11 • 10 • 2020 Mass Immunization Training For personnel responsible for managing PODS
Previous Topics Selecting a Site ● Staffing Your Clinic ● Vaccine Storage & Handling ● Screening for ● Contraindications Vaccine Administration ● Typical Reactions vs. Adverse ● Reactions Workflows (including drive-thru) ●
Preparing for Tough Conversations Vaccine Safety How the Immune System Works COVID-19 Vaccine Development
Mission We foster community wellness and advocate for good public policy and best immunization practices. ● Partners like you! ● Over 400 coalition members ● Working together can improve outcomes
Welcome Rebecca Nevedale The Arizona Partnership for Immunization (TAPI) Facilitator Machrina Leach , RN, BSN Nurse Program Manager Maricopa County Department of Public Health Will Humble Immunization Expert The Arizona Public Health Association Executive Director Public Health Expert
Questions? Selecting a Site • Staffing your Clinic • Vaccine Storage & Handling • Screening for • Contraindications Vaccine Administration • Typical Reactions vs. • Adverse Reactions Workflows (including drive-thru ) •
What to discuss Physical considerations Availability of volunteers Marketing Assistance Parking/ traffic control Phoenix Fire Historic Station 8
POLL: Where are you most likely to host your next mass immunization clinic?
POLL: What mistakes did you make in your mass immunization clinics?
Preparing for Tough Conversations Your Staff Immunizers
Preparing for Tough Conversations Your Staff Other Colleagues Community Immunizers Closed POD Patients & Families
POLL: Which statements do you AGREE with regarding the COVID-19 vaccine?
Immune System How does it work again? Types of Vaccines How are they made? Vaccine Safety How are they tested and monitored?
Nova Immunity and Vaccines Explained Video https://www.youtube.com/watch?v=lXMc15dA-vw
The Human Vaccines trick your immune system to do this Immune System Functions • Detect • Destroy - Takes time - Cough, inflammation, fever • Remember Vaccines trick the body into doing these things
4 Toxoid Inactivated Subunit, Hepatitis A recombinant, Diphtheria Flu (shot only) Tetanus polysaccharide Polio and conjugate Rabies 5 Hib Hepatitis B HPV 1 Whooping cough Pneumococcal DNA Types of Meningococcal Diphtheria Shingles Tetanus Vaccines
2 4 5 1 3 4 Live- Inactivated Subunit, Toxoid DNA attenuated recombinant, Toxoid Inactivated Subunit, Diphtheria polysaccharide Hepatitis A Measles, mumps, Hepatitis A recombinant, Tetanus Diphtheria and conjugate rubella (MMR) Flu (shot only) Flu (shot only) Tetanus polysaccharide Polio Rotavirus Polio Hib Rabies Smallpox and conjugate Rabies Hepatitis B 5 Chickenpox HPV Yellow rever Whooping cough Pneumococcal 1 Meningococcal DNA Shingles 6 Types of Diphtheria Recombinant vector Tetanus Vaccines (platform-based)
1 4 • Live- • attenuated Toxoid Inactivated Subunit, • Measles, mumps, Hepatitis A recombinant, Diphtheria • rubella (MMR) Flu (shot only) Tetanus polysaccharide Rotavirus Polio Smallpox and conjugate Rabies 5 Chickenpox Hib Yellow fever Hepatitis B HPV 1 Whooping cough Pneumococcal DNA Types of Meningococcal Diphtheria Shingles Tetanus Vaccines
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2 4 • • Inactivated • Toxoid Inactivated Subunit, • Hepatitis A Measles, mumps, Hepatitis A recombinant, Diphtheria rubella (MMR) Flu (shot only) • Flu (shot only) Tetanus polysaccharide Polio Rotavirus Polio • Rabies Smallpox and conjugate Rabies 5 Chickenpox Hib Yellow fever Hepatitis B HPV 1 Whooping cough Pneumococcal DNA Types of Meningococcal Diphtheria Shingles Tetanus Vaccines
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3 4 • Subunit, recombinant, Toxoid Inactivated Subunit, • polysaccharide Hepatitis A recombinant, Diphtheria and conjugate Flu (shot only) Tetanus polysaccharide Polio Hib and conjugate Rabies Hepatitis B 5 • Hib HPV Hepatitis B Whooping cough HPV Pneumococcal 1 • Whooping cough Meningococcal Pneumococcal DNA Shingles Types of Meningococcal Diphtheria Shingles Tetanus Vaccines
Why do some vaccines require “boosters”?
