Background The ChAdOx1 nCoV-19 (AZD1222) vaccine has been approved for emergency use by the UK regulatory authority, Medicines and Healthcare products Regulatory Agency, with a regimen of two standard doses given with an interval of 4–12 weeks. The planned roll-out in the UK will involve vaccinating people in high-risk categories with their first dose immediately, and delivering the second dose 12 weeks later. Here, we provide both a further prespecified pooled analysis of trials of ChAdOx1 nCoV-19 and exploratory analyses of the impact on immunogenicity and efficacy of extending the interval between priming and booster doses. In addition, we show the immunogenicity and protection afforded by the first dose, before a booster dose has been offered. Methods We present data from three single-blind randomised controlled trials—one phase 1/2 study in the UK (COV001), one phase 2/3 study in the UK (COV002), and a phase 3 study in Brazil (COV003)—and one double-blind phase 1/2 study in South Africa (COV005). As previously described, individuals 18 years and older were randomly assigned 1:1 to receive two standard doses of ChAdOx1 nCoV-19 (5 × 10 10 viral particles) or a control vaccine or saline placebo. In the UK trial, a subset of participants received a lower dose (2·2 × 10 10 viral particles) of the ChAdOx1 nCoV-19 for the first dose. The primary outcome was virologically confirmed symptomatic COVID-19 disease, defined as a nucleic acid amplification test (NAAT)-positive swab combined with at least one qualifying symptom (fever ≥37·8°C, cough, shortness of breath, or anosmia or ageusia) more than 14 days after the second dose. Secondary efficacy analyses included cases occuring at least 22 days after the first dose. Antibody responses measured by immunoassay and by pseudovirus neutralisation were exploratory outcomes. All cases of COVID-19 with a NAAT-positive swab were adjudicated for inclusion in the analysis by a masked independent endpoint review committee. The primary analysis included all participants who were SARS-CoV-2 N protein seronegative at baseline, had had at least 14 days of follow-up after the second dose, and had no evidence of previous SARS-CoV-2 infection from NAAT swabs. Safety was assessed in all participants who received at least one dose. The four trials are registered at ISRCTN89951424 (COV003) and ClinicalTrials.gov , NCT04324606 (COV001), NCT04400838 (COV002), and NCT04444674 (COV005). Findings Between April 23 and Dec 6, 2020, 24 422 participants were recruited and vaccinated across the four studies, of whom 17 178 were included in the primary analysis (8597 receiving ChAdOx1 nCoV-19 and 8581 receiving control vaccine). The data cutoff for these analyses was Dec 7, 2020. 332 NAAT-positive infections met the primary endpoint of symptomatic infection more t...

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Background:Wound complications, including surgical site infections (SSIs) and wound dehiscence, are among the most common complications following spine surgery often leading to readmission. The authors sought to identify preoperative characteristics predictive of wound complications after spine surgery.Methods:The American College of Surgeons National Surgical Quality Improvement Program database for years 2012–2014 was reviewed for patients undergoing spine surgery, defined by the Current Procedural Terminology codes. Forty-four preoperative and surgical characteristics were analyzed for associations with wound complications.Results:Of the 99,152 patients included in this study, 2.2% experienced at least one wound complication (superficial SSI: 0.9%, deep SSI: 0.8%, organ space SSI: 0.4%, and dehiscence: 0.3%). Multivariate binary logistic regression testing found 10 preoperative characteristics associated with wound complications: body mass index ≥30, smoker, female, chronic steroid use, hematocrit <38%, infected wound, inpatient status, emergency case, and operation time >3 hours. A risk score for each patient was created from the number of characteristics present. Receiver operating characteristic curves of the unweighted and weighted risk scores generated areas under the curve of 0.701 (95% CI: 0.690–0.713) and 0.715 (95% CI: 0.704–0.726), respectively. Patients with unweighted risk scores >7 were 25-fold more likely to develop a wound complication compared to patients with scores of 0. In addition, mortality rate, reoperation rate, and total length of stay each increased nearly 10-fold with increasing risk score.Conclusion:This study introduces a novel risk score for the development of wound dehiscence and SSIs in patients undergoing spine surgery, using new risk factors identified here.

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