#WarpSpeed Slaoui says he just learned about @SteveFDA at White House today on #COVID19 #vaccines.
What we need is good science, good focus.
Says "don't know" of the tensions between FDA/White House.

#PostLive
#WarpSpeed Slaoui: #FDA should be doing a thorough job to ensure review of #COVID19 #vaccines are complete/scientifically driven.
Then #VRBPAC & come to appropriate decision.
Says nothing in his interactions that it was sped up or slowed down.
#PostLive
#WarpSpeed Slaoui: #FDA has always been on outside of this integrated coalition [Warp Speed]
Our interactions have been very few/from time to time sought advice on trial design or if placebo recipients should be immunized.

[Note @DrWoodcockFDA on Warp Speed]
#PostLive
#WarpSpeed Slaoui: Our plan is to be as soon as approval is granted shipments start immediately after. Shipped to sites through FedEx, UPS, etc
Ancillary materials: syringes, swabs, etc. already shipped or are being shipped.
So within 24-48hrs after approval in arms.
#PostLive
#WarpSpeed Slaoui: We stay completely out of the politics. Work doesn't depend on White House intervention.
Says he's had very limited interaction with Scott Atlas. Only personally met once.
Would resign if political interference.
#PostLive
#WarpSpeed Slaoui: The data are very clear. The power of data comes from fact two different vaccines from two different companies yielding remarkable data.
Really robust data.
He notes 100% efficacy for $MRNA vaccine in severe #COVID19 vaccine.

#PostLive #vaccines
#WarpSpeed Slaoui notes adverse events in $PFE $BNTX & $MRNA/ #NIH #COVID19 #vaccines has been mostly pain at injection site, some redness, fever, some chills, some muscle ache & some headache.
Majority of recipients have no adverse events.
Only time will tell on AEs.
#PostLive
#WarpSpeed Slaoui insists "nothing special" in adverse events for #COVID19 #vaccines.

But …
science.sciencemag.org/content/370/65…

#PostLive $PFE $BNTX $MRNA
#WarpSpeed Slaoui: Any advice we can give to others we will.
We will need a lot of doses to immunize almost 8 billion on Earth.

#PostLive
#WarpSpeed Slaoui: Each of 6 U.S. contracted has capability to make 500M & 1B #COVID19 #vaccines doses by time 2021 completed.
Hope by mid-2022 most of the world would have been immunized against

#PostLive
#WarpSpeed Slaoui: Our plans with 6 or maybe only 4 we will have produced enough vaccine to immunize U.S. population [by June 2021]

#PostLive
Vaccines allocation? Who should be last?
#WarpSpeed Slaoui: We should end with pediatric/young, very healthy populations
We should start with those most impacted.
Frail/elderly & health care workers/front line dealing with #COVID19 patients.

#PostLive
#WarpSpeed Slaoui: There's social responsibility for everyone to really think hard before not taking #COVID19 vaccine.
Killed many more than many wars.
Turned economy upside-down
Listen to the data & allow yourself to understand performance. If do, will feel confident.

#PostLive
Wow, #WarpSpeed Slaoui says he's still not been in contact with #BidenHarrisTransition about #COVID19 & Warp Speed project.

#PostLive #vaccines
#WarpSpeed Slaoui: Going to need help with administration -- whichever it is -- current one & next one.

Repeats his goal was to only stay with Warp Speed until 2 #COVID19 drugs OK'd [done] & 2 #vaccines, expect in Dec.
[he's said this a few times already]

#PostLive
#WarpSpeed Slaoui says expects after Christmas his involvement only sporadic from time to time
Leaving has nothing to do with transition.
Says he's "much more aligned with the future administration" than current Trump.
But time to move on & go back to personal life.
#Postlive

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More from @DonnaYoungDC

2 Dec
#FDA's #VRBPAC doesn't meet until Dec. 10 on $PFE/ $BNTX & Dec. 17 for $MRNA/#NIH vaccines. Does Meadows think he can really push FDA to move the dates up sooner?
What is Meadows & Trump doing to ensure states have enough funding to actually distribute #COVID19 #vaccines?
Maybe Topol needs to ask his friend @SteveFDA if that meeting went so well yesterday & Hahn stood up for #FDA then, why is Meadows & Hahn doing it all over again today?

