Thread by @DonnaYoungDC

#CDC #ACIP now getting underway on allocation of #COVID19 #vaccines
cdc.gov/vaccines/acip/…
Webcast here: ustream.tv/channel/VWBXKB…

https://twitter.com/SPGMIHealthcare/status/1333360463854383107

#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

Here's the slides from the Nov. 23 #CDC #ACIP explaining phase 1a population & allocation of #COVID19 #vaccines.
cdc.gov/vaccines/acip/…

$PFE $MRNA

Here's the #CDC #ACIP members: cdc.gov/vaccines/acip/…
#COVID19 #vaccines

And we have our first dog bark of today's #CDC #ACIP meeting.

#COVID19 #vaccines

#ACIP Slides for #CDC's Bell: cdc.gov/vaccines/acip/…

She notes 180 people in the U.S. would have died from #COVID19 during today's meeting.

1 person per minute.

#vaccines

#ACIP slides for #CDC's Dooling cdc.gov/vaccines/acip/…

#COVID19 #vaccines $PFE $MRNA

#CDC's Dooling:
Phase 1a:
21 million health care workers
About 3 million in long-term care facilities [1.3M in nursing homes].

#COVID19 #vaccines #ACIP

About 69,000 deaths in U.S. nursing homes from #COVID19 as of Nov. 15. Also 5,469 deaths in Assisted living facilities as of Oct. 15.

#ACIP #CDC #vaccines

#CDC Dooling: 99% of total skilled nursing facilities nationwide have enrolled or, 15,353, in U.S. pharmacy partnership program to get #COVID19 #vaccines.

#ACIP

#ACIP: Atmar: Does U.S. pharmacy partnership for long-term care vaccinate residents & staff?

#CDC Dooling: Yes. Both

#COVID19 #vaccines

#CDC's Dooling notes waiting on more details of phase 3 data to know efficacy of single dose of #COVID19 #vaccines.

#ACIP

#CDC's Dooling notes pharmacies will be making three separate visits to vaccinate all persons at long-term care facilities.

#ACIP #COVID19 #vaccines

#ACIP members want to ensure outpatient health care professionals, home health aides & small community practices among the phase 1a to get #COVID19 #vacciines.

#CDC

#CDC's Cohn: Assume most planning around long-term care facilties have vaccinate both residents & health care professionals. But there will be some jurisdictions that start with HCPs & then residents.
Dependent on supply & local context.

#ACIP #COVID19 #vaccines

#CDC notes turnover at long-term care facilities is a challenge when ensuring 2nd dose of #COVID19 #vaccines.
There will need to be additional visits to LTCFs.

#ACIP

#ACIP Frey: People in LTCFs are going to be vaccinated, that this is another situation where need a lot of guidance post-vaccination to evaluate symptoms of adverse events, side effects. If elderly suffer fatigue/fever, people worry about infections.
#CDC #COVID19 #vaccines

#CDC: Recommendation from #ACIP today pertains to adults in LTCFs, not pediatrics.

Age cutoff will be determined when #COVID19 #vaccines are authorized.

#ACIP slides for #CDC Oliver: cdc.gov/vaccines/acip/…
#COVID19 #vaccines

#CDC Oliver: Initial doses of any #COVID19 vaccine will be limited. We expect a constrained supply environment for some months and need to make the best use of available vaccine.

#ACIP $PFE $MRNA #vaccines

#CDC Oliver: By the end of December, the number of #COVID19 #vaccines doses available will be about 40 million, enough to vaccinate 20 million people

Anticipate 5-10 million doses per week post-authorization

#ACIP

#CDC Oliver: 75% of health care workforce are women

Approximately 330,000 health care personnel could be pregnant or recently postpartum at the time of vaccine implementation

#COVID19 #vaccines #ACIP

#CDC Oliver: There's No data on use of mRNA #vaccines in pregnant/breastfeeding women

[Both $PFE/ $BNTX & $MRNA/#NIH #COVID19 vaccines are mRNA platforms]

#ACIP

#CDC Oliver urges consider staggering vaccination of health care personnel from similar units or positions

#ACIP #COVID19 #vaccines

#CDC Oliver: As of Nov 26, there's been about 730,000 #COVID19 cases and 100,240 deaths among long-term care facility residents & staff.

#ACIP #vaccines

#CDC Oliver Reactogenicity appears lower in older adult population for mRNA vaccines

BUT -- There's no reactogenicity data in LTCF residents

#ACIP #COVID19 #vaccines $MRNA $PFE $BNTX

#ACIP Hunter praises #CDC for pointing out may consider not getting all health care professionals in same unit vaccinated at same time/staggering in case they all experience adverse events & need to stay out.

#COVID19 #vaccines

#ACIP Maldonago & Szilagyi ask about sub-prioritizations of health care workers getting vaccinated.
#CDC notes there will be 40M doses by end of December to cover 15M to 20M individuals, a large portion of HCPs.
Goal direct immunization for individual/health care system as whole.

