Thread by @EricTopol

My interview with @US_FDA Commissioner @SteveFDA today @Medscape on the #SARSCoV2 vaccines, monoclonal antibodies, and rapid home tests 1/
medscape.com/viewarticle/93…

Recall I had sent an open letter to him August 31 after the convalescent plasma "breakthrough" press conference, w/o any supportive evidence, and the prior EUA on hydroxychloroquine medscape.com/viewarticle/93…
He didn't take either option I suggested. He called me. 2/

We've since spoken several times and now I understand his intentions, what he's been through, the immense pressures that have been placed upon him. For me, the trust in him and the FDA has been restored. 3/

EUA has become a buzzword, even now in the public domain. What is it? 4/

Fortunately, we got 4 Phase 3 vaccine full protocols released (after a lot of push thru social media + other routes). They each set out for completion at 150-164 events. How do you extrapolate this limited N of infection events to 10s-100s of millions people to get vaccinated? 5/

Many of the vaccine trials are run under Operation Warp Speed (OWS) with one Data and Safety Monitoring Board (15-20 members). Pfizer is on their own w/ a much smaller DSMB. All shoot for 50-60% efficacy, 95% lower CI 30%. What is OWS, how does it work? 6/

Does @SecAzar @HHS have the authority to issue an EUA without FDA's involvement? 7/

Reassuring: while that could happen Dr. Hahn has indicated that it won't 8/

Now onto what Dr. Hahn did to show independence from WH, Trump. He/FDA developed more stringent guidelines for a vaccine EUA. Sent them to the companies, Advisory Committee, and published on the FDA website this week 9/

These tighter guidelines with longer safety follow-up (2 months median) and inclusion of some severe infections in endpoints were blocked by Trump, White House for weeks 10/

The tighter EUA vaccine guidelines 11/

https://twitter.com/EricTopol/status/1313552846361485312

Winning the battle against the White House 12/

https://twitter.com/EricTopol/status/1313560551537012736

Despite that, later that evening Trump tweeted vs Dr. Hahn

This was all about getting a vaccine EUA's before November 3rd. That is now, fortunately, put aside because EUA tighter guideline w/ FDA internal and external reviews, makes it mathematically impossible 13/

Now onto the monoclonal antibodies. It's a very different picture than HCQ or convalescent plasma EUAs which did not have supportive evidence from any randomized trials 14/

The problem here is that there is an unmet need (early covid, high risk), some supportive data--nothing to do with Trump's treatment or his cure claims. How can the review be done with this cloud? Approved pre-November 3rd? 15/

We're into transparency. You are too. I've been asking some tough questions. 16/

Now onto rapid home diagnostic tests. Can't we get a new path at FDA and not use the PCR standard? 17/

Our final remarks. Stop the political interference. Let FDA do their work and it'll get done right.
18/end