By Salvatore Alesci, MD, PhD, Beyond Celiac Chief Scientist and Strategy Officer
Updated August 23, 2021 to reflect that Pfizer-BioNTech coronavirus vaccine was granted full FDA approval.
In the United States, there is now one fully FDA-approved COVID-19 vaccine, Pfizer-BioNTech, along with two COVID-19 vaccines currently available under Food and Drug Administration Emergency Use Authorization. The three vaccines have been developed by Pfizer, Moderna and Janssen (Johnson & Johnson). Clinical trials of all three of these vaccines show they are highly effective against hospitalizations and death from COVID-19.
There are currently no specific head-to-head comparison studies on these three vaccines available in the US, so any comparison on safety and efficacy is based on data from trials that ran independently with each of the vaccines.
Beyond Celiac is not aware of any specific published, publicly available or anecdotal report of severe adverse events related to administrations of any of the three vaccines in celiac disease patients.
Similar to the Pfizer and Moderna mRNA vaccines, the Johnson & Johnson vaccine was authorized by the FDA under an emergency use authorization. However, what is especially relevant is that all three of these vaccines are close to 100 percent effective in preventing COVID-19-related hospitalization and death.
The Johnson & Johnson vaccine was shown to be 72 percent protective against moderate to severe COVID-19 in the US (vs 95 percent for Pfizer and Moderna) but 85 percent effective overall in reducing severe disease. Those rates are above the thresholds originally set by the FDA for a vaccine to be considered useful.
There were no hospitalizations or deaths reported among people in the vaccine arm of the Johnson & Johnson clinical trials, which points to its very good safety profile. This is even more impressive considering that trials run with the Johnson & Johnson vaccine included a larger number of high-risk people (i.e., hypertension, diabetes, HIV, >60 years old, and so forth) and also populations deemed vulnerable to COVID-19 (i.e., Hispanics, South Africans, where people were also potentially exposed to more aggressive mutations of the COVID-19 virus).
The Pfizer and Moderna Vaccines are RNA-based (i.e., mRNA is delivered to produce a viral protein that induces the immune response needed to achieve protection), and the Johnson & Johnson COVID-19 vaccine is DNA-based. The DNA is shuttled to the cell nucleus via an adenoviral vector (i.e, an adenovirus, a different type of virus from the one causing COVID-19, that is engineered in a way that can’t replicate or cause disease). There is no scientific rationale to believe that either of these mechanisms could put patients with celiac disease at higher risk. Even if some viruses have been identified as a trigger for celiac disease, the most recent scientific evidence suggests that adenoviruses don’t belong to this category. Further, as pointed out, the adenovirus used in the vaccine is modified, and cannot replicate or cause disease.
As of today, no one who has received a COVID-19 vaccine died from COVID-19, a very important statistic.
Beyond Celiac encourages all members of the celiac disease community to receive a COVID-19 vaccine as soon as they are able. Both currently approved mRNA vaccines (Moderna and Pfizer) require two doses to be effective, while the DNA vaccine (Johnson and Johnson) requires one dose. You should make the decision to receive the vaccine in consultation with your doctor, who knows your personal health history. The Beyond Celiac recommendation is based on CDC guidelines along with publicly available evidence and the expert opinion of our science team.
The information above is not intended nor suited to be a replacement or substitute for professional medical treatment or for professional medical advice relative to a specific medical question or condition. The above information is not intended to replace a doctor/patient relationship with any physician. There is no replacement for personal medical treatment and advice from your personal physician.
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