COVID-19 vaccines and immunodeficiency

On this webpage you will find information on the COVID vaccines and answers to frequently asked questions.The most recent information is at the top of the page covering third primary doses, booster vaccinations and vaccinations for chiildren.

(8th October 2021)

Third primary dose vaccination is being offered to people who are severely immunocompromised

The third primary dose vaccination is specifically for those people who, by the nature of their underlying condition have been unable to mount a full immune response to two previous COVID vaccinations.  By definition, this will include many people affected by primary and secondary immunodeficiency.  By giving a third primary dose vaccination it is hoped to give people in this group as much protection as they can.  This NHS letter to GPs and hospital doctors explains that they need to invite people for their 3rd vaccine.  Annex A of the letter lists those eligible.  Please share it with your GP if they are unsure about the 3rd dose process.

For those aged 18 years and over, JCVI advises a preference for mRNA vaccines (Moderna or Pfizer) for the 3rd primary dose based on the evidence. For those aged 12 to 17 years the Pfizer-BNT162b2 vaccine remains the preferred choice.

Statement from Dr Matthew Buckland, Chair of our Medical Panel:

'Patients who have made some response to their first two doses may benefit from a third to consolidate their immunity.  Patients who have secondary immunodeficiency, in particular those who may have been on more potent immune suppressive or ablative therapy when they had their primary vaccine course but are now on less treatment are likely to benefit the most. 

The recommendation by the NHS for a third dose follows a review of safety, but there is unlikely to be efficacy data in each different type of primary or secondary immunodeficiency.  If people tolerated the first two doses well, we encourage them to have a third dose on the same basis as before, i.e. that it may not be maximally or highly effective in many of our patient group, but even limited benefit is better than none.  Clinicians have seen patients vaccinated who have not had a demonstrable antibody or T-cell response who have nonetheless had a mild course of COVID-19.  We cannot say conclusively that it was a vaccine benefit rather than chance, but so much remains to be learnt about COVID and the immune response and protection, that we would encourage people not to over-think it.

For those that had major side effects with primary vaccination, they may wish to discuss further with their GP or immunology team their individual risk-benefit.  It is worth remembering that whilst many patients will have had the AZ vaccine the first time, all third doses are Pfizer or Moderna.'

Information from the four home nations:

England

Scotland

Wales

Northern Ireland

FAQs about 3rd primary dose vaccines

Q. I have had little antibody response to the first two Covid vaccinations. What evidence is there that indicates I might get a better vaccine response after a 3rd dose?

A. Recent studies suggest that having the AstraZeneca vaccine followed by the Pfizer vaccine gives a better immune response than two AstraZeneca vaccines 1,2,3, although these studies did not include people who were affected by primary or secondary immunodeficiency.

1.    Hall VG et al. Randomized Trial of a Third Dose of mRNA-1273 Vaccine in Transplant Recipients. N Engl J Med. 2021 Aug 11. doi: 10.1056/NEJMc2111462
2.    Kamar, N et al. Three Doses of an mRNA COVID-19 Vaccine in Solid-Organ Transplant Recipients. N Engl J Med 2021 Aug 12;385(7):661 to 662. doi: 10.1056/NEJMc2108861
3.    Werbel, WA et al. Safety and Immunogenicity of a Third Dose of SARS-CoV-2 Vaccine in Solid Organ Transplant Recipients: A Case Series. Ann Intern Med 2021 Jun 15;L21-0282. doi: 10.7326/L21-0282

Q. How and when will I get my third dose?

A. This is how we understand this should be working: Consultants identify eligible patients and write a letter, using a NHS template, to the patient and their GP saying the patient needs vaccination. If the patient lives near the hospital and it has its own patient vaccination hub, the consultant can refer the patient to it. If the patient lives further afield, the patients GP should arrange vaccination via the primacy care network/hub.

We understand that people are experiencing difficulties and the roll out is not happening smoothly.  Immunodeficiency UK has passed details of the problems patients are having to the NHS.

Your third dose should be given at least eight weeks after your second dose with timing advised by your medical team to decide the most appropriate time to give people a third dose based on any other treatment you are receiving. 

Please note there is no on-line booking option for the third dose vaccine. Access depends on a clinical decision.

Q. Will this happen in all the four home nations?

A. The JCVI issues guidance for the whole of the UK so this means their recommendations cover those eligible for a third dose England, Scotland, Wales and Northern Ireland. 

