medwireNews: Findings from three studies provide further support for the effectiveness and safety of COVID-19 vaccines in young people with rheumatic and musculoskeletal diseases (RMDs).
‘Excellent’ effectiveness of mRNA vaccine in adolescents
In the first study, Yosef Uziel (Meir Medical Center, Kfar Saba, Israel) and team used data from an Israeli insurance database to assess the ability of the Pfizer–BioNTech (BNT162b2) mRNA vaccine to prevent SARS-CoV-2 infection in 1639 adolescents aged 12–18 years with juvenile-onset RMDs.
This addresses an important knowledge gap, because most previous studies conducted in this population “have evaluated the immunogenicity (ability to induce humoral and cellular immune responses) of vaccines, rather than the effect of vaccination on infection rates (i.e. vaccine efficacy or effectiveness),” explain the researchers in Rheumatology.
In all, positive SARS-CoV-2 tests were reported in 16.9% of adolescents with RMDs who were vaccinated in February–December 2021 and in 51.9% of those who were not vaccinated. The median follow-up time after vaccination was 21.6 weeks, 19.0 weeks, and 8.9 weeks after the first, second, and third dose, respectively.
When the analysis was restricted to those who received at least two vaccine doses, COVID-19 occurred in 2.1% of 1009 adolescents with RMDs, and in 2.1% of 292,445 adolescents without RMDs who were vaccinated during the same period.
The researchers then calculated estimates for vaccine effectiveness, defined as one minus the risk ratio for vaccination relative to no vaccination. They say that this was “excellent,” and similar in the adolescents with versus without RMDs after one (76.3 vs 66.1%), two (94.8 vs 93.0%), and three (99.2 vs 99.5%) doses.
Uziel et al say that their study also “demonstrates that immunomodulatory drug treatment did not affect the effectiveness of the vaccine.”
Analysis of the cohort by diagnosis and drug treatment revealed that none of the patients with juvenile idiopathic arthritis (JIA) treated with an immunomodulatory agent – namely methotrexate (n=47), tumor necrosis factor inhibitors (n=84), or tocilizumab (n=7) – contracted COVID-19 after their second vaccine dose. Among the 91 adolescents with systemic lupus erythematosus (SLE), none of those who received two or three vaccine doses developed COVID-19 after completing their vaccinations.
“These results can encourage adolescents with [RMDs] to get vaccinated against COVID-19,” conclude the researchers.
Reassuring safety results in adolescents with a range of RMDs
The second study, from Kimme Hyrich (Manchester University NHS Foundation Trust, UK) and team, focused on the safety profile of COVID-19 vaccination in 36 adolescents (median age 15 years) with RMDs – including JIA (42%), SLE (14%), and spondyloarthropathies (14%) – who were included in the EULAR COVAX registry in 2021–2022.
The vast majority (92%) of patients were given the Pfizer–BioNTech vaccine; 44% had received the full recommended course of vaccinations, while the remaining 56% were partially vaccinated.
The team reports that disease flares postvaccination were “rare,” with one reactive arthritis patient experiencing a mild flare of polyarthralgia. Over half (56%) of patients experienced early adverse events (AEs) following vaccination, primarily fever (25%), injection site pain (22%), and generalized muscle pain (17%).
These AEs were “not unexpected as they are considered normal minor early side effects in the general population,” write the study authors in RMD Open.
“Overall, these data present a reassuring picture of rare disease flares and AEs after full or partial SARS-CoV- 2 vaccination,” they conclude.
Vaccination well tolerated in patients with Kawasaki disease
The final study used electronic medical records from 2020–2022 to describe the safety outcomes of 153 patients with Kawasaki disease (KD) aged an average of 13 years (range 5–21 years) who received at least one dose of an mRNA COVID-19 vaccine, primarily the Pfizer–BioNTech vaccine (93.5%).
Michael Portman and colleagues, from the Seattle Children’s Research Institute in Washington, USA, say that no clinically severe AEs, clinician or emergency department visits, or hospitalizations occurred within 30 days of vaccination in this cohort.
The team also evaluated outcomes of COVID-19 infection in a cohort of 37 individuals with KD (mean age 11 years), 10 of whom were vaccinated at the time of infection. None of the patients included in the study required hospital admission, and the most common symptoms – low-grade fever, fatigue, myalgia, and cough – resolved within a few days.
“Results of our study suggest that both COVID-19 and SARS-CoV-2 mRNA vaccination are well tolerated in patients with preceding KD,” concludes the team in JAMA Network Open.
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