VP In-Q-Tel, fmr NSC Director for Medical & Biodefense Preparedness, fmr FDA Acting Chief Scientist
(views are my own)
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"@nytimesnytimes.com/2020/04/01/hea…