Q. Why is this being called a third dose and not a booster?

A. The JCVI are calling this a third dose as they are recommending it be given as part of primary treatment to prevent COVID in people who are unlikely to have had a strong immune response to doses one and two. A booster on the other hand is given to everyone in certain categories regardless of their immune response. A booster vaccine is to make sure that protection does not decrease over time whereas a third dose exists for people who are unlikely to have responded as well to the first two doses of the vaccine.

Q. Is it safe to mix the vaccines?

A. A recent study carried out by the University of Oxford found that giving the AstraZeneca vaccine followed by the Pfizer vaccine gave a better immune response than two AstraZeneca vaccines, although this wasn't in people who had primary or secondary immunodeficiency. Although this was when the vaccines were given four weeks apart, there weren't any safety concerns, and the study suggests that mixing vaccines may even give a better response 4. This evidence is backed up by several other studies also 5,6.

4. https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3874014
5. https://www.medrxiv.org/content/10.1101/2021.05.19.21257334v2
6. https://www.medrxiv.org/content/10.1101/2021.06.13.21258859v1

Q. After I have had my third dose will I get to know if I have made a better immune response?

A. If you are participating in the COVAD study you may in time get to know this, but, at the moment, there is unlikely to be mass testing to determine benefit.

Q. Will I be as well protected after a 3rd dose as a member of the general public?

A. Please see the statement from Dr Matthew Buckland above. Some patients will and some will not make good responses and the benefit of a booster will be highly variable dependent on your condition. You should discuss your COVID risk profile with your medical team.

Q. Will I receive the flu jab at the same time?

A. This was a suggestion from the government initially and we are still awaiting further information as to if and how this may be rolled out. It may be that if some vaccination centres have supply of the flu vaccines that you will be offered one at the same time as your COVID jab. This may depend on where in the country you are being vaccinated and the set up locally. A study at the University of Bristol called ComFluCov is looking at whether it is safe and effective to give people both vaccines at the same time.  Please note the ComFluCov trial does not involve people with immunodeficiency. 

Patients with primary and secondary immunodeficiency are usually offered annual flu vaccination and our usual advice stands regarding this. 

The booster vaccination programme

Health ministers in all UK nations have accepted the JCVI recommendation for offering booster doses to priority groups 1-9, in the same order as the first roll-out, with the addition of household members of severely immune-suppressed people.  This is separate to the 3rd doses (see above) and the booster programme is aimed at maintaining a high level of protection in vulnerable adults throughout winter. It will include people who have been identified as Clinically Extremely Vulnerable.

Eligible groups are:

  • Those living in residential care homes for older adults;
  • All adults aged 50 years or over;
  • Frontline health and social care workers;
  • All those aged 16 to 49 years with underlying health conditions that put them at higher risk of severe COVID-19 and adult carers;
  • and adult household contacts of immunosuppressed individuals.

The booster dose should be given at least six months after the 2nd dose of Covid vaccine. Pfizer or a half dose of Moderna is recommended, regardless of which vaccine was given as a 1st and 2nd dose, as there is evidence that both provide a strong booster dose. Where neither can be offered, for example for those who have an allergy to either vaccine, the JCVI advise that the Oxford/AstraZeneca vaccine can be used for those who received this vaccine for their first and second doses as it is safe, effective and has already saved thousands of lives in the UK and around the world.

These country specific websites provide more detail on how people can access a booster dose:

England  

Northern Ireland 
Scotland 
Wales 

We have been advised that immunosuppressed people who are invited for their booster dose of vaccine before they are invited for the 3rd primary dose (do check the wording of your invite) should accept the offer. You will then be invited for your fourth dose 'booster' at an appropriate time in the future.

Access to vaccines for household members of severely immunocompromised people

To provide additional protection, people aged 12 and over who are household contacts of people who are severely immunosuppressed are being invited for vaccination. The process for booking appointments differs in UK countries (see below for arrangements for 12-15 year olds).

England: the person who is immunosuppressed should be given a letter from their GP to pass on to their household members. The letter has information about how to book. See these links for Government guidance and letter to GPs.

Northern Ireland: follows the same process as England. This Government announcement confirms household contacts will be able to access the vaccine (5th paragraph of announcement).

Scotland: Please telephone the vaccination helpline on 0800 030 8013 for more information about how household contacts can book. This Government guidance lists household contacts amongst those being offered vaccination.

Wales: household contacts of a severely immunosuppressed adult should complete the self referral form on the NHS website.

Children and vaccination

Children aged 12 to 15 at increased risk of serious Covid

The Government has announced that the following groups are now being offered the vaccine:

Children aged 12 to 15 at increased risk of serious Covid: such as those with severe neurodisabilities, Down's syndrome, or immunocompromised with an interval of 8 weeks between the two doses. Please click this link for more information. 