#COVID19 #vaccines
It was just last week when @SecAzar insisted the "proof was in the pudding" about Trump & pressuring #FDA.

So, two trips in two days to the White House for @SteveFDA.

What kind of pudding are they making at the White House @SecAzar?


#COVID19 #vaccines
Read 28 tweets
2 Dec
On #CDC call, Henry Walke says CDC has identified two acceptable quarantine options: Quarantine can end after 10 days without test if no symptoms or 7 days after negative test result if no symptoms.
cdc.gov/media/releases…
#CDC Henry Walke: If people travel, CDC recommends travelers should get tested one to three days before travel and then again three to five days after travel.

#COVID19 #pandemic
#CDC's John Brooks says CDC's change in quarantine guidelines was based on extensive modeling – not just by CDC but by other partners.
Some data published peer-reviewed websites. Will put this on CDC's website later today.

#COVID19 #pandemic
Read 10 tweets
1 Dec
#CDC #ACIP slides should be up soon here, Dr. Cohn says: cdc.gov/vaccines/acip/…

#COVID19 #vaccines
#CDC received 75 requests for public comment at today's #ACIP meeting but had to limit to 10.
So Dr. Cohn urges people to submit written public comment to CDC docket.

#COVID19 #vaccines $PFE $MRNA #FDA #pharma #biotech
Read 76 tweets
1 Dec
Last week, @SecAzar said the "proof was in the pudding" about Trump's political pressure on #FDA .

Yes, yes it is.


Reminder: Trump said he wasn't aware of #coronavirus until late January. $MRNA /#NIH launched their R&D mid-Jan.

#COVID19 #vaccines $PFE
#WarpSpeed Slaoui today at #PostLive on any tensions between Trump/White House & #FDA: "I don't know."
"I wouldn't think there would be."

And later Slaoui distanced himself from Trump, saying he's more aligned with #BidenHarris administration.

#COVID19 #vaccines
And if the #pharma #biotech, pharmacy & distributor execs are "irritated at pressure from the White House to attend an event they perceive to be largely political," they certainly don't have to attend. So, will they anyway?
$PFE $MRNA $FDX $UPS $MCK $WBA $CVS #COVID19 #vaccines
Read 7 tweets
30 Nov
#CDC has scheduled an emergency meeting of #ACIP for Dec. 1 to vote on which groups of Americans should receive the limited initial doses of the #COVID19 #vaccines once those products are cleared for the U.S. market.
On Dec. 1, #CDC's #ACIP is expected to vote on whether the 21 million U.S. healthcare personnel & 1.3 million residents of long-term care facilities should be first in line for the #COVID19 shots — phase 1a of the vaccination program.
If both the $PFE - $BNTX and $MRNA-NIAID #COVID19 #vaccines are granted EUAs in December, there are expected to be only enough doses by the end of 2020 to vaccinate about 20 million people in the U.S., with more doses not coming for the other 310 million Americans until later.
Read 9 tweets
29 Nov
Today, Pres-elect @JoeBiden disclosed that while playing with his dog Major he slipped & twisted his ankle & seeing an orthopedist out of caution.

Versus

Nov. 2019, Trump made an unscheduled 2-hour trip to @WRBethesda & Americans still don't have the details about why.
Statement from Dr. Kevin O’Connor: "President-elect @JoeBiden sustained a sprain of his right foot. Initial X-rays are reassuring that there is no obvious fracture and he will be getting an additional CT for more detailed imaging."

#BidenHarrisTransition
Statement from Dr. Kevin O’Connor: "Follow-up CT scan confirmed hairline (small) fractures of President-elect @JoeBiden’s lateral and intermediate cuneiform bones, which are in the mid-foot. It is anticipated that he will likely require a walking boot for several weeks."
Read 4 tweets

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