COVID-19 vaccines and MDS: Approvals and Advice from UK MDS Forum of experts

COVID-19 Vaccines and MDS Update 07/01/21

Advice on the Covid-19 vaccines from the government and MHRA:

Both Pfizer/BioNTech vaccine and Oxford University/AstraZeneca vaccines have been deemed safe for MDS patients. There are no known risks to cancer patients, or those on cancer treatment.

Patients with an immune compromised system will still need to shield even after receiving the vaccine, as the protection may not be as effective as in healthy individuals.

Gap between doses of the vaccine

There has been some discussion on the decision to extend the gap between the 1st and the 2nd dose of the vaccines. The consensus is that a 12 week gap (instead of the 3 week in the clinical trials) will generally not be detrimental.

However, the current thought is that patients with an immune compromised system, who are less likely to fully respond to the vaccine, should have the 2nd dose sooner rather than later. This will still need to be confirmed.

Allergies

Patients with a known allergy to any of the ingredients in either vaccine should NOT have these vaccines. BUT patients with allergies such as food, CAN now have the vaccine.

Click here for more information: https://www.gov.uk/government/news/oxford-universityastrazeneca-covid-19-vaccine-approved

STOP PRESS: A third COVID-19 Vaccine developed by Moderna has just been approved (08/01/2021) by the MHRA in the UK

The COVID-19 vaccine developed by the pharmaceutical company Moderna has today 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).

Click here for more information: https://www.gov.uk/government/news/moderna-vaccine-becomes-third-covid-19-vaccine-approved-by-uk-regulator

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

  • Oxford University/AstraZeneca Covid-19 vaccine approved by the UK regulator - 30th December 2020
  • Pfizer/BionTech Covid-19 vaccine - 24th December 2020
  • Advice from UK MDS Forum of experts - 16th December 2020

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

COVID-19 vaccine advice for patients with haematological disorders by the British Society for Haematology

This statement produced by the British Society for Haematology, 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 also contributed.

"The Pfizer/BioNTech COVID-19 vaccine has been authorised for use by the Medicines and Healthcare products Regulatory Authority (MHRA), it was introduced into use in the UK on 8th Dec 2020. This is not a ‘live’ vaccine so should be safe for most patients with blood cancer. 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 if 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. This document aims to support medical staff in providing this advice and has been collated from information currently available and from expert opinion. It will be updated as more information becomes available."

Click here for more information: https://b-s-h.org.uk/media/19195/haematology-covid-19-v10-vaccination-statement-231220.pdf
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EMA (European Medicines Agency) approval of the Pfizer/BionTech Covid-19 vaccine

The EMA (European Medicines Agency) approved the Pfizer/BionTech Covid-19 vaccine, which the MHRA had approved for the UK. This is an additional source of validation and reassurance, from the institution which the UK has depended on for many years, until Brexit. You will read that the plan is clearly to continue monitoring all people being vaccinated, and especially those with an immune compromised system.
Again – as MDS patients, do agree to be vaccinated with this Pfizer/BionTech vaccine, with the precautions we highlight below. The work carries on, evaluating all the other vaccines in the pipe-line, and we hope to have more news in early 2021.

Additional information on the first COVID-19 vaccine, Comirnaty, published on the EMA website:

  • CHMP assessment report, in English
  • Translations in all EU languages of the medicine overview
  • Translations in all EU languages of the product information
  • Full body of the core Risk Management Plan (plus Annex 4), in English

The documents can be accessed by clicking here.

Please check EMA’s dedicated webpage on COVID-19 for the latest updates

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.

http://www.ukmdsforum.org.uk/

UK MDS Forum guidance:

There is currently only one licensed and available vaccine for Covid-19 – the Pfizer/BioNtech vaccine.

This is a not a ‘live’ vaccine and therefore should be safe for blood cancer patients, including MDS patients. The Joint Committee of Vaccination and Immunisation (JCVI) have set out a prioritisation for persons at risk, including those who are defined as clinically extremely vulnerable (CEV). This can be found on the government website (NHS UK Coronavirus JCVI ).

Download and print this advice.

Download PDF

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.

Further Information

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

References:

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