Luciana Borio, MD Profile picture
VP In-Q-Tel, fmr NSC Director for Medical & Biodefense Preparedness, fmr FDA Acting Chief Scientist (views are my own)
Aviva Gabriel Profile picture 2 subscribed
Sep 3, 2020 11 tweets 5 min read
Thread: 1. Recent statements by @SteveFDA that @US_FDA may authorize #COVID19 vaccines before completing clinical trials are generating much anxiety and setting up a twitter storm. @Pfizer frequent messaging that it will have results on its vaccine soon isn’t helping. 2. Some prominent scientists & public health experts have called for full @US_FDA licensure before #COVID19 vaccines are distributed. I disagree with that.
Jul 27, 2020 9 tweets 3 min read
Today marked the start of Phase 3 RCT for @moderna_tx mRNA #COVID19 vaccine. Will enroll 30,000 volunteers across 87 locations. Half will receive two 100 microgram injections & half (control group) will receive a placebo. Both will receive the 2 injections about 4 weeks apart.(1) Many are asking “when will we get results?” @NIH stated that it could have results as early as Nov. It is possible but unlikely. How fast we get results depends on several factors. (2)
May 2, 2020 11 tweets 4 min read
THREAD: 1. There has been a lot of back and forth on the conduct of the #Remdesivir study for #COVID19 conducted by the @NIH and several academic centers across the U.S., Europe and Asia. I thought I would share my assessment. 2. The amount of suspicion is understandable given the rapid growth of ill-conceived clinical studies and regulatory actions that have occurred recently.
Apr 3, 2020 12 tweets 3 min read
THREAD: 1. Many are asking questions about the latest RCT on hydroxychloroquine (HCQ), preprinted on @medrxivpreprint Chen A, et al. Efficacy of HCQ in patients with COVID-19: results of a RCT; doi: doi.org/10.1101/2020.0… 2. As expected, it generated some headlines. E.g., "Malaria Drug Helps Virus Patients Improve, in Small Study"@nytimes nytimes.com/2020/04/01/hea…