Safety of the BNT2b2 vaccine
The safety profile of the 3 vaccine doses was favourable, with most
participants experiencing either no or mild side-effects (Table 2).
Local reactions to vaccination were more common among AIIRD patients
compared with controls at 2–8 weeks after the second vaccination, 71%
(n=88) and 55% (n=44), p=0.0293, respectively; whereas after the third
vaccine dose, AIIRD patients had significantly fewer local reactions
than controls did, 39% (n=25) vs. 73% (n=22), p=0.004, respectively.
The prevalence of systemic side-effects was comparable between patients
with AIIRD and controls. The most common systemic side-effects were
fatigue, myalgia, headache and arthralgia, with a comparable prevalence
among AIIRD patients and controls. Importantly, there were no serious
side-effects in either group. No cases of pericarditis or myocarditis
were observed. Five patients (4%) experienced an exacerbation of
rheumatic disease shortly after the first vaccine dose and 3 patients
(2%) after the second dose. Two patients, both with AAV, were
hospitalized shortly after the first vaccine dose, as previously
reported by our group. None of the patients who received the third
vaccine reported subsequent rheumatic disease exacerbation or
hospitalization. Disease activity remained stable at 1-year clinical
follow-up in all patients.