaccination.

Alternatively, if you already have a letter from a GP or hospital consultant confirming your eligibility for a third dose, you will be able to get a booster at a walk-in vaccination site if you take the letter with you, subject to assessment on site by a qualified healthcare professional. It is important to be aware that not every walk-in site is able to offer boosters for people who are severely immunosuppressed, so please use our online walk-in site finder to make sure you choose the right site for you.

Q: NHS systems record third doses as a booster – is that a problem and could it prevent a patient from getting their vaccine?
A: A third primary vaccination dose for patients defined as severely immunosuppressed is recorded in the Point of Care system as a booster, with the booster (fourth dose) recorded as a second booster. The classification of a third dose does not preclude a patient from receiving a booster, nor will it impede access to any subsequent vaccinations they might require. Eligibility is based upon the patient being identified as severely immunosuppressed rather than on the number of vaccinations they have received. If a patient has been identified by a clinician as being eligible for a third primary dose or a booster dose, the Point of Care system will not be a barrier to vaccination.

COVID-19 Community Treatments

Q: What new treatments are being offered to people at the highest risk of becoming seriously ill if they become infected with Covid-19?
A: Since 16 December 2021, the NHS has been offering new treatments to people with coronavirus (COVID-19) who are at highest risk of going to hospital and becoming
seriously ill. Around 1.3 million of these highest risk patients are due to be contacted from 20 December with information on how they may be considered to receive these
treatments if they test positive for COVID-19 by PCR. A copy of the letter sent to 1.3 million patients is available here:
https://www.england.nhs.uk/coronavirus/publication/letter-to-patients-important-information-about-new-treatments-for-coronavirus/
Specialist doctors, including cancer doctors, have also been written to asking them to assist in identifying eligible patients not captured in the initial 1.3 million. A copy of this
letter is available here: https://www.england.nhs.uk/coronavirus/community-treatments/

Q: Who can access these treatments? How can I access them?
A: Further information on who can access these treatments and how they can be accessed
is available at www.nhs.uk/CoronavirusTreatments

Q: It doesn’t look like I am in the highest risk patient groups. Is there another way I can access coronavirus treatments?
A: If you are not in the highest risk group, you may be eligible to join the PANORAMIC study. The PANORAMIC study is open to individuals living anywhere in the UK who
meet the following criteria:
• Have received a PCR positive test for COVID-19.
• Feel unwell with symptoms of COVID-19 that started in the last five days.
• Are aged 50+, or 18-49 years old with an underlying medical condition that can
increase the risk of developing severe COVID-19.

Participants in the study will be randomly selected to either be in a group who receives a course of oral antiviral treatments, or a group that doesn’t. Two different groups are needed
so the study team can see any difference in the health of those who received the antiviral treatment compared to those who didn’t. All participants will be able to access any other
NHS care that they would normally expect to receive.
Further information on eligibility for the national study can be found on the PANORAMIC website: www.panoramictrial.org. If you receive a positive PCR test for COVID-19 and
believe you may be eligible for the study, we encourage you to call the trial team on freephone number 08081 560017 to discuss your eligibility to enrol in the study.

Q: What happens after an NHS clinician confirms I need treatment?
A: If a neutralising monoclonal antibody treatment is right for you, it will usually be given to you through a drip in your arm (infusion). You’ll usually get it at a local hospital or health
centre. Treatment takes approximately 30 minutes with time afterwards to check you feel OK.

Your local NHS provider will give you instructions on where the treatment will be given to you, and how to get there and back home safely. The NHS may be able to arrange for
your transport if you are unable to make your own COVID-safe travel arrangements.
If you are given an antiviral treatment, they normally come as capsules that you swallow and they can be taken at home. A hospital pharmacy will usually arrange for the
medicine to be delivered to you or it can be collected by someone else such as a friend, relative or NHS volunteer responder.

Q: Where is my local treatment centre? How do I travel there safely?
A: Your local NHS provider will give you instructions on where the treatment will be given to you. Some people are eligible for non-emergency patient transport services (PTS). To
find out if you're eligible for PTS and how to access it, you'll need to speak to the local NHS staff who have organised your appointment at the treatment centre.