The JCVI currently advise children aged 12-17 are offered the Pfizer-BioNTech vaccine as it was originally the only one approved by the MHRA for use in children aged 12 to 17 in the UK. The MHRA have now also approved the use of the Moderna vaccine (SpikeVax) in this age group and the JCVI will advise on whether this age group should be vaccinated with the COVID-19 vaccine made by Moderna, as well as Pfizer.

These children will be contacted by their doctor. In Northern Ireland, children aged 12-15 with a letter showing they are in this group, can also book via the online portal

12 to 15-year-olds who live with a severely immunosuppressed person

England: people who are immunocompromised should be written to by their GP and household contacts aged 12-15 (or their parents) can call their GP to arrange a vaccine appointment. See here for a FAQ document from NHS England.

Wales: The parent or guardian of a household contact aged 12-15 can complete the self referral form on the NHS website on their behalf.

Scotland: Please telephone the vaccination helpline on 0800 030 8013 for more information about how to book.

Northern Ireland - People aged 12-15 with a letter showing they are household contacts of an immunosuppressed person can book via the online portal.

Children aged 12-15 who do not fall into any of the above groups

Each UK nation is implementing the roll out of one dose of the Pfizer vaccine for this group. Parent consent will be required and much of the rollout will be done through schools. You may also which to look at country specific government announcements for more details:

England
Scotland
Wales
Northern Ireland

Children who are aged 16 or 17

Parental consent will not be required for young people aged 16 and 17 to receive the vaccine.

England: GPs will invite 16- and 17-year-olds for vaccination and some walk-in centres are available to this age group.

Scotland: those aged 16 and 17 will be able to register their interest through the online portal and will be sent an appointment by SMS or email. Walk in clinics will also be opening for this age group.

Northern Ireland: regional vaccination centres will offer walk-in Pfizer vaccines for all 16 and 17 year olds or you can book via the online portal

Wales: invites are being sent out to people in this age group and walk in clinics are available. Call your health board for more information.

Information from the 18th November 2020

Statement from Immunodeficiency UK

In response to the positive news about the development of COVID-19 vaccines, Dr Matthew Buckland, Chair of our Medical Advisory Panel, issued the following statement on behalf of Immunodeficiency UK:

'The recent news concerning the vaccines is highly encouraging. Patients with primary and secondary antibody deficiency, cannot produce reliable antibody responses, by definition, and this includes patients with CVID and XLA. Those with combined immune deficiencies, including SCID, will not make good T cell responses to a vaccine.  For these individuals a non-live vaccine is'safe' but will not offer protection against COVID. For patients with milder immunodeficiencies e.g. specific antibody deficiency, MBL deficiency, Selective IgA deficiency a normal vaccine response is likely. For PID and SID patients a vaccine means the likely development of robust herd immunity, protecting them by reducing the amount of virus circulating in the community.  It will also mean reliable antibody levels in plasma donors, reflected in replacement IVIG/SCIG about 6 months or so after the vaccine is widely taken up. 

As with the advice on seasonal flu vaccine, we encourage immunocompromised patients, with PID and SID, to have the safe vaccines offered, since they may get some albeit minor benefit, and as a way of encouraging those around them to have it, where the highest benefit is likely to be derived.'

This statement has been endorsed by UK PIN.

Immunodeficiency UK endorses the statement released by the British Society for Immunology on COVID-19 vaccines for patients who are immunocompromised or immunosuppressed (19th January 2021)

This reads in full:

'This statement has been developed by the British Society for Immunology COVID-19 and Immunology Taskforce which is made up of experts on how the immune system works. This statement is aimed at people who either have a medical condition which means their immune system doesn't function optimally or people who take medication that suppresses their immune system.

All three of the COVID-19 vaccines (Pfizer/BioNTech; AstraZeneca/Oxford; Moderna) that have currently been approved for use in the UK are safe to use for people who are immunocompromised or immunosuppressed. None of these approved COVID-19 vaccines contain any active SARS-CoV-2 virus. The Pfizer/BioNTech and Moderna COVID-19 vaccines are both mRNA vaccines which contain a small piece of genetic code from the SARS-CoV-2 virus to generate an immune response. The AstraZeneca/Oxford COVID-19 vaccine is a viral vector vaccine, which uses an inactive unrelated virus (the viral vector) which cannot replicate to deliver SARS-CoV-2 genetic material to generate an immune response.

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

COVID-19 vaccination will work best if you have a functioning immune system. For people currently undergoing whole organ or stem cell transplant and who may be severely immunocompromised, you should talk to your medical treatment team about the most suitable time to get your COVID-19 vaccination.

