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Los Angeles County Department of Public HealthAcute Communicable Disease Control Program
December 11, 2020
COVID-19 Vaccine Preparation Checklistfor Skilled Nursing Facilities
Disclosures
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There is no commercial support for today’s webinar.
Neither the speakers nor planners for today’s webinar have disclosed any financial interests related
to the content of the meeting.
This webinar is meant for skilled nursing facilities and is off the record. Reporters should log off now.
DISCLAIMER
• This is a rapidly evolving situation so the information being presented is current as of today (12/11/2020), so we highly recommend that if you have questions after today you utilize the resources that we will review at the end of this presentation.
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Presentation Agenda
1. Updates on the COVID-19 roll out for SNFs
2. New clinical data and guidance
3. Review preparation steps in the checklist
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1. COVID-19 Vaccine Rollout for Skilled Nursing Facilities
LA County Epidemiology Update
LA County Vaccine Roll Out• Expecting 82,875 Pfizer doses with the first allocation• May arrive Tuesday 12/15/2020, allocated to 83 ACHs • Next allocation larger with both Pfizer and Moderna
• Arrives 12/21-23• Plans to allocate 100% requirement to all SNFs for staff and residents• Using Moderna vaccine (good for 28 days in the fridge)• By licensed beds and fixed staff:bed ratio (~2:1)• Will be oversupply but will allow vaccinating new residents for the
next month as well as visiting/contractual non-employee staff
Why not the Pharmacy Partnership?
• Per ongoing discussions with CDPH, CVS and Walgreens this week:– Anticipating significant delays– Activated after 12/21 with uncertain start and uncertain speed for 338 facilities– Limited availability, 3 onsite visits over 2 months for BOTH doses– One time only, you still need a system for the subsequent dose
• Advantages of facilities receiving vaccine and administering directly:– Allows staggering staff to minimize absences – Will reach you faster– Will achieve higher vaccine coverage– Prepares you for ongoing vaccination for the rest of the pandemic
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SNF Reported Population
HFID Survey
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Facility type N Beds Staff
SNF
≥200 beds 21 5,258 5,210
≥100-200 89 12,380 12,937
≥50-100 178 14,670 15,349
<50 50 1,915 3,332
SNF Total 339 34,223 36,070
Upcoming Timeline
• Daily office hours• 9:00-9:30AM everyday including weekends starting 12/18• Contact us directly for emergent needs
• Friday PrepMOD training webinar
• Sunday HCW KAP Survey Prelim Summary and Action Items
Can we do this?• Yes!
• Key steps• Registration• Storage • Administration • Reporting
• DPH support including limited onsite support
• Potentially reduced testing during vaccination 1st week to help
Upcoming Health Officer Order Preview• COVID-19 Vaccine Requirements• The Facility must offer COVID-19 vaccination to all residents and Facility staff including
directly employed staff and staff not directly employed by the Facility, paid and non-paid, who regularly enter Facility premises one time per week or more.
• For residents who have been discharged or transferred to another facility by the time the second dose is due, the Facility should offer the second dose if requested and if there is sufficient supply.
• For staff who no longer regularly work at or visit the Facility by the time the second dose is due, the Facility should offer the second dose if requested and if there is sufficient supply.
• The Facility must maintain a record of COVID-19 vaccination status of residents; for residents who received vaccination at the Facility, this record should document the date(s) the resident was vaccinated.
• The Facility must maintain a record of COVID-19 vaccination status of staff; this should document the date(s) the staff member was vaccinated. For staff members who decline vaccination, there must be documentation of a signed declination statement that indicates the reason for declination.
• The Facility must provide information on COVID-19 vaccination status of residents and staff to County Public Health if requested.
