RSV Vaccination in Patients on Hydroxychloroquine and Methotrexate
Yes, the RSV vaccine can and should be administered to patients taking hydroxychloroquine (Plaquenil) and methotrexate, as all currently approved RSV vaccines are non-live recombinant subunit vaccines that are safe for immunocompromised patients. 1, 2
Vaccine Safety Profile for Immunosuppressed Patients
The approved RSV vaccines (Arexvy/RSVPreF3 and Abrysvo/RSVpreF) are completely inactivated recombinant protein subunit vaccines containing no live viral particles and cannot replicate in the human body. 2 This makes them fundamentally safe for patients on immunosuppressive therapy, including those taking methotrexate and hydroxychloroquine. 1, 2
Key distinction: Unlike live-attenuated vaccines (such as the old Zostavax for shingles), these RSV vaccines carry no risk of vaccine-strain infection or disseminated disease in immunocompromised individuals. 3
Vaccination Recommendations Based on Age and Risk Factors
For Patients Aged ≥60 Years
- All adults aged ≥60 years should receive RSV vaccination, with immunocompromise (including those on DMARDs like methotrexate) being a recognized risk factor for severe RSV disease. 1, 2
- Adults aged ≥75 years should receive vaccination regardless of other comorbidities due to significantly elevated hospitalization and mortality rates. 1
For Patients Aged 50-59 Years
- Adults in this age range with risk factors (including immunocompromise from methotrexate therapy) should receive RSVPreF3 (Arexvy), which is the only vaccine currently approved for this younger age group. 1, 2
Medication Management Around Vaccination
Critical consideration: While the RSV vaccine itself is safe to administer, you should consider whether to hold methotrexate around the time of vaccination to optimize immunogenicity.
Methotrexate-Specific Guidance
- Current ACR guidelines conditionally recommend continuing methotrexate around the time of non-influenza vaccinations (which includes RSV vaccines). 4
- The evidence for holding methotrexate applies primarily to influenza vaccination, where holding for 2 weeks post-vaccination improves immunogenicity. 4
- For RSV vaccination specifically, there are no published studies addressing whether holding methotrexate improves vaccine response. 4
Hydroxychloroquine
- Hydroxychloroquine does not require any dose adjustment or holding around vaccination time. 4
- This medication is considered a mild immunosuppressant that does not significantly impair vaccine responses. 4
Practical Administration Algorithm
Verify age and indication: Confirm patient is ≥60 years (or ≥50 years with risk factors including immunosuppression). 1, 2
Select appropriate vaccine: Either RSVPreF3 (Arexvy) or RSVpreF (Abrysvo) for patients ≥60 years; only RSVPreF3 for ages 50-59 years. 1, 2
Timing: Preferably administer between September and November before RSV season peaks. 1, 2
Methotrexate decision: Continue methotrexate per current guidelines, though shared decision-making with the patient's rheumatologist may be considered if disease activity is stable and optimizing vaccine response is a priority. 4
Co-administration: RSV vaccine can be given simultaneously with influenza vaccine at different injection sites. 4, 1, 2
Dosing: Single 0.5 mL intramuscular injection; currently recommended as a one-time dose with no booster indicated. 1, 2
Important Clinical Caveats
Patient attestation is sufficient: Do not require extensive medical documentation of immunosuppressive therapy or risk factors, as this creates unnecessary barriers to vaccination. 1, 2
Previous RSV infection: Does not confer long-lasting immunity and does not contraindicate vaccination. 1, 2
Safety monitoring: Postlicensure surveillance has identified a potential increased risk of Guillain-Barré syndrome after protein subunit RSV vaccination, though this remains rare. 1
Expected side effects: Most common adverse events include injection site pain, fatigue, myalgia, and headache, which are typically mild to moderate and transient. 4, 5, 6