Safety and immunogenicity of BNT162b2 mRNA COVID-19 vaccine in adolescents with rheumatic diseases treated with immunomodulatory medications

Abstract

Objectives Adolescents with juvenile-onset autoimmune inflammatory rheumatic diseases (AIIRD) could be at-risk for disease flare secondary to SARS-CoV-2 infection or to withholding anti-inflammatory therapy. While vaccination can protect against COVID-19, safety and immunogenicity data regarding anti-SARS-CoV-2 vaccines among adolescents with AIIRD are limited. This international, prospective, multicentre study evaluated the safety and immunogenicity of the BNT162b2 anti-SARS-CoV-2 vaccine among adolescents and young adults with juvenile-onset AIIRD, 80% of whom are on chronic immunomodulatory therapy. Methods Vaccine side effects, disease activity, and short-term efficacy were evaluated after 3 months in 91 patients. Anti-spike S1/S2 IgG antibody levels were evaluated in 37 patients and 22 controls, 2–9 weeks after the second dose. Results Ninety-one patients and 40 healthy controls were included. Safety profile was good, with 96.7% (n = 88) of patients reporting mild or no side-effects, and no change in disease activity. However, 3 patients had transient acute symptoms: 2 following the first vaccination (renal failure and pulmonary haemorrhage) and 1 following the second dose (mild lupus flare vs viral infection). Seropositivity rate was 97.3% in the AIIRD group compared with 100% among controls. However, anti-S1/S2 antibody titres were significantly lower in the AIIRD group compared with controls (242 ± 136.4 vs 387.8 ± 57.3 BAU/ml, respectively; p< 0.0001). No cases of COVID-19 were documented during the 3-month follow-up. Conclusion Vaccination of juvenile-onset AIIRD patients demonstrated good short-term safety and efficacy, high seropositivity rate, but lower anti-S1/S2 antibody titres compared with healthy controls. These results should encourage vaccination of adolescents with juvenile-onset AIIRD, even while on immunomodulation.

SARS-CoV-2 vaccine safety in adolescents with inflammatory rheumatic and musculoskeletal diseases and adults with juvenile idiopathic arthritis: data from the EULAR COVAX physician-reported registry

“… 26 Existing data on adolescents with RMDs has also showed similarly low levels of vaccine AEs and disease flares across their cohort, as well as post-vaccine SARS-CoV-2 infection, although this was limited to a 3-month follow-up period. 27 Patient-reported survey data from Turkey on Pfizer/CoronaVac vaccine AEs among adolescents and young adults with RMDs also showed low levels of serious AEs and early reactogenic-like AEs, although reported higher levels of disease flare (11%). 28 The Global Rheumatology Alliance also conducted a survey among adults with RMDs to capture their early experiences of SARS-CoV-2 vaccination, again with similar proportions of common AEs and very few serious AEs, while 13% reported a postvaccine disease flare, 29 perhaps related to the difficulty in distinguishing some reactogenic-like AEs from rheumatic disease flares (eg, arthralgia, myalgia, fatigue), and the tendency for these reactogenic-like AEs to be more often interpreted by patients as rheumatic disease flares.…”

EULAR/PRES recommendations for vaccination of paediatric patients with autoimmune inflammatory rheumatic diseases: update 2021

“…The past months (after these recommendations were completed) the first studies became available on the BNT162b2 mRNA COVID-19 vaccine 144–147. These first reports show good short-term immunogenicity (97%–100% seropositivity in patients 1–3 months postvaccination) and only mild AE, including children on TNFi 145 146. Flares after vaccination were reported, but no case control studies have been performed yet 147.…”

Apparent lack of association of COVID-19 vaccination with Herpes Zoster

“… 11 , 12 In individuals with underlying conditions that may impair immunity or those receiving immunomodulating therapy, observations indicate Covid 19 vaccination is efficacious and safe. 13 Nonetheless, concerns about the safety of vaccines produced over a short time span and the hesitancy about unforeseen side effects are barriers towards reaching vaccination goals. 14 , 15 …”