COVID-19 VACCINES AND - EPIDERMOLYSIS BULLOSA (EB) - International - Alligatura

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COVID-19 VACCINES AND - EPIDERMOLYSIS BULLOSA (EB) - International - Alligatura
International.

   COVID-19 VACCINES
          AND
EPIDERMOLYSIS BULLOSA
          (EB)
COVID-19 VACCINES AND - EPIDERMOLYSIS BULLOSA (EB) - International - Alligatura
INTRODUCTION

There are now a number of COVID-19 vaccines that have been approved
for use. Arguably, the three most well-known and widely available
vaccines at the moment are the Pfizer/BioNTech mRNA vaccine, the
Oxford/AstraZeneca adenovirus vector vaccine, and the Moderna mRNA
vaccine. A number of other COVID-19 vaccines have been approved for
use in some countries and there are over 230 more in development.

Whilst the roll-out of these vaccines is certainly a positive and welcomed
development, there are questions and concerns about whether vaccination
against SARS-CoV-2 (the virus that causes COVID-19) is safe for people
living with hereditary EB and whether they should be prioritised to
receive it. Widespread misinformation online about the COVID-19
vaccines and vaccines in general can also cause additional worry.

We have put together the following general and EB-specific information
on vaccination against SARS-CoV-2 to address some of the concerns
you may have. All information has been derived from reputable sources
and been reviewed by EB clinical experts. It is important to note that
we are learning more about both COVID-19 itself and the different
vaccines that are being developed all the time. We will endeavour to
provide updates on this page as and when new information is released.

If you have any questions or concerns about vaccination, consult your healthcare
provider and/or EB healthcare team.

EB AND THE COVID-19 VACCINE                                                                   04
COVID-19 VACCINES                                                                             06
VACCINES IN GENERAL                                                                           10

                     COVID-19 VACCINES AND EPIDERMOLYSIS BULLOSA (EB)   DEBRA INTERNATIONAL   3
COVID-19 VACCINES AND - EPIDERMOLYSIS BULLOSA (EB) - International - Alligatura
EB and the
                                                                   EB AND THE COVID-19 VACCINE

COVID-19 vaccine
                   The following information relates to those with a form of hereditary EB (EB simplex, dystrophic EB, junctional EB,
                   Kindler EB) and to known data of the Pfizer/BioNTech mRNA vaccine, the Oxford/AstraZeneca adenovirus vector
                   vaccine, and the Moderna mRNA vaccine.

                   I have EB...
                   … is it safe for me to be vaccinated with the COVID-19 vaccine?
                   Yes. There is no evidence to suggest that people with hereditary EB should avoid getting vaccinated.
                   However, if you have a known allergy to any of the components in a particular COVID-19 vaccine,
                   consult your healthcare provider and an allergist/immunologist before receiving the COVID-19
                   vaccine in question.

                   … should I get the COVID-19 vaccine?
                   Yes. Vaccination to help prevent the spread of a disease-causing virus is essential for the global
                   population, including people with EB. Vaccination is strongly recommended for patients with all
                   types of EB, particularly those with severe mucocutaneous fragility and systemic complications,
                   such as malnutrition and cardiomyopathy, among others. If you have any questions or concerns
                   about being vaccinated, consult your healthcare provider and/or EB healthcare team.

                   … will I be prioritised for vaccination?
                   This will depend on where you live as each country will have its own plan for deciding the order in
                   which people are vaccinated. If you have any questions or concerns regarding when you are likely
                   to receive your COVID-19 vaccine, consult your healthcare provider/EB healthcare team.

                   … and I am enrolled in a gene therapy clinical trial, can I get the COVID-19 vaccine?
                   Anyone with EB currently participating in a gene therapy clinical trial should contact the trial provider
                   for confirmation before receiving the vaccine.

                   … and I am over 65, am I allowed to get the vaccine?
                   Adults with EB are recommended to be vaccinated regardless of their age. Every country is managing
                   their vaccination programmes in different ways, some of which limit the types of vaccines allowed
                   for different age groups.

