Listening to @DukeMargolis seminar on Covid vaccine.
Peter Marks mentions that they expect a median of 2 month follow-up of safety for individuals in trials at time of EUA.

He says most adverse events seen within 1.5 months of vaccine.

He confirms again that any vaccine that goes to an EUA would go first to a vaccine advisory committee.

This has now been confirmed by every official possible.

He says if EUA issued, it would be issued in population 'that makes sense based on population studied."

He also confirms that there could be evidence that a certain subset benefits more from the vaccine, and they could put that in an EUA

(that's where I think political influence could come to play, fyi)

I just want to editorialize that my confidence in the FDA has increased by leaps and bounds based on the visual on my screen of Peter Marks in his basement. Room rater be damned.

Um. Per Peter Marks also sounds like there is am imminent new guidance coming on vaccine EUA on FDA website any second now.

something to watch for.

This is what the public needs to see more. Peter Marks talking about the under-appreciation of vaccines, pointing to his own measles and chicken pox scars.

This helps the public have confidence in FDA. Let's get him in front of the public.

Peter Marks on vaccine adverse events:

No specific comment on Oxford vaccine trial pause. In general, if you see one event about a specific side effect, less concerned than if you see 2 events, than if you see 3 events, then get worried.

Peter Marks on safety of vaccine:

Most adverse events occur within 1.5 months of vaccination. If there are major ones, they hope they will have data prior to EUA.

Mentions FDA sentinel.

(FYI, one thing to have infrastructure in place. Another thing to analyze it quickly)

Peter Marks emphasizing how covid is shutting down lives and killing many people daily - emphasizing this is the context in risks/benefit decision.

then emphasizing again that vaccines go into healthy individuals.

(this is the balance of risk/benefit that FDA will be weighing)

Peggy Hamburg:

"this is one of the most important decisions FDA will be taking, probably in our lifetimes"

(I agree. Give Peter Marks a 10/10 room rater rating because the guy is busy)

Marion Gruber, CBER -

Emphasizing Marks' message differentiating EUA vs. approval of BLA. For covid, with EUA they could expose millions of healthy to vaccine, so efficacy has to be clear.

Interim efficacy would have to meet same standards as primary outcome (50% effect)

Rob Califf -

5 points.
1. reiterate first rate team, integrity, at FDA

2. few people really know how trials work - many people would have to be corrupted for process to be corrupted. He's writing a blog on this now.

3. Efficacy outcomes come in different flavors.

4. Efficacy is easier to look at quickly than safety, which have to track down data. "So how you deal with trailing safety data in face of EUA is big issue."

5. Google is committed to making their data on searches available. Yes, 5th point is about google.

Marion Gruber -

For safety, duration of follow up at EUA is only few months. Still need reasonable safety follow up - they have discussed with manufacturers that they have safety collection information after EUA.

(so clearly they're thinking hard about how to make EUA work)

Marion Gruber -

if they had safety follow up for 6 months, that could support a BLA, but they would still want follow up longer than that after BLA for long-term safety and duration of protection

(feels like FDA will issue EUA with commitment of close follow up)

(this also feels like FDA feeling more comfortable approving drugs and relying on REMS and post marketing surveillance to feel them better about approving. feels like similar conversation here about vaccine and post marketing safety)

I am really disappointed to have to leave this session to go back to 'work.'

Thanks to @DukeMargolis for organizing