It's important to remember that the COVID-19 vaccines can protect you from getting seriously ill with COVID-19, although if your immune system isn't functioning optimally this protection will not be complete. We don't currently have any evidence that the vaccines can stop you passing on the virus to others even if you make a good immune response. This means that even after you have been vaccinated, it's very important that you still follow social distancing guidelines and wash your hands regularly.'

On Wednesday 30 December 2020, the Medicines & Healthcare products Regulatory Agency (MHRA) announced that the Oxford/AstraZeneca COVID-19 vaccine had been approved for use in the UK, with a dosing schedule of 12 weeks between first and second dose. In this announcement, the dosing schedule for the Pfizer COVID-19 vaccine was also changed to a 12-week gap between first and second dose. These announcements were made based on recommendations from the UK's Joint Committee on Vaccination and Immunisation (JCVI).

JCVI changes to the vaccine dosing schedule

PID UK endorses The British Society for Immunology (BSI) statement on their position and rationale on these announcements concerning the change of dosing schedule for the two approved COVID-19 vaccines. You can read the full BSI statement here. It is important to note that everyone will still receive their second dose and this will be within 12 weeks of their first.  The second dose completes the course and is important for longer term protection.

Frequently asked questions

You can download our COVID vaccine FAQs infographic here.  

Q. Which of the COVID vaccines is best for people with primary and secondary immunodeficiency?

A. Both the Pfizer/BioNTech and Oxford-AstraZeneca coronavirus vaccine in clinical trials, have been found to be safe and offer good protection. However, we do not yet know how effective these vaccines might be for people with immunodeficiency.  Please see read our statement above on vaccines for those affected and news of a research project that will help understand what protection is given.

Q. Do I have a choice about what COVID vaccine I'll receive?

A. The vaccine you will be offered will be dependent largely on the supplies available from the manufacturers and the logistics of the roll out of the COVID vaccine programme.

Q. Will the COVID vaccines work for patients with specific antibody deficiency (SPAD) and people without a spleen?

A. Patients with no spleen or specific antibody deficiency do not respond well to encapsulated polysaccharides (bacteria such as pneumococcus), but can respond normally to protein vaccines (COVID19, Tetanus) or conjugate vaccines (Menitorix, Prevanar).

Q. Some companies are offering tests that measure antibody responses following a COVID vaccination. Would the test be a good indicator of my level of protection against COVID?

A. These tests come at a cost and people affected by primary and secondary antibody deficiency can get free testing via the COVAD study or via their NHS clinic if your clinical team think it will be useful in your diagnosis or management.  At present we do not know what level of antibody confers protection, this might be high or low and the presence of a detectable antibody is not a replacement for strict adherence to "hands, face and outdoor space".  It is worth noting that if you are on immunoglobulin replacement therapy the test will be measuring your IgG levels and not your own specific antibody response.  If your diagnostic work-up previously showed complete antibody failure (low Ig's and no response to any vaccination) then a test for COVID19 antibodies is unlikely to be useful in detecting any response to vaccination in you.

Q.  I have selective IgA deficiency (IgAD). Will the COVID vaccines work for me?

A. The currently available vaccines produce a protective IgG response against COVID19, so IgAD should not affect protection. As yet we do not know if vaccine induced IgA responses provide additional protection in COVID but we hope that data will follow from the COV-AD study (see 'Study starts to look at COVID vaccine responses in patients affected by primary and secondary antibody deficiency'), which measures responses to IgG/A/M in patients with immune deficiency of all types receiving vaccination. We do know that males with the primary immunodeficiency XLA, who never make any IgA or IgM, and who are on lifelong IgG replacement only, are very well served by IgG protection only, suggesting that IgA is redundant in the immune system for most people.

Q. Should I contact my immunology centre or GP about getting the COVID vaccination?

A. No, all services are over stretched. Wait to be contacted by the NHS, your NHS number is being used to track people wherever you are vaccinated. In some areas you will be contacted by a Hub not your own GP, but they will contact you. Your immunology centre will not have any vaccine and will not have a means to liaise with the vaccination hubs.

Q. Who will let me know when I can get the COVID vaccine?

A. The NHS is working through a priority list as set out by the Joint Committee on Vaccination and Immunisation (JCVI). You SHOULD NOT contact the NHS or your local GP surgery about the COVID vaccination. The NHS will let you know when it is your turn to have the vaccine.  This will be in the form of a letter/email from your GP or the NHS. It will include all the information you need to book appointments, including your NHS number.
Do not respond to texts, emails or messages that are not from your GP/NHS or that ask for personal details including bank details. There are a number of scams using COVID vaccination to get peoples' details. You will either be sent an appointment or there will be a web booking system, but you will not have to enter personal details.