                   My child has EB…
                   … when can my child be vaccinated?
                   None of the COVID-19 vaccines have been approved for children (those under the age of 16 for
                   the Pfizer/BioNTech mRNA vaccine and those under the age of 18 for the Oxford/AstraZeneca
                   adenovirus vector vaccine and the Moderna mRNA vaccine). It is uncertain whether or when the
                   vaccines may be approved for children. In February 2021, Oxford University extended its COVID-19
                   vaccine study to children to assess if children and young adults aged 6-17 years make a good
                   immune response with the vaccine. However, the study has since been put on hold pending further
                   information about rare blood-clotting issues in adults who have received the vaccine.

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COVID-19 VACCINES AND - EPIDERMOLYSIS BULLOSA (EB) - International - Alligatura
COVID-19
                                                                              COVID-19 VACCINES

vaccines
           The following information relates to known data of the Pfizer/BioNTech mRNA vaccine, the Oxford/AstraZeneca
           adenovirus vector vaccine, and the Moderna mRNA vaccine.

           How do the COVID-19 mRNA vaccines work?
           mRNA vaccines teach the body’s cells how to make a (piece of a) protein that triggers an immune
           response inside the body. The mRNA vaccine gives instructions for our cells to make a harmless
           piece of the “spike protein” that is found on the surface of the virus that causes COVID-19. Once
           the protein piece is made, the cell breaks down the instructions and gets rid of them. If someone
           is subsequently exposed to COVID-19, their body’s immune system recognises the spike protein
           on the surface of the virus and makes antibodies that destroy SARS-CoV-2 therefore protecting the
           person from developing the disease.

           How does the COVID-19 adenovirus vector vaccine work?
           Like an mRNA vaccine, the adenovirus vector vaccine delivers instructions to the body’s cells to
           create a harmless piece of the “spike protein” that is found on the surface of the virus that causes
           COVID-19 in order to trigger an immune response. Unlike the mRNA vaccine, the instructions are
           delivered using a virus (the vector) that we know is harmless.

           Are the COVID-19 vaccines safe?
           Yes, the COVID-19 vaccines are safe and effective. They have been evaluated in tens of thousands
           of participants in clinical trials and have now been given safely to tens of millions of people across
           the world.

           Which is the best vaccine to have?
           In this case, “any vaccine is a good vaccine.” All three vaccines have been shown to be safe and
           to work well at preventing disease from the virus. Each country has its own regulators that decide
           which vaccines are approved for use. It is unlikely that you will be able to choose which vaccine you
           have so it is important to have the vaccine you are offered.

           What are the side effects of the COVID-19 vaccines?
           Common side effects include pain and/or swelling from the injection site and a fever, chills, tiredness,
           and/or a headache. These are normal signs that your immune system is responding to the vaccine.
           If any side effects are worrying you or do not seem to be going away after a few days, contact your
           healthcare provider.

           Should I be worried about having an allergic reaction to the COVID-19 vaccines?
           A very small number of people have had a severe allergic reaction (called “anaphylaxis”) after
           vaccination, but this is extremely rare. If this does occur, vaccination providers will have medicines
           available to effectively and immediately treat the reaction. Unless you have had an allergic response
           to vaccines in the past, you should not be worried about this with a COVID-19 vaccine. If you have
           a known allergy to any of the components in a particular COVID-19 vaccine, consult your healthcare
           provider and an allergist/immunologist before receiving the COVID-19 vaccine in question.

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COVID-19 VACCINES AND - EPIDERMOLYSIS BULLOSA (EB) - International - Alligatura
COVID-19 VACCINES
                                                                                                                               MYTHS VS FACTS
Should I be worried about getting blood clots if I receive the Oxford/AstraZeneca adenovirus                                      ABOUT COVID-19 VACCINES
vector vaccine?
According to the European Medicines Agency (EMA), unusual blood clots with low blood platelets
are very rare side effects of the vaccine. The overall benefits of the vaccine in preventing COVID-19
outweigh the risks of side effects. Anyone who receives the vaccine should seek medical assistance
                                                                                                                 MYTH                                     MYTH                                    MYTH
immediately if they develop symptoms of this combination of blood clots and low blood platelets:        The COVID-19 vaccine                    The COVID-19 vaccine                    The COVID-19 vaccine
ࠚ shortness of breath                                                                                   can affect women’s                      enters your cells and                   was developed with or
ࠚ chest pain                                                                                            fertility.                              changes your DNA.                       contains controversial
ࠚ swelling in your leg                                                                                                                                                                  substances.
ࠚ persistent abdominal (belly) pain
ࠚ neurological symptoms, including severe and persistent headaches or blurred vision
ࠚ tiny blood spots under the skin beyond the site of injection

