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

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

https://www.fda.gov/media/144245/download

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

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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

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&sectionNum=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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http://cairweb.org/enroll-now/

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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��Los Angeles County Department of Public Health�Acute Communicable Disease Control Program�DisclosuresDISCLAIMERPresentation Agenda1. COVID-19 Vaccine Rollout for Skilled Nursing FacilitiesLA County Epidemiology UpdateLA County Vaccine Roll OutWhy not the Pharmacy Partnership?SNF Reported PopulationUpcoming TimelineCan we do this?Upcoming Health Officer Order PreviewOther news2. New Clinical Data and GuidanceSlide Number 15COVID-19 vaccine resultsCOVID-19 vaccine developmentSlide Number 18FDA Pfizer vaccine review releasedSub-group efficacy analysisSafety Data: Unsolicited Adverse EventsSlide Number 22Other AE pointsSpecial populationsContinued safety plansReporting Adverse EventsReturn to work guidance: preliminary StaggeringTesting after vaccination3. Checklist for preparationSlide Number 31Slide Number 32Checklist contentsChecklist contentsCOVIDReadi EnrollmentCOVIDReadi: Provider Enrollment and RegistrationCreate EnrollmentCreate or Edit an Organizational AccountReview Enrollment CriteriaSection A: Responsible Officers and Provider AgreementAgree to CDC RequirementsOfficer AcknowledgementSlide Number 43Adding Vaccination LocationsSection B: Provider Profile InformationProvide Site InformationEstimate Patient PopulationIIS ReportingList Practicing ProvidersFinal StepsCAIR EnrollmentCalifornia Immunization Registry (CAIR)CAIR StatuteWho can use CAIR?Steps to TakeChecklist contentsChecklist contentsChecklist contentsChecklist contentsSlide Number 60Questions and Answers