Update for people with liver disease on the Covid-19 vaccine

Posted on: 1st May 2022

If you or a loved one has a liver condition, you may have questions about the COVID-19 vaccine and its effectiveness particularly if you are immunosuppressed.

Below you will find information about the latest studies and a series of FAQs for patients - both those who are immunosuppressed and those who are affected by another liver condition.

Latest COVID-19 vaccine advice for people who are immunosuppressed

COVID-19 is more serious in older people and those with a weakened immune system. Protection from the vaccine may be lower and may decline more quickly in these people. For this reason, people aged 75 years and over, those in care homes for older adults and those aged 12 years and over with a weakened immune system are being offered the spring booster.

JCVI’s advice is that people should wait until around six months since their last dose for maximum effectiveness, and people are asked to wait until they are invited by the NHS to book. People should wait to be contacted by the NHS. The NHS began inviting people on 21 March and will offer a top-up dose to all who are eligible during Spring and early Summer before the end of June.

The booster vaccine is not the same as having a third dose of the primary vaccine, which has been offered to all adults over the age of 18 in the UK.

The Joint Committee on Vaccination and Immunisation (JCVI) advises that a third primary dose is offered to people aged 12 and over with severe immunosuppression.  More information below.

The third dose is offered to people over who were severely immunosuppressed at the time of their first or second dose, including liver transplant patients and some people with liver disease who receive immunosuppressant treatment.

This affects around half a million people and the NHS will contact you as soon as possible to discuss your needs and arrange an appointment for a third dose where clinically appropriate.

Some individuals who are immunosuppressed due to underlying health conditions or medical treatment may not achieve the same full immune response to the initial 2 dose COVID-19 vaccination course as those who are not immunosuppressed.

In response to the emergence of Omicron variant, the JCVI advises that severely immunosuppressed individuals who have completed their primary course (3 doses) should be offered a booster dose with a minimum of 3 months between the third primary and booster dose. Those who have not yet received their third dose may be given the third dose now to avoid further delay. A further booster dose can be given in 3 months, in line with the clinical advice on optimal timing.

This affects around half a million people and the NHS will contact you as soon as possible to discuss your needs and arrange an appointment for a third dose where clinically appropriate.

The OCTAVE study is examining responses to COVID-19 vaccines in clinically at-risk groups.

The OCTAVE trial preliminary results show that the majority (60%) of clinically at-risk people produce strong immune responses following two doses of a vaccine. However, 40% of patients mounted a low, or undetectable, immune response after two doses. Participants in the trial received either Pfizer/BioNTech or AstraZeneca vaccines.

A recent study has looked into the effectiveness of the vaccine in people who have had a solid organ transplant.  After two doses of the vaccine, liver transplant patients do not have as much protection as non-transplant patients so we advise that patients with liver disease, particularly those with cirrhosis, those after a liver transplant, and those who have liver disease and are immunosuppressed have their third vaccine and/or the booster dose.  For more information on this study,  please look at: New study looks at real world effectiveness of Covid-19 vaccines in solid organ transplant recipients - British Liver Trust

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.

Yes. Severely immunosuppressed individuals will become eligible for a booster dose as part of a routine booster programme with a minimum of 3 months between the third primary and booster dose. Third doses are being given not to combat waning immunity but to bring these individuals up nearer to the same level of immunity as the non-immunosuppressed achieve from 2 doses.

  • The recent SIREN study shows that people who have received two primary doses plus a booster were less likely to test positive for COVID-19 or display any symptoms
  • While the vaccine cannot guarantee you won’t become infected, evidence suggests that getting boosted will reduce the chance of you catching the virus and having to isolate.
  • Recently vaccinated people may experience fewer and milder symptoms and recover more quickly.

The JCVI advises that the booster dose is offered no sooner than three months after completion of the primary course (usually two doses).

  • According to the latest UKHSA surveillance report, the effectiveness against hospitalisation:
  • Two doses of either Oxford-AstraZeneca or Pfizer/BioNTech booster vaccines was associated with a vaccine effectiveness of approximately 25 to 35% against hospitalisation following infection with the Omicron variant, after 25+ weeks.
  • After a Pfizer/BioNTech booster (after either primary vaccination course), vaccine effectiveness against hospitalisation started at around 90% dropping to around 75% after 10 to 14 weeks.
  • After a Moderna booster (after either primary vaccination course) vaccine effectiveness against hospitalisation was 90 to 95% up to 9 weeks after vaccination
Omicron vaccine and booster update - 13/12/21
COVID-19 vaccine guidance has recently been updated in light of Omicron and the need to take additional steps to protect ourselves, especially for those who may not have developed a strong immunity response to the vaccines.

Initial results of the OCTAVE study

The OCTAVE study has published initial results on the vaccine effectiveness in people with weakened immune systems on 24th August 2021. This included patients with certain immunosuppressed liver conditions.

Initial findings found that 89% of people involved in the trial produced who are immunocompromised or immunosuppressed generate antibodies following vaccination. It also found that 6 in 10 of clinically at-risk patients with certain immunocompromised or immunosuppressed condition, who took part in the trial, produced a strong antibody response but 4 in 10 had a low, or undetectable, immune response after two doses of the same COVID-19 vaccine.

