ImportanceGreater than 20% of cases and 0.4% of deaths from COVID-19 occur in children. Following demonstration of the safety and efficacy of the adjuvanted, recombinant spike protein vaccine NVX-CoV2373 in adults, the PREVENT-19 trial immediately expanded to adolescents.ObjectiveTo evaluate the safety, immunogenicity, and efficacy of NVX-CoV2373 in adolescents.Design, Setting, and ParticipantsThe NVX-CoV2373 vaccine was evaluated in adolescents aged 12 to 17 years in an expansion of PREVENT-19, a phase 3, randomized, observer-blinded, placebo-controlled multicenter clinical trial in the US. Participants were enrolled from April 26 to June 5, 2021, and the study is ongoing. A blinded crossover was implemented after 2 months of safety follow-up to offer active vaccine to all participants. Key exclusion criteria included known previous laboratory-confirmed SARS-CoV-2 infection or known immunosuppression. Of 2304 participants assessed for eligibility, 57 were excluded and 2247 were randomized.InterventionsParticipants were randomized 2:1 to 2 intramuscular injections of NVX-CoV2373 or placebo, 21 days apart.Main Outcomes and MeasuresSerologic noninferiority of neutralizing antibody responses compared with those in young adults (aged 18-25 years) in PREVENT-19, protective efficacy against laboratory-confirmed COVID-19, and assessment of reactogenicity and safety.ResultsAmong 2232 participants (1487 NVX-CoV2373 and 745 placebo recipients), the mean (SD) age was 13.8 (1.4) years, 1172 (52.5%) were male, 1660 (74.4%) were White individuals, and 359 (16.1%) had had a previous SARS-CoV-2 infection at baseline. After vaccination, the ratio of neutralizing antibody geometric mean titers in adolescents compared with those in young adults was 1.5 (95% CI, 1.3-1.7). Twenty mild COVID-19 cases occurred after a median of 64 (IQR, 57-69) days of follow-up, including 6 among NVX-CoV2373 recipients (incidence, 2.90 [95% CI, 1.31-6.46] cases per 100 person-years) and 14 among placebo recipients (incidence, 14.20 [95% CI, 8.42-23.93] cases per 100 person-years), yielding a vaccine efficacy of 79.5% (95% CI, 46.8%-92.1%). Vaccine efficacy for the Delta variant (the only viral variant identified by sequencing [n = 11]) was 82.0% (95% CI, 32.4%-95.2%). Reactogenicity was largely mild to moderate and transient, with a trend toward greater frequency after the second dose of NVX-CoV2373. Serious adverse events were rare and balanced between treatments. No adverse events led to study discontinuation.Conclusions and RelevanceThe findings of this randomized clinical trial indicate that NVX-CoV2373 is safe, immunogenic, and efficacious in preventing COVID-19, including the predominant Delta variant, in adolescents.Trial RegistrationClinicalTrials.gov Identifier: NCT04611802
Objective To implement a collaborative statewide antibiotic stewardship initiative in both the ambulatory and inpatient settings. Methods Five participating Delaware health systems each convened internal team(s) to translate the vision set forth by the eBrightHealth LLC Choosing Wisely Work Group into clinical action through process improvement efforts at their institutions. The teams focused on implementing antibiotic time-outs, and on improving antibiotic prescribing for upper respiratory infections in ambulatory settings. The learning network utilized an “all teach, all learn” methodology via monthly conference calls and quarterly face-to-face meetings. Results All inpatient teams implemented antibiotic time-outs for at least 1 unit. Other interventions included commitment posters; submitting antibiotic utilization data nationally; provider/patient surveys; local stewardship champions; and provider prescribing data feedback. Barriers to implementation included competing priorities, lack of reliable utilization data, and suboptimal provider engagement. Overall antibiotic utilization decreased by 9%, compared to the pre-intervention period. Conclusions This initiative has demonstrated the value of multidisciplinary teams, from varying healthcare systems, coming together to work on a single project. While each team’s interventions and specific goals differed slightly, all teams implemented new initiatives to promote appropriate use of antibiotics. Policy Implications Antibiotic stewardship is a national priority. Acute care hospitals are required to have antibiotic stewardship programs; similar programs are proposed for ambulatory settings.
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