#CDC #ACIP now getting underway on allocation of #COVID19 #vaccines
https://www.cdc.gov/vaccines/acip/index.html
Webcast here: https://www.ustream.tv/channel/VWBXKBR8af4 https://twitter.com/SPGMIHealthcare/status/1333360463854383107

#CDC #ACIP slides should be up soon here, Dr. Cohn says: https://cdc.gov/vaccines/acip/meetings/index.html

#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.
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-11/COVID-04-Dooling.pdf

$PFE $MRNA

Here's the #CDC #ACIP members: https://www.cdc.gov/vaccines/acip/members/index.html
#COVID19 #vaccines

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

#COVID19 #vaccines

#ACIP Slides for #CDC's Bell: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-12/COVID-01-Bell.pdf

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 https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-12/COVID-02-Dooling.pdf

#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: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-12/COVID-03-Oliver.pdf
#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 https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-12/COVID-04-Shimabukuro.pdf
#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