The Sjögren’s Foundation is recommending that people with Sjögren’s syndrome ages 16 and older be vaccinated against COVID-19 infection, and advices patients to talk with their healthcare provider about potential decisions and vaccination timing.
The recommendation, released online in a statement, was based on safety and effectiveness data made available to the public, and on the expert opinion of the foundation’s Sjögren’s-COVID-19 Vaccination Committee, composed of rheumatology and immunization experts.
Established in December 2020, the committee comprehensively analyzed the mode of action, effectiveness, side effects, and risk factors of the two currently distributed vaccines in the U.S. — the Pfizer-BioNTech and the Moderna vaccines.
It aimed to determine whether to recommend these vaccines to Sjogren’s syndrome patients, if vaccination is more urgent in specific patients, and whether one vaccine might be better than the other.
“Based on what we know and the mechanism of action of these vaccines, we expect these vaccines to be safe in people affected by Sjögren’s. We thus recommend COVID vaccination for individuals with Sjögren’s, given their demonstrated efficacy against a deadly disease and favorable side effect profile,” the statement read.
It is to be updated as new information is made available, and is consistent with guidelines established by the U.S. Centers for Disease Control and Prevention (CDC) and other professional healthcare organizations.
Both available vaccines are mRNA-based, meaning that they work by delivering messenger RNA (mRNA) — the molecule generated from DNA that serves as template for protein production — to cells rather than weakened viruses or protein fragments of the virus.
After entering cells, the mRNA containing the instructions to produce a virus-specific protein is used by the cell to produce that protein, which then is “shown” to immune cells to induce an immune response. It also creates memory of that virus so that in the likelihood of exposure, the body is able to promote a prompt immune reaction against it.
Of note, the delivered mRNA does not integrate with the person’s DNA.
Based on their mechanism of action, these vaccines are expected to be safe and have minimum risks in people with Sjögren’s syndrome, the foundation stated.
This is in agreement with a December CDC guidance statement noting that “people with autoimmune conditions may receive an mRNA COVID-19 vaccine,” but “they should be aware that no data are currently available on the safety” of such vaccines for these patients.
The vaccines’ safety and effectiveness have been proven in clinical trials that involved more than 75,000 people, of whom 40% were considered at risk of developing severe COVID-19 infection based on their age (65 years or older) and/or the presence of simultaneous medical conditions. These included diabetes, chronic lung disease, severe obesity, cardiovascular disease, liver disease, HIV infection, and autoimmune disease.
Children younger than 16 were not included in these trials, and the vaccines are only approved for people age 16 and older (the Pfizer-BioNtech vaccine) or 18 and older (the Moderna vaccine).
As such, the foundation recommends that the decision to vaccinate children with Sjögren’s be made in consultation with the treating healthcare team.
While vaccine-induced flares in Sjögren’s patients have never been reported with any COVID-19 or other vaccine, the foundation expects that if they occur, these flares would be mild and easily managed and should not be a reason against vaccination.
In addition, some data suggest that the vaccine’s effectiveness may be reduced if given close to a dose of methotrexate or rituximab — two immunosuppressive treatments commonly used off label with Sjögren’s patients. Patients are advised to discuss the timing of the COVID-19 vaccine in relation to the dosing of such treatments with their rheumatologist.
“This decision must be individualized in order to balance the risk of a disease flare while stopping these medications temporarily versus ensuring an optimal response to the vaccine,” the foundation said in the statement.
Available data also indicate that Sjögren’s patients with simultaneous health conditions or disease-related chronic lung or kidney disease may be at higher risk of complications from COVID-19, suggesting that these specific groups should be extra careful and receive the vaccine as soon as possible.
The foundation also noted that, to date, available data does not favor one vaccine over the other.
Additional information is continuously being collected from the millions of people receiving these vaccines around the world.
“We anticipate learning more as additional people are vaccinated and data gathered,” the foundation said.
The U.S. vaccination plan prioritizes healthcare workers and those in nursing homes, to be followed by people older than age 74 and other essential frontline workers, such as those in grocery stores and teachers.
Individual states, however, can differ in their ranking of priority groups by profession, age, or risk.
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