medwireNews: Study findings suggest that messenger (m)RNA vaccines against SARS-CoV-2 have good short-term safety and immunogenicity profiles in adolescents with juvenile-onset rheumatic diseases.
“While data on adult patients are accumulating, information on the safety and immunogenicity of COVID vaccines among adolescents with [rheumatic diseases] are limited,” say Merav Heshin-Bekenstein (Tel Aviv Sourasky Medical Center, Israel) and co-authors.
“Therefore, there is still hesitancy among patients and caregivers, with resultant sub-optimal vaccination rates,” they add.
The study included 91 adolescents and young adults (mean age 15.9 years) with juvenile-onset rheumatic diseases, most commonly juvenile idiopathic arthritis (JIA; 46%) or systemic lupus erythematosus (SLE; 14%), who had received two doses of the Pfizer–BioNTech (BNT162b2) mRNA vaccine given 3 weeks apart. The majority (80.2%) were on immunomodulatory therapy, with 39.7% on conventional DMARDs and 37.4% on biologics.
Heshin-Bekenstein and team report in Rheumatology that “[t]he safety profile of the vaccine was good,” with minimal or no adverse events (AEs) reported in 96.7% of patients. There were no significant differences in rates of local and systemic AEs between these people and a cohort of 40 healthy controls with a mean age of 14.0 years.
A total of three (3.2%) patients with rheumatic diseases experienced severe transient AEs, including two individuals with systemic vasculitis treated with rituximab who had short-term disease exacerbation and required hospitalization following the first vaccine dose, and one patient with SLE on hydroxychloroquine who required emergency department treatment for fever, headache, vomiting, and arthralgia following the second dose.
The researchers say that disease activity remained stable in 94.4% of participants following the first vaccine dose and in 98.8% following the second dose.
They then compared vaccine immunogenicity in 37 patients and 22 controls with available serum samples at 2–9 weeks after the second dose, finding that a comparable 97.3% and 100%, respectively, tested positive for immunoglobulin G antibody levels against the SARS-CoV-2 spike protein. However, mean antibody levels were significantly lower among the adolescents with rheumatic diseases than controls, at 242.0 versus 387.8 binding antibody units/mL.
There were no cases of COVID-19 reported in either study group during 3 months of follow-up postvaccination.
“Our results should provide reassurance to physicians, patients and families with [rheumatic diseases] regarding the short-term safety and immunogenicity of the mRNA COVID-19 vaccine, even while on immunomodulatory therapy,” write the researchers.
They recommend that “further studies are needed to determine the safety of the vaccine over time, the duration of the vaccine-induced immune response, and its actual correlation with COVID-19 prevention in our patients.”
medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2022 Springer Healthcare Ltd, part of the Springer Nature Group
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