Q. What do I need to bring with me to the vaccination centre?

A. If you are taking medication, please bring a list of these with you to the vaccination centre. Do not bring the medicines themselves.

If you are taking a blood thinner called 'warfarin' you will also be going for regular blood tests to monitor the thickness of your blood using a test called INR. The INR test result is a number (for example 2.5). Please make sure you know your latest INR reading and when that was last checked.  If you don't know this, you can get if from your GP surgery.

Q. Are there any side effects from having a COVID vaccination?

A. Like all medicines, vaccines can cause side effects. Most of these are mild and short-term, lasting no longer than a week, and not everyone gets them. These may include: a sore arm where the needle went in; feeling tired; a headache; feeling achy; feeling or being sick.

You can take painkillers, such as paracetamol, if you need to. If you have a high temperature you may have coronavirus or another infection. If your symptoms get worse or you are worried, call 111.

Read about the coronavirus vaccines at https://www.nhs.uk/conditions/coronavirus-covid-19/coronavirus-vaccination/coronavirus-vaccine/

You can report side effects at Yellow Card Scheme - MHRA

Q. Can I do what I want after I have been vaccinated?

A. It is essential that everyone continues to stay at home whether they have had the vaccine or not.  We do not know how much protection people with certain types of immunodeficiency will have so it's absolutely essential that you continue to follow any shielding guidance you may have been given. It's tough but really important.  Continue to follow social distancing guidance; wear a face covering and remember hands, face, space and cut down on your interactions with other people. 

Q. Can I catch COVID from the vaccines?

A. 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: www.nhs.uk/conditions/coronavirus-COVID-19/symptoms/

Q. Can I be vaccinated if I have had a severe allergy?

A. The Pfizer vaccine is not recommended for people who have had anaphylaxis (severe allergic reaction) to drugs or vaccines.  It is still recommended when there is a history of allergy without anaphylaxis, but this would be discussed with you.  Every person attending for vaccination will be asked. If you cannot have the Pfizer vaccine, you will be added to a wait list for the Astra-Zeneca vaccine.

Q. Do I need to be registered with a GP to get the vaccine?

A. To get the vaccine, you will need to be registered with a GP surgery. If you aren't you will have to get registered or wait until the vaccine is offered more widely at other locations.

Q. Can I have pay for a private COVID vaccination?

A. COVID vaccines will ONLY be available through the NHS.

Q. What are RNA vaccines and how are they different from 'conventional' vaccines?

A. RNA is an abbreviation for ribonucleic acid. mRNA acts as a messenger carrying instructions from DNA to make proteins.

Traditional virus vaccines use actual viruses that are weakened so they do not harm people and have to be grown in chicken eggs; a process that can take many months.  By contrast, the COVID-19 RNA vaccines delivers part of the virus genetic coding for the 'spike' protein. This RNA is then coated in a lipid so it can enter the body's cells and this is injected into the patient. The RNA vaccine then enters the cells and instructs them to produce the COVID spike protein. This prompts the immune system to produce antibodies and activate T cells to destroy infected cells.

RNA based vaccines are easier and faster to develop, once scientists have the genetic sequence of the protein they want to create.  Protein based vaccines are harder to manufacture but many successful vaccines have been produced in this way, e.g. Hepatitis B and some flu vaccines use this method.

Q. How much do we know about the vaccines recently in the news?

A. Pfizer/BioNtech, Oxford/AstraZeneca and Moderna have recently announced highly successful results from their COVID-19 vaccines trials, and results from other vaccine trials are expected soon. 

Interim findings from Pfizer/BioNtech indicate their RNA vaccine is 90% effective in preventing COVID-19. Two doses are needed to give protection. The vaccine has been tested on 43,500 people in six countries and no safety concerns have been raised. However, the data presented is not the final analysis as it is based on only the first 94 volunteers to develop COVID so the precise effectiveness of the vaccine may change when the full results are analysed. On the 23rd November the Medicines and Healthcare products Regulatory Agency (MHRA) approved the use of this vaccine for a mass vaccination programme.

The Moderna trial involved 30,000 people in the US and the analysis was based on the first 95 to develop COVID-19 symptoms. Two doses are needed to give protection. Only five of the COVID cases were in people given the vaccine and 90 were in those given the placebo treatment. The company says the vaccine is protecting 94.5% of people. The data also shows there were 11 cases of severe COVID in the trial, but none happened in people who were immunised.  Again, these are interim results.

