COVID-19 vaccines and MDS: Approvals and Advice – Updated 24/01/2022

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.

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.

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Covid-19 vaccination: 3rd and 4th vaccine doses for MDS patients

COVID-19 vaccination for the severely immunosuppressed

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 are 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 with the 3rd and 4th doses if you are 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.

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.

Boosters (4th doses) at walk-in sites
If you or your child are eligible for a booster (4th dose), you can go to any walk-in vaccination site that is offering boosters if you have a letter from a GP or hospital specialist inviting you for either a 3rd dose or a booster (4th dose) for people with a severely weakened immune system.

You must take your letter with you to the walk-in site. Please also check that the site is offering vaccines for your or your child’s age group.

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 or a 4th dose of the vaccine.

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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