Study endpoints
The primary endpoint of the study included the long-term safety of the
BNT162b2 mRNA vaccine, as evaluated by side-effects following the second
and third doses in adolescents with AIIRDs compared with healthy
controls, and the impact of vaccination on clinical disease activity in
the patient group. The secondary endpoints were long-term immunogenicity
of the BNT162b2 mRNA vaccine in adolescents with AIIRDs measured at
2–8 weeks and 6 months after the second vaccine and at 2–8 weeks after
the third vaccine dose, compared with controls. Breakthrough COVID-19
infections were recorded based on positive SARS-CoV-2 polymerase chain
reaction (PCR) tests, documented ≥14 days following vaccination.