geoffrey modest medical blogs

  The FDA released the Moderna coronavirus vaccine briefing document, see  https://www.fda.gov/media/144434/download  , (the peer-reviewed journal article has not been released yet, though I usually wait for the formal article prior to analysis. Of note, “the FDA has not independently verified the complete efficacy data from this dataset, beyond those analyses presented”, similarly for the safety dataset). This is a long blog, since I’ve gone through a lot of details from this (much longer) 54-page report   Details:  -- 15,210 patients were randomized to vaccine versus placebo, as a two-dose regimen 28 days apart, in adults at least 18 years old from 99 sites in the United States       -- patients were stratified by age and health risk  -- 47% female; mean age 52, 25% (3527) at least 65 years old; 79% white/10% Black/5% Asian/20% Latinx; occupational risk: 82% high-risk (healthcare workers, emergency workers, service workers, of which 25% healthcare workers)  -- high risk condition: no

  a recent large RCT found that patients at particularly high risk of cardiovascular disease did not seem to benefit clinically from high dose vs standard dose influenza vaccine, in the INVESTED trial, though their conclusion is highly suspect... (see  influenza high dose not dec mortality  jama2020 in dropbox or  doi:10.1001/jama.2020.23649 )    Details:  -- 5260 participants were randomized to receive high-dose trivalent influenza vaccine vs regular quadrivalent inactivated influenza vaccine, and could be revaccinated for up to 3 seasons. In a pragmatic, multicenter trial in 157 sites in the US and Canada between September 2016 and February 2019  -- study patients all had had an acute MI in the past 12 months or heart failure hospitalization in the past 24 months, and at least one additional risk factor (see below) -- mean age 66, 72% men, 63% with heart failure, 78% white/15% Black/3% Asian/10% Latinx, LVEF 42%, BMI 31  -- risk factors: age>65 57%, BMI>30 49%, LVEF<40% 42%,