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Preparing for the COVID-19 Vaccine


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Preparing for the COVID-19 Vaccine

  1. 1. Preparing for the COVID-19 Vaccine September 30, 2020
  2. 2. CME Credit • Bridgeport Hospital Yale New Haven Health is accredited by the Connecticut State Medical Society to sponsor continuing medical education for physicians. The Bridgeport Hospital Yale New Haven Health designates this live activity for a maximum of one (1) AMA PRA Category 1 CreditsTM. Physicians should claim only credits commensurate with the extent of their participation in the various activities. • This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of Bridgeport Hospital Yale New Haven Health and the Weitzman Institute. Bridgeport Hospital Yale New Haven Health is accredited by the Connecticut State Medical Society to provide continuing medical education for physicians. • The content of this activity is not related to products or services of an ACCME- defined commercial interest; therefore, no one in control of content has a relevant financial relationship to disclose and there is no potential for conflicts of interest.
  3. 3. Preparing for the COVID-19 vaccine
  4. 4. COVID-19 in the United States 7,186,527 cases on 9/29/20 up from 6,895,549 cases on 9/22/20 205,895 deaths
  5. 5. Last week:
  6. 6. 1,004,314 deaths USA 204,378 Brazil 142, 058 India 96, 318 Mexico 76,603 UK 42,001 Italy 35,851
  7. 7. Resources • Nuvance health ~1250 articles reviewed: • CDC: • WHO: • Johns Hopkins: • Others
  8. 8. Infection and Immunology
  9. 9. COVID-19 Vaccine overview * # vaccines • 169 COVID-19 vaccine candidates under development*, # – 40 of these in human trials – 10 are in Phase 3 • Different platforms: – Inactivated, non-replicating viral vector, protein subunit, RNA, DNA, VLP, replicating viral vector…
  10. 10. Lead candidates • mRNA vaccine, BNT162b2 – Encodes SARS-CoV-2 full length spike glycoprotein (S), -the target of virus neutralizing antibodies • 2 doses: mild to moderate side effects • 30,000 -> 43,000 participants • Pfizer CEO: Results by ‘end of October’ • **USA: 100 million doses by December**
  11. 11. Lead candidates • mRNA vaccine, mRNA-1273 • Lipid nanoparticle dispersion containing mRNA – Encodes for the prefusion SARS-CoV-2 spike protein • 2 doses - no trial-limiting safety concerns • Given almost $2.5 billion from US gov’t • Phase 3 - 30,000 people in 89 sites – may take till the end of 2020 or early 2021 to reach the necessary numbers
  12. 12. Lead candidates • Non-replicating viral vector – Adenovirus 26, or ‘Ad26’ for short – recombinant, replication-incompetent adenovirus type 26 (Ad26) vector, constructed to encode (SARS-CoV-2) spike (S) protein • Same platform as the Ebola vaccine – We know that works, safe • Phase 3 trial - 60,000 participants • 1.5 billion from US gov’t
  13. 13. Lead candidates • Modified chimp adenovirus vector (ChAdOx1) • In Phase 1/2 trial, no severe side effects… • Study halted in the US Sept 6th – 1 case transverse myelitis • Would have been ready for emergency use by October
  14. 14. Other vaccines • Russian vaccine – Sputnik – Gamaleya Research Institute, part of Russia’s Ministry of Health, launched clinical trials in June of led Gam-Covid-Vac. Contains two adenoviruses, Ad5 and Ad26, both engineered with a coronavirus gene • Chinese vaccines – Military use – CanSino Biologics , in partnership with Academy of Military Medical Sciences –developed adenovirus Ad5 – Strong immune response – Chinese military approved the vaccine on June 25 as a “specially needed drug”
  15. 15. Preparing for the COVID-19 Vaccine Jennie McLaurin, MD, MPH; Board-Certified Pediatrician NACHC Consultant
  16. 16. Overview • Scale and Scope of Vaccine Initiative: Truly novel in rapid and universal deployment ideal • How will these groups be efficiently addressed? – High Risk Groups (up to 40% of users of CHC?) – Health and Safety for Workers (define “workers”) – General Population • Exclude those already with documented disease? • Role of antibody tests? • Role of testing for infection prior to immunization? • Need for second dose?
