Vaccinating patients on biologics for atopic disease: Clinical considerations and evidence-based recommendations

Background: Biologics that target type 2 inflammation have transformed the management of atopic diseases, but questions remain with regard to vaccine administration in these patients. Current product labeling recommends caution with vaccine administration in patients taking these medications, particularly live-attenuated vaccines, despite limited evidence of actual risk. Objective: The objective was to review clinical concerns and available evidence, and to provide practical recommendations for vaccination in patients receiving biologics for atopic diseases, with a focus on dupilumab. Methods: A comprehensive PubMed/MEDLINE literature search was conducted to identify relevant studies and clinical guidance with regard to vaccination strategies in patients receiving biologic therapy. The primary search terms included the following: "biologic therapy" or "biologic therapy" or "monoclonal antibodies" combined with "vaccination" or "immunization" or "vaccine response" or "live vaccines" or "inactivated vaccines." Priority was given to randomized controlled trials, large observational studies, and registry data published within the past 10 years. Results: For non-live vaccines, evidence supports safety and efficacy, although results of some studies suggest moderately reduced responses. A randomized controlled trial found comparable antibody responses between dupilumab and placebo groups for tetanus (83.3% versus 83.7%) and meningococcal vaccines (86.7% versus 87.0%). Coronavirus disease 2019 (COVID-19) vaccine studies show mixed results, with some reporting lower antibody levels and neutralization capacity in patients on biologics. For live-attenuated vaccines, emerging evidence challenges traditional prohibitions. Conclusion: Current evidence supports the safety and efficacy of non-live vaccines in patients receiving biologics for atopic diseases, although responses may be moderately reduced. Analysis of emerging data suggests certain live-attenuated vaccines may be safer than previously thought, particularly in pediatric patients on dupilumab. Vaccination decisions should be individualized based on risk-benefit assessment. Further research is needed to establish definitive guidelines, particularly for live vaccines and long-term immunity.