Sarah Karlin-Smith Profile picture
Apr 4 19 tweets 4 min read Twitter logo Read on Twitter
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.
Moderna CEO burton said last year at this meeting everyone was in masks and look at them now. (Fwiw I’m masked) #wvcusa
question raised about lack of global surveillance making it harder to follow a flu-like model with vaccine deveolpment.
Marks: having lived through influenza mismatches - it will be challenge this year selecting what we need to select for next year b/c of manufacturing delay (2-3 months for mrna) - sars-cov-2 likes to do these" funny things"
Marks- key learning has been not to oversell vaccines for what they are. preventing hospitlization and death is a good thing. it would be nice to have sterilizing vax but won't hold my breath b/c might become very blue in the face.
Even if we don't hit it right on (w/ vax strain) chances are what we do provide will protect against severe disease #WCVUSA --- if some reassortment with virus happens then we'd push vax manufacturers to shift in same way as we'd do if pandemic flu.
$MRNA's Paul Burton - said he's a huge convert to the power of mRNA (I would hope so) ---

#WVCUSA
Marks: to me the greatest catastrophe of Covid has been the erosion of confidence of vaccination as a major public health tool. I’m concerned that we continue to see this. And it seems like rather than dwindling that seems to be building & its impacting vaccines outside of covid.
I want to make a deal on the stage that you all (the UK) agree to take Wakefield back if we send him, Mayo Clinic's Gregory Poland (vax humor) #WVCUSA
Paul Burton - there are efforts at foot to make it a crime, a misdemanor, to administer mRNA vaccines in parts of the US. - those of you who don't live in US probably are scratching your head about that. #WVCUSA
Marks: I don't think we will reset it (vax confidence) by having mandates. I'm post trying to argue with people who think vaccines are bad - we have to make case that they save their lives to people who want lives saved. (doesn't that include some people who think vax are bad?)
wonder if Poland's next joke is a sign that many people don't understand how to counter antivaxxers - he says should start rumor the chips are in the ivermectin.
Marks: We will be thinking of staffing up to a place where we can accommodate the need to mobilize quickly for whatever new pathogen comes along without having to completely disrupt the rest of the function. #WVCUSA
Marks: cold manufacturing are basically worthworthless.
What’s the future of viral vectors in vaccine and am I a fool to continue to use them (this person also suggested vv longer durability than mrna)? Marks: everything remains on table. We should be using all the different vax platforms at our disposal & not dispose of any of them.
Mayo Clinic's Poland doesn't seem to think censure, revoking docs licensing would be helpful to deal with docs who are antivax.
Marks describes trying to reach antivax communities or just vax hesitant in US as " a little bit like hand-to -hand combat."
Marks: part of the probelm is that Covid hit us right at right place for vax hesitancy. W/ ebola if you see death all around, you would get vaxed. it's a little gross to say, people didn't experience the death up close and personal enough and those that did tended to get vaxed

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More from @SarahKarlin

Oct 26, 2021
Another day, another vaccine advisory committee for COVID-19.

Pfizer's going for emergency use authorization for children 5-11.

Watch here: fda.gov/advisory-commi…
key question for me ...will Hayley Gan's audio quality hold up.
Read 118 tweets
Oct 25, 2021
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.
However given the highly public nature of these decisions I think that would have just added to the public confusion here is they justified a decision based more on comments than vote totals.
Read 5 tweets
Oct 14, 2021
FDA kicking off two-day vaccine advisory committee on COVID-19 vaccine boosters. Today the focus is on Moderna.

pink.pharmaintelligence.informa.com/PS145086/Moder…
Watch live here: fda.gov/advisory-commi…
Question from advisory commmittee member on potential confusion that may arise due to Moderna's immunocompormised EUA for third shot - which is different dose than current Moderna booster EUA app. FDA says immuocompormised can get another booster dose -- aka a fourth shot
Read 75 tweets
Jun 10, 2021
#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).
CDC now presenting some data on inital safety surveillance of use of $PFE vaccine in adolescents.

also on myocarditis and pericarditis w/ mrna vaccines.
Read 28 tweets
Jun 9, 2021
About to watch @realrickpazdur on @statnews #ASCO21 recap.

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.
@realrickpazdur @statnews .@realrickpazdur: People must undersatnd we have to move on from the traditional overall survival endpoint to meet patients needs. #ASCO21
Read 23 tweets
Jun 8, 2021
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.

pink.pharmaintelligence.informa.com/PS144439/Bioge…
@brendasandburg .@PinkSheetSutter looks at the implications of FDA approving the drug via the accelerated approval pathway, including what it means for future FDA decisions.

pink.pharmaintelligence.informa.com/PS144437/Aduca…
@brendasandburg @PinkSheetSutter .@ScripMandy goes into more detail on the other drugs in Alzheimer's space that could benefit from the decision to used amyloid-beta as a surrogate.

scrip.pharmaintelligence.informa.com/SC144494/Aduhe…
Read 4 tweets

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