key: cord-0722233-zoovy815 authors: Rosa Duque, Jaime S.; Leung, Daniel; Au, Elaine Y. L.; Lau, Yu‐Lung title: Second dose of COVID‐19 vaccination in immediate reactions to the first BNT162b2 date: 2021-11-02 journal: Pediatr Allergy Immunol DOI: 10.1111/pai.13683 sha: 3372ec0fb0b467b290142217122271869598c706 doc_id: 722233 cord_uid: zoovy815 Iatrogenic causes of anaphylaxis, such as by drugs and vaccines, can be fatal and are a major concern to the public.1-3 On the other hand, inappropriate apprehension towards the possibility of anaphylaxis may lead to COVID-19 vaccination delays or hesitancy, which are relevant impediments against achieving protective immunity for individuals and our community.3 Recently, Krantz and colleagues performed a retrospective analysis and observed that all adult patients were able to tolerate a second mRNA vaccine administration despite first-dose immediate anaphylactic hypersensitivity reactions.4 In Hong Kong (HK), Sinovac-CoronaVac and BNT162b2 have been approved for emergency use in ≥18-year-old and ≥12-year-old individuals, respectively. To the Editor, Iatrogenic causes of anaphylaxis, such as by drugs and vaccines, can be fatal and are a major concern to the public. [1] [2] [3] On the other hand, inappropriate apprehension toward the possibility of anaphylaxis may lead to COVID-19 vaccination delays or hesitancy, which are relevant impediments against achieving protective immunity for individuals and our community. 3 Recently, Krantz and colleagues per- as part of the research study to explore possible correlations between assay results and potential subsequent reactions during the rechallenge. 6 Blood was incubated with a negative control, positive control (anti-IgE receptor antibody), PEG 2,000 (Sigma-Aldrich), and liposomal doxorubicin-PEG 2,000-3,500 complex separately in stimulation buffer. 6 The activation marker, CD63, on basophils was measured by flow cytometry (Beckman Coulter Inc). 6 The test was considered positive when CD63 expression was >5% according to the manufacturer's instructions and based on this criteria as the most common cutoff used for drug allergy workup. 7-9 Skin testing was not performed due to its anaphylaxis-eliciting and accuracy concerns. 10 After comprehensive counseling, legal guardians and patients were allowed to select between receiving their second dose of BNT162b2 by a graded approach (10%, or 0.03 mL of full dose, followed by 1-h close monitoring prior to the remainder 90%, or 0.27 mL, injection) or a single full-dose administration. 2 All participants were observed for at least 1 h after each injection. The study protocol required their recording of no or any symptom in an electronic diary for 1 week. Three participants who reported occasional rhinitis symptoms without any history of urticaria or other atopy were enrolled (Table 1) . After their first BNT162b2 injection, generalized urticaria appeared within 1-3 h and lasted several days for 2 patients, whereas 1 patient continued to experience intermittent urticaria ( Figure 1 ). BAT for participant 1 was indeterminant since his positive control was a non-responder (Table 1 ). 6 He received his second BNT162b2 by the graded approach. A small wheal developed at his lower back 1 h afterward, which resolved 30 min after cetirizine. He had urticaria at his legs the next day and also intermittently for the next 17 days. BAT for the other 2 participants was negative, and 1 h of observation was uneventful after they received their second single full 0.3 mL BNT162b2 dose. Participant 2 complained of itchiness, which resolved after taking cetirizine. There was no moderate-to-severe reaction or serious adverse event reported in their diaries. Note: Definitions for severity of symptoms: mild = tolerable, not affecting daily activities, moderate = performance of some daily activities affected, severe: performance of some daily activities prevented. Abbreviations: AR, allergic rhinitis; day 0, day of BNT162b2 administration; day 1, 1 day after BNT162b2 administration; Yrs, years. a See Figure 1 . This is the first prospective study to demonstrate that children with immediate BNT162b2 first-dose reactions can safely receive their second injection according to the recommended immunization schedule without the need for premedication. Cutaneous symptoms persisted or recurred transiently after the second injection, which was successfully treated by oral an F I G U R E 1 The skin manifestation for participants 1, 2, and 3 (horizontal panels A, B, and C, respectively) after their first dose of BNT162b2 was consistent with generalized urticaria Fatal anaphylaxis in children in France: analysis of national data Practical guidance for the evaluation and management of drug hypersensitivity: specific drugs Maintaining safety with SARS-CoV-2 vaccines Safety evaluation of the second dose of messenger RNA COVID-19 vaccines in patients with immediate reactions to the first dose Department of Health, the Government of Hong Kong Safety monitoring of COVID-19 vaccines in Hong Kong Basophil reactivity to BNT162b2 is mediated by PEGylated lipid nanoparticles in patients with PEG allergy BÜHLMANN Laboratories AG. Flow CAST® Basophil Activation Test (BAT) Flow Cytometry Basophil activation test application in drug hypersensitivity diagnosis: an empirical approach Basophil reactivity as biomarker in immediate drug hypersensitivity reactions-potential and limitations Polyethylene glycol-induced systemic allergic reactions (anaphylaxis)