COVID-19 vaccines and MDS: Approvals and Advice9 Sep. 2021
COVID-19 Vaccines and MDS - Updated 09/09/21
Advice on a 3rd Covid-19 vaccine for immunosuppressed patients:
We attended a special briefing from NHS England, where it was explained that patients who are immunocompromised would be offered a 3rd COVID vaccine, maybe even a 4th one, in the hope to trigger an increased response to the vaccine. This step is necessary, as some early studies are showing that the vaccines are less effective in immunocompromised patients.
The JCVI advice states:
"This third dose should be offered to people over 12 who were severely immunosuppressed at the time of their first or second dose, including those with leukaemia, advanced HIV and recent organ transplants. These people may not mount a full response to vaccination and therefore may be less protected than the wider population.
Studies are ongoing to see how effective a third dose is for immunosuppressed people, but it is very unlikely to cause any harm. Therefore, on balance, the JCVI’s view is that a third dose can be safely offered as it may increase their protection."
Read more by clicking the 2 links below. The NHS England link covers the letters addressed to GP's and consultants, as well as details of which patients are eligible.
MDS is not listed as such, but definitely covered.
More information on COVID-19 vaccines and recommendations for MDS Patients
- COVID-19 vaccine advice for patients with haematological disorders by the British Society for Haematology: Updated 13th Jan 2021
- 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
- Advice from UK MDS Forum of experts - 16th December 2020
COVID-19 vaccine advice for patients with haematological disorders by the British Society for Haematology
This statement has been produced by the British Society for Haematology and has been reviewed by the Intercollegiate Committee on Haematology, on behalf of the Royal College of Physicians of London and the Royal College of Pathologists. Specialist haematology groups have also contributed. V2 13th Jan 2021
"The vaccines approved for use in the UK have been developed by Pfizer/BioNTech and Oxford/AstraZeneca. These have been authorised for use by the Medicines and Healthcare products Regulatory Authority (MHRA) and were introduced into use in the UK on 8 December 2020/4 January 2021.
These are non-replicating vaccines so do not pose a risk of infection and are safe for patients with blood cancer and other haematological conditions. It is likely that other vaccines will be authorised and be available over the coming weeks.
Patients with haematological conditions will be invited for the vaccination over the next weeks and months and many will fall within the priority groups for vaccination.
Patients who are receiving chemotherapy or immunosuppression should discuss with their hospital clinicians how they can safely receive the vaccine and optimal timing of administration. There is no current evidence that the vaccine might be a risk to the immunosuppressed patient.
Many patients with haematological conditions are on therapy that will induce immunosuppression or will be immunocompromised as a consequence of their underlying disease and they may have a reduced response to the vaccine.
Patients should therefore not presume they are immune after receiving the vaccine (and booster) and should still follow government advice on use of face masks, social distancing and hand hygiene to reduce their exposure to the virus"
Click here for more information: https://b-s-h.org.uk/media/19236/haematology-covid-19-v11-vaccination-statement-13121-clean.pdf
Oxford University/AstraZeneca Covid-19 vaccine: UK Medicines & Healthcare products Regulatory Agency (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.
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.
Advice from UK MDS Forum of experts
MDS patients are asking about the safety and advisability of the vaccines, on the background of being amongst the highest risk groups for COVID-19.
In the current absence of precise information on the safety and efficacy of the current Covid-19 vaccines in patients with blood cancers, we asked the UK MDS Forum (MDS expert group in the UK), for their initial opinion, and they produced the following guidance.
The consensus is that generally, for blood cancer patients, the benefits of the vaccine far outweigh any potential side effects of the vaccine and the risks associated with having COVID-19 infection. Therefore, vaccination is recommended, except in people with a history of severe allergic reactions.
As time goes by, other vaccines will become available, and they will be assessed on their own merit, depending on precise details of the trial population (e.g. – was it tested on immuno-compromised or blood cancer patients?)
For now, we are only looking at the Pfizer/BioNtech vaccine.
Which MDS patients should get the Pfizer/BioNtech vaccine?
The MAJORITY of MDS patient should be receiving the Pfizer/BioNtech vaccine.
This will include:
- All MDS subtypes regardless of age
- All IPSS & IPSS-R risk groups
- MDS patients on watch & wait or treatment, now or in the past
- MDS Patients on clinical trials
Which MDS patients should exercise caution regarding the vaccine, and speak to their haematologist before receiving the vaccine?
- patients with a known severe allergy
- patients who carry an EPI-PEN
- Patients who have a low platelet count who may bleed or bruise at the injection site. To reduce this risk, we recommend the platelet count should be 30 x 109/l or above and that prolonged pressure at the injection site should be applied for 5 minutes. Those receiving regular platelet transfusions should have their vaccine after a platelet transfusion. If the platelet count is less than 30 x 109/l and the patient is not receiving regular platelet transfusions, they should discuss with their haematologist.
