Introduction

Four COVID vaccines have been approved for use in the UK (as of July 2021), developed by Pfizer/BioNTech, Oxford/AstraZeneca, Moderna,^[1] and Janssen. There are other vaccines either being considered for approval or still being developed, and these will only be available on the NHS when they have been tested to make sure they are safe and effective.

Are the vaccines safe?

The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the UK and is responsible for the approval of any vaccine that is used in the UK, including those for COVID. As part of this approval process, they closely examine all the evidence about the vaccines, including a rigorous assessment of how well they work, and their safety.

Guidance on COVID vaccination has now been published in Chapter 14a of the Green Book and is available on the gov.uk website.^[2] The Green Book provides the evidence and reasoning behind the UK vaccination schedule and is constantly updated.

The MHRA has issued a statement that people should continue to receive the Oxford/AstraZeneca COVID vaccine as the benefits far outweigh the risks,^[3] including the risk of blood clots, concluding that such reaction is extremely rare and unlikely to occur in most people.4 However, in adults under the age of 30 without underlying health conditions, an alternative COVID vaccine may be offered, if available.^[5]

Will the vaccines worsen my skin disease?

To date, there is no robust evidence to indicate that COVID vaccines make underlying skin conditions worse. As part of the roll-out of any vaccine including the COVID vaccines, we encourage everyone to report any safety concerns formally (by your doctor or yourself) using the Coronavirus Yellow Card system,^[6] including any problem with your skin.

I am taking an immunosuppressant or biologic therapy – is it safe for me to have the COVID vaccines?

Yes. People taking medicines that affect the immune system (for example, prednisolone, methotrexate, ciclosporin and biologics) can receive the three COVID vaccines that have been approved in the UK. If you still have concerns, then you should discuss with your doctor.

Can I choose to have one vaccine over the others?

No. You will be offered whichever vaccine is available at the vaccination hub where you are booked to receive it. Adults under the age of 30 will be offered an alternative to the Oxford/AstraZeneca COVID vaccine, if available.^[5]

I have been offered one of the vaccines – should I stop or delay my immunosuppressant or biologic therapy?

Currently, we do not usually advise stopping or delaying immunosuppressant or biologic therapy before receiving the COVID vaccine.

We do not yet know if being on immunosuppressant or biologic therapy reduces the effectiveness of COVID vaccines.^{[7] [8] [9] [10]} Therefore, government advice on reducing the risk of COVID infection should still be followed after your vaccination.^[11] However, even a reduced response to the vaccine is better than none, so you are still advised to get vaccinated even if on these therapies.

There may be situations where your doctor advises reducing or stopping your treatment. For example, if your risk of COVID is high and your skin disease is well controlled and unlikely to flare up. This should be discussed with you by your doctor on an individual basis. Do not stop any of your treatments without first discussing with your doctor.

I am about to start taking an immunosuppressant or biologic therapy for the first time – can I have one of the vaccines?

Yes. Your doctor may offer you COVID vaccination before you start your treatment to give your immune system enough time to respond to the vaccine. Ideally, the time between receiving your vaccine and starting treatment is at least 2 weeks.^[2] Also, and where possible, it is preferable for the two-dose schedule to be completed before starting treatment, which may mean that the second dose of the vaccine needs to be given at the recommended dosing interval for that vaccine (that is, 3-4 weeks after the first dose). However, this may not be possible, depending on the severity of your skin condition and the type of immunosuppressant or biologic therapy you are about to start taking. Your doctor will discuss this with you.

I am taking an immunosuppressant or biologic therapy and have received my first dose of one of the COVID vaccines – can I stop shielding?

Currently, there is not enough information on this, therefore, government advice on reducing the risk of COVID infection should still be followed.^[10]

Are there situations where the COVID-19 vaccine is NOT recommended?

There are very few people where COVID vaccines cannot be used. You should not receive the vaccine if you have had a previous systemic allergic reaction (e.g. anaphylaxis) to:

• a previous dose of the same COVID vaccine
• any component of the COVID vaccines

The Pfizer/BioNTech and Moderna vaccines contain polyethylene glycol (PEG). This is present in the biologic drug certolizumab pegol (Cimzia) for treating psoriasis. Reactions to PEG are very rare. However, if you have had a severe allergic reaction to certolizumab pegol (Cimzia®) you should not receive the Pfizer/BioNTech vaccine. People who have had a systemic allergic reaction either to the Pfizer/BioNTech or Moderna vaccines should not be given a dose of the other vaccine.^[2] Such reactions should be reported using the COVID Yellow Card system.^[6]

People with latex allergy are safe to receive the currently available vaccines as the rubber bung in the vials is made of bromobutyl or halobutyl rubber, and not latex. A full list of ingredients has been published for each approved vaccine. ^[7][8][9]

Is it safe to receive the vaccines if I have already had a COVID infection or positive antibodies test result?

There is no evidence of any safety concerns from vaccinating people with a history of COVID infection or with detectable COVID antibodies (as of February 2021).

Can I receive the vaccines if I am pregnant?

The COVID vaccines available in the UK have been shown to be effective and safe. In the USA, around 90,000 pregnant women have been vaccinated, mainly with the Pfizer/BioNTech and Moderna vaccines, with no safety concerns raised. Therefore, the Pfizer/BioNTech and Moderna vaccines are the preferred vaccines for pregnant women, of any age, who are coming for their first dose. Anyone who has started the vaccination, and is offered a second dose whilst pregnant, should have a second dose with the same vaccine unless they had a serious side effect after the first dose. The Green Book advises that pregnant women should discuss the risks and benefits of vaccination with their doctors, including the latest evidence on safety and which vaccines they should receive. The Royal College of Obstetricians and Gynaecologists and Royal College of Midwives have produced a decision tool to assist you in deciding what to do next.

https://www.rcog.org.uk/globalassets/documents/guidelines/2021-02-24-combined-info-sheet-and-decision-aid.pdf

Will the vaccines be offered to children and teenagers?