Other news
• Survey
• Distribution• Direct shipment• DPH
2. New Clinical Data and Guidance
Brief review
Several protocol amendments16 and up
HIV includedActive cancer
Prior SARS-CoV-2
Vaccine Preparation Route Dosing Storage Ages Exclusions**
Pfizer/BioNTech
30µg in 0.3mL
5 dose vial
IM 2 doses
21d apart
-80°C 6m >16 Severe immunocompromisedPregnancy4°C 5d
Room 6h
Moderna 100µg in 0.5mL
10 dose vial
IM 2 doses
28d apart
-20°C 6m >18 Severe immunocompromisedPregnancy4°C 28d
Room 12h
COVID-19 vaccine results• A scientific, collaborative triumph with
better and faster results than expected: 94% efficacious
• Endpoint was symptomatic disease. Also reduced severe COVID-19.
• Reassuringly similar results from two largely similar vaccines
• Extensively studied with 43,000+ (Pfizer) and 30,000+ (Moderna) phase 3 participants
• Wide ages and 42% and 37% respectively from diverse racial and ethnic groups
• Jump started thanks to lessons from vaccine development since 2003 with SARS-CoV then MERS coronaviruses
• No skipped steps: Phases 1, 2, 3 completed
• Timeline shortened by overlapping certain phases including manufacturing
• 2 months of full safety data available for EUA
COVID-19 vaccine development
Demming et al. NEJM, 2020
Mechanism of Action
BioNTech
Moderna
• mRNA codes for the viral spike (S) protein which is used to enter human cells through the ACE2 receptor
• Encapsulated in lipid nano-particles that stabilize and allow cell entry
• Translated by ribosomes with the spike protein then anchored on the cell wall
• Recognized by antigen presenting cells leading to the development of humoral (antibody) and cellular immunity
• Does NOT affect our DNA
FDA Pfizer vaccine review released
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• Re-analysis and review of Pfizer submission• 12/8/2020
• Detailed data• Efficacy• Safety• Product information
• https://www.fda.gov/media/144245/download
• Moderna EUA 12/17/2020
Sub-group efficacy analysis
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• Age, race, sex, co-morbidity subgroups analyzed• Not powered for these• Similar efficacy for all (mid-90s, not statistically different)
• Partial immunization efficacy:
Safety Data: Unsolicited Adverse Events
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Safety data: solicited AEs (systemic)
• Median onset• 1-2 days after either dose
• Median duration• 1 day after either dose
• Mild, moderate, severe
• Fewer in elderly
• More after 2nd dose
Polack et al. NEJM, 2020
Other AE points
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• Among unsolicited non-serious AE, transient lymphadenopathy was vaccine associated
• <0.5%
• No serious AEs were vaccine associated
• Unsolicited AE within 30 mins 0.3-0.4% (same as placebo)
• Hypersensitivity related AE 0.6% (similar to placebo 0.5%) • UK update: Any person with a history of a significant allergic reaction to a
vaccine, medicine or food (such as previous history of anaphylactoid reaction, or those who have been advised to carry an adrenaline autoinjector) should not receive the Pfizer/BioNtech vaccine
Special populations
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• Pregnancy• 23 pregnancies (12 vaccine, 11 placebo)• Unsolicited AEs include spontaneous abortion and retained POCs (placebo)
• Immunocompromised• Data are insufficient • Narrow definition of immunocompromised (severe)• UK allows• Efficacy more of a question than safety
• Prior SARS-CoV-2, n=1,093• Data are insufficient for benefit• No safety concerns noted
Continued safety plans
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• Total follow-up period of 18 months
• Active and passive data collection
• Continued repeat efficacy and safety analysis among sub-groups
• Pediatric, HIV, lactation, and pregnancy data needs highlighted
Reporting Adverse Events
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• Mandatory reporting to VAERS :• Vaccine administration errors whether
associated with an adverse event• Serious adverse events (irrespective of
attribution to vaccination)• Multisystem Inflammatory Syndrome in
children and adults• Cases of COVID-19 that result in
hospitalization or death
• V-safe is a new smartphone-based opt-in program
• Telephone follow-up to anyone who reports medically important adverse events
• Missed work, inability to do daily activities, or receiving healthcare triggers VAERS Call Center
Return to work guidance: preliminary
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*http://publichealth.lacounty.gov/acd/ncorona2019/healthfacilities/HCPMonitoring/#rtw
Symptomatic HCW
>2 days after the day of vaccination
≤2 days after the day of vaccination
Routine guidance* Fever ≥38°C Other symptoms
High-risk exposures
Symptoms ≥48 hours
Can work
None
Staggering
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• Less of a concern for this allocation round• Assume <5% post-vaccination symptoms with first dose• Median 1 day duration loss of work
• For groups with critical staffing concern separate by 2-3 days
Testing after vaccination
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• No problem
• SARS-CoV-2 RT-PCR targets• Rarely use S protein
• Rapid tests• BD, Abbot, Sofia all use NC protein
Kubina et al. Diagnostics, 2020
3. Checklist for preparation
• Priority group number 1 for the limited supplies of the new vaccine
• Healthcare workers are the most trusted source of information on COVID-19 and vaccination for the public.