Can a COVID-19 vaccine make me sick with COVID-19?                                                      The COVID-19 vaccines                   The COVID-19 vaccines                   The COVID-19 vaccines
No. None of the three vaccines contain the live virus that causes COVID-19, which means that a          will not affect fertility. A            do not affect or interact               were not developed
COVID-19 vaccine cannot make you sick with the virus. It is possible, however, to have caught           false report on social                  with your DNA in any                    using foetal tissue and
COVID-19 and not realise you have the symptoms until after your vaccination appointment.                media said that the spike               way. The mRNA vaccine                   they do not contain
                                                                                                        protein on the SARS-                    never enters the nucleus                any material, such as
                                                                                                        CoV-2 virus was the                     of the cell where DNA                   implants, microchips, or
Will I be immediately protected from COVID-19 after my first vaccination?                               same as another called                  is kept and the genetic                 tracking devices.
It may take up to a couple of weeks for your body to build up some protection from the first dose       syncitin-1 involved in the              material delivered by
of the vaccine. Like all medicines, no vaccine is 100% effective so you should continue to take         growth and attachment                   the viral vector vaccine
recommended precautions to protect yourself from catching COVID-19 and to prevent spreading             of the placenta during                  does not integrate into a
it to others. Some people may still get the virus despite having a vaccination, but the symptoms        pregnancy.                              person’s DNA.
should be less severe.
                                                                                                                  FACT                                     FACT                                    FACT
If I have already had COVID-19 and recovered, do I still need to get vaccinated with a COVID-19
vaccine?
Yes. You should be vaccinated regardless of whether you have already had COVID-19 as experts
                                                                                                                                                          MYTH
do not yet know how long you are protected from getting sick again after recovering from the
                                                                                                        Researchers rushed the development of the COVID-19 vaccine so its effectiveness and safety
disease. If you have had a positive COVID-19 test, you are advised to wait 28 days before receiving
                                                                                                        cannot be trusted.
the COVID-19 vaccine.

Do the COVID-19 vaccines contain pork or other animal products?
No. None of the COVID-19 vaccines contain any products derived from animals.
                                                                                                        The COVID-19 vaccines are safe and effective and there are many reasons why they could be
                                                                                                        developed so quickly, including:
Will the COVID-19 vaccine become a yearly injection like the flu vaccine?                               ࠚ The method used to create the Pfizer/BioNTech and Moderna COVID-19 vaccines has been in development
The need for regular booster doses of the COVID-19 vaccine is not yet recommended because the
                                                                                                           for years so the companies could start the vaccine development process early in the pandemic. mRNA is
need for, and timing of, such boosters has not yet been determined.
                                                                                                           also a faster approach than traditional methods of vaccine creation.
                                                                                                        ࠚ China quickly shared genetic information about COVID-19 so researchers could start work on vaccines.
Where can I find reputable sources of information about the COVID-19 vaccines?                          ࠚ No steps were skipped during testing of the vaccines but some overlapped to gather data more quickly.
Consult your national government and/or health authority for information on COVID-19 vaccines           ࠚ Vaccine projects had plenty of resources: governments invested in research and/or paid for vaccines in
approved in your country. If you have any questions or concerns, consult your healthcare provider          advance. Social media helped to recruit study volunteers willing to help with COVID-19 vaccine research.
and/or EB healthcare team.                                                                              ࠚ Companies began making vaccine early on so supplies were ready to ship when approvals happened.

                                                                                                                                                           FACT
   8       DEBRA INTERNATIONAL   COVID-19 VACCINES AND EPIDERMOLYSIS BULLOSA (EB)
COVID-19 VACCINES AND - EPIDERMOLYSIS BULLOSA (EB) - International - Alligatura
Vaccines in
                                                                              VACCINES IN GENERAL

general       What is a vaccine?
              A vaccine is a type of medicine that trains the body’s immune system to fight a disease it has not
              come into contact with before. Vaccines are designed to prevent rather than treat a disease. It is
              much safer for your immune system to be trained through vaccination rather than by catching a
              disease and learning how to treat it itself.

              How do vaccines work?
              There are different types of vaccines that work in different ways to offer protection. With all types of
              vaccines, the body is left with a supply of “memory” defensive white blood cells called T-lymphocytes
              and B-lymphocytes that will remember how to fight a particular disease in the future.

