geoffrey modest medical blogs

  The formal study on safety and efficacy data were released for the single-dose Johnson & Johnson/Janssen Covid-19 vaccine (see   covid vaccine J&J nejm2021  in dropbox, or DOI: 10.1056/NEJMoa2101544 )   Details:  -- international, randomized, double-blind, placebo-controlled trial with 19,630 SARS-CoV-2 negative participants who received the J&J vaccine and 19,691 placebo recipients, from September 21, 2020 to January 22, 2021      -- this vaccine is a recombinant, replication-incompetent human adenovirus type 26 vector encoding full-length SARS-CoV-2 spike protein -- median age 52 (67% 18-59yo, 34% >60yo), 45% female, BMI 27,   41%  at least one coexisting condition, 59% white/20% Black/ indigenous South American/ Hispanic -- 41% from Latin America (Brazil 17%, Colombia 10%, rest from Argentina, Chile, Mexico, Peru); 15% South Africa; 44% US -- primary endpoints: vaccine efficacy against moderate to severe-critical Covid-19 with onset at least 14 days, and at least 28

  A recent data-mining study found that the combination of direct oral anticoagulants (DOACs) plus aspirin (ASA) did not improve outcomes , but did increase the risk of bleeding (see cad aspirin and DOACs bleeding jamaintmed2021 in dropbox, or  doi:10.1001/jamainternmed.2021.1197)    Details:  -- 3280 patients with atrial fibrillation or venous thromboembolic (VTE) disease, but without a recent MI or history of heart valve replacement, were followed in 4 anticoagulation clinics in Michigan, from January 2015 to December 2019  -- mean age 68, 51% men, BMI>30 in 50%, alcohol or drug use 6%, tobacco current 9%/former 33%  -- indications for DOAC: atrial fibrillation/flutter 61%, DVT/PE 40%  -- comorbidities: CAD 15%, cancer 22%, heart failure 15%, CKD 16%, diabetes 22%, hypertension 53%  -- modified HAS-BLED 2.0 (mod risk of bleed, approx 2/100 patient-yrs), Charlson Comorbidity Index 4.0  (10-year survival 53%) -- DOACs used included apixaban 55%, dabagatran  8%, riv

  A new preliminary assessment suggested that the mRNA vaccines were safe for pregnant women and their subsequent infants ( see  covid pregnancy mRNA vax safe  in dropbox, or  DOI: 10.1056/NEJMoa2104983 )   Details: -- results were derived from 3 databases, from December 14, 2020 to February 28, 2021:      -- the V-safe Surveillance System and Pregnancy Registry, a new CDC smartphone-based active surveillance system developed for the Covid-19 vaccination program. Voluntary enrollment. Text messages were sent to participants to assess adverse reactions and health status postvaccination. For the 1 st  week after vaccination participants were prompted to report local and systemic signs and symptoms during daily surveys and rank them as mild, moderate, or severe. Eligible patients were vaccinated when pregnant or in the perconception period          -- 35,691   v-safe participants 16-54yo were identified as pregnant     --  VAERS, national passive surveillance system established in 1990 an