EULAR takes ‘precautionary position’ in support of third, booster COVID-19 vaccine doses
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Citing a lack of available data and time, EULAR has taken a “precautionary position” in support of third and booster COVID-19 vaccine doses for patients with rheumatic and musculoskeletal diseases.
“There are concerns that individuals on certain immunosuppressive or immunomodulatory drugs may not mount an adequate protective response to COVID-19 vaccination,” Robert B.M. Landewé, MD, PhD, of Amsterdam UMC, and colleagues wrote in the Annals of the Rheumatic Diseases. “Data are not currently available to reliably identify who might, or might not, benefit from a third primary dose of a SARS-CoV-2 vaccine. Taking a precautionary position, third primary doses are being recommended by some authorities in selected groups of individuals and EULAR supports this approach.”
Similarly, EULAR cautioned that insufficient time has passed to determine what levels of protection can be expected 4 to 6 months following a primary course of COVID-19 vaccination. Noting that booster doses are being recommended by several authorities, Landewé and colleagues stated the organization supports this approach as well.
The two positions are part of the November 2021 update to the EULAR recommendations for the management and vaccination of patients with rheumatic and musculoskeletal diseases in the context of COVID-19, specifically as “points to consider.” The new update, published in February, is just the third version of EULAR’s COVID-19 recommendations released since the start of the pandemic.
“EULAR’s first set of provisional recommendations addressing several clinical aspects of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the disease caused by SARS-CoV-2, coronavirus disease 2019 (COVID-19), was published in June 2020,” Landewé and colleagues wrote.
“The document addressed the implications of the pandemic for patients with rheumatic and musculoskeletal diseases (RMDs), at a time when very little was known about the epidemiology and the clinical course of patients with RMDs who contracted SARS-CoV-2 infection, and in particular about the risks that patients with RMDs faced, as well as preventive measures that these patients and their caregivers should take,” they added. “The task force that dealt with the matter was — from a scientific point of view — flying blindly and had to rely on sparse clinical experience, a lot of common sense and a paucity of scientific evidence.”
To update its COVID-19 recommendations using a more measured and evidence-based approach — in contrast to the atmosphere of urgency that produced their first provisional recommendations in June 2020 — the EULAR task force took the time to carefully follow standard operating procedures. The task force included 26 experts from 11 EULAR member states and two experts from the United States. Landewé, as chair of EULAR’s committee for the quality of care, was a member of the task force.
The procedure involved four separate video conferences between task force members, establishing research questions for, and discussing the results of, two tiers of systematic literature reviews. The task force reached a consensus regarding updated overarching principles and recommendations during its third virtual meeting. A fourth meeting was convened to inform members of the post hoc literature review limited to vaccination studies. It was during this meeting that members reached a consensus on the two additional points to consider on third and booster vaccine doses.
The latest update includes five overarching principles and reduces the total number of recommendations from 13 to nine. The nine recommendations are:
- Patients with rheumatic and musculoskeletal diseases should be strongly advised to follow all prevention and control measures detailed by publish health authorities, both prior to and following vaccination;
- Patients should be counseled to receive COVID-19 vaccination with any of the formulations approved in their country;
- Patients who have received a COVID-19 vaccine should be advised to continue their treatment unchanged, while those who have not been vaccinated should continue with their therapy with the understanding that certain drugs have been associated with an increased risk for severe COVID-19;
- If an individual receiving long-term glucocorticoids develops suspected or confirmed COVID-19, this treatment should be continued;
- In the event a patient receiving rituximab (Rituxan, Genentech) contracts COVID-19, delaying the next treatment cycle should be considered;
- Patients with initially mild COVID-19 who later develop worse symptoms should seek immediate advice from an expert in treating the disease;
- Patients with rheumatic and musculoskeletal diseases should update their general vaccination status, with a focus on pneumococci and influenza;
- Among patients not using immunomodulatory or immunosuppressive drugs, COVID-19 vaccination should precede a treatment start with such therapy if feasible; and
- In patients receiving rituximab or other B-cell depleting therapy, COVID-19 vaccination should be timed as to maximize vaccine immunogenicity.
“The task force hopes that these updated, now more evidence-based, recommendations on how to manage patients with RMDs in the context of SARS-CoV-2 and COVID-19 give HCPs the tools to make clinical decisions about SARS-CoV-2 prevention, DMARD management and SARS-CoV-2 (re)vaccination,” Landewé and colleagues wrote. “More importantly, it hopes that it will help build confidence among patients with RMDs that, (in general), their risk of severe COVID-19 is not importantly increased and that SARS-CoV-2 (re)vaccination, crucial to finally contain the pandemic, can safely take place.”
Perspective
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EULAR’s first recommendations for the management and vaccination of patients with COVID-19 were initially made in 2020. A formal update was then started in January 2021 and, as more data emerged, a systemic review of the literature was performed. In July 2021, a set of overarching principles and recommendations were provided and in the November 2021 update, two additional recommendations and points to consider were added.
The first recommendation was to suggest COVID-19 vaccine prior to initiating therapy with immunosuppressants or immunomodulators, and the second was to schedule COVID-19 vaccines in patients on Rituxan (rituximab, Genentech) or B-cell depleting therapy to maximize immune response.
The first additional point to consider was whether patients should take a third primary dose of the COVID-19 vaccine. The second point to consider was the waning protection of the vaccine over 4 months to 6 months after the primary course. EULAR supported a booster dose when recommended in certain populations.
The EULAR recommendations and points to consider will greatly aid in the management and treatment of patients with rheumatic disease, and will assist rheumatologists in their treatment of patients. With the dramatic rise in information on SARS-CoV-2 and the COVID-19 virus, the landscape on the management of rheumatic disease seems to be continuously shifting, and we can look forward to more updates in the coming months.
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