The Oxford University/AstraZeneca vaccine uses a modified, inactivated cold virus to carry the genetic information of COVID into the body to get the immune system to mount a response. Early data from the clinical trials suggests it is safe and could protect up to 70% of people. There is good data that it will work in elderly people.  The vaccine does not need to be shipped or stored in an ultra-cold environment, it is also considerably cheaper than the Pfizer/BioNtech and Moderna vaccines.

On the 30th December 2020 the government accepted the recommendation from the Medicines and Healthcare products Regulatory Agency (MHRA) to authorise Oxford University/AstraZeneca's COVID-19 vaccine for use. See
https://www.gov.uk/government/news/oxford-universityastrazeneca-vaccine-authorised-by-uk-medicines-regulator

There are some unknowns about the vaccines, for example, we do not know if the vaccine stops you spreading the virus or just from developing symptoms; or if it works equally well in high-risk elderly people.  We also do not know how long the immunity will last and this question will only be answered by long-term follow up studies.

Vaccine update 1st February 2021

Following the initial vaccines to complete trials (Pfizer, Moderna and Astra Zeneca), the high case numbers of COVID have resulted in further vaccines being able to give information on the protection offered vs placebo. The additional vaccines (Valneva, Novovax and Jannssen) will probably not be available until later this year, if approved by the MHRA (the medicines regulator).  These vaccines, like those already licenced are made up of components of the virus and an immune stimulator and none of them are live vaccines, so all are safe for those with impaired immunity.

Valneva vaccine

The Valneva vaccine is an inactivated whole virus vaccine. Clinical trials, which began in December, are taking place at four National Institute for Health Research sites in Bristol, Southampton, Birmingham and Newcastle and results are expected by April.  If the results look promising larger tests will take place in April with more than 4,000 UK volunteers taking two doses.  The vaccine is stable in a normal fridge.  The UK has ordered 60 million doses of this vaccine and could be available by the end of 2021.

Novovax vaccine

The Novovax vaccine will be given as two doses.  The vaccine comprises an artificial form of the spike protein (recombinant protein) and a special immune stimulator (adjuvant) to boost the immune response. Novavax is stable for up to three months in a normal fridge.  It has been shown to be 89.3% effective at preventing COVID-19 in participants in its Phase 3 clinical trial in the UK, and around 86% effective at protecting against the new UK variant. This vaccine needs approval from the MHRA and is hoped it will be available later this year.  The UK has secured 60 million doses of this vaccine.

Jannssen (Johnson and Johnson) vaccine

This is a single dose vaccination and uses a common cold virus that has been engineered to make it harmless.  This approach is similar to that used by the University of Oxford and AstraZeneca. This vaccine can be stored at a fridge temperature so it will be easier to roll out. The results that show that this vaccine gives 66% protection against COVID based on clinical trials involving nearly 44,000 people. This vaccine needs approval from the MHRA and is hoped it will be available later this year. The UK has ordered 30 million doses of this vaccine. 

Q. Have any of the vaccine trials involved people with immunodeficiency? 

A. We do not know precisely the mix of people who have taken part in the clinical trials but patients who are immunocompromised would not be eligible to take part in a vaccine trial in the way that they are conventionally set up.  

Q. Is there any evidence about the effectiveness of the RNA vaccines for PID patients?

A. In short, no, because immunocompromised patients haven't been enrolled in the trials.  Our experience to date of patients with antibody deficiency and COVID-19 infection suggests that the antibody response is at least as important as T-cell responses for clearing this virus. The pre-clinical vaccine trial data suggests that antibody is essential for preventing primary infection. There will be more research data available about this over the coming months. The preliminary data indicates, therefore, some people with certain types of PID may not respond to the vaccination to get reliable protection.

Q. I have CVID, and since many other immunodeficient patients don't develop antibodies to vaccines and have poor T cell responses why are you encouraging people to have the vaccine when available?

A. Taking flu as an example, unfortunately we don't have routine antibody tests or T-cell function tests to see if patients have responded to vaccination given in the clinic and we suspect that many will not.  We do know the licenced vaccines are safe. We also know that those with poorer immunity such as the elderly can make a useful response. If patients might derive even a tiny amount of protection from a safe vaccine, many doctors think that is a worthwhile balance, given that influenza like COVID can result in deaths.  The exception to this is we do not recommend live vaccine in many children with more significant PID.

The community can do its bit to encourage friends and family to have an approved COVID vaccination. This will help protect those who don't have immunity to COVID-19 infection.

