Safety outcomes
As a primary safety outcome, we tracked ARs for 7 days and AEs for 28
days after each dose. IEI patients receiving both vaccines mainly
reported mild and moderate ARs (Fig. 1). Severe ARs, e.g. pain at
injection site and fatigue, were reported in some patients receiving
BNT162b2 but not CoronaVac, in line with previous findings in healthy
adolescents of milder reactogenicity with CoronaVac.15Eight AEs were reported within 28 days after BNT162b2 (n=4) or CoronaVac
(n=4), including rash (n=3), chest discomfort (n=3), nodule in tongue
(n=1) and lymphadenopathy (n=1), which were all of mild severity. One
patient reported two non-fatal resolved severe AE (asthma exacerbation
and poisoning respectively) 107 days after dose 2 and 73 days after dose
3 of BNT162b2. Both severe AEs were deemed not relevant to study
vaccination.