COVID-19 Vaccination What's happening? - January 2021 - Monash Health
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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 19/01/2021 3
Vaccination Vaccines prime your immune system to recognize and fight off an infection They don’t actually cause the disease
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
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
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
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 19/01/2021 13
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 19/01/2021 15
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 19/01/2021 17
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 19/01/2021 18
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 19/01/2021 19
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 19/01/2021 25
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 19/01/2021 26
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