• Heroes in the eyes of the public for their dedication, and commitment during the pandemic.
• Professional obligation to get vaccinated and continue to lead by example
Healthcare workers and vaccination
Source: Marvel comics
Source: Banksy
• You know how to do this better than we do
• Use best practices from your experience with flu
• Documentation of all staff refusals
• Goals should be the same or higher rate as your previous highest influenza vaccine coverage
Improving healthcare worker vaccination
Checklist contents
Checklist contents
COVIDReadi Enrollment
COVIDReadi: Provider Enrollment and Registration
• California’s COVID-19 Vaccine Program• Administered by CDPH• Web-based registration portal• Enrollment currently limited• Participation by invitation• Consists of two sections
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Create Enrollment
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Create or Edit an Organizational Account
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Review Enrollment Criteria
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Section A: Responsible Officers and Provider Agreement
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Agree to CDC Requirements
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Officer Acknowledgement
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Adding Vaccination Locations
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Section B: Provider Profile Information
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Provide Site Information
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Estimate Patient Population
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IIS Reporting
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List Practicing Providers
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Final Steps
• Provide additional data– Vaccine delivery windows– Storage unit and temperature monitoring device details– Signature of Medical/Pharmacy Director or location’s Vaccine Coordinator
• Submit enrollment• CDPH review/approval
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CAIR Enrollment
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California Immunization Registry (CAIR)• Secure, confidential, computerized statewide immunization information system (IIS)
for CA residents• Consolidates immunizations into a single record• Assists providers in determining immunizations due• Manages vaccine inventory• Assists providers to do reminder/recall• Produces a variety of patient-specific and aggregate reports
And…enrollment is required to participate in the COVID-19 Vaccination Program
CAIR Statute
• CA Health & Safety Code– Division 105, Communicable Disease Prevention and Control
[120100 – 122450]– Part 2. Immunizations [120325 – 120480]– Chapter 2.5. Disclosure of Immunization Status [120440]
http://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?lawCode=HSC§ionNum=120440
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Who can use CAIR?
• Health care providers (vaccinators)• Schools• Child care facilities• WIC agencies• Health plans• Foster care agencies• County welfare departments• Public Health
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Steps to Take
• Be prepared to provide your CAIR ID during enrollment in COVIDReadi; if unsure of your status, you can contact the CAIR Help Desk or a Local CAIR Representative
• Visit the CAIR enrollment webpage for additional information: http://cairweb.org/enroll-now/
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Checklist contents
Checklist contents
Checklist contents
Checklist contents• Appendix included
• All referenced documents with brief descriptions
• Digital “binder”• Zipped file of all the
above resources
• Fast moving and starting soon
• You are better at this than we are
• We will help as best we can
Take home points
Questions and Answers
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