Bacillus Calmette-Guérin vaccine for prevention of COVID-19 and other respiratory tract infections in older adults with comorbidities: a randomized controlled trial.

OBJECTIVES: To test whether Bacillus Calmette-Guérin (BCG) vaccination would reduce the incidence of COVID-19 and other respiratory tract infections (RTIs) in older adults with one or more comorbidities. METHODS: Community-dwelling adults aged 60 years or older with one or more underlying comorbidities and no contraindications to BCG vaccination were randomized 1:1 to BCG or placebo vaccination and followed for 6 months. The primary endpoint was a self-reported, test-confirmed COVID-19 incidence. Secondary endpoints included COVID-19 hospital admissions and clinically relevant RTIs (i.e. RTIs including but not limited to COVID-19 requiring medical intervention). COVID-19 and clinically relevant RTI episodes were adjudicated. Incidences were compared using Fine-Gray regression, accounting for competing events. RESULTS: A total of 6112 participants with a median age of 69 years (interquartile range, 65-74) and median of 2 (interquartile range, 1-3) comorbidities were randomized to BCG (n = 3058) or placebo (n = 3054) vaccination. COVID-19 infections were reported by 129 BCG recipients compared to 115 placebo recipients [hazard ratio (HR), 1.12; 95% CI, 0.87-1.44]. COVID-19-related hospitalization occurred in 18 BCG and 21 placebo recipients (HR, 0.86; 95% CI, 0.46-1.61). During the study period, 13 BCG recipients died compared with 18 placebo recipients (HR, 0.71; 95% CI, 0.35-1.43), of which 11 deaths (35%) were COVID-19-related: six in the placebo group and five in the BCG group. Clinically relevant RTI was reported by 66 BCG and 72 placebo recipients (HR, 0.92; 95% CI, 0.66-1.28). DISCUSSION: BCG vaccination does not protect older adults with comorbidities against COVID-19, COVID-19 hospitalization, or clinically relevant RTIs.

Simplifying Breast Imaging Reporting and Data System classification of mammograms with pure suspicious calcifications.

Objectives To investigate the risk of malignancy following stereotactic breast biopsy of calcifications classified as Breast Imaging Reporting and Data System (BI-RADS) 3, 4, and 5. Methods The study included women with pure calcifications (not associated with masses or architectural distortions) who underwent stereotactic breast biopsy at the Dutch Cancer Institute between January 2011 and October 2013. Suspicious calcifications (Breast Imaging Reporting and Data System 3, 4, or 5) detected on mammography were biopsied. All lesions were assessed by breast radiologists and classified according to the BI-RADS lexicon. Results Overall, 473 patients underwent 497 stereotactic breast biopsies. Sixty-six percent (326/497) of calcifications were classified B4, 30% (148/497) B3, and 4% (23/497) B5. Of the 226 (45%) malignant lesions, there were 182 pure ductal carcinoma in situ, 22 mixed ductal carcinoma in situ and invasive carcinomas (ductal or lobular), 21 pure invasive carcinomas, and one angiosarcoma. Malignancy was found in 32% (95% confidence interval [CI] 0.24 to 0.39) of B3, 49% (95% CI 0.43 to 0.54) of B4, and 83% (95% CI 0.61 to 0.95) of B5 calcifications. Conclusions Considering the high predictive value for malignancy in B3 calcifications, we propose that these lesions should be classified as suspicious (B4), especially in a screening setting.