Q: How do I know if I have a health condition that means I should get antiviral treatment or neutralising monoclonal antibodies?
A: A summary of the health conditions is provided at www.nhs.uk/CoronavirusTreatments, with more detail provided in Appendix 1 of the policy.
Most people with one of these health conditions will receive a letter or email from the NHS by the end of December 2021 and receive a PCR testing kit (to be used if COVID
symptoms are experienced) by 10 January 2022. This letter tells you about the treatments but does not guarantee treatment as doctors will need to assess you.
If you have a health condition which makes you eligible for one of these treatments and you test positive for COVID by PCR, you should be contacted by an NHS clinician to
discuss the treatments which may be suitable for you.

Q: What should I do if I think I might be eligible for treatment but have not been sent a PCR testing kit?
A: If you think you may have one of the health conditions which makes your eligible and you have not received a PCR testing kit, you can request one by calling 119, selecting the
option for Test & Trace, and telling them that you think you might be eligible.
You can also request a PCR test kit to keep at home by going online at https://www.gov.uk/get-coronavirus-test. For the question, ‘Does the person who needs a test currently have any coronavirus symptoms?' you should answer: ‘No’. When it asks ‘Why are you asking for a test?’, select ‘I’ve been told to get a test by my local council, health protection team or healthcare professional’, and then select ‘A GP or other healthcare professional has asked me to get a test’.

Q: What should I do if I think I might be eligible for treatment but have not received a letter from the NHS about these treatments?
A: If you think you may have one of the health conditions which makes your eligible, but you haven’t received a letter, you can contact your GP practice or consultant to discuss
whether you are in the highest risk group. They will make an assessment of any conditions you may have, and will provide you with information on what to do, should you
test positive for coronavirus.

Q: What should I do if I think I’m eligible for treatments and have tested positive for COVID, but I have not been contacted by the NHS?
A: If you think you may have one of the health conditions which makes you eligible, but you haven’t received a letter, you can contact your consultant or GP practice if you test
positive to discuss whether you might be in the highest risk group. If they feel you may be eligible, they will be able to make a referral for you so that you can be considered for
treatment.

Q: Why have I received a letter or email about COVID treatment?
A: Health experts, including the UK chief medical officers, have looked at the health conditions which put people at the highest risk of coronavirus. The majority of patients in
this highest risk group will be informed by a letter or email which tells them that they may be eligible to receive these treatments, should they test positive for COVID.
If you have received a letter from NHS England about coronavirus treatments, it means your medical records show that you have, or previously had, one or more of those health
conditions, which means that these new treatments might be suitable for you if a PCR test confirms you have coronavirus.
You can find out how the NHS has used your information to identify and contact you about this treatment at www.digital.nhs.uk/coronavirus/treatments/transparency-notice.

Q: I need this information in another language or alternative format
A: Easy read and other language versions of the letter that went out to patients are available at https://www.england.nhs.uk/coronavirus/treatments.
Braille can also be posted to potentially eligible patients on request by emailing england.contactus@nhs.net.

Q: Where can I get further information?
A: Further information for patients is available here:

www.nhs.uk/CoronavirusTreatments

Covid-19 vaccination

December 2021

Please see latest on 3rd and 4th vaccine doses.

Please also see a poster you can print and ask your GP to display in their surgery – if they have not yet done so.
Share on facebook/Instagram/twitter if you have access to these platforms.

COVID-19 vaccination for the severely immunosuppressed

Background

People with a weakened immune system who are classified as severely immunosuppressed either due to underlying health conditions or medical treatment are being identified and offered a third primary dose of COVID-19 vaccination to help reduce their risk of getting seriously ill.

If someone was immunosuppressed when they had their first two doses, the vaccine may not have provided as much protection as it can for people who do not have a weakened immune system.

It is recommended that the third dose be given at least eight weeks after the second, as part of the primary course of immunisation, but if the patient’s GP or consultant believes that a different interval should be offered, because of ongoing treatment or starting treatment which will suppress the individual’s immune system, then this timing may be altered.

The JCVI also recommends a booster dose for this group a minimum of three months (91 days) after the third primary dose.

Who is eligible for a third primary COVID-19 dose?

Guidance from the Joint Committee on Vaccination and Immunisation (JCVI) recommends that a third dose be offered to individuals aged 12 years and over with severe immunosuppression.

This includes people who had or have:

• a blood cancer (such as leukaemia or lymphoma)
MDS UK note: MDS and CMML is included
• a weakened immune system due to a treatment (such as steroid medicine, biological therapy, chemotherapy or radiotherapy)
• an organ or bone marrow transplant
• a condition that means you have a very high risk of getting infections
• a condition or treatment your specialist advises makes you eligible for a third dose

Further information about the eligibility criteria for a third dose has been published by the JCVI and is available here.