Results of COVID vaccine trials in children and teenagers are emerging. Most recently, the Pfizer/BioNTech vaccine has been approved for those aged 12-15 years old,2 and the Moderna vaccine has been approved for those aged 12-17 years old. ^[13]

Children and young people whose immune system are not suppressed have a very low risk of catching COVID and rarely come to harm due to COVID infection. However, there is an increased risk of getting COVID in residential care homes. Currently, teenagers aged 12 to 15 years with specific underlying health conditions that put them at risk of severe COVID should be offered two doses of the Pfizer/BioNTech vaccine, 8 weeks apart. This includes those with severe neurological disabilities (including cerebral palsy, severe autism and Down’s syndrome), underlying conditions resulting in immunosuppression, profound and multiple learning disabilities, severe learning disabilities or who are on the learning disability register. ^[15]

Additionally, all teenagers aged 16 and 17 years should be offered a first dose of the Pfizer/BioNTech vaccine. Pending further evidence on effectiveness and safety, a second vaccine dose is anticipated to be offered later, to increase the level of protection and contribute towards longer term protection. ^[14]

How will the vaccines be prioritised?

The Joint Committee of Vaccination and Immunisation (JCVI),^[11] which advises UK health departments on immunisation, have set out a prioritisation list for people most at risk. Evidence from the UK indicates that the dangers from COVID infection increases with age in both healthy adults and in adults with underlying health conditions.

*Please note this is an evolving situation and the priority grouping may change at short notice ^[10]

Who is in the clinically extremely vulnerable group?

There are two ways an individual may be identified as clinically extremely vulnerable:

• if you have one or more of the conditions listed on the government website,^[11] (combined potentially with medication you are on)^[12] or

• a hospital clinician or GP has added you to the Shielded Patients list because, based on their clinical judgement and national guidance, they think you may be at higher risk of serious illness from COVID infection.

How do I know if I am registered as clinically extremely vulnerable?

Your doctor will have registered you as clinically extremely vulnerable and you should have received a letter during the recent lockdown/restrictions to confirm this. If you have not received a letter, and believe that you are in this group, then please contact your dermatology team or GP.

If I am in the clinically extremely vulnerable (shielded) group how will I be notified about vaccination?

If you have been registered as clinically extremely vulnerable, then there is nothing further that you need to do. You will be contacted when appropriate.

What if I am at risk due to the medication I am taking, but not in the clinically extremely vulnerable group?

Currently, the advice is that you will be in the priority group 6 (see table above) to receiving the vaccine.

Additional resources (support groups that have produced of their own guidance):

International Psoriasis Council statement on the COVID-19 vaccines

Crohn’s and Colitis UK FAQ on the COVID-19 vaccines

UK Mastocytosis FAQ on the COVID-19 vaccines

N.B. the British Association of Dermatologists is not responsible for any third-party content.

[1] https://www.bmj.com/content/372/bmj.n74 (Accessed 23rd August 2021)

[2] https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/955548/Greenbook_chapter_14a_v6.pdf (Accessed 23rd August 2021)

[3] https://www.gov.uk/government/news/uk-regulator-confirms-that-people-should-continue-to-receive-the-covid-19-vaccine-astrazeneca (Accessed 23rd August 2021)

[4] https://www.gov.uk/government/news/mhra-issues-new-advice-concluding-a-possible-link-between-covid-19-vaccine-astrazeneca-and-extremely-rare-unlikely-to-occur-blood-clots (Accessed 23rd August 2021)

[5] https://www.gov.uk/government/publications/use-of-the-astrazeneca-covid-19-vaccine-jcvi-statement/jcvi-statement-on-use-of-the-astrazeneca-covid-19-vaccine-7-april-2021 (Accessed 23rd August 2021)

[6] https://coronavirus-yellowcard.mhra.gov.uk/ (Accessed 23rd August 2021)

[7] https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19 (Accessed 23rd August 2021)

[8] https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca (Accessed 23rd August 2021)

[9] https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna (Accessed 23rd August 2021)

[10] https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-janssen (Accessed 23rd August 2021)

[11] https://www.gov.uk/government/groups/joint-committee-on-vaccination-and-immunisation (Accessed 23rd August 2021)

[12] https://www.bad.org.uk/shared/get-file.ashx?itemtype=document&id=6946 (Accessed 23rd August 2021)

[13] https://www.gov.uk/government/news/moderna-covid-19-vaccine-approved-by-mhra-in-12-17-year-olds (Accessed 23^rd August 2021)

[14] https://www.gov.uk/government/publications/jcvi-statement-august-2021-covid-19-vaccination-of-children-and-young-people-aged-12-to-17-years/jcvi-statement-on-covid-19-vaccination-of-children-and-young-people-aged-12-to-17-years-4-august-2021 (Accessed 23^rd August 2021)

[15] https://www.gov.uk/government/publications/covid-19-vaccination-of-children-and-young-people-aged-12-to-17-years-jcvi-statement/jvci-statement-on-covid-19-vaccination-of-children-and-young-people-aged-12-to-17-years-15-july-2021 (Accessed 23^rd August 2021)

[16] https://www.gov.uk/government/groups/joint-committee-on-vaccination-and-immunisation (Accessed 23^rd August 2021)

First published 07.12.20; updated 11.12.20, 04.02.21, 08.04.21, 24.05.21, 04.06.21, 02.07.21, 24.08.21