.@DrNancyM_CDC: In discussions with jurisdictions, most believe they can vaccinate all health care workers in 3 weeks.
That's dependent on support for vaccine that workforce will be drawn together.
Operational standpoint, some less than 3 weeks.

#COVID19 #vaccines #ACIP #CDC

#ACIP member notes it will take partnership with local/state health departments, etc. to ensure smaller hospitals can stagger out #COVID19 #vaccines.

#CDC

#FDA's Fink: #COVID19 #vaccines EUA fact sheets will be updated when new info FDA considers important to allow HCPs & vaccine recipients to understand benefits/risks.
Can't give specific timeframe how often, b/c that will depend on when receive info that warrants a change.
#ACIP

#CDC notes each #COVID19 vaccine will have individual EUA fact sheet.
Individual will receive fact sheet for the vaccine product they receive.
Part of the EUA package.

Cohn notes there will be "information toolkits" provided.

#ACIP #vaccines

Q: Reporting requirements for adverse events?
#FDA Fink: The EUA when issued will lay out requirements for adverse events reports.

#COVID19 #vaccines #ACIP #CDC

#ACIP member: Should more facilities be given fewer doses or should fewer facilities be given more doses?

#COVID19 #vaccines #CDC

#ACIP Lee: My concern about equity, if we ask people to self-disclose, it may create some unintended inequities.
I think some health care workers are more easily able to self-advocate/feel comfortable in their position & being able to declare medical conditions.
#COVID19 #CDC

#ACIP member: I would hate to see a large system get huge amount of #COVID19 #vaccines & vaccinate everyone … not in patient care & it's not getting out to community it needs.
Must make sure getting vaccines where need to be.
Some rural providers may not know where to go.
#CDC

#ACIP Fryhofer: Is EUA authorization form something patient signs? Will frail elderly understand? Will family member have to sign?
@DrNancyM_CDC: We agree with your concerns. Important frail elderly/family members understand.
Going to need everybody pulling together.
#COVID19

#CDC's Shimabukuro #ACIP slides cdc.gov/vaccines/acip/…
#COVID19 #vaccines

Reminder on #CDC's slides: They pull them down after #ACIP meeting b/c they haven't yet undergone the 508 review.
So download & save them now (:

#COVID19 #vaccines

#CDC's notes the VAERS #vaccines monitoring system covers the entire U.S. population.

#COVID19 #ACIP

Waiting on the #ACIP member who finally asks why the U.S. needs so many duplicate/overlapping #vaccines monitoring/reporting systems.

Why?

#CDC #COVID19

#CDC's Shimabukuro notes #COVID19 #vaccines adverse events reporting: 1 day for death reports, three days for serious reports & five days for non-serious reports.

#ACIP

#CDC's Shimabukuro: Early data on #COVID19 #vaccines safety in healthcare workers will be mainly
available through V-safe & VAERS & systems that report to VAERS
Early data on safety in LTCF residents will be mainly available through VAERS/systems that report to VAERS.

#ACIP

.@DrNancyM_CDC: #FDA will not authorize/#ACIP will not recommend #COVID19 #vaccines unless safe.
BUT vaccine safety doesn't stop there. Will hold ourselves to exceedingly high standard on monitoring.
Vaccine systems partly dependent on reporting.
Need everybody rowing together.

#CDC's Shimabukuro notes the V-Safe system will require people who got #COVID19 #vaccines to self-enroll online.

So, those people not online or who don't have smartphones?

#ACIP

There it is: #ACIP member brings up the potential confusion for health care providers of which system they're supposed to be reporting #COVID19 #vaccines adverse events to.
#CDC Shimabukuro again reiterates V-safe is the interactive system for people who got the shots.

#CDC Shimabukuro: If two reports get in there we have way of identifying & consolidating reports.

#ACIP #COVID19 #vaccines

#ACIP Maldonado also brings up concern about multiple #vaccines reporting/monitoring systems.

#CDC #COVID19

#ACIP Maldonado asks what happens when signal detected/how prioritized/addressed?
#CDC Cohn: Role of VaST to interpret data/provide advice to ACIP
We do anticipate there will be signals that will need to be assessed b/c of populations, like older adults.

#COVID19 #vaccines

#ACIP Talbot: Pediatric doctors well-versed with VAERS, but don't think doctors treating adults are.

#CDC's Shimabukuro acknowledges there's work to do for ensuring LTCFs education on reporting. Plans for outreach. "Need to get the word out."

#COVD19 #vaccines

#ACIP Romero: In educating the public on vaccine safety systems, it's going to be very important to have culturally/linguistically appropriate information, so can enter data as appropriate.
We want to capture all signals.

#CDC #COVID19 #vaccines

#CDC's Cohn says materials are available in five languages
Have hundreds of partners that we need to engage/listen to/educate/talk to about all of this [Before #COVID19 #vaccines EUAs granted???]. Have very strong partnerships across the healthcare sector.

#ACIP

Voting Q for interim recommendation: When a #COVID19 vaccine is authorized by #FDA & recommended by #ACIP, health care personnel & residents of long-term care facilities should be offered vaccination in the initial phase [phase1a]?