 

Getting vaccinated

According to the latest available data, 89% of individuals identified as severely immunosuppressed have now had a third primary dose.

At present, it’s a relatively small number of people within the cohort who are eligible for a booster, with the majority due in the New Year.

Included below is all the information someone needs to get vaccinated if they’re severely immunosuppressed.

How to get your third dose of a COVID-19 vaccine

If you're eligible for a third dose, your GP or hospital consultant should contact you to let you know.

You may also have received a letter from the NHS advising that you may be eligible and to discuss this with your doctor.

Your doctor will discuss with you how you can get your vaccine. You'll usually get vaccinated at your local hospital or a local NHS service, such as a GP surgery.

If you are aged 18 or over and have a letter from a GP or hospital consultant confirming your eligibility for a third dose, you can also book your vaccination appointment online through the National Booking System or attend a walk-in vaccination site if you bring the letter with you to your appointment.

If you are eligible and you do not have a referral letter from your GP or hospital consultant, you can still opt for a walk-in vaccination appointment, but you will need to present relevant medical documentation confirming your condition and have an assessment on site by a qualified healthcare professional.

It’s important to be aware that not every walk-in site is able to offer vaccination for people who are severely immunosuppressed, so please use our online walk-in site finder to make sure you choose the right site for you.

Examples of medical evidence that can be used to confirm your eligibility includes, but is not limited to:

• A hospital letter describing your condition at the time of your 1st and/or 2nd dose
• Evidence of prescribed medication at the time of your 1st/2nd dose – either in a hospital letter that describes the medication being prescribed, a prescription copy or a medication box with your name and the date on it

How to get your COVID-19 booster (fourth dose)

If you are aged 18 and over and have already received a third dose of the vaccine, you should get a booster three months after your third vaccination.

If you are eligible for a booster, your GP or hospital consultant should contact you to let you know and invite you to book your appointment.

Your doctor will discuss with you how you can get your vaccine. You'll usually get vaccinated at your local hospital or a local NHS service, such as a GP surgery.

If it has been three months since your third dose and you haven’t heard from your doctor yet, you should contact them to discuss your vaccination.

Alternatively, if you already have a letter from a GP or hospital consultant confirming your eligibility for a third dose, you will be able to get a booster at a walk-in vaccination site if you take the letter with you, subject to assessment on site by a qualified healthcare professional.

It is important to be aware that not every walk-in site is able to offer boosters for people who are severely immunosuppressed, so please use our online walk-in site finder to make sure you choose the right site for you.

How are third doses recorded?

NHS England is aware that some stakeholders have raised questions about how third doses are logged in a patient’s record. A third primary vaccination dose for patients defined as severely immunosuppressed is recorded in the Point of Care system as a booster, with the booster (fourth dose) recorded as a second booster.

The classification of a third dose should not preclude a patient from receiving a booster, nor should it impede access to any subsequent vaccinations they might require. In the unlikely event that a patient is challenged on this point and is told a third shot or booster is unable to be recorded on the system, please point the contact at the vaccination centre towards the above content.

Eligibility is based upon the patient being identified as severely immunosuppressed rather than on the number of vaccinations they have received. If a patient has been identified by a clinician as being eligible for a third primary dose or a booster dose, the Point of Care system will not be a barrier to vaccination.

What adjustments are being made to support people who are severely immunosuppressed attending walk-in vaccination appointments?

Vaccination sites have been asked to ensure that appropriate arrangements and reasonable adjustments are in place such as priority lanes to support people who are less able to queue, including those in the severely immunosuppressed cohort.

NHS England have produced a poster highlighting that staff should ensure people who are immunosuppressed, alongside other priority groups, have their wait time reduced.

 

Download the document here:

Third Covid Dose Available To Book Online For People Who Are Severely Immunosuppressed

Please read the official information from NHS England:

People who are severely immunosuppressed can book their third COVID jab online from today, as the NHS national booking system opens up to more people.

In line with Joint Committee on Vaccination and Immunisation (JCVI) guidance, those who are classed as severely immunosuppressed as a result of treatment, for conditions such as cancer or for those with long-term chronic conditions where their immunity is affected by medication, are eligible for a third dose eight weeks after their second dose.

