COVID-19 Vaccines

Welcome to COVID Conversations

• This is a webinar format, so all lines are automatically muted for the duration • There is a question-and-answer box which can be utilized to communicate with the moderators • Each panelist will speak for approximately 15 minutes, followed by another 15 minutes of questions • The webinar will be recorded and posted to the California Immunization Coalition website (https://www.immunizeca.org/) as well as the CIC YouTube page GoToWebinar Platform

• All Participants will join the webinar in “listen only” mode. You should be able to hear through your computer audio – please make sure your speakers are not on mute. You should have received dial in information with your confirmation email if you need to listen by phone. • Technical difficulties during the webinar? • For assistance, please visit this link: https://support.goto.com/webinar/help/how-do-i- contact-gotowebinar-customer-support-g2w090151 • If you still need assistance please call: CIC at 916-414-9015 or GoTo Technical Support at: 1- (833) 851-8340

3 Questions for Presenters?

• To ask a question or leave a comment use the question window • Questions will be answered after the presentations • Additional questions may be sent to [email protected] for email response after the webinar. The California Immunization Coalition (CIC) is a 501(c)(3) non- profit public-private partnership dedicated to achieving and maintaining full immunization protection for all Californians to promote health and prevent serious illness, disability and death. • The AAP-CA is a partnership of the four local California AAP Chapters • AAP-CA is committed to the attainment of optimal physical, mental, and social health and well- being for all infants, children, adolescents, and young adults living in California. Future Conversations (save the date!)

Program #2: California state logistics and allocation • Wednesday, January 13 at 6PM • Co-chairs of the California COVID-19 Vaccine Drafting Guidelines Workgroup • Dr. Oliver Brooks, Chief Medical Officer, Watts HealthCare Corporation • Dr. Robert Schechter, Branch Chief, California Department of Public Health Immunization Branch Program #3: COVID vaccine hesitancy and combatting misinformation • Monday, February 8 at NOON • Dr. Peter Hotez, founding dean of the National School of Tropical Medicine, Professor of Pediatrics and Molecular Virology & Microbiology at Baylor College of Medicine COVID Vaccine Guiding Principles

• California’s distribution of COVID-19 vaccines will be guided by the following overarching principles: • The vaccine meets safety requirements • The vaccine is distributed and administered equitably. • People with the highest risk of infection will get the vaccine first. • Community stakeholders are brought in from the outset for transparency • A safe and effective COVID-19 vaccine will be one of the most important tools to end the COVID-19 pandemic. California will be transparent, careful, and above all, equitable in its vaccine distribution. The state will provide a COVID-19 vaccine to everyone in California who needs and requests vaccination. Today’s Hosts and Moderators

• Dr. Pia Pannaraj • Associate Professor of Pediatrics, Molecular Microbiology and Immunology, Keck School of Medicine, University Southern California • Director, Pediatric Immunization Advancement Laboratory, Division of Infectious Diseases, Children’s Hospital Los Angeles • Co-chair, Emerging Issues Committee, California Immunization Coalition

• Dr. Eric Ball • Primary Care Pediatrician, CHOC Primary Care Network • Board of Directors, American Academy of Pediatrics, California • Co-chair, Emerging Issues Committee, California Immunization Coalition

9 Today’s Panelists

• Dr. Yvonne Maldonado • Senior Associate Dean for Faculty Development and Diversity; Professor, Chief of the Division of Infectious Diseases and Director of Global Child Health for the Department of Pediatrics, Stanford University School of Medicine • AAP liaison representative to the ACIP • Member of the California COVID-19 Vaccine Scientific Safety Review Workgroup Update on COVID-19 Vaccines

Yvonne (Bonnie) Maldonado, MD, FAAP, FPIDS, FIDSA Senior Associate Dean for Faculty Development and Diversity Professor of Pediatrics, Epidemiology and Population Health Stanford University School of Medicine

December 6, 2020 Coronavirus (CoV) Virology

• CoVs are enveloped, single positive-stranded RNA viruses with a nucleocapsid. • ~ 30 kb in length — the largest known RNA viruses • Structural proteins include spike (S), membrane (M), envelope (E), nucleocapsid (N) proteins and accessory proteins chains • Seven known human strains • A spike mutation, which probably occurred in late November 2019, likely triggered spillover into humans

https://www.ncbi.nlm.nih.gov/books/NBK554776/

12 SARS-CoV2 Targets for Therapy

Vaccine

Monoclonal Antibodies

Convalescent Plasma TMPRSS2

Camostat

Favipiravir Remdesivir

13 14 COVID-19 Vaccines in the United States

15 COVID-19 Vaccines in the United States

16 COVID-19 Vaccines in the United States

17 CDC Proposed Phase I Vaccine Rollout

18 Specific Phase Ia Groups

19 What’s Next?

. FDA EUA filing for Pfizer and Moderna vaccines

. FDA review of Pfizer on December 10, if approved could be deployed within 24 hours . Approximately 30 million doses available in December for the United States

. FDA review of Moderna in mid-December, assume similar deployment timeline as Pfizer . Approximately 20 million doses available in December in the United States

20 Phases of COVID-19 Vaccination in the US

21 Global Scramble for Coronavirus Vaccines

Callaway, Ewen. Image from “The unequal scramble for coronavirus vaccines — by the numbers” by Nature. 24AUG2020. Received from: https://www.nature.com/articles/d41586-020- 02450-x

22 What Does the Future Hold?

• Combination therapy – Antiviral, immunomodulatory, anti-inflammatory, monoclonal – Clinical trials approaches must be flexible and adaptive – Ideally development of biomarkers or clinical indices to measure outcomes

• Vaccines – Herd immunity is the ultimate goal but may not happen rapidly – Degree and durability of immunity to be determined – Vaccine associated immune effects unknown

• Non-pharmacologic interventions to continue for an undefined period

Today’s Panelists

• Dr. Peter Szilagyi • Professor of Pediatrics, Executive Vice-Chair of the Department of Pediatrics, and Vice-Chair for Clinical Research at the University of California-Los Angeles. • One of 15 voting members of the CDC’s Advisory Committee on Immunization Practices (ACIP) • Member of the California COVID-19 Vaccine Scientific Safety Review Workgroup Patient Prioritization and Logistics COVID-19 Vaccines .Peter G. Szilagyi, MD, MPH .Professor & Executive Vice-Chair .Department of Pediatrics .UCLA Mattel Children’s Hospital December 9