#vaccines

From #CDC's Dooling's slide: Health care personnel are defined as paid and unpaid persons serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials.

#COVID19 #vaccines #ACIP

#CDC Dooling: Long-term care facility residents are defined as adults who reside in facilities that provide a variety of services, including medical and personal care, to persons who are unable to live independently

#COVID19 #vaccines #ACIP

#CDC Dooling: LTCFs are primarily on skilled nursing & assisted living with priority for SNF first.
Gating criteria will be needed to move from one phase to next. So may still be working on assisted living as move on to other phases.

#COVID19 #vaccines #ACIP

#CDC Cohn: The intent of the vote today is to provide guidance & recommendations for health departments to place their orders for #COVID19 #vaccines & determine how they want to take this & implement at state/local levels.

#ACIP

#ACIP Talbot: We enter the realm hope it works/hope it's safe. That concerns me on many levels.
Don't feel like safety networks for LTCFs are strong enough yet. Work needs to be done.
But workers need vaccinated.
Still struggling.

#COVID19 #vaccines #CDC

#CDC Cohn notes public comment session begins at 5pmET.
After that 30-40 minutes, then ACIP will VOTE.
After go through votes, then will open up for comments from #ACIP.
Meeting should be done at about 6pmET.
Sorry late, but appreciate the robust discussion.
#COVID19 #vaccines

#ACIP meeting back. Public comment session now on.
Recall, #CDC said it had initially received 75 requests for today but had to limit to 10. [there is a public docket for written]
Romero notes those 10 were determined by lottery.

#COVID19 #vaccines

#CDC #ACIP Pub speaker 1: A peds nurse/Air Force vet raises safety concerns.
She notes survey showed 36% nurses will refuse/31% unsure if they'll take it.
Are we risking our essential health care workers by not having safety questions answered?

#COVID19 #vaccines

Skipped #CDC #ACIP pub spkr 3 for now.

CDC ACIP pub spkr 4 "Why We Vaccinate" says she supported today's motion.
Raises concerns about people who spread misinformation.
Urges conduct outreach/education on #COVID19 #vaccines to ensure widespread uptake.

#CDC #ACIP pub spkr 6: A "Polio pioneer": Recommendations were well thought out
But says firefighters should be included as health care workers for phase 1a purposes.
Rural areas should get #COVID19 #vaccines that don't require ultra-cold temps [so not $PFE's]

#CDC #ACIP pub spkr 7 from UCLA: Urges to consider correction officers for highest tier to get #COVID19 #vaccines.

Now on to the #CDC #ACIP vote on phase 1a priority group for allocation of #COVID19 #vaccines. [Health care professionals & long-term care facility residents/health workers].

#CDC #ACIP vote: 13 Yes, 1 No [Talbot]
When a COVID-19 vaccine is authorized by #FDA & recommended by ACIP, it should be offered to both health care personnel/residents of long-term care facilities [phase 1a]

#COVID19 #vaccines

#ACIP Chair Romero: Our discussions have been transparent & our motives are clear: Maximizing benefits, minimizing harms, promoting justice & mitigating health inequities.

#CDC #COVID19 #vaccines

#ACIP Szilagyi: This been a Solomon's choice. But we will all have access very soon.
Quotes Gandhi: A nation's greatness is measured by how it treats its weakest members.
Prioritizing health care providers/LTCF residents "represents the right decision."

#COVID19 #vaccines #CDC

#ACIP Talbot [the only "No" vote]: I struggled with this. It was not an easy vote.
Need to find ways to test #vaccines to prolong life of LTCF residents.
But says she has "no reservations" about providing #COVID19 vaccines to health care workers.

#CDC

#ACIP Atmar & Bell both note today's vote is on allocation, not on a recommendation for any #COVID19 #vaccines themselves.
Atmar says he had some same concerns as Talbot in LTCF residents but ultimately persuaded b/c of tremendous hospitalization/mortality burden.
#CDC

#CDC Cohn notes next #ACIP meeting will be after #FDA has issued EUA - shortly after Dec. 10 #VRBPAC meeting.
And will be vote on recommendation on specific #COVID19 vaccine [ $PFE's].

#vaccines

.@DrNancyM_CDC: To all the people out there that are anxiously waiting for this vaccine, we hope that this gets us all one step closer to the day when we can all feel safe again and when this pandemic is over.

#CDC #ACIP #COVID19 #vaccines $PFE $BNTX #MRNA

And #CDC #ACIP meeting adjourned.

#COVID19 #vaccines

Reminder of this remark today from #CDC's Dr. Bell:

180 people in the U.S. would have died from #COVID19 during today's #ACIP meeting. But the meeting was four hours so even more: 240 dead.

That's 1 person every minute who have by now left this Earth.

https://twitter.com/DonnaYoungDC/status/1333854158118662146

Out from the paywall:
Health workers, nursing home residents should get COVID-19 vaccine first – panel spglobal.com/marketintellig… #COVID19 #vaccines #CDC #ACIP $PFE $MRNA $BNTX