COVID-19 Vaccination What's happening? - January 2021 - Monash Health

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COVID-19 Vaccination What's happening? - January 2021 - Monash Health
COVID-19 Vaccination

What’s happening?

 January 2021
COVID-19 Vaccination What's happening? - January 2021 - Monash Health
Twelve Months of COVID-19

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COVID-19 Vaccination What's happening? - January 2021 - Monash Health
Why Vaccinations?

• Vaccines save lives
      • Estimated 5 lives a minute are saved
          • Smallpox vaccine – eradicated the disease - saves 5 million lives annually
          • Measles vaccine – prior to vaccination availability – caused 2.6 million deaths annually

                            Vaccines only save lives if people are vaccinated

• Why COVID-19 vaccination?
      • COVID-19 is a serious disease
      • Physical distancing, mask-wearing and isolating have slowed the disease – but….
      • We now have safe and effective vaccines available
          • Vaccines have been tested on millions of people
          • Risk of COVID-19 far outweighs any risks associated with the vaccines

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COVID-19 Vaccination What's happening? - January 2021 - Monash Health
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COVID-19 Vaccination What's happening? - January 2021 - Monash Health
Vaccination

               Vaccines prime your
                immune system to
              recognize and fight off
                   an infection

               They don’t actually
               cause the disease
COVID-19 Vaccination What's happening? - January 2021 - Monash Health
New Platforms

             Years of research
               behind them

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COVID-19 Vaccination What's happening? - January 2021 - Monash Health
Vaccine characteristics and approvals

                     Vaccine               Temperature
                                                                     Trial Phase            Safety Results             Efficacy Results     TGA Approval
                     Details               Requirements

                                              Frozen for                                                                95% efficacy
                                        storage/transport: -                                                          (consistent across
                  mRNA vaccine
      Pfizer                           70°C ± 10°C for up to 10    Phase 3 results          Administration well        age, gender, race
                    from the                                                                                                                 Provisional
                                           days unopened           to be published     tolerated; no serious safety      and ethnicity
                  US/Germany                                                                                                                Determination
                                       Thawed: three -five days                            concerns observed.         demographics with
                                         at refrigerated 2-8°C                                                        over 94% in adults
                                              conditions                                                              over 65 years old)

                                                                                                                      Half dose/Full Dose
                                                                    Phase 3 interim
                    Viral vector                                                                                       regimen = 90%
    AstraZeneca                        Routine refrigerated cold   results published       Administration well                               Provisional
                   vaccine from                                                                                       Full dose/Full dose
                                           chain at 2-8°C            in The Lancet     tolerated; no serious safety                         Determination
                      the UK                                                                                           regimen = 64%
                                                                     (08DEC2020)           concerns observed
                                                                                                                       Pooled efficacy =
                                                                                                                        70.4% across

                  Protein vaccine
     Novavax                                                        Phase 3 trials
                   from the US                                                             Administration well
                                                                    ongoing in US
                  (clinical trial in             N/A                                   tolerated; no serious safety          TBA                N/A
                                                                     and Mexico,
                     Australia)                                                            concerns observed
                                                                   complete in UK
COVID-19 Vaccination What's happening? - January 2021 - Monash Health
Doses, deliveries, requirements

                     Purchase Agreement          Weekly deliveries         Weekly Deliveries       Minimum Delivery
                                                   (Australia)               (Victoria)

                                                                                                   Approximately 1000
        Pfizer      10 million doses spread    100-200,000 per week                             doses (one tray) for use in
                                                                         Max. 50,000 per week
                          across year              from February                                3 days once thawed, has
                                                                                                 maximum freeze times
                                                                                                  once left the factory

                    30 million doses across
      AstraZeneca                             Up to 1 million per week   Approx. 250,000 per
                        the year (local                                                                    TBA
                                                    from March                 week
                        manufacturing)

       Novavax      40 million doses spread
                        across the year
COVID-19 Vaccination What's happening? - January 2021 - Monash Health
Overall Victorian model

                                                                                         Local
                               General Practice               Pharmacy
     AstraZeneca
                                                                                       Government

                       Health                Community                  GP Respiratory
                      Services                                                                     ACCHOs                    Base capacity
                                               Health                      Clinics

                            Targeted populations, health care workers, high risk industries, general population

                                                       Health Services
        Pfizer (1a)

                              Pfizer-Hubs                                             Targeted
                                                              V   HUB
                                  (6-8)                                               Outreach                    Rapid and early roll out
                                                                                                                  in highest risk cohorts

                       • Health Care Workers (highest risk)                    • Hotel Quarantine Workers
                      • Public Sector Residential Aged Care                     • Ports of Entry Workers
                                 staff and residents
COVID-19 Vaccination What's happening? - January 2021 - Monash Health
PPhase 1a vaccine program
                                                                       Coverage
                                                                                                                                                 Anticipated
                      Vaccine Recipient Cohorts                      Projection for                     Delivery Model
                                                                                                                                              recipient numbers
                                                                       Phase 1a