Post-transplant haematology patients should speak to their haematologist and/or transplant team, who will follow the up-to-date advice from British Society of Bone Marrow Transplantation (BSBMT).
What remains to be decided?
Whether it will be the hospital or GP who will administer the Pfizer/BioNtech vaccine to blood cancer patients.
Whether the vaccine will offer a sufficient level of protection against COVID-19 in immune-compromised and blood cancer patients.
What will patients need to do post vaccination?
As the effectiveness of the Pfizer/BioNtech vaccine may not be guaranteed in immune-compromised patients, it will be necessary for all vaccinated patients to maintain social distancing and follow the currently recommended government precautions against COVID-19. These precautions are updated regularly on www.gov.uk/coronavirus.
These precautions will need to be maintained until the COVID-19 pandemic is over, or until it can be proven that the Pfizer/BioNtech vaccine works well enough in immune-compromised patients.
What about the alternatives to the Pfizer/BioNtech vaccine?
Editor's Note: Both Moderna & Oxford University/AstraZeneca vaccines were approved by the UK regulator after this recommendation was written.
The Pfizer/BioNtech vaccine is the only licensed and approved method to protect patients from COVID-19. There are 2 further COVID-19 vaccines under review, which may become available, but nothing is certain. There is also an on-going antibody clinical trial from Astra Zeneca, which in time could be available, for patients who cannot be vaccinated. It may even be used as a prophylaxis (preventatively) for patients in care homes for example. BUT - again – it is unknown if, and when any of these options may become available in the future. Hence the recommendation is to have the Pfizer/BioNtech vaccination, when it will be offered.
Efficacy of the Pfizer/BioNtech vaccine and longer-term thinking?
To check the full efficacy of the Pfizer/BioNtech vaccine, the plan is to set up a monitoring study to measure the COVID-19 antibody response in blood cancer and immuno-compromised patients.
This anti-body response will be measured through a blood test.
If the antibody response is less than required to guarantee COVID-19 protection, it is thought that patients may then still have the option of a new vaccine, or the antibody option, if these become available.
Further advice will be made available, as more data is shared with clinicians and carefully analysed, and as the government and/or regulatory agencies issue more guidance on specific sub-groups of patients.
Specific advice and guidance will be given for each new vaccine, each MDS sub-group, and age group of MDS patients.
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.
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 will conduct their own assessment.
The EMA ran a public meeting on the topic: “Public stakeholder meeting: development and authorisation of safe and effective COVID-19 vaccines in the EU Live broadcast - 12noon - 15:30 (GMT) ; Event summary ; Documents
More information on COVID-19 vaccines via our colleagues at Blood Cancer UK
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
- Blood Cancer UK https://bloodcancer.org.uk/news/coronavirus-vaccine-what-you-need-know/ Professor Mark Drayson, Dr Graham Collins, Dr Karthik Ramasamy and Dr Matthew Buckland.
- MHRA vaccine approval https://www.gov.uk/government/news/uk-medicines-regulator-gives-approval-for-first-uk-covid-19-vaccine
- JCVI https://www.gov.uk/government/publications/priority-groups-for-coronavirus-covid-19-vaccination-advice-from-the-jcvi-25-september-2020/jcvi-updated-interim-advice-on-priority-groups-for-covid-19-vaccination - 2nd Dec: No data is currently available on the efficacy of COVID-19 vaccines, and initial data from smaller early trials provides only limited information on safety. This is the start of a longer process, and the advice provided at this stage is subject to change. There are a number of unknown factors about any potential vaccines, and there are still important gaps in our understanding of COVID-19. The committee will be keeping its advice under review and as more information becomes available will update its advice as and when deemed appropriate. Specifically, this advice will be updated as more information becomes available on: vaccine efficacy and/or immunogenicity in different age and risk groups, the safety of administration in different age and risk groups, the effect of the vaccine on acquisition of infection and transmission, the transmission dynamics of the SARS-CoV-2 virus in the UK population, the epidemiological, microbiological, and clinical characteristics of COVID-19
- Covid-19 – antibody jab: https://www.bbc.co.uk/news/health-55022288
- ASH https://www.hematology.org/covid-19/ash-astct-covid-19-and-vaccines
- EMA https://www.ema.europa.eu/en/news/ema-organises-public-meeting-covid-19-vaccines
- EMA event https://www.ema.europa.eu/en/events/public-stakeholder-meeting-development-authorisation-safe-effective-covid-19-vaccines-eu
- Extremely vulnerable letter https://www.gov.uk/government/publications/covid-19-letters-to-clinically-extremely-vulnerable-people