  17. 17. Prior Examples • Hepatitis B started in infants and in health workers and then high risk; idea was to gradually build immunity in population. 10 years of trial data. • MMR added second vaccine; this also was gradually added to population, as was extra pertussis dose • Polio eradication focused on schoolchildren • HPV controversial for gender, age and business issues… • Most examples of infectious disease had age risk highest in youngest; part of WCC. Vaccines that protect elderly aren’t seen as needed in young (shingles) 27
  18. 18. ALL Prior Vaccines… • Rolled out by CDC with ACIP endorsement • Had years of R&D • Had private marketing by pharma industry • Trust is at all time low in CDC and government recommendations • Even Congressmen with MDs are challenging Fauci and vaccine components 28
  19. 19. Vaccine Readiness Will Need to Address • Regular repetitive community education that is uniform and trustworthy—may need to be championed by trusted community member • Transparent information on – Vaccine availability – Cost – Side effects – Effectiveness – Length of immune response • Role of health center with community and state partners, both public and private 29
  20. 20. Vaccine Readiness Will Need to Address • Immunization registry use and real time data sharing • Population to be served by each organization (only established users? Family members? Entire community?) • How campaign will be incorporated into existing practices of organization • Vaccine procurement and storage needs 30
  21. 21. Vaccine Workflow Considerations • Existing staff or new staff? • Existing locations and hours or additional locations and hours? • Expanded scope of providers? • Decrease in other services or maintain? Redeployment of resources? • Permanent or temporary changes? 31
  22. 22. Vaccine Workflow Considerations • What FTE of staff are currently used to provide flu immunizations? What is current rate of organization’s flu vaccine coverage among eligible population? How many months is organization engaged in active flu vaccine campaigns? • How does population in need of flu vaccine at organization mirror or depart from the population that will need a COVID-19 vaccine? • What time frame would organization set as goal to get to 25% of eligible population immunized against COVID-19? (from point of vaccine availability). To 50%? • What are the financial implications for the organization of undertaking a strategic effort to implement COVID-19 vaccination campaigns? 32
  23. 23. Preparing for the COVID-19 Vaccine Community Health Center Inc. Veena Channamsetty, MD, FAAFP; Chief Medical Officer Community Health Center Mary Blankson, DNP, APRN, FNP-C; Chief Nursing Officer Community Health Center
  24. 24. It is not too early! • CDC: COVID-19 Vaccination Program Interim Playbook • Create a central taskforce or workgroup • Leverage current infrastructure • Plan for the various likely scenarios • Create your timelines • Allocate resources • Develop the communication plan COVID 19 Vaccine Preparedness Community Health Center, Inc.
  25. 25. • Four subgroups within task force: Members to work local government: stay updated with local & state government, department of public health Members to communicate with community partners: hospitals, other local task forces Members to review the updated science of the vaccine Members to work with national partners: best practices • Task Force works to update choreography from current infrastructure (Flu vaccine, COVID testing) & modify for COVID vaccinations COVID Vaccine Task Force Community Health Center, Inc.
  26. 26. • Build a relationship with those who are creating vaccine protocols and policies and get yourself at the table! • Advocate for your patient population • Advocate for your organization – Success regarding flu vaccines & COVID testing – Organization can do things at large scale 36 Working With The Government Community Health Center, Inc.
  27. 27. • Plans for before the vaccine becomes available – Sites & locations – Storage for any type of vaccine • Freezer / fridge etc • Gather supplies ahead of time (needles) – Plan for different phased approach • Planning for prioritization if limited vaccine availability • Planning for full vaccine availability – Staffing • Workflow for high volume clinics • Leveraging knowledge from flu clinics Planning Phase One Community Health Center, Inc.
  28. 28. • Plans for when we know which vaccine will be available • Build trust in your community – Increase patient education, patient outreach, patient trust • Steps when a vaccine becomes available: 1. Enter into E.H.R. 2. Update your vaccine standing order 3. Create a vaccine template 4. Workflow for high volume clinics 5. Recalls for additional doses if needed Planning Phase Two Community Health Center, Inc.
  29. 29. COVID 19 Vaccine Preparedness El Rio Community Health Center Tucson, AZ 09/30/2020
  30. 30. El Rio’s COVID 19 Response • Incident Command initiated to coordinate an expedited response to COVID 19 pandemic in Tucson & Pima County • Coordinated efforts for partnerships with Health Department, homeless outreach & other community partners • Overall Testing • 22,500 Tests – over 10% of Pima County tests • 13.6% - Positive Rate • Homeless testing • 1900 patients – 3% positive • Proactive creation and management of streamlined clinic workflows: • Symptom screening at all locations • Telehealth visits • In-clinic testing • Drive through workflows: • COVID 19 Testing • Childhood Immunizations • Adult Vaccinations • Flu Vaccination Patients scheduled every 10 minutes through drive through process!
  31. 31. Example of Workflow
  32. 32. 43 * This initiative is supported by
  33. 33. Thank You!