On August 13, 2021, the CDC recommended a third mRNA vaccine dose for moderately to severely immunocompromised individuals who originally received two doses of an mRNA COVID-19 vaccine (Pfizer or Moderna) (https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html). This recommendation is based on studies showing substantive improvement in COVID-19 immunity in such individuals following a third mRNA vaccine dose. No additional COVID-19 vaccine dose of any type (Pfizer, Moderna, J&J) is recommended for immunocompromised individuals who originally received the J&J/Janssen single dose vaccine. Insufficient data are available at this time to determine whether immunocompromised people who received the J&J/Janssen vaccine will have improved protection against COVID-19 infection following an additional dose of this same vaccine.
Pursuant to the CDC guidelines, the Sjögren’s Foundation COVID-19 Vaccination Committee recommends:
- A third dose of mRNA vaccine (Pfizer or Moderna) for individuals with Sjögren’s disease who are currently receiving active treatment with high-dose corticosteroids (i.e. ≥prednisone 20 mg/day or equivalent), methotrexate (Trexall, Otrexup, Rasuvo), mycophenolate (Cellcept) or mycophenolic acid (Myfortic), leflunomide (Arava), cyclophosphamide (Cytoxan), azathioprine (Imuran), cyclosporine (Neoral, Gengraf), tacrolimus (Prograf), tofacitinib (Xeljanz), upadacitinib (Rinvoq), baricitinib (Olumiant), and biologic agents (especially rituximab) for Sjögren’s and/or associated autoimmune/inflammatory diseases.
- A third dose of mRNA vaccine for individuals with Sjögren’s disease who have a second condition that could lead to immunocompromise. This includes:
- Active treatment for cancer, including lymphoma. This does not include excisional treatment for non-melanoma skin cancers.
- Receipt of a solid organ transplant that requires ongoing immunosuppressive therapy
- Receipt of CAR-T cell or hematopoietic stem cell transplant within the past 2 years or ongoing immunosuppressive therapy
- Moderate or severe primary immunodeficiency disorder, including combined variable immunodeficiency
- Advanced or untreated HIV infection
The 3rd dose vaccine should preferably be the same type of mRNA vaccine as the original two-dose series and should be given at least 28 days following the 2nd dose.
There is no need for your physician to verify that you are immunocompromised in order to receive the 3rd vaccine dose. However, you should discuss this with your physician if you are unsure.
Hydroxychloroquine (Plaquenil) is not considered to be immunosuppressive. Thus, individuals on hydroxychloroquine who are not taking the medications listed in #1 above and who do not have other conditions listed in #2 above do not need a 3rd vaccine dose.
As with the original two-dose mRNA vaccination, those on immunosuppressive drugs (listed above) should discuss with their physician whether to temporarily stop these therapies before or immediately after receipt of the 3rd vaccine dose.
Immunocompromised people remain at risk for an inadequate immune response to COVID-19 vaccines, even after a 3-dose series, and thus need to practice personal protection strategies (wear a mask, stay 6 feet away from others, avoid crowds and poorly ventilated spaces, wash your hands often, clean and disinfect, and ensure that those in your family and fellow workers are vaccinated). These strategies are discussed in greater detail at https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html.
These are interim recommendations. As new data emerge regarding duration of the primary vaccine response and efficacy of additional vaccine doses, it is likely that the FDA and CDC will issue revised recommendations. The Sjögren’s Foundation will issue new information as it becomes available.
Janet E. Church
President & Chief Executive Officer
Sjögren’s COVID-19 Vaccination Committee
Alan Baer, MD, Rheumatology and Director of Jerome L. Greene Sjögren’s Syndrome Center, Johns Hopkins, and Chair, Sjögren’s Foundation Medical & Scientific Advisory Council
Cassandra Calabrese, DO, Rheumatology and Infectious Diseases, Cleveland Clinic
Steven Carsons, MD, Chief of Rheumatology, NYU Winthrop; Senior Associate Dean, Translational Science Integration; and Chair, NYU-Winthrop Vaccine Center for Treatment and Evaluation
Nancy Carteron, MD, Rheumatology and Immunology, University of California San Francisco and Sjögren’s Center, University of California Berkeley
Katherine M. Hammitt, MA, Vice President, Medical & Scientific Affairs, Sjögren's Foundation
Marie Wahren-Herlenius, PhD, Professor of Experimental Rheumatology and Department of Molecular & Cell Biology, Karolinska Institute, Sweden