#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?
While @SecAzar at today's briefing insisting #COVID19#vaccines going through rigorous #FDA review process, @SteveFDA reportedly back at the White House today being pressured to speed up the process even faster.
#VRBPAC meeting Dec. 10 for $PFE / $BNTX & Dec. 17 for $MRNA.
#WarpSpeed Perna: We are planning to be ready when EUA is approved.
It's not about getting in front of EUA.
It's so we have everything locked so when EUA comes can distribute.
You can't execute if you don't have a plan.
#WarpSpeed Perna says only half the #COVID19#vaccines doses will be sent to jurisdictions & agencies b/c 2-dose shots to start.
Then, 21 days later for $PFE & 28 days for $MRNA, send second half of allocations to ensure don't over administer/ensure supply of 2nd dose.
#WarpSpeed Perna: The states know their people/populations the best.
"Our responsibility is to enable" states/territories/jurisdictions plans.
40M total doses in December. Then push as vaccine becomes available. Not waiting for cluster & then push.
#WarpSpeed Perna says after initial 40M #COVID19#vaccines distributed, "We visualize each week vaccines getting out."
#WarpSpeed Perna commends #CDC for its work.
Well-trained experts set up elaborate coordination with states. Run daily/weekly meetings. Make recommendations about how test to operationalize/enable plans.
Well done.
#WarpSpeed Perna: We want to enable/empower jurisdictions to execute their plans.
That is our sole goal/responsibility to do.
Over-communication is an asset to our execution.
#WarpSpeed Perna: #Vaccines are only as good as being administered to American people.
Be informed in your process. Don't allow one headline to determine what you're going to do.
#WarpSpeed Slaoui:
20M people vaccinated in December
30M people vaccinated in January
50M people vaccinated in February with $PFE/ $BNTX & $MRNA/NIH #COVID19#vaccines.
There is a chance may have more in February if $JNJ gets approved.
#WarpSpeed Slaoui on $PFE / $BNTX UK approval: We don't know how the process has taken place. We stay totally away from #FDA. There's rolling submissions.
We know FDA process is completely transparent process.
MHRA is extremely high-grade agency.
Q: Data-use agreements from jurisdictions? #WarpSpeed Perna: Down to 17. Down to dot the "I" & cross the "T" & feel confident all data-use agreements & everything will be alright.
Meanwhile, @SecAzar is at #ForbesHealth trying to justify what Trump administration has done to the U.S. health care system.
Reminder: Trump failed in trying to replace #Obamacare in his four years in office [no plan ever revealed] & never lowered #drugprices.
#WarpSpeed Slaoui: In the trials, people were recruited in not having overt #COVID19 disease.
5 to 10% were seropositive to COVID-19, which means they likely had mild disease.
So we know #vaccines are safe in those populations.
#WarpSpeed Slaoui: If states choose hub/spoke & require additional assets/support, we've been talking to them about having detailed plan/specificity.
They've received funding: $200M & additional $140M this month [@ASTHO said states/jurisdictions need about $9B] #COVID19#vaccines
#WarpSpeed Perna says 5 U.S. federal agencies will receive #COVID19#vaccines doses: Veterans Affairs, Department of Defense, Department of State, Indian Health Services & the Bureau of Federal Prisons.
Q: Chalk line Dec. 15? Pressure on #FDA? #WarpSpeed: I'm an Army general & Army generals plan.
They filed EUA this day. Then #VRBPAC on this day.
Somewhere in this window probably earliest opportunity for EUA.
White Board speculates only if EUA approved would distribution begin.
#WarpSpeed Perna on Dec. 15 distribution timeline: It is a white board plan. It is meant to help us prepare but it is not constraining with execution & no interference with #FDA.
Q: What if $JNJ #COVID19 vaccine get EUA? #WarpSpeed Slaoui: One dose but also studying two-dose. [Interesting he used "we" in speaking about J&J vaccine.]
It will literally enter into the cadence. It's going to be a more efficient/faster strategy to immunize.
Again noting @SecAzar didn't even acknowledge the number of dead today in his briefing. He quickly noted "concerning epidemiological trends" & then moved on.
More than 271,000 Americans are dead under Azar's watch.
I asked #HHS about #WarpSpeed Slaoui's remarks today on 20M vaccinated #COVID19 in Dec, 30M Jan & 50M Feb for total of 100M.
HHS pointed me to Fox interview where he said 50M "BY" February. So Slaoui gave conflicting info today 🙄 video.foxnews.com/v/621359560700…
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.
#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.
#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.
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
#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.
#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.
#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.
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."
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."