Vaccines Generally Appear Safe for Kids on Biologic Therapy

NEW YORK (Reuters Health) – Available data and real-world experience on vaccine safety in children on most immune-modifying biological (IMB) agents are “encouraging,” with few serious adverse events and a low risk of worsening the underlying disease, according to a new report.

Over the past two decades immune-modifying biologics (IMB) have “revolutionized” the treatment of immune-mediated and auto-inflammatory diseases, due to their efficacy, rapid onset of action and favorable tolerability, Dr. Baldassarre Martire of Monsignor A.R. Dimiccoli Hospital in Barletta, Italy, and colleagues note in The Journal of Allergy and Clinical Immunology: In Practice.

Patients with disorders are more susceptible to common and opportunistic pathogens, making immunization strategies to control vaccine-preventable diseases a “critical” issue in this population, they point out.

However, there are limited data on the safety, immunogenicity and efficacy of available vaccines in patients on biologics, particularly in children.

In their 40-page report, Dr. Martire and colleagues offer a practical approach to help clinicians make vaccine decisions in children receiving biologics, based on a review of the available literature, the real-life experience and practice of the Italian Society of Pediatric Allergology and Immunology (SIAIP) Vaccine Committee and of the Italian Primary Immunodeficiency Network (IPINET) Centers.

Among the key statements and recommendations:

– Safety concerns essentially regard live vaccines, but multifactorial interactions may affect immunogenicity and efficacy for select vaccines.

– Vaccine schedule should be individualized according to the clinical and immunological status of the patient.

– Once IMB have been planned, patient’s vaccination status should be documented and incomplete vaccinations should be completed whenever possible.

– If the treatment has already been started, vaccinations should be administered ideally during disease remission and when the immunosuppression is at its lowest level.

– Patients on IMB should be advised of potential suboptimal immune response.

– Inactivated vaccines should be preferably given two weeks before the initiation of biologics. Conversely, live attenuated vaccines are generally contraindicated during and for weeks to months after stopping IMB.

– Live vaccines should be administered at least four weeks before the initiation of biologic drugs, unless contraindicated by a condition or other therapies.

– Serology testing for varicella zoster virus (VZV) and hepatitis B virus (HBV) should also be considered.

– For some pathogens, low persistence of protective antibody levels has been demonstrated since the biological therapy seems to accelerate the decline of vaccine-induced antibody concentrations. Therefore, in these cases administration of booster vaccines is important to ensure long-term protection.

– In general, there is no need to routinely assess antibody titers either before or after the vaccination program, since they may not be predictive of long-term protection as cellular immunity can persist regardless of antibody levels.

– Specific antibody testing should be considered case by case. Studies on post-vaccine cellular response in children on biological agents are required to evaluate its role in long-term protection against vaccine-preventable diseases and design optimal vaccine schedule.

Summing up, the researchers say “protection of children receiving biologicals is a priority and, as new data emerge, the potential risk of vaccine adverse effects or suboptimal responses should be appropriately balanced.”

SOURCE: https://bit.ly/3Gwpz4c The Journal of Allergy and Clinical Immunology: In Practice, online January 24, 2022.

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