We know these findings may be particularly concerning for liver patients who are immunocompromised only based on tests of a small number of people covering a number of conditions. However, these initial results will guide clinical practice, including prioritising booster vaccines for immunosuppressed patients to ensure they have better protection through the winter.

The effectiveness a booster vaccine in immunosuppressed patients will be examined as part of a new clinical trial, OCTAVE DUO, to find out if it gives a stronger immune response. Find out more here: New study to test third COVID-19 vaccine for people with weakened immune systems. - British Liver Trust

Other studies:

  • Data from Public Health England (PHE) suggests that the COVID-19 vaccines used in the UK are as effective at preventing symptomatic disease in the majority of people with underlying health conditions compared to the rest of the population.
  • Liver disease patients over the age of 16 who are considered clinically extremely vulnerable and/or immunosuppressed may be offered a third booster jab from September. More information can be found here: Potential COVID-19 booster vaccine programme.
  • Data on COVID-19 cases in people who have had an organ transplant or are on the waiting list supports vaccination for maximum protection.
  • A recent study by Public Health England (PHE) shows that two doses of the COVID-19 vaccines are highly effective against the Delta (B.1.617.2) variant. Vaccine effectiveness against symptomatic disease from the Delta (B.1.617.2) variant is similar after two doses compared to the Alpha (B.1.1.7) variant, and we expect to see even higher levels of effectiveness against hospitalisation and death.

FAQs for liver disease patients who are immunosuppressed
We are aware that if you or a loved one is immunosuppressed you have particular worries about the coronavirus (COVID-19) and the effectiveness of the vaccine. We have raised these concerns with government and seek clarification from DHSC and clinicians on a regular basis. Here are some answers to some of the most pressing questions you may have.

A study by researchers at Oxford University Hospitals into the effects of the Covid-19 virus on patients with auto-immune hepatitis (AIH) suggests that patients with AIH using immunosuppression medication have similar outcomes to people with other forms of liver disease.

This suggests that the use of immunosuppression is not a risk factor for death from COVID-19.

Researchers collected data between March 2020 and October 2020 for nearly 1,000 patients with chronic liver disease and Covid-19 infection, including 70 with AIH.

The results showed that there were no differences in rates of hospitalization, intensive care unit (ICU) admission, and death between AIH patients and those with other types of liver disease.

When compared to patients without liver disease, patients with AIH had higher rates of hospitalisation but no increased risk of intensive care admission or death.

 

There is a spectrum of immunosuppression among patients with liver disease and only a very small proportion are considered severely immunosuppressed.  This includes but is not limited to:

  • individuals who are receiving immunosuppressive or immunomodulating biological therapy and individuals treated with steroid sparing agent
  • Individuals treated with or likely to be treated with systemic steroids for more than a month at a dose equivalent to prednisolone at 20mg or more per day for adults.
  • Anyone with a history of haematological malignancy, and those who may require long term immunosuppressive treatments.

Patients identified as severely immunosuppressed should be contacted by their medical team as advised by JCVI.   They are advising that household contacts aged over 16 of severely immunosuppressed people are vaccinated as a priority.

For more information contact your consultant or visit: Coronavirus » Vaccination of permanent adult household contacts of severely immunosuppressed individuals alongside JCVI priority cohort 6 (england.nhs.uk)

All three of the COVID-19 vaccines - Pfizer/BioNTech,  AstraZeneca/Oxford, Moderna - that have been approved for use in the UK are considered safe for patients who are immunosuppressed.

While the vaccine might provide a lower level of protection in people who are immunosuppressed compared with the rest of the population, it is still very important to have it as will provide with significant protection against catching COVID-19.   It is also important that you receive two doses of the vaccine to maximise the protection that vaccination offers you.

Data from the NHS Blood and Transplant registry supports the recommendation that people who have had an organ transplant or are on the waiting list should have both their vaccinations.

Research into the effectiveness of the vaccine in people who are immunosuppressed is currently taking place and we received the following update from the DHSC in June 2021.

"We are largely awaiting results of the OCTAVE study for this. As part of the National Core Studies Immunity Programme, UK Research and Innovation (UKRI) is providing initial funding of £1.8 million for 12 months towards the OCTAVE study.

The OCTAVE study will examine the effectiveness of COVID-19 vaccines in clinically at-risk groups. This includes COVID-19 vaccine responses in patients with certain immunosuppressed conditions, including those with inflammatory disorders, high risk cancer patient groups, and patients with severe kidney and liver disease. Cancer patient groups include those with blood cancer (leukaemia, myeloma, and bone marrow (stem cell) transplants).

Key sample timings include 28 days and 6 months post vaccine boost. Results will be available within 3 months of sampling date. It is estimated that that initial results for the immediate response to vaccine (28 days post vaccine) will be available across the majority of the cohort by the middle of June.

This will provide us with a more accurate picture of how effective the vaccine is if you are immunosuppressed."

An antibody test is a blood test, which tests if your immune system is making proteins (antibodies) to fight COVID-19.