                    Staff involved in the Vaccination                                              Small vaccination site                           500-1000
                                                                      Full coverage
                                Program                                                   (potentially coupled w ith dry run site practice)           initial

                          Hotel Quarantine Staff
                      (and staff associated w ith the Hotel           Full coverage     A combination of small vaccination sites                     5,000
                             Quarantine Program)                                           (proximal to locations) or mobile clinics

                   Health Care Workers at Victorian                                         A combination of large vaccine
                                                                                                                                                     5,000
Prioritisation

                          COVID19 Testing Sites                       Full coverage     administration sites at health services or
                    (all staff including administrative staff)                                mobile clinics to some sites

                                                                                             A combination of large vaccine
                  High risk staff at Victorian Airports               Prioritisation              administration sites
                     (International & Domestic)                       according to      (Tullamarine/Avalon/Port Melbourne) and                      16,500
                 - including airline staff w here necessary; and      exposure risk     small or mobile clinics (Tullamarine & Avalon/
                 high-risk staff at Victoria's Sea Ports of entry.
                                                                                                          Port Melbourne)

                         Prioritised Hospital Staff                   Prioritisation
                                                                                        Hospital staff administered within hospital           Unknown (should be a
                  (ER; ICU; COVID w ards - all staff physically       according to
                                                                                        or mobile clinic delivering it to the hospital        proportion of 386,000).
                       associated w ith these w ork areas)            exposure risk

                 Prioritised health care workers (other)             Partial coverage
                                                                                                    Under consideration.                            Unknown
                  e.g. General Practice, Paramedics                    acceptable
Detailed planning for Phase 1a

                                                           Coverage
                                                                                                                            Anticipated recipient
                      Vaccine Recipient Cohorts           Projection for                 Delivery Model
                                                                                                                                  numbers
                                                            Phase 1a

                                                                                                                              Health and disability
                                                                                                                                 care workers:
                                                                                                                            (should be a proportion
                                                              Partial      A combination of small vaccination sites              of ~386,000)
                     Health, aged care and disability        coverage         (proximal to locations) or mobile clinics
Prioritisation                care workers                  acceptable                                                       Aged care workers:
                                                                                                                                  ~56,800

                                                                                                                               Total: ~442,800

                          Residents in residential            Partial      A combination of small vaccination sites
                      disability, permanent residential      coverage       (proximal to locations) or mobile clinics and       ~50,000 TBC
                               and respite care             acceptable      coordination with local council services
The Pfizer vaccine will be the first available in Australia

 Australian capacity
 • 10 million doses of the Pfizer mRNA available in first half of 2021
 • TGA approval expected by end of January 2021

 Victorian capacity
 • 450k to be vaccinated (900k doses ordered)

 Dosage
 • 2 dose administration, administered 21 days apart (+/- 2 days)

 Supplier cold chain procedure
 • Pfizer boxes contain 1,000 doses per batch, 5 doses/vial (195 vials)
 • If a box is opened for longer than a few minutes, the vials need to be
   refrigerated and then used within three days

 Cold chain storage
 • Freezer storage: -70°C
 • Refrigerator storage: 2-8°C
 • 3 day shelf life from time left freezer
 • 6-hour shelf life once vial is opened

 Australian Immunization Register (AIR)
  • COVID-19 vaccination is currently voluntary
  • Provider reporting on AIR will become mandatory in 2021
mRNA Vaccines

• mRNA
      • Instructs our cells on what proteins to produce   Easy design
      • In vaccine is in a nano-lipid layer
      • COVID vaccine is toward the viral spikes          Rapid manufacture

• Enters cells                                            Robust response
      • Cell makes the “viral” proteins
• Viral proteins released
      • Immune response triggered
• mRNA digested by enzymes
• Immunity
      • To viruses entering the body that have these
        spike proteins

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Pfizer / BioNTech

• mRNA Vaccine
• Trial:> 43,500 participants: 2 doses @ 0 and 3 weeks
• Preliminary data indicating vaccine is > 90% percent effective.
   • 7 days after second dose
• Logistics for this vaccine require vaccine “hubs”
• Effective after dose 1
   • 2nd dose for durability
   • Unclear duration of effect
• Prevents severe disease
• Ongoing studies on if it prevents transmission
Safety
• mRNA vaccines are quite safe
      • Importantly no vaccine is ever 100% safe but greatly outweigh risks
• Safety will be assessed ongoing
      • New vaccines for a new disease
      • Very Rare events are likely to appear in media, amplify attention and increase worry that is
        disproportionate to risk
• These vaccines are classified as “reactogenic”
      • Will cause some small side effects in most people who receive than as a marker of the brisk
        immune response they generate
• Most important side effects
      • Pain at injection site, fatigue and headache – all resolve in first few days
      • Younger > older and second dose > first dose

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Anaphylaxis

             • Likely not due to mRNA itself
                 • Polyethylene glycols/polysorbate 20
                 • also in other medications, moisturisers etc.

