https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30843-4/fulltextIn the phase 1 trial, the overall incidence of adverse reactions was seven (29%) of 24 participants in the 3 μg group, nine (38%) of 24 in the 6 μg group, and two (8%) of 24 in the placebo group in the days 0 and 14 vaccination cohort; and three (13%) of 24 in the 3 μg group, four (17%) of 24 in the 6 μg group, and three (13%) of 23 in the placebo group in the days 0 and 28 vaccination cohort, with no significant difference seen among the three groups for both vaccination schedules (figure 2; appendix 2 pp 5–6). The most common symptom was injection-site pain, which was reported by four (17%) participants in the 3 μg group, five (21%) in the 6 μg, and one (4%) in the placebo group in the days 0 and 14 vaccination cohort and three (13%) in the 3 μg group, three (13%) in the 6 μg group, and three (13%) in the placebo group in the days 0 and 28 vaccination cohort. Most adverse reactions were mild (grade 1) in severity and participants recovered within 48 h. Only one case of acute hypersensitivity with manifestation of urticaria 48 h after the first dose of study drug was reported in the 6 μg group (one [4%] of 24) in the days 0 and 14 vaccination cohort, which was graded as severe and considered to be possibly related to vaccination. The participant was given chlorphenamine and dexamethasone and recovered within 3 days, and no similar reaction was observed after the second dose of vaccine. No vaccine-related serious adverse events were noted within 28 days of vaccination (figure 2; appendix 2 pp 4–5). Additionally, ten (7%) of 143 participants in phase 1 had a clinically significant increase of laboratory indicators at day 3 after vaccination (appendix 2 pp 15–16), but none was considered to be related to the vaccination. No significant increases in inflammatory factors in serum were detected at day 7 after each dose (appendix 2 pp 17–18).
in Brasile lo avevano sospeso perché a San Paolo uno si è suicidato. 4 gg fa hanno reiniziato il trial