4 4 • Toxoid • Toxoid Inactivated Subunit, Diphtheria Hepatitis A recombinant, Tetanus Diphtheria Flu (shot only) Tetanus polysaccharide Polio • and conjugate Rabies 5 Hib Hepatitis B HPV 1 Whooping cough Pneumococcal DNA Types of Meningococcal Diphtheria Shingles Tetanus Vaccines
5 4 • DNA Toxoid Inactivated Subunit, Measles, mumps, • Hepatitis A recombinant, Diphtheria rubella (MMR) Flu (shot only) • Tetanus polysaccharide Rotavirus Polio Smallpox and conjugate Rabies 5 Chickenpox Hib Yellow fever Hepatitis B HPV 1 Whooping cough Pneumococcal DNA 6 Types of Meningococcal Diphtheria Recombinant vector Shingles Tetanus Vaccines (platform-based)
Why do I need to know this? Lots of different ways to create • immunity – no one way is cleaner, safer or better Methods researched for many, • many years: • How immune systems respond • Pros/ cons of different strategies Creating vaccines is NOT • NEW
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Animal Model Pre-Clinical Phase Studies Identify Disease Isolation of antigens Prove the concept Vaccine Development Examine immune response & safety Phase I Phase II Phase III Safety & immune Dose-ranging, safety Compare to placebo response & immune response Tens of thousands of Small # of healthy Thousands of people people people Licensure & Launch/ Phase 4 Recommendation Manufacturing Continual Monitoring Process FDA Licensing Testing for immunocompromised CDC recommendation
Animal Model Pre-Clinical Phase Studies Identify Disease Isolation of antigens Prove the concept Vaccine Development Examine immune response & safety Phase I Phase II Phase III Safety & immune Dose-ranging, safety Compare to placebo response & immune response Tens of thousands of Small # of healthy Thousands of people people people Licensure & Launch/ Phase 4 Recommendation Manufacturing Continual Monitoring Process FDA Licensing Testing for immunocompromised CDC recommendation
Animal Model Pre-Clinical Phase Studies Identify Disease Isolation of antigens Prove the concept Vaccine Development Examine immune response & safety Phase I Phase II Phase III Safety & immune Dose-ranging, safety Compare to placebo response & immune response Tens of thousands of Small # of healthy Thousands of people people people Launch/ Phase 4 Licensure & Recommendation Manufacturing Continual Monitoring FDA licensing Process Testing for CDC recommendation immunocompromised
Animal Model Pre-Clinical Phase Studies Identify Disease Isolation of antigens Prove the concept Vaccine Development Examine immune response & safety Phase I Phase II Phase III Safety & immune Dose-ranging, safety Compare to placebo response & immune response Tens of thousands of Small # of healthy Thousands of people people people Launch/ Phase 4 Licensure & Recommendation Manufacturing Continual Monitoring FDA Licensing Process Testing for CDC recommendation immunocompromised
Phases of Clinical Trials Phase 1 : clinical trials focus on safety • • 20 – 100 healthy volunteers • Assesses how the size of the dose may be related to side effects • Determines whether vaccine creates immune response Phase 2: clinical trials assess dosing • • Several hundred volunteers • Additional information on common short-term side effects/ safety and how the size of the dose relates to immune response Phase 3: clinical trials assess efficacy and safety • • Participation of thousands of volunteers • Placebo-controlled RCTs
Other Information – Human Trials Oversight Safety Standards Constant progress reports Drug trials VS Vaccine trials Site visits throughout trial
Pre-Clinical Animal Model 6 – 36 Phase Studies months Identify Disease Isolation of antigens Prove the concept Vaccine Examine immune Development response & safety Phase I Phase II Phase III Safety & immune Dose-ranging, safety Compare to placebo response & immune response Tends of thousands Small # of healthy Thousands of people of people people Launch/ Phase 4 Licensure & Recommendation Manufacturing Continual Monitoring FDA Licensing Process Testing for CDC recommendation immunocompromised
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Pre-Clinical Animal Model 6 – 36 Phase Studies months Identify Disease Isolation of antigens Prove the concept Vaccine Examine immune Development response & safety Phase I Phase II Phase III Safety & immune Dose-ranging, safety Compare to placebo response & immune response Tends of thousands Small # of healthy Thousands of people of people people Launch/ Phase 4 Licensure & Recommendation Manufacturing Continual Monitoring FDA Licensing Process Testing for CDC recommendation immunocompromised
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