Antibody testing in the general population is not being systematised in part because clinicians are not able to calibrate what a ‘good’ level of immune response is yet for COVID. Some studies are monitoring this such as Virus Watch (see below):

About Virus Watch

Virus Watch is a research study run by University College London, in cooperation with the NHS. The study has released its preliminary findings (yet to be peer reviewed) on 14 May 2021, available at the following: Findings – Virus Watch Study – join with your household to help us stop the spread of COVID-19 (ucl-virus-watch.net)

The study found that 96.42% of Virus Watch participants were antibody positive 28-34 days after a single dose of a COVID-19 vaccine. This increased to 99.08% 7-14 days after a second vaccine dose.

Antibody positivity rates rose faster in participants who received the Pfizer vaccine compared to the AstraZeneca vaccine, but by 4 weeks after the first vaccine dose antibody positivity rates were equivalent for both Pfizer and AstraZeneca vaccines.

The study found evidence that antibody levels were lower with increasing age following the first dose of vaccine. They were also lower in people with some long term health conditions including diabetes, heart disease, cancer and those currently on immunosuppressive therapies. However, following a second dose of either the AstraZeneca or the Pfizer vaccine, high antibody levels were observed for nearly all individuals including those with long term health conditions.

The British Liver Trust will be working closely with the public health bodies and experts to confirm plans to further protect patients who are immunosuppressed.

It is thought that the most likely course of action will be a third booster dose of the vaccine in the autumn/winter.

Vaccination of permanent adult household contacts of severely immunosuppressed individuals alongside JCVI priority cohort 6

Adult household contacts of severe immunosuppressed adults (aged 16 years and over) are offered COVID-19 vaccination alongside priority group 6. This is in response to regular monitoring of data on vaccine effectiveness and impact, which indicates lower protection in vaccinated adults who are immunosuppressed. Those with severe immunosuppression are therefore more likely to suffer poor outcomes following infection and are less likely to benefit from the vaccines offered.

The JCVI’s recommendation to vaccinate adult household contacts aims therefore to reduce the risk of infection in the immunosuppressed who may not be able to fully benefit from vaccination.

The JCVI definition of severely immunosuppressed individuals is those currently included in either priority group 4 and 6 using the definition set out in the Immunosuppression section of Table 3 ‘Clinical risk groups 16 years of age and over who should receive COVID-19 immunisation’ in the Greenbook Chapter 14A.

This section covers immunosuppression due to disease or treatment. This includes but is not limited to:
• individuals who are receiving immunosuppressive or immunomodulating biological therapy and individuals treated with steroid sparing agents
• Individuals treated with or likely to be treated with systemic steroids for more than a month at a dose equivalent to prednisolone at 20mg or more per day for adults.
• Anyone with a history of haematological malignancy, and those who may require long term immunosuppressive treatments.

Immunosuppressed children are not included in the definition, in that their adult household contacts are not being advised for vaccination as part of the JCVI guidance.

JCVI advises that children and young people aged 12 years and over who are household contacts of persons (adults or children) who are immunosuppressed should be offered COVID-19 vaccination on the understanding that the main benefits from vaccination are related to the potential for indirect protection of their household contact who is immunosuppressed.

Members of ‘bubbles’ that do not live with the immunosuppressed individual for the majority of the week (frequent visitors and other non-carers who might visit the house often but not for the majority of the week, including overnight stays) are excluded from the definition.

Those living in long-stay residential care homes or other long-stay care facilities will already be eligible for a vaccine in priority cohorts 1 and 6, in line with JCVI recommendation. As with the influenza vaccine, this does not include prisons, young offender institutions, university halls of residence etc.

 

Full priority groups for vaccination can be found here: Priority groups for coronavirus (COVID-19) vaccination

The Department of Health and Social Care (DHSC) has provided answers to many questions about the vaccine rollout which you can find the answers to below.

For more general information for liver patients about Covid-19, please read our FAQs.

Please note that the liver nurses on the British Liver Trust helpline are only able to provide the general information outlined below and are not able to advise you on whether a particular vaccine would be safe or effective for you as an individual.

Covid-19 vaccine FAQs 

We know that liver patients have questions about the vaccine, its safety and its suitability for people who are immunosuppressed.  That's why we asked Professor Richard Aspinall to answer some of the main questions we have had from patients.  You will also find the most up-to-date FAQs from the DHSC below.


The emergence of the Omicron variant has shown how important it is that we put preparations in place to future-proof the country from further potential threats. Our best weapon to fight COVID-19 is to get as many people vaccinated as possible and to boost the booster programme. So when you are called forward, either for a first, second, or booster vaccination, get it as soon as you can.

Most people who have received two doses of COVID-19 vaccine no longer need to self-isolate if they are identified as a close contact of someone with COVID-19, however those who have been in contact with someone who tests positive for the Omicron virus variant must self-isolate, irrespective of age or vaccination status.

Whilst the vaccine trials have not looked specifically at safety in patients with liver disease, there is no data to suggest harm for people with chronic liver disease. Vaccines are, in general, less effective in patients with chronic liver disease and those post-liver transplant. But, there is no data specifically with the COVID-19 vaccines.

