COVID-19 Vaccination

What’s happening?

January 2021

Twelve Months of COVID-19

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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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Vaccination

Vaccines prime your

immune system to

recognize and fight off

an infection

They don’t actually

cause the disease

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New Platforms

Years of research

behind them

Vaccine characteristics and approvals

Vaccine Details

Novavax

AstraZeneca

Pfizer

Trial PhaseTemperature Requirements

mRNA vaccine from the

US/Germany

Efficacy Results

Viral vector vaccine from

the UK

Protein vaccine from the US

(clinical trial in Australia)

Routine refrigerated cold chain at 2-8°C

N/A

Phase 3 interim results published

in The Lancet (08DEC2020)

Phase 3 trials ongoing in US and Mexico,

complete in UK

Half dose/Full Dose regimen = 90%

Full dose/Full dose regimen = 64%

Pooled efficacy = 70.4% across

TBA

Frozen for storage/transport: -

70°C ± 10°C for up to 10 days unopened

Thawed: three -five days at refrigerated 2-8°C

conditions

95% efficacy(consistent across age, gender, race

and ethnicity demographics with over 94% in adults over 65 years old)

Phase 3 results to be published

TGA Approval

Provisional Determination

N/A

Provisional Determination

Safety Results

Administration well tolerated; no serious safety

concerns observed

Administration well tolerated; no serious safety

concerns observed

Administration well tolerated; no serious safety

concerns observed.

Doses, deliveries, requirements

Purchase Agreement

Novavax

AstraZeneca

Pfizer

Weekly Deliveries (Victoria)

Weekly deliveries (Australia)

10 million doses spread across year

Minimum Delivery

30 million doses across

the year (local manufacturing)

40 million doses spread

across the year

Up to 1 million per week

from March

Approx. 250,000 per

weekTBA

100-200,000 per week

from February

Approximately 1000 doses (one tray) for use in

3 days once thawed, has maximum freeze times once left the factory

Max. 50,000 per week

Overall Victorian model

GP Respiratory

Clinics

Targeted

Outreach

General Practice PharmacyLocal

Government P

fize

r (1

a)

As

tra

Ze

ne

ca

• Health Care Workers (highest risk)

• Public Sector Residential Aged Care

staff and residents

• Hotel Quarantine Workers

• Ports of Entry Workers

Rapid and early roll out in highest risk cohorts

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

Base capacity

Health Services

Health

ServicesCommunity

HealthACCHOs

V HUB

Pfizer-Hubs

(6-8)

Pri

ori

tisati

on

PPhase 1a vaccine program

Vaccine Recipient Cohorts

Coverage

Projection for Phase 1a

Delivery ModelAnticipated

recipient numbers

Staff involved in the Vaccination

ProgramFull coverage

Small vaccination site(potentially coupled w ith dry run site practice)

500-1000

initial

Hotel Quarantine Staff(and staff associated w ith the Hotel

Quarantine Program)

Full coverage A combination of small vaccination sites

(proximal to locations) or mobile clinics 5,000

Health Care Workers at Victorian COVID19 Testing Sites

(all staff including administrative staff)

Full coverage

A combination of large vaccine

administration sites at health services or mobile clinics to some sites

5,000

High risk staff at Victorian Airports

(International & Domestic)- including airline staff w here necessary; and

high-risk staff at Victoria's Sea Ports of entry.

Prioritisation

according to exposure risk

A combination of large vaccine

administration sites (Tullamarine/Avalon/Port Melbourne) and

small or mobile clinics (Tullamarine & Avalon/ Port Melbourne)

16,500

Prioritised Hospital Staff(ER; ICU; COVID w ards - all staff physically

associated w ith these w ork areas)

Prioritisation

according to exposure risk

Hospital staff administered within hospital

or mobile clinic delivering it to the hospitalUnknown (should be a proportion of 386,000).

Prioritised health care workers (other)

e.g. General Practice, Paramedics

Partial coverage

acceptableUnder consideration. Unknown

Prioritisation

Detailed planning for Phase 1a

Vaccine Recipient Cohorts

Coverage

Projection for Phase 1a

Delivery ModelAnticipated recipient

numbers

Health, aged care and disability

care workers

Partial

coverage acceptable

A combination of small vaccination sites

(proximal to locations) or mobile clinics

Health and disability

care workers:(should be a proportion

of ~386,000)

Aged care workers:

~56,800

Total: ~442,800

Residents in residential

disability, permanent residential and respite care

Partial

coverage acceptable

A combination of small vaccination sites

(proximal to locations) or mobile clinics and

coordination with local council services

~50,000 TBC

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

The Pfizer vaccine will be the first available in Australia

mRNA Vaccines

• mRNA• Instructs our cells on what proteins to produce

• In vaccine is in a nano-lipid layer

• COVID vaccine is toward the viral spikes

• Enters cells• 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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Easy design

Rapid manufacture

Robust response

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

Who can have the vaccine?

• Very few contraindications• Not if you are allergic to any components of the vaccine

• Age > 16 years

• Pregnancy

• 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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Separate by 7 days

Influenza vaccine

program

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

What we are planning for

Monash Health as one of the first Pfizer Hubs

• Hub and spoke model between MMC and: • Casey

• Dandenong

• Peninsula Health

• Private Hospitals• Alfred Health

• Scaled vaccine delivery to identified HCW priority groups

What we are working on

Workforce

• 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• Number of vaccines clinically delivered

• 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

Clinical

Advisory

Workforce

Advisory

Systems

Advisory

Project Team

Sub-Working

Groups

Sub-Working

Groups

Sub-Working

Groups

Operations

Rhonda Stuart

Sarah HirschiTom McLaughlin

Fiona Sherwin

Eliisa Fok

Vaccine delivery is driven by clinical sub-working groups with support from the

Project Team

Approx 4,000 HCWs are identified as first priority across all Monash Health sites (similar to fit testing schedule)

Priority HCW

groups

Nursing/

MidwiferyMedical Allied Health Pharmacy Others Total

Proportion

of

anticipated

(Vic)5

Immunisation

Clinic197 0 0 9 12 118 12%

COVID-19

testing sites130 1 10 0 152 193 4%

Priority Hospital

Staff – ICU and

COVID wards21493 1028 192 119 45 2,877

Vaccine doses to be delivered in a 6 week period

Spread out HCWs over a 3 week period

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

Monash

Health HCWs(3 MH sites)

• Cohort 1

• Dose 1

• Cohort 2

• Dose 1

• Cohort 3

• Dose 1

• Cohort 1

• Dose 2

• Cohort 2

• Dose 2

• Cohort 3

• Dose 2

Non-pt

facing & mop-up

~4000 Doses ~4000 Doses

Cohorted dosing for HCW

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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