Q. Do allergic reactions to vaccines usually occur?  

A. The Department of Health (DOH) green book (the DOH vaccine reference book) gives the following statement:

'Anaphylaxis
Anaphylactic [severe allergic] reactions to vaccines are extremely rare but have the potential to be fatal. Between 1997 and 2003, there were 130 reports to the Medicines and Healthcare products Regulatory Agency (MHRA) of anaphylaxis or
anaphylactic-type reactions following immunisation (excluding the meningitis C campaign), although no deaths as a result of the reaction were reported. In that time, around 117 million doses of all vaccines were supplied to hospitals and GPs.
This rate (approximately one per million vaccine doses) is similar to that reported from other countries (Bohlke et al., 2003; Canadian Medical Association, 2002).'

Other reactions are non-anaphylactic vaccine events and they are more common, but can usually be managed with antihistamines or will go of their own accord.
In the vaccine trials of COVID vaccines, there were no anaphylactic events. 

In hospital settings, healthcare workers are often sensitised to cleaning agents, latex and other compounds to which they may have inadvertently been re-exposed in their vaccinations. 

The MHRA says that anyone who has previously had a significant allergic reaction to a medicine, food or another vaccine should not have the Pfizer-BioNTech jab and anyone due to receive their vaccine should discuss any medical history of
serious allergies with their healthcare professional beforehand.

More information is needed from the regulators and NHS England about the exact causes of the allergic reactions seen in the two NHS workers who received the Pfizer-BioNTech jab.

This is a useful article on vaccine safety: Covid vaccine: What you need to know about vaccine safety - BBC News

Q. Will carers/immediate family members of clinically extremely vulnerable people be prioritised for vaccinations as this may protect those most at risk to COVID?

A. The Joint Committee on Vaccination and Immunisation (JCVI) has advised that pregnant women should be offered the COVID-19 vaccine at the same time as the rest of the population, based on their age and clinical risk group.

Professor Wei Shen Lim, COVID-19 Chair for JCVI, said: 'We encourage pregnant women to discuss the risks and benefits with their clinician – those at increased risk of severe outcomes from COVID-19 are encouraged to promptly take up the offer of vaccination when offered. There have been no specific safety concerns from any brand of COVID-19 vaccines in relation to pregnancy. There are more real-world safety data from the US in relation to the Pfizer-BioNTech and Moderna vaccines in women who are pregnant therefore, we advise a preference for these to be offered to pregnant women'.

Dr Mary Ramsay, Head of Immunisation at Public Health England (PHE), said:
'The available data on the Pfizer-BioNTech and Moderna vaccines provide confidence that they can be offered safely to pregnant women.  The COVID-19 vaccines continue to save thousands of lives and it is important that we encourage as many people as possible to take it up'.

There have been no specific safety concerns identified with any brand of COVID-19 vaccines in relation to pregnancy.  Real-world data from the United States show that around 90,000 pregnant women have been vaccinated, mainly with mRNA vaccines including Pfizer-BioNTech and Moderna, without any safety concerns being raised.

Based on these data, the JCVI advises that it is preferable for pregnant women in the UK to be offered the Pfizer-BioNTech or Moderna vaccines where available. There is no evidence to suggest that other vaccines are unsafe for pregnant women, but more research is needed.

Data shows that vaccines are effective in protecting people from serious illness from COVID-19. Though uncommon, severe illness due to COVID-19 is more likely in later pregnancy. Pregnant women who do get symptomatic COVID-19 infection are 2 to 3 times more likely to give birth to their baby prematurely.

Women who are planning pregnancy, are in the immediate postpartum, or are breastfeeding can be vaccinated with any vaccine, depending on their age and clinical risk group.

The JCVI has advised that, as a precaution, it is preferable for people under the age of 30 with no underlying health conditions to be offered an alternative to the AstraZeneca vaccine where possible.

Q. What wider benefits will a COVID vaccination programme have for the immunodeficiency community?

A. Wider benefits include the likely development of robust herd immunity, protecting immunodeficiency patients by reducing the amount of virus circulating in the community.  It will also mean reliable antibody levels in plasma donors and this will be reflected in replacement IVIG/SCIG therapies after about 6 months or so after the vaccine is widely taken up. 

Q. Will be the COVID vaccines be appropriate for children under 16 years?

A.  For the under 16 years there is also not yet enough data to make a conclusion on safety or efficacy. Since most children have mild or asymptomatic disease, they were not prioritised in the first trials, but Pfizer/BioNtech and Moderna are already recruiting to paediatric studies.