So far more than three quarters of those who are severely immunosuppressed have had a third COVID vaccination.

From today, adults who are eligible for a third dose of the COVID vaccine and have received a clinical referral letter from their doctor can go online and book an appointment, as the NHS COVID-19 vaccination programme continues to protect those most at risk from the virus.

The NHS COVID-19 vaccination booking service offers an option to ‘book my 3rd dose appointment’ for adults who had a weakened immune system at the time they had a second dose.

After JCVI recommended offering a third primary dose to those who are severely immunosuppressed, the NHS wrote twice to trusts and GPs asking that doctors identify and contact people in this important group, either to offer them a third dose directly or to provide them with a letter so that this can be accessed elsewhere at vaccination sites.

The NHS also wrote directly to around 400,000 potentially eligible patients encouraging them to speak to their clinician if they had not already done so.

Professor Stephen Powis, NHS National Medical Director, said: “NHS staff continue to deliver first, second and third doses, to those who are eligible, alongside administering around 14 million boosters in just over nine weeks.

“Decisions on when to get a third dose remains between a patient and their clinician who knows about their ongoing treatment – more than three quarters of people who are severely immunosuppressed have had their third dose so far, and from today people can also book in online with a letter from their GP or clinician.

“It’s incredibly important that people get the full recommended course of COVID vaccines, especially those most at risk from the virus – boosters and third doses are not a nice to have, they are the best way to protect you and your loved ones this winter”.

Although the number of people in this cohort can change over relatively short periods of time – for example patients may start chemotherapy or other treatments and so their eligibility for third and subsequent doses will change – around half a million are eligible for a third jab in England, and more than seven in 10 have already had theirs.

The decision on when to get a third jab for people who are severely immunosuppressed is made between patients and their clinicians, and the majority of third doses are being administered through hospital consultants and GPs.

In line with JCVI guidance, the third dose for those with severe immunosuppression should usually be given at least eight weeks after the second dose.

Those with a clinical referral letter from their doctor can also use the NHS online COVID vaccine walk-in finder and attend their local vaccination centre for their third dose.

The NHS has already taken steps to improve access for those who are severely immunosuppressed, such as writing to trusts and GPs asking them to identify and contact people in this group; writing to around 400,000 eligible patients encouraging them to speak to their clinician if they had not already done so; and writing to cancer leads to support patient identification and the provision of a clinical authorisation letter.

In addition to people being vaccinated through their GP or hospital, for those with a referral letter there are currently around 1400 vaccination sites offering bookings for third dose COVID-19 vaccinations and 300 sites offering walk-in appointments.

The offer of a third dose for people who are severely immunosuppressed is separate to the booster programme.

Since the NHS in England made history with the first COVID vaccination delivered outside a clinical trial in December 2020, 95 million doses of the life-saving vaccine have been delivered – with more than nine in 10 adults having had their first vaccination.

Around 14 million boosters have been delivered in total since the booster campaign kicked off in September, less than 48 hours after updated JCVI guidance.

There are more places delivering vaccines now than at any other point in the programme, including pharmacies, GP practices and other community sites, meaning the vast majority of people live within 10 miles of a fixed vaccination clinic.

Please contact us should you have any issues or queries:
Tel: 02077337558 - Email: info@mdspatientsupport.org.uk

Important:

You must have a letter from your GP or hospital doctor. If you do not bring the letter, you will not be able to receive a 3rd dose of the vaccine at your appointment.

The 3rd dose and the booster: Differences

There seems to be a lot of confusion in GP practices and from the 119 Covid Helpline about the differences between the 3rd primary dose and a booster.

A third primary dose is an extra ‘top-up’ dose for those who may not have generated a full immune response to the first 2 doses. This is about half a million people in the UK.

The decision on the timing of the third dose should be made by their specialist. As a general guideline, the third dose should usually be at least 8 weeks after the second dose but with flexibility to adjust the timing so that, where possible, immunosuppression is at a minimum when the vaccine dose is given. Most MDS patients who were identified as (CEV) Clinically Extremely Vulnerable, would now be well over this 8-week interval.

A booster dose is a later dose to extend the duration of protection from the primary course of vaccinations. This is given to other, often vulnerable, people but who are not immunocompromised. It is given to people 6 months after their first course has ended.

In addition, if the Moderna vaccine is used as a 3rd dose, a full dose should be given. When given as a booster, only a half dose of Moderna is used. It is very important to check this when you have the vaccine.