             • Now known to be rare but observation for 15
               minutes warranted

             • Rate ~ 1 in 100,000
                • Penicillin rate ~ 1 in 5000
                • All vaccines ~ 1 in 1000,000

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Who can have the vaccine?

• Very few contraindications
      • Not if you are allergic to any components of the vaccine
                                                                   Separate by 7 days
•   Age > 16 years                                                 Influenza vaccine
•   Pregnancy                                                           program
•   Immunosuppressed
•   Past-history of COVID
      • Yes – wait ~ 90 days
• Acute illness
      • Defer until better
• History of anaphylaxis to other medications/foods
      • Watch for 30 minutes post vaccination

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Monash COVID-19 Vaccination Program

• Gradual role out dependent on vaccine availability
      •   Commonwealth led
      •   High risk HCWs first
      •   Aged care HCWs and residents next
      •   Other patient facing staff
• Pfizer vaccine will be delivered from clinics
      •   5 sites – 3 to begin with
      •   HCWs must come to the clinic
      •   Specific preregistered appointments
      •   End to end IT system
      •   Closely working with managers to ensure easy process that impacts least on health service
          delivery

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Monash HCW Vaccination Program
Vaccine delivery is driven by clinical sub-working groups with support from the
Project Team                                                                      What we are planning for

                                                                                   Monash Health as one of the first Pfizer Hubs
                                                                                   • Hub and spoke model between MMC and:
                                     Operations                                          • Casey
                                                                                         • Dandenong
                                                                                         • Peninsula Health
                                                            Rhonda Stuart                • Private Hospitals
                                                            Sarah Hirschi                • Alfred Health
                                    Project Team            Tom McLaughlin
                                                            Fiona Sherwin          • Scaled vaccine delivery to identified HCW priority groups
                                                            Eliisa Fok
                                                                                  What we are working on

       Clinical                       Workforce                       Systems      Workforce
       Advisory                       Advisory                        Advisory     • Who is allowed to deliver the vaccine (e.g. Nurse Immunisers)
                                                                                   • Training requirements

                                                                                   Vaccine delivery by Monash Health
                                                                                   • Priority populations to be advised by DHHS
     Sub-Working                    Sub-Working                    Sub-Working     • Number of vaccines clinically delivered
       Groups                         Groups                         Groups        • Number of vaccines to be stored

                                                                                   Systems
                                                                                   • DHHS and Federal go live dates and reporting requirements

                                                                                   TGA administration advice
                                                                                   • Including clinical delivery and SOP’s across S&Ts
Approx 4,000 HCWs are identified as first priority across
      all Monash Health sites (similar to fit testing schedule)
                                                                                      Proportion
Priority HCW        Nursing/                                                               of
                                Medical   Allied Health   Pharmacy   Others   Total
groups              Midwifery                                                         anticipated
                                                                                         (Vic)5     Key takeaways

Immunisation                                                                                        • Approx. 4,000 Monash Health are
                       97         0            0             9         12     118        12%          identified for Phase 1a
Clinic1
                                                                                                      vaccinations
COVID-19
                       30         1            10            0        152     193         4%        • Vaccine clinic sites planned for:
testing sites1                                                                                          • MMC
                                                                                                        • Casey
Priority Hospital
Staff – ICU and       1493       1028         192           119        45     2,877
Cohorted dosing for HCW

                             Week 1                  Week 2                        Week 3                    Week 4                Week 5                    Week 6

                • Cohort 1              • Cohort 2                    • Cohort 3                • Cohort 1            • Cohort 2                • Cohort 3
     Monash     • Dose 1                • Dose 1                      • Dose 1                  • Dose 2              • Dose 2                  • Dose 2
Health HCWs
 (3 MH sites)                                                                                                                                                         Non-pt
                                                                                                                                                                      facing &
                                                                                                                                                                      mop-up

                                               ~4000          Doses                                                         ~4000       Doses

                    Vaccine doses to be delivered in a 6 week period

                                      Spread out HCWs over a 3 week period
After the vaccine….

• The virus will still be circulating
      • Until herd immunity is established worldwide
      • COVID-19 is with us for a long time
• Masks and distancing will still be required until we know a bit more
      • Until immunity develops
         • 7 days or more after second dose
      • Until we know more around the ability of the vaccine to stop transmission
         • Likely to be so – as this is the case for other vaccines
         • Decreases disease severity
         • Likely decreases viral load

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Summary

               On track for Australian vaccine delivery 2021
                Pfizer vaccine to role out at Monash Health
               First doses to high-risk employees in February

                              Monash Staff
             Vaccination of everyone who can be immunized
                 Protect yourself and those around you

                     DHHS/Commonwealth to decide on mandates

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