Q. How safe are the vaccines and who will monitor their safety?

A. All vaccines undergo extensive safety testing and must meet exacting standards to progress through the different stages of clinical trials. Their use must be approved and licensed before their use through expert review of all trial data through the Medicines and Healthcare products Regulatory Agency (MHRA). They check that the trial meets the necessary efficacy and safety levels. You can find out more about this process at http://vk.ovg.ox.ac.uk/vaccine-development

Q. When will we know if the vaccines are working for the general population?

A. The government is keeping tabs on infection by age and location.  The vaccination programme is starting to see a fall in cases and hospitalisation in those groups targeted by the vaccine first within 2 months of the vaccination roll-out.

Q. How will the safety of the vaccines be monitored after the vaccination programmes start?

A. The safety of the vaccines will be monitored on an ongoing basis, as with all licensed drugs. This is undertaken by the Medicines and Healthcare products Regulatory Agency (MHRA) through the Yellow Card Scheme. Reports of suspected side effects are sent to the MHRA by drug companies (who are obliged to pass on any reports of suspected side effects that are defined as serious), health professionals, and patients themselves.

The data are evaluated each week, and the reported side effects are compared against the expected side effects as detailed in the information sheet for the vaccine. If a previously unidentified reaction emerges, or the frequency of reactions is not in line with what is expected, then the MHRA will investigate carefully. What happens next depends on the kind of side effect identified, but options include insisting that details of the new side effect are given in the product information leaflet or giving out warnings identifying groups of patients who should not be given the vaccine. In rare circumstances, the vaccine may be withdrawn from use.

Q. Will people with antibody deficiency get any direct benefit from having a vaccination?

A. This remains unclear and until we know most doctors are likely to give the same advice as flu-vaccine, if it gives even a tiny benefit from T-cell responses to reduce either the risk of infection or to make the illness less severe then as long as it has been licenced and is safe, then antibody deficient patients should consider having it.  We should also acknowledge that some people with e.g. specific antibody deficiency may make a good response to COVID vaccines, just as they might to tetanus but not to e.g. pneumococcus.

Q. Can family members living with people who are affeced by immunodeficiency get vaccination?

A. 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.

Q. Who decides on the priority list for a COVID vaccination programme?

A. The Joint Committee on Vaccination and Immunisation (JCVI) provides advice to the Government about this. They examine data on who suffers the worst outcomes from coronavirus and who is at highest risk of death.  More information can be found at https://www.gov.uk/government/publications/priority-groups-for-coronavirus-covid-19-vaccination-advice-from-the-jcvi-30-december-2020

Q. Who will be prioritised for the COVID vaccination programme?

A. Age is, by far, the biggest risk factor for COVID so older age groups will be targeted first.

The JCVI guidance says the order of priority would be as below:

    1.    residents in a care home for older adults and their carers
    2.    all those 80 years of age and over and frontline health and social care workers
    3.    all those 75 years of age and over
    4.    all those 70 years of age and over and clinically extremely vulnerable individuals
    5.    all those 65 years of age and over
    6.    all individuals aged 16 years to 64 years with underlying health conditions which put them at higher risk of serious disease and mortality
    7.    all those 60 years of age and over
    8.    all those 55 years of age and over
    9.    all those 50 years of age and over

    It is estimated that taken together, these groups represent around 99% of preventable mortality from COVID-19.

    Q. When will the vaccines become widely available?

    A. The vaccines need to authorised for use by the MHRA first and their decision will be based on the full data as to the safety and how well the vaccines work to protect against COVID.  The Government has yet to announce the start date of an immunisation programme but infrastructure and logistical plans are being drawn up.

    Q. Will the vaccines stop the spread of COVID?

    A. It is unlikely that a vaccination programme will be able to fully stop the spread of the COVID virus unless we see high level uptake of a highly effective vaccine. The disease may well become endemic in the global population like flu and have to be managed on a yearly basis through vaccination programmes.  This means that everyone, and most importantly those clinically vulnerable should continue to take measures to protect themselves from catching the virus.

    Q. Why are so many different types of vaccines being developed?

    A. Given the scale and importance of the challenge of developing a COVID vaccine and the need for vaccination programmes to be available globally, different strategies and approaches are being used in the hope that some of these avenues of research and development will pay off. The pace of the research is unprecedented.  

    Q. How can I find out more about the development of COVID vaccines and vaccination programmes?

    A. These websites may be helpful:

    Reviewed by the Chair of the PID UK Medical Advisory Panel 18th November 2020 ; updated 24th November 2020; 4th December 2020; 17th December; 12th January 2021; 1st February 2021; 1st October 2021.