The frequency of local reactions was higher in the 18–64 age group than the ≥65 age group (80.9% vs 61.7% after dose 2). Vaccine recipients reported higher rates of local reactions after dose 2 than dose 1. Local reactions were reported by the majority of vaccine recipients and at higher rates than placebo recipients. Based on the timing of onset following vaccination and multiple similar cases of temporally related myocarditis and pericarditis, FDA considers this event related to the vaccine. FDA determined that none of the events following vaccination were related to study vaccine.Ī 16-year-old male experienced myocarditis two days after dose 2 of the post-crossover period of the trial. Serious adverse events were reported by 7 vaccine recipients (0.5%) and 2 placebo recipients (0.2%). Serious Adverse EventsĪ serious adverse event was defined as: death life-threatening event hospitalization or prolongation of existing hospitalization persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or a congenital anomaly/birth defect. 0.0% placebo recipients), and myalgia (0.1% vaccine recipients vs. 0.0% placebo recipients), injection site pruritus (0.2% vaccine recipients vs. 0.0% placebo recipients), arthralgia (0.2% vaccine recipients vs. 0.0% placebo recipients), decreased appetite (0.3% vaccine recipients vs. A plausible biological mechanism and imbalances in the following additional non-serious unsolicited events are suggestive of a causal relationship to vaccine: fatigue (0.5% vaccine recipients vs. Lymphadenopathy-related events (lymphadenopathy, axillary pain, and lymph node pain) were reported by 0.9% of participants in the vaccine arm and 0% of participants in the placebo arm and are considered plausibly related to vaccination. Additional related adverse events were consistent with local and systemic reactogenicity. The most frequently reported related AEs in the vaccine arm included lymphadenopathy-related events, chills, diarrhea, and decreased appetite. Non-serious unsolicited AEs considered related by the investigator were reported by 2.9% of participants in the vaccine arm and 0.8% of participants in the placebo arm. The most frequently reported (>1.0%) unsolicited AEs among vaccine recipients were consistent with common conditions in adolescents, including nasal congestion, cough, and oropharyngeal pain. Frequencies of unsolicited adverse events were similar between the vaccine group (15.5%) and placebo group (15.3%). Unsolicited adverse events were collected from dose 1 to 28 days post-dose 2. Systemic reactions in persons aged 12-17 years, Novavax NVX-CoV2373 COVID-19 vaccine and placeboī Grade 3: Significant prevents daily activity Grade 4: ER visit or hospitalization.Ĭ Grade 3: Significant any use of narcotic pain reliever or prevents daily activity Grade 4: ER visit or hospitalization.ĭ Grade 3: Prevents daily activity, requires outpatient intravenous (IV) hydration Grade 4: ER visit or hospitalization for hypotensive shock. For systemic reactions, the median time to onset was between 1 and 3 days after vaccination and persisted for 1-2 days. Following dose 2, there was one report of grade 4 headache and one report of grade 4 nausea/vomiting among vaccine recipients. Grade 4 fever (>40.0☌) was reported by two vaccine recipients after dose 1. Following Dose 2, 21.8% of participants reported any severe systemic reaction the most frequently reported severe systemic reactions were fatigue/malaise and myalgia. The majority of systemic reactions were mild or moderate in severity. Fever was reported by 16.9% of vaccine recipients following dose 2. Fatigue/malaise were the most common systemic reaction (57.9% after dose 2). The frequency of systemic reactions was higher after dose 2 than dose 1 (74.5% vs 55.3%) the severity of systemic reactions was also higher after dose 2 than dose 1 (3.7% vs 22.0% reporting reactions of grade 3 or higher). Systemic reactions were reported by the majority of vaccine recipients and at higher rates than placebo recipients.
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