              Why are vaccines important?
              Vaccination is the most important thing we can do to protect ourselves against ill health. Vaccines
              prevent up to 3 million deaths worldwide every year. If people stop having vaccines, it is possible
              for infectious diseases to quickly spread again.

              What is herd immunity?
              When a high percentage of a population is vaccinated, it is difficult for infectious diseases to spread
              because there are not many people who can be infected. This offers a greater level of protection for
              people who are unable to be vaccinated because of illness or a weakened immune system.

              What is in a vaccine?
              The main ingredient of any vaccine is a small amount of bacteria, virus, or toxin that has been
              weakened or destroyed in a laboratory first. This means that there is no risk of catching a disease
              from a vaccine. Vaccines sometimes contain other ingredients that make the vaccine safe and more
              effective.

              What are the side effects and why do they happen?
              Most side effects from a vaccine are mild and not long lasting. Serious side effects from a vaccine
              are extremely rare. Common side effects are from the injection site including soreness/pain,
              redness, and/or swelling. Other side effects experienced, such as headaches or fever are a sign of
              the immune system responding to the vaccine.

              What happens if I have an allergic reaction to a vaccine?
              It is rare for anyone to have a serious allergic reaction to a vaccine. If this does happen, it usually
              happens within minutes and the person vaccinating will be trained to deal with and treat the allergic
              reaction immediately.

                                          COVID-19 VACCINES AND EPIDERMOLYSIS BULLOSA (EB)   DEBRA INTERNATIONAL   11
VACCINES IN GENERAL                                                                                                                         REFERENCES & ACKNOWLEDGEMENTS
                                                                                                    American Society of Gene + Cell Therapy 2021, accessed 10 March 2021, https://patienteducation.asgct.org/gene-therapy-101/
                                                                                                    mrna-vaccines-for-covid19
                                                                                                    Anaphylaxis Campaign 2021, accessed 10 March 2021, https://www.anaphylaxis.org.uk/covid-19-advice/pfizer-covid-19-vaccine-
                                                                                                    and-allergies/
                                                                                                    AstraZeneca 2020, accessed 10 March 2021, https://www.astrazeneca.com/media-centre/press-releases/2020/azd1222-oxford-
                                                                                                    phase-iii-trials-interim-analysis-results-published-in-the-lancet.html
                                                                                                    British Broadcasting Corporation (BBC) 2021, accessed 13 April 2021, https://www.bbc.co.uk/news/health-56656356