The British Society of Gastroenterology and BASL have advised that they recommend that patients with chronic liver disease, autoimmune hepatitis and those post-liver transplant should strongly consider vaccination for COVID-19 with any of the available vaccines. However, although it is likely that the vaccine will offer some level of protection, they do not know whether the vaccines will be equally effective in transplant patients or those who are  immunosuppressed. On 30th June 2021, NHS Blood and Transplant registry published new data on COVID-19 cases in people who have had a transplant or on the waiting list.

It is important that everyone who has the Covid vaccine, does not change their behaviours and continues to take precautions against catching Covid 19. No vaccine is 100% effective and the government  also does not know whether having the vaccine stops people passing coronavirus on to others. It is particularly important for those who are immunosuppressed  or who have had a transplant continue to continue to keep themselves safe after vaccination.

We will only get good information about the full safety and effectiveness in those who have been transplanted and are immunosuppressed once these vaccines start being used in clinical practice. The Government will be undertaking ongoing active surveillance on the effectiveness of the vaccine and will be gathering data as the vaccination programme is implemented. When enough of the UK population have been vaccinated, then the COVID-19 pandemic should start to ease. This is likely to be the most important way in which the vaccine helps those who are immunosuppressed.

Patients who have autoimmune hepatitis and are worried that being vaccinated may make their condition worse or cause a ‘flair up’ should have an individual conversation with their consultant clinician.

Please note that the nurses on the Helpline are only able to provide the general information outlined above and are not able to advise you on whether a particular vaccine would be safe or effective for you as an individual.

The only vaccines that are ‘live’ are Oxford Uni/Astra Zeneca and Janssen. DHSC have indicated to us verbally that they are not ‘live’ in the ‘conventional’ sense (they don’t replicate) and that “it is unlikely that anyone would be contra indicated for any of the live vaccines that are currently being developed unless they have a specific allergy to that vaccine.

Each of the vaccines are tested on tens of thousands of people across the world. They are tested on both men and women, on people from different ethnic backgrounds, representative of the UK population and of all ages between 18-84.

Pfizer/BioNTech trials took place in the US, Europe, Turkey, South Africa and South America. Approximately 42% of global participants and 30% of U.S. participants had racially and ethnically diverse backgrounds.

AstraZeneca also included a trial in South Africa of 2,130 participants, and another in the US including African American, Hispanic and Native American participants.

In the AstraZeneca trials, the non-white demographic in the UK trial was 8%. In the Brazil trial it was 34.2% and in South Africa it was 87.5%.

  • The trials for both vaccines have involved people with chronic underlying conditions deliberately, and they have involved people from very broad age ranges and quite a lot of people in the elderly bracket. The JCVI have looked at this, there’s no indication that there should be any difficulty in giving it to people with chronic underlying conditions.
  • The JCVI has picked out, not just by age, but people 18 to 65 with at-risk conditions. And, and the reason for that is that they are at extremely high risk from coronavirus compared with the general population.

The Joint Committee on Vaccination and Immunisation (JCVI) has advised the government to prioritise people for the coronavirus (COVID-19) vaccine who are over 16 and living with adults who have weakened immune systems, such as those with blood cancer, HIV or those on immunosuppressive treatment including chemotherapy.

There is growing evidence that the COVID-19 vaccines may reduce the chance of someone who has been vaccinated passing the virus on. Given this emerging evidence, the JCVI advises that those over 16 years of age who live with severely immunosuppressed adults are offered the COVID-19 vaccination alongside priority group 6. This will help limit the spread of the virus to immunosuppressed adults.

Protection from any vaccine takes time to build up. In general, the older you are the longer it takes. It will take at least two weeks in younger people and at least three weeks in older people before you can expect to have a good antibody response. Even then, you must return when called for your second dose. Vaccines offer important protection to reduce risk but they do not make you invincible. No vaccine offers 100% protection against any disease.

The Pfizer / BioNTech and Astra Zeneca (Oxford) vaccines have been shown to provide a high level of protection from symptomatic COVID-19.

New Public Health England data (01/03/2021) shows that both the Pfizer and Oxford-AstraZeneca vaccines are highly effective in reducing COVID-19 infections among older people aged 70 years and over. Since January, protection against symptomatic COVID, 4 weeks after the first dose, ranged between 57 and 61% for one dose of Pfizer and between 60 and 73% for the Oxford-AstraZeneca vaccine. In the over 80s, data suggest that a single dose of either vaccine is more than 80% effective at preventing hospitalisation, around 3 to 4 weeks after the jab. There is also evidence for the Pfizer vaccine, which suggests it leads to an 83% reduction in deaths from COVID-19. (Full statement and data here).

