Covering intersection of pharma, policy & politics for @pharmapinksheet. Past @politico. Inflexible Yogi, Volunteer Clown. @amaxsmith's #1 fan.
Jun 15, 2023 • 45 tweets • 6 min read
I'm watching FDA's advisory committee on COVID-19 vaccine strain change for fall today. $PFE $BNTX $MRNA $NVAX
fda.gov/advisory-commi…
First question of day is related to a BARDA workshop recently on protein-based vaccines and next gen vaccines.
Apr 4, 2023 • 19 tweets • 4 min read
It took me 35 minutes navigating the convention center to make it to Peter Marks. Feel like I deserve a concert but I guess FDA CBER head will have to do. #WVCUSA
Marks: it’s optimistic thinking to think the immunity we have now (to Covid) will serve us well next winter. No time for next gen for that time point but need to get to broader breadth of protection - most important- and then longer duration of action.
Oct 26, 2021 • 118 tweets • 14 min read
Another day, another vaccine advisory committee for COVID-19.
Pfizer's going for emergency use authorization for children 5-11.
this is a good overview of a lot of the dissonance during the review of boosters compared to the actual votes and clearance outcomes by the government. Still a bit confusing to me why certain people felt compelled to vote yes despite some of their concerns.
for typical advisory committee meetings FDA often says they value the comments of committee members more than the actual vote itself and that gives people some chance to deal with what they feel are poorly worded or constructed votes.
Oct 14, 2021 • 75 tweets • 9 min read
FDA kicking off two-day vaccine advisory committee on COVID-19 vaccine boosters. Today the focus is on Moderna.
#FDA's vaccine advisory committee about to discuss COVID-19 vax approvals and emergency use authorizations in children. Key thing will be whether they think EUAs are OK for younger children.
pink.pharmaintelligence.informa.com/PS144444/US-FD…
FDA's Dorian Fink emphasizes they are asking the committee to focus on safety for this panel (agency feels confident with their established efficacy process).
Pazdur is one of thoe FDA voices that silences the room when he pipes up. When he speaks, you listen.
@realrickpazdur@statnews .@realrickpazdur: People want to put regulations that don’t exist on us. For exmaple, we have to demonstrate that drug is safe and effective not that it is better than what we approved yesterday.
Jun 8, 2021 • 4 tweets • 4 min read
Here's a run down of some of our stories on $BIIB's Aduhelm approval for Alzheimer's (and then I'll try to stop tweeting about this for a bit :)
@brendasandburg on the unexpectedly BROAD label that doesn't align with trial population.
CDC's ACIP now talking about what data would be needed to inform delaying the 2nd dose of mRNA vaccines or single dose of mRNA vaccine for individuals w/ prioir confirmed SARs-coV-2 infection.
Sanchez - said have to go with what the RCTs showed us for timing of 2nd dose.
for single dose for peope w/ past infection -- he thinks need more data but could see this being a possibility down the line.
Mar 1, 2021 • 5 tweets • 1 min read
I'm watching the second day of CDC's ACIP meeting today. This meeting if focused more broadly on COVID-19 vaccines than yesterday's.
ACIP going to discuss possibility of delaying 2nd dose of mRNA vaccines as well as whether people who already had COVID-19 only need 1 dose. $BNTX $PFE $MRNA
Feb 5, 2021 • 7 tweets • 4 min read
screams into the abyss becuase people just don't get it!!!
.@NateSilver538 please please please please please call some people who understand the FDA and vaccine review.
@NateSilver538 1. the US needs to stop pretending that vaccines are our ONLY tool. There are many and we need to do a lot better job using the other ones while the vaccine deveolpment does its thing.