VACCINE FACTS:
                                                                                                    Centers for Disease Control and Prevention 2021, accessed 10 March 2021, https://www.cdc.gov/coronavirus/2019-ncov/
                                                                                                    vaccines/different-vaccines/how-they-work.html;            https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/
                                                                                                    mRNA.html;       https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/viralvector.html;       https://www.cdc.gov/
                                                                                                    coronavirus/2019-ncov/vaccines/safety/safety-of-vaccines.html;           https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/
                                                                                                    after.html; https://www.cdc.gov/coronavirus/2019-ncov/vaccines/facts.html
                                                                                                    Coventry City Council, accessed 10 March 2021, https://www.coventry.gov.uk/info/265/health_protection/3830/covid-19_
                                                                                                    coronavirus_vaccines/2
 VACCINES DO:                                                                                       European Medicines Agency 2021, accessed 13 April 2021, https://www.ema.europa.eu/en/news/astrazenecas-covid-19-vaccine-
                                                                                                    ema-finds-possible-link-very-rare-cases-unusual-blood-clots-low-blood
                                                                                                    European Reference Networks Skin, accessed 10 March 2021, https://ern-skin.eu/vaccination-advices/
      protect those vaccinated from many serious and potentially deadly diseases
                                                                                                    John Hopkins Medicine 2021, accessed 10 March 2021, https://www.hopkinsmedicine.org/health/conditions-and-diseases/
                                                                                                    coronavirus/covid-19-vaccines-myth-versus-fact
      protect other people by helping to stop diseases from spreading to those who cannot
                                                                                                    Full Fact 2021, accessed 10 March 2021, https://fullfact.org/health/there-isnt-pork-in-covid-19-vaccines/
      have vaccines
                                                                                                    National Health Service England 2021, accessed 10 March 2021, https://www.england.nhs.uk/coronavirus/wp-content/uploads/
                                                                                                    sites/52/2021/01/Information_for_UK_recipients_COVID-19_Vaccine_AstraZeneca.pdf
      undergo rigorous safety and efficiency testing in clinical trials before being administered
                                                                                                    National Health Service UK 2019, accessed 10 March 2021, https://www.nhs.uk/conditions/vaccinations/why-vaccination-is-safe-
      to the wider population
                                                                                                    and-important/; https://www.nhs.uk/conditions/vaccinations/bcg-tb-vaccine-side-effects/
                                                                                                    National Health Service UK 2020, accessed 10 March 2021, https://www.nhs.uk/conditions/vaccinations/flu-influenza-vaccine/
      sometimes cause mild side effects but these do not usually last long. Vaccines may
                                                                                                    National Health Service UK 2021, accessed 10 March 2021, https://www.nhs.uk/conditions/coronavirus-covid-19/coronavirus-
      also cause stronger side effects or a reaction, but these occurrences are incredibly rare
                                                                                                    vaccination/coronavirus-vaccine/
                                                                                                    National Health Service Scotland 2021, accessed 10 March 2021, https://www.nhsinform.scot/covid-19-vaccine/the-vaccines/
      reduce or even eliminate some diseases if enough people are vaccinated
                                                                                                    side-effects-of-the-coronavirus-vaccines
                                                                                                    National Organization for Rare Disorders 2021, accessed 17 February 2021, https://rarediseases.org/covid-19-vaccines-update-
                                                                                                    fda-and-cdc-leaders-address-the-rare-disease-community/
                                                                                                    NC State University, 2020, accessed 10 March 2021, https://news.ncsu.edu/2020/12/vaccines-koci-101/
                                                                                                    Northeastern University 2020, accessed 10 March 2021, https://news.northeastern.edu/2020/12/15/allergic-reactions-and-the-
                                                                                                    covid-19-vaccine/

 VACCINES DO NOT:                                                                                   Oxford Vaccine Group 2019, University of Oxford, accessed 10 March 2021, https://vk.ovg.ox.ac.uk/vk/how-do-vaccines-work;
                                                                                                    https://vk.ovg.ox.ac.uk/vk/herd-immunity
                                                                                                    Oxford Vaccine Group 2021, University of Oxford, accessed 10 March 2021 https://www.ovg.ox.ac.uk/news/oxford-university-
      cause autism                                                                                  extends-covid-19-vaccine-study-to-children
                                                                                                    Public Health England 2021, accessed 10 March 2021, https://www.gov.uk/government/publications/covid-19-vaccination-
      overload or weaken the immune system                                                          what-to-expect-after-vaccination/what-to-expect-after-your-covid-19-vaccination;             https://assets.publishing.service.gov.uk/
                                                                                                    government/uploads/system/uploads/attachment_data/file/951769/PHE_COVID-19_vaccination_guide_what_to_expect_after_
      cause allergies or any other conditions                                                       your_vaccination_English_v2.pdf; https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/
                                                                                                    file/955901/Temporary_Authorisation_Patient_Information_BNT162_6_0_UK_clean.pdf;             https://assets.publishing.service.gov.uk/
                                                                                                    government/uploads/system/uploads/attachment_data/file/955848/Information_for_UK_recipients_Moderna_26012021.pdf
                                                                                                    https://www.ovg.ox.ac.uk/news/oxford-university-extends-covid-19-vaccine-study-to-children
                                                                                                    vaccines.gov 2021, U.S. Department of Health & Human Services, accessed 10 March 2021, https://www.vaccines.gov/basics/
                                                                                                    safety/side_effects
                                                                                                    World Health Organization, accessed 10 March 2021, https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-
                                                                                                    19-vaccines

                                                                                                    We thank the adult epidermolysis bullosa (EB) team at Guy’s and St Thomas’ NHS Foundation
                                                                                                    Trust, UK for reviewing the content in this booklet.

 12     DEBRA INTERNATIONAL   COVID-19 VACCINES AND EPIDERMOLYSIS BULLOSA (EB)                                                          COVID-19 VACCINES AND EPIDERMOLYSIS BULLOSA (EB)            DEBRA INTERNATIONAL           13
International.

For the latest information on the COVID-19 vaccines and EB visit:
                    www.debra-international.org

                                                   V. 2021/02 | Publication date 13 April 2021
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