  • Every single vaccine authorised for use in the UK has been authorised by the MHRA. The three components of authorisation are a safety assessment, an effectiveness assessment and a manufacturing quality assessment.
  • Like all medicines, vaccines can cause side effects. Most of these are mild and short-term, and not everyone gets them.
  • These are important details which the MHRA always consider when assessing candidate vaccines for use.
  • For the Pfizer/BioNTech vaccine, like lots of others, they have identified that some people might feel slightly unwell, but they report that no significant side effects have been observed in the over 43,000 people involved in trials.
  • All patients will be provided with information on the vaccine they have received, how to look out for any side effects, and what to do if they do occur, including reporting them to the MHRA.

Some side effects may include:

  • a sore arm where the needle went in
  • feeling tired
  • a headache
  • feeling achy
  • feeling or being sick
  • All patients are given information on the vaccine they have received, how to look out for any side effects, and what to do if they do occur, including reporting them to the Medicines and Healthcare products Regulatory Agency (MHRA).

Healthcare professionals are asked to report any suspected side effects to COVID-19 vaccines. Report using the dedicated Coronavirus Yellow Card reporting site or the Yellow Card app.

More info here on patient information leaflets from PHE

https://www.gov.uk/government/publications/covid-19-vaccination-guide-for-older-adults

More information on the vaccination from NHS

https://www.nhs.uk/conditions/coronavirus-covid-19/coronavirus-vaccination/coronavirus-vaccine/?priority-taxon=774cee22-d896-44c1-a611-e3109cce8eae

Every single vaccine authorised for use in the UK has been authorised by the MHRA and the three components of authorisation are a safety assessment, an effectiveness assessment and a manufacturing quality assessment.

  • You cannot catch Covid from the vaccines. But it is possible to have caught Covid and not realise you have the symptoms until after your vaccination appointment.
  • If you have any of the symptoms of Covid, stay at home and arrange to have a test.
  • If you need more information on symptoms visit: nhs.uk/conditions/coronavirus-COVID-19/symptoms/

  • The Pfizer/BioNTech vaccine is rapidly being rolled out across the UK, starting with the highest priority groups.
  • The AstraZeneca/Oxford vaccine and other candidates will be deployed alongside the Pfizer/BioNTech vaccine to increase the pace and volume of the UK programme.
  • More evidence is needed to understand whether a seasonal vaccination or booster dose might be needed.
  • The vaccines people are offered will be appropriate for them. This decision is based on clinical judgement supported by the advice of Joint Committee on vaccination and immunisation. This will take into account individual vaccine characteristics, which may mean they are more suitable for some groups of people, and not others – for example, some may be less well tolerated or effective in certain age groups.

You can still carry the virus on your body and clothes if you come into contact with it. You will therefore still need to follow the guidance in your workplace, including wearing the correct personal protection equipment and taking part in any screening programmes.

To continue to protect yourself, your residents, your family, friends and colleagues you should follow the general advice at work, at home and when you are out and about:
practise:

  • social distancing
  • wear a face mask
  • wash your hands carefully and frequently
  • follow the current guidance
  • Guidance is at gov.uk/coronavirus

  • The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK’s independent regulator. Their role is to ensure medicines, devices and vaccines work effectively and are safe for use.
  • Each COVID-19 vaccine candidate is assessed on a case by case basis and will only be authorised once it has met robust standards of effectiveness, safety and quality.
  • Teams of scientists and clinicians carefully, methodically, scientifically rigorously review all data on safety, effectiveness and quality as soon as they become available, and have done so throughout all tests and trials
  • The data looked at includes all the results from laboratory studies, clinical trials, manufacturing and quality controls and testing the product. The public on that basis should be very confident that all tests are done to the very highest standards, and only then will a COVID-19 vaccine be made available.

 

Yes, if they are in a priority group identified by JCVI. The MHRA have looked at this and decided that getting vaccinated is just as important for those who have already had Covid-19 as it is for those who haven’t.

Daily data summary

https://coronavirus.data.gov.uk/?_ga=2.218839707.329771229.1610380715-938063789.1606390656

Government vaccination programme information

https://www.gov.uk/government/collections/covid-19-vaccination-programme

All patient leaflets and translated leaflets can be viewed, downloaded or ordered as paper copies via the Health Publications order line website

https://www.healthpublications.gov.uk/Login.html

The Easy Read leaflet

https://www.gov.uk/government/publications/covid-19-vaccination-easy-read-resources

Vaccination deployment plan

https://www.gov.uk/government/publications/uk-covid-19-vaccines-delivery-plan

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/951284/UK_COVID-19_vaccines_delivery_plan.pdf

Vaccine uptake plan published 13 February 2021. Sets out the government's approach to making sure that as many people as possible take up the offer of vaccination.

https://www.gov.uk/government/publications/covid-19-vaccination-uptake-plan

NHS England vaccination sites

https://www.england.nhs.uk/coronavirus/hospital-hubs-and-local-vaccination-services/

Joint letter from four CMOs

https://www.gov.uk/government/publications/letter-to-the-profession-from-the-uk-chief-medical-officers-on-the-uk-covid-19-vaccination-programmes/letter-to-the-profession-from-the-uk-chief-medical-officers-regarding-the-uk-covid-19-vaccination-programmes

Green book - Coronavirus (COVID-19) vaccination information for public health professionals

Daily data summary

https://www.gov.uk/government/publications/covid-19-the-green-book-chapter-14a

MHRA – latest monitoring data confirms safety of Vocid-19 vaccines

https://www.gov.uk/government/news/latest-monitoring-data-confirms-safety-of-covid-19-vaccines

How did the AstraZeneca/Oxford vaccine become available so quickly?