It is very important you insist you qualify for a 3rd primary dose - not a booster - so that you can be vaccinated on time and with the right dose.

Initial Feedback from our Members

Chris: "I emailed my GP practice on 28th September, pointing out the JCVI advice and requesting an invitation for a 3rd vaccine for myself and a booster for my husband, as somebody living with an immunosuppressed person.  I received an automated reply, stating “PLEASE NOTE - if your email is enquiring on your eligibility for your covid vaccination or attempting to book your covid vaccination we will not respond to your email.”"

"I was then quite surprised to get a phone call from the GP practice the next morning inviting me to get a vaccine that afternoon! And also, to ask my husband to make an appointment the following week for his booster dose!  All then went well, except that when I gave my details to the admin person at the point of having my vaccine she said “Oh, but you shouldn’t be having your booster yet as it hasn’t been 6 months since your 2nd dose!" So I had to tell her that this wasn’t a booster but a 3rd dose as I had leukaemia and was immunosuppressed! I was surprised that she didn’t seem to know this. "

Claudia: "I had been waiting, as instructed, to hear from my GP or specialist regarding a 3rd vaccine, but instead received an email and a text from the NHS on 29th September, inviting me to make an appointment for a COVID-19 booster, on the basis of my “age, gender or ethnicity.” I rang 119 the next day to clarify, and started by explaining that I was classed as CEV due to being a blood cancer patient and had been expecting to be contacted regarding a 3rd vaccine, rather than the booster."

"The scheduler evidently didn’t understand the distinction, as she began to look for a booster appointment for me. I then again explained that this was not what I was expecting, based on the JCVI advice that immune-compromised people should first have a 3rd primary dose. At that point, she put me on hold in order to consult her supervisor. After 5-10 minutes, she came back on the line to inform me that they had today received a Bulletin containing the JCVI advice and that she could now see from the system that she could make an appointment for me to have a 3rd dose. If I hadn’t insisted that she shouldn’t make me a booster appointment, I’m sure that is what I would have been given. "

New survey to evaluate antibody response in individuals with cancer

The SOAP Study

King's College Hospital is monitoring MDS patients, as part of the SOAP study.

This study is measuring how effective the vaccines are in blood cancer patients and specifically MDS patients, as initial results have shown vaccines may not be as effective as in the general population.

The study is testing for T-cell response as well as antibodies and its results are expected soon.

More information on COVID-19 vaccines and recommendations for MDS Patients

  • Oxford University/AstraZeneca Covid-19 vaccine approved by the UK regulator
  • Pfizer/BionTech Covid-19 vaccine approved by the UK regulator
  • Moderna Covid-19 vaccine approved by the UK regulator

UK Medicines & Healthcare products Regulatory Agency (MHRA) Approvals

All vaccines undergo a review by the Medicines and Health Regulatory Agency (MHRA) (in the UK).  Other regulatory agencies, such as the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in the USA conduct their own assessment.

Oxford University/AstraZeneca Covid-19 vaccine:  MHRA Approval

The COVID-19 vaccine developed by Oxford University/AstraZeneca has today (30 December 2020) been given regulatory approval by the Medicines and Healthcare products Regulatory Agency (MHRA) after meeting required safety, quality and effectiveness standards.

Following a rigorous, detailed scientific review by the MHRA’s expert scientists and clinicians and on the basis of the advice of its scientific, independent advisory body, the Commission on Human Medicines, the UK regulator has approved COVID-19 Vaccine AstraZeneca for use across the UK.

MHRA Chief Executive Dr June Raine said:

"We are delighted to announce the good news that the Oxford University/AstraZeneca vaccine for COVID-19 is now approved for supply following a robust and thorough assessment of all the available data."

"A huge collaborative effort and commitment goes into these assessments which include reviewing vast amounts of data. Our staff have worked tirelessly to ensure we continue to make safe vaccines available to people across the UK."

"No stone is left unturned when it comes to our assessments. This approval means more people can be protected against this virus and will help save lives. This is another significant milestone in the fight against this virus. We will continue to support and work across the healthcare system to ensure that COVID-19 vaccines are rolled out safely across the UK. Protecting health and improving lives is our mission and what we strive for."

The Oxford University/AstraZeneca vaccine has been approved for use for people 18 years or older and consists of two doses, with the second dose administered 4-12 weeks after the first dose. The transportation and storage requirements for this vaccine mean that it needs to be kept at temperatures of 2C to 8C, which is similar to a conventional fridge for up to six months and can be administered within existing healthcare settings.

