Update December 16, 2020, from the Society for the Study of Celiac Disease (SSCD):
As scientists and clinicians who care for people with celiac disease, we urge people with celiac disease to receive a Covid-19 vaccine that has met government regulatory approval. This includes agents comprised of RNA (a vaccine technology that has been in development and has undergone safety testing for years) and peptide (protein) vaccines.
Update December 14, 2020, from the FDA:
On December 11, 2020, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.
WHO SHOULD NOT GET THE PFIZER-BIONTECH COVID-19 VACCINE?
You should not get the Pfizer-BioNTech COVID-19 Vaccine if you:
WHAT ARE THE INGREDIENTS IN THE PFIZER-BIONTECH COVID-19 VACCINE?
The Pfizer BioNTech COVID-19 Vaccine includes the following ingredients: mRNA, lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3- phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose
by the Beyond Celiac team
On December 8, 2020, 90-year-old Briton Margaret Keenan became the first person to receive a shot of Pfizer/BioNTech’s COVID-19 vaccine as a part of the UK’s mass vaccination program for the novel coronavirus. This marked a giant leap forward in the fight against this global pandemic.
The U.S. Food and Drug Administration is expected to follow suit with approval of this vaccine in the coming days or weeks. Yet as the world begins to roll out these vaccines for COVID-19, we’ve received a number of inquiries from our community about their safety along with the safety of vaccines in general for those with celiac disease.
To help answer some of the most common questions we’re receiving, we asked Salvo Alesci, MD, Beyond Celiac chief scientist and strategy officer for his thoughts. Below are his responses.
Are the COVID-19 vaccines safe for those with celiac disease?
There is no scientific evidence for the time being to indicate that the Pfizer or Moderna vaccines (or any other being developed for COVID-19) could be less safe and/or effective in the celiac population vs. the general population.
Note: UK regulators advised people with severe allergies/previous anaphylactic reactions to not get the new Pfizer vaccine (npr.org/sections/coronavirus-live-updates/2020/12/09/944539982/u-k-regulators-tell-people-with-severe-allergies-not-to-get-vaccine). As a reminder, celiac disease is an autoimmune disease and not an allergy.
Are messenger RNA (mRNA) vaccines safe for those with celiac disease?
Information released so far indicates that these vaccines appear to be safe and effective, but there has been no specific mention of the celiac disease population. We put trust the regulatory process.
Since both vaccines are under emergency use authorization and still going through the formal approval process, we shall wait for the FDA to determine the overall safety and efficacy on such vaccines. And even after regulatory approval, as with any drug, it will not be until the vaccine reaches millions of people that we will have more robust data to have a better picture on safety and efficacy in the general population as well as in subpopulations like patients with celiac disease.
Regulators mandate companies to have safety surveillance and life cycle management programs after approval is granted to continue assessing safety and efficacy of the treatments.
Are vaccines in general safe for those with celiac disease?
All currently available vaccines worldwide that are parenterally administered can be safely taken by celiac patients, as stated by the University of Chicago Celiac Disease Center (https://www.
cureceliacdisease.org/faq/are- childhood-vaccines-safe-to- administer-to-a-child-with- celiac-disease/).
There is also no evidence that vaccine administration can cause celiac disease, as concluded by a couple of studies, including a pretty large Swedish study (https://www.reuters.com/
article/us-vaccinations- celiac/vaccinations-cleared- in-babies-celiac-epidemic- idUSBRE85P14220120626; https://onlinelibrary.wiley. com/doi/abs/10.1111/j.1651- 2227.2000.tb01210.x; https://pediatrics. aappublications.org/content/ 130/1/e63).
A few studies, including work done by Joseph Murray, MD, have shown that a particular type of vaccine, the one for hepatitis B may be less effective in celiac disease patients. The reason is not clear. Genetics may be a factor. However, it was shown that adherence to the gluten-free diet may be another factor. In fact, researchers found that if children are on a gluten-free diet, then the response to this vaccine is similar to people who don’t have celiac. Also, children who originally did not respond well to the vaccine, develop a better response after a gluten-free diet. If anything, the lesson here is that if a child doesn’t respond to HBV vaccination, they should be tested for celiac disease (https://pubmed.ncbi.nlm.nih.
gov/14572581/; http://www.ncbi.nlm.nih.gov/ pubmed/18519462; http://www.ncbi.nlm.nih.gov/ pubmed/19584738).
There has been a report of a higher rate of celiac disease in women who received a vaccine for HPV, which aims at preventing cervical cancer. However, the authors noted that women who received the shots and subsequently were diagnosed might have had their celiac disease “unmasked” because they talked to their doctors about their celiac symptoms when they received their HPV shots (https://onlinelibrary.wiley.
The information found on this page is not intended to be a replacement or substitute for professional medical treatment or for professional medical advice relative to a specific medical condition. We urge you to always seek the advice of your physician. There is no replacement for personal medical treatment and advice from your personal physician.