  • The UK was the first country in the world to procure and authorise the Oxford/AstraZeneca vaccine, and we were the first country in the world to start a vaccination programme with it w/c 4th January.
  • The Oxford vaccine is a British success story – it has had UK government backing throughout.
  • We have signed deals for substantial future supply of both vaccines to replenish our stocks and enable swift vaccination of first and second doses across the UK

Can the Oxford/AstraZeneca vaccine be used for all adults regardless of age?

    • The WHO’s Strategic Advisory Group of Experts on Immunisation has issued interim recommendations on the Oxford/AstraZeneca vaccine, saying that the jab could be given to people aged 18 and above “without an upper age limit”.
  • Dr Alejandro Cravioto, chairman of the WHO's Strategic Advisory Group of Experts on Immunisation, said: "In the case of the data coming from clinical trials, we have seen that there was a small participation of people over 65 years of age.

Is the Oxford/AstraZeneca vaccine safe for people over 50?

  • Yes, the vaccine has been thoroughly assessed by MHRA – the UK medicines regulator – for its safety and efficacy.
  • Routine safety monitoring and analysis of the approved COVID-19 vaccines by the UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), shows that the safety of these vaccines remains as high as expected from the clinical trial data that supported the approvals. (5 February)
  • The benefits of the Oxford/AstraZeneca Covid vaccine outweigh any risks and the shot should be recommended for use, including in people aged 65 and older, a World Health Organization panel said on Wednesday 10 February.

  • The UK was the first country in the world to start a vaccination programme using the Pfizer/BioNTech vaccine.
  • We have signed deals for substantial future supply of both vaccines to replenish our stocks and enable swift vaccination of first and second doses across the UK in the weeks and months ahead.
  • We have been monitoring the requirements across the supply chain from supplier through to patient for some time. There are clear supply chain plans in place for both the supply and onward deployment of all vaccine candidates. This includes materials, manufacturing, transport, storage and distribution.
  • The Vaccines Taskforce has conducted supply chain risk assessment and is working with the vaccine suppliers to understand the optimal logistics and timings.

 

How effective is the Pfizer vaccine?

  • Public Health England data (17/03/21) - Analysis of routine testing data continues to show a vaccine effect against symptomatic COVID19 from either vaccine in those aged 70 year and over, for whom the vaccine effectiveness (VE) of a single dose reaches ~ 60%. This analysis includes additional weeks' of data which gives us increased confidence in the levels of protection the vaccines are offering. (Read full study and results). High protection against any COVID-19 infection is shown in health care workers with no decline in protection after a single dose beyond 56 days (which is the length of time people have been studied). Among those who develop symptomatic infection, risk of hospitalisation is reduced by 35 to 45% after one dose of either vaccine. Combined with the reduced risk of becoming a case, this is consistent with a vaccine effectiveness against hospitalisation which is similar to previously reported value of 80%. Risk of death for cases over 80 is reduced by 54%. Combined with the reduced risk of becoming a case, this is consistent with a vaccine effectiveness against mortality which is similar to previously reported value of 85%.

 

How effective is the Moderna vaccine? 

  • The Moderna vaccine has been shown to be 94% effective in its Phase Three clinical trials.

When will the first doses become available and how many doses will we have by 1 April?

  • Moderna are currently scaling up their European supply chain. These doses would become available in the UK by Spring 2021 at the earliest.
  • Moderna are currently scaling up their European supply chain, which means these doses would become available in spring 2021 in the UK at the earliest.
  • We have now purchased 17 million doses of the Moderna vaccine

 

Is it true we’ve paid more for Moderna doses compared to EU countries?

  • The financial information in our contracts is commercially sensitive, so we are unable to disclose this at the present time.
  • The price of any vaccine is a commercial decision for the company developing it. We take this into account when deciding whether or not to procure any vaccine.

A press statement from Novavax on 11/03/2021 said they had confirmed high efficacy against both original and variant COVID-19 strains in United Kingdom and South Africa Trials. In it’s press statement, the company said:

“100% protection against severe disease

“Final analysis in U.K. trial confirms 96% efficacy against original strain of COVID-19

“Efficacy against variants confirmed in U.K. and South Africa”

Read full statement.

What’s the latest on the Novavax Phase Three safety and efficacy data (updated on 29/01/2021)

  • The company is planning to submit its data to the MHRA. Once our medicines regulator receives the data, it will begin to carry out its crucial, independent work to assess whether the vaccine meets robust standards of safety, effectiveness and quality.
  • We have procured 60 million doses of the Novavax vaccine that will be delivered during this year, if approved for use, boosting our vaccination programme and our efforts to tackle Covid-19.

 

How effective is the Novavax vaccine?