Read the full article: https://www.gov.uk/government/news/oxford-universityastrazeneca-covid-19-vaccine-approved

Pfizer/BionTech Covid-19 vaccine approved by MHRA

MHRA approval of the Pfizer/BionTech Covid-19 vaccine

The first COVID-19 vaccine for the UK, developed by Pfizer/BioNTech, has today been given approval for use following a thorough review carried out by the Medicines and Healthcare products Regulatory Agency (MHRA).

The decision by the UK regulatory authority was made with advice from the Commission on Human Medicines (CHM), the government’s independent expert scientific advisory body. A dedicated team of MHRA scientists and clinicians carried out a rigorous, scientific and detailed review of all the available data, starting in October 2020.

The MHRA expert scientists and clinicians reviewed data from the laboratory pre-clinical studies, clinical trials, manufacturing and quality controls, product sampling and testing of the final vaccine and also considered the conditions for its safe supply and distribution
MHRA Chief Executive, Dr June Raine said:

We have carried out a rigorous scientific assessment of all the available evidence of quality, safety and effectiveness. The public’s safety has always been at the forefront of our minds – safety is our watchword.

I’m really pleased to say that the UK is now one step closer to providing a safe and effective vaccine to help in the fight against COVID-19 – a virus that has affected each and every one of us in some way - and in helping to save lives.

Read the full article: https://www.gov.uk/government/news/uk-medicines-regulator-gives-approval-for-first-uk-covid-19-vaccine

Moderna Covid-19 vaccine approved by MHRA

MHRA approval of the Moderna Covid-19 vaccine

The COVID-19 vaccine developed by Moderna has been given regulatory approval for supply by the Medicines and Healthcare products Regulatory Agency (MHRA). This follows a thorough and rigorous assessment by the MHRA’s teams of scientists, including advice from the independent Commission on Human Medicines, which reviewed in depth all the data to ensure this vaccine meets the required standards of safety, quality and effectiveness.

This is the third COVID-19 vaccine to be approved for use by the MHRA and is the second mRNA vaccine (the Pfizer/BioNTech vaccine approved in December 2020 is also an mRNA vaccine).

MHRA Chief Executive Dr June Raine said:

Today’s approval brings more encouraging news to the public and the healthcare sector. Having a third COVID-19 vaccine approved for supply following a robust and thorough assessment of all the available data is an important goal to have achieved and I am proud that the agency has helped to make this a reality.

The progress we are now making for vaccines on the regulatory front, whilst not cutting any corners, is helping in our global fight against this disease and ultimately helping to save lives. I want to echo that our goal is always to put the protection of the public first.

Read the full article: https://www.gov.uk/government/news/moderna-vaccine-becomes-third-covid-19-vaccine-approved-by-uk-regulator

More information on the different COVID-19 vaccines

Pfizer/BioNtech: 95% effective in a study of 43,000 people. The trial also looked at people aged 65 and over, whose immune systems are weaker than those of younger people. In this older group, 94% effectiveness was observed. This vaccine works by taking part of the genetic code of the coronavirus and putting it in a vaccine. Once injected, this code tells our cells to produce a protein found on the surface of the coronavirus. Our immune systems respond to this and ‘remember’ what coronavirus looks like. When encountered again, our body will recognise it, allowing us to respond quickly to avoid becoming ill.

Moderna: Similar technology to the Pfizer/BioNtechvaccine. This saw 95% effectiveness levels in a study of 30,000 participants. They looked specifically at 7,000 people over the age of 65, as well as people with diseases that put them at high risk of complications from the coronavirus, such as diabetes and cardiac disease.

Astra Zeneca Oxford: This vaccine is made from a modified version of a virus that causes the common cold in monkeys. Researchers have inserted a gene in this vaccine, which when injected, prompts our bodies to make a protein found on the coronavirus. This is NOT a protein that will cause infection. Our immune system should then respond to this, preventing infection in the future. This vaccine has been shown to be between 60 and 90% effective depending on how doses are administered in a clinical trial of 20,000 people.

This summary was created by the MDS UK team and approved by the UK MDS Forum experts:

Prof G. Mufti, Dr D. Culligan, Prof D. Bowen, Dr S. Killick, Dr A. Kulasekararaj

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