  • The Novavax vaccine has been shown to be 89.3% effective in its Phase Three clinical trials.
  • If approved by the medicines regulator, the MHRA, the Novavax vaccine will be a significant boost to our vaccination programme.
  • Novavax’s candidate differs from those currently being used in the UK, combining an engineered protein from the virus that causes Covid-

What is the latest on the Janssen single-dose Phase Three safety and efficacy data (updated 01/03/2021)

  • Janssen submitted data to MHRA on Friday 26 February 2021 for their single-dose vaccine.
  • Trials for the two-dose vaccine are ongoing (including at 16 sites in the UK) - and they are just about to have recruited all 6,000 necessary UK participants for those trials.
  • This is yet more promising news from Janssen. Once the full data has been submitted to the regulator they will consider the evidence to determine whether the vaccine meets robust standards of safety, effectiveness and quality.
  • Thanks to the life-saving work of our Vaccine Taskforce, the UK moved quickly to secure 30 million doses of Janssen’s vaccine last summer. If this vaccine is authorised by our medicines regulator, we are set to receive the doses in the second half of this year.
  • The Janssen vaccine works in the same way as vaccine developed by Oxford and AstraZeneca and is designed to prompt an immune response including neutralising antibodies against the spike protein to eliminate the virus. Again similarly to the Oxford / AstraZeneca vaccine it can be safely stored and transported at standard refrigeration temperatures.

 

How effective is the Janssen vaccine?

  • The Janssen single-dose vaccine has been shown to be 66% overall effective in its Phase Three clinical trials.
    • Phase Three trials for the company’s two-dose regimen are ongoing worldwide. While a single dose of a safe and effective vaccine would offer a significant advantage during a global pandemic emergency, a two-dose schedule may have the potential to offer enhanced durability in some participants.
  • The data did not report any significant safety concerns relating to the vaccine, with no serious adverse events in vaccine recipients.

 

Where is the latest on the Valneva vaccine and where is it being manufactured (updated 28/01/2021)

  • Thanks to the UK Vaccine Taskforce, we have ordered up to 100 million jabs of Valneva’s promising vaccine if it proves to be safe, effective and suitable in its clinical trials this year.
  • By starting manufacturing, we will have a running start at rolling these out as quickly as possible to protect the British public if it receives regulatory approval.
  • This facility in Scotland, backed by millions from the Government, will help us beat coronavirus and boost our resilience against future pandemics.

Which vaccine is better/more effective?

    • All vaccines that are approved by the MHRA are very safe and effective vaccines. Comparisons between the vaccine efficacies are unhelpful due to the different methodologies used.
    • It’s not as simple as saying one vaccine is better than the other. An effective vaccine will save lives and reduce hospitalisations.
  • Public Health England data (17/03/21) - Analysis of routine testing data continues to show a vaccine effect against symptomatic COVID19 from either vaccine in those aged 70 year and over, for whom the vaccine effectiveness (VE) of a single dose reaches ~ 60%. This analysis includes additional weeks' of data which gives us increased confidence in the levels of protection the vaccines are offering. (Read full study and results). High protection against any COVID-19 infection is shown in health care workers with no decline in protection after a single dose beyond 56 days (which is the length of time people have been studied). Among those who develop symptomatic infection, risk of hospitalisation is reduced by 35 to 45% after one dose of either vaccine. Combined with the reduced risk of becoming a case, this is consistent with a vaccine effectiveness against hospitalisation which is similar to previously reported value of 80%. Risk of death for cases over 80 is reduced by 54%. Combined with the reduced risk of becoming a case, this is consistent with a vaccine effectiveness against mortality which is similar to previously reported value of 85%.
  • Public Health England data (01/03/2021) shows that both the Pfizer and Oxford-AstraZeneca vaccines are highly effective in reducing COVID-19 infections among older people aged 70 years and over. Since January, protection against symptomatic COVID, 4 weeks after the first dose, ranged between 57 and 61% for one dose of Pfizer and between 60 and 73% for the Oxford-AstraZeneca vaccine. In the over 80s, data suggest that a single dose of either vaccine is more than 80% effective at preventing hospitalisation, around 3 to 4 weeks after the jab. There is also evidence for the Pfizer vaccine, which suggests it leads to an 83% reduction in deaths from COVID-19. (Full statement and data here).
    • No vaccine has ever been 100% effective so no-one will have 100% protection from the virus. The way to reduce everyone’s risk is to break the chains of transmission and push down the number of cases.
    • Comparing vaccines on a simple percentage of effectiveness is a mistake. A vaccine with slightly lower headline efficacy than another may prove to be the one that offers more durable protection or a greater effect on transmission
  • Vaccines have been approved because they pass the MHRA’s tests on safety and efficacy, so people should be assured that whatever vaccine they get will be highly effective and protect them from Coronavirus.

 

If you're given one type of vaccine does that mean you have to stick with that vaccine forever? 

  • The Pfizer/BioNTech vaccine is rapidly being rolled out across the UK, starting with the highest priority groups.
  • The AstraZeneca/Oxford vaccine and other candidates will be deployed alongside the Pfizer/BioNTech vaccine to increase the pace and volume of the UK programme.
  • More evidence is needed to understand whether a seasonal vaccination or booster dose might be needed.
  • The vaccines people are offered will be appropriate for them. This decision is based on clinical judgement supported by the advice of Joint Committee on vaccination and immunisation. This will take into account individual vaccine characteristics, which may mean they are more suitable for some groups of people, and not others – for example, some may be less well tolerated or effective in certain age groups.

 

Can people choose what vaccine they have? It has been suggested that vaccines could be mixed and matched?

  • No. Any vaccines that are available will have been approved because they pass the MHRA’s tests on safety and efficacy, so people should be assured that whatever vaccine they get will be highly effective and protect them from coronavirus.
  • The Pfizer/BioNTech vaccine is being rolled out as fast as possible by the NHS across the UK. Now authorised, the AstraZeneca/Oxford vaccine will be deployed alongside the Pfizer/BioNTech vaccine to increase the pace and volume of the UK programme. There are no current plans to mix these vaccines.
  • The Government’s Vaccine Taskforce keeps its approach under review, ensuring the UK is in the strongest position to protect people. The science is uncertain about how mixing vaccines could produce a better immune response, so trials and testing will continue to assess and test vaccine responses.

 

Is a clinical trial being done to see whether vaccines could be mixed?

  • A new clinical trial, backed by £7 million of government funding, is looking into alternating Covid-19 vaccine doses. The study, run by the National Immunisation Schedule Evaluation Consortium (NISEC) across eight National Institute for Health Research (NIHR) supported sites, will examine whether different vaccines can safely be used for two dose regimes in the future. The current programme of two doses of the same vaccine over twelve weeks remains unchanged
  • The study will also gather immunological evidence on different intervals between the first and second dose for a mixed-vaccine regimen against control groups when the same vaccine is used for both doses.

In rare cases can the Pfizer/BioNTech and AstraZeneca/Oxford vaccine be mixed and matched?

  • We do not recommend mixing the COVID-19 vaccines – if your first dose is the Pfizer vaccine you should not be given the AstraZeneca vaccine for your second dose and vice versa.
  • However, there may be extremely rare occasions where the same vaccine is not available, or where it is not known what vaccine the patient received.
  • Our guidance is very clear that every effort should be made in these instances to give the same vaccine to the patient, but where this is not possible it is better to give a second dose of another vaccine than not at all.
  • This is a reasonable measure on a very exceptional basis, when the alternative is to leave someone with an incomplete course – which is the greater concern, especially if the individual is likely to be at immediate high risk or is considered unlikely to attend again.
  • In these rare circumstances, as both vaccines are based on the spike protein, it is likely the second dose will help to boost the response to the first dose.
  • While there is no evidence on the interchangeability of the COVID-19 vaccines at this time, this is a pragmatic and scientific approach agreed by many scientists and vaccine experts, including the UK’s Deputy Chief Medical Officer.

What is ‘QCOVID’? What can it be used for?

  • New technology has been introduced in England to help clinicians identify for the first time a new group of people who may be at high risk from COVID-19.
  • The technology analyses a combination of risk factors based on medical records, to assess whether somebody may be more vulnerable than was previously understood, helping clinicians provide vaccination more quickly to them and ensuring patients can benefit from additional advice and support.
  • The data-driven approach to medical risk assessment will help the NHS identify further individuals who may be at high risk from COVID-19 due to a combination of personal and health factors.
  • This action ensures those most vulnerable to COVID-19 can benefit from both the protection that vaccines provide, and from enhanced advice, including shielding and support, if they choose it.

How many individuals are being added to the Shielded Patient List (SPL) as a result of the QCovid model? How many of those will already have had their vaccine?

  • Around 1.7 million patients could be identified. Those within this group who are over 70 will have already been invited for vaccination and 820,000 adults between 19 and 69 years will now be prioritised for a vaccination.
  • Vaccines are now being offered to people aged 56 and over and those who are clinically vulnerable, which includes a wider group of people at higher clinical risk (see PHE Green Book, p.10), including carers and young adults in residential settings.
  • GPs and other primary care professionals have been asked to invite those eligible for vaccination within cohort 6 to attend an appointment for vaccination from Monday 15 February.  Information about whether your clinical condition is eligible within cohort 6 is found on your patient record, which your GP will review. It can also be found from carers allowance data and from information held within local authority systems and by local carers organisations. Guidance has been provided to the NHS on utilising this data and local intelligence in order to identify and offer a vaccine to those in this priority group as soon as possible.
  • However, there will be individuals who have not been captured on such systems and therefore cannot be identified through such means. Therefore, the guidance places a strong emphasis on Local Authorities and NHS services working with voluntary sector groups to reach out and identify these individuals in order to offer them a vaccine.
  • A hospital clinician or GP can also add a patient to the list, based on their clinical judgement, because they consider them to be at very high risk of serious illness from COVID-19.

People who are defined as clinically vulnerable are thought to be at high risk of serious illness from COVID-19. The PHE Green Book identifies the following conditions which are automatically deemed clinically vulnerable including chronic liver disease Cirrhosis, biliary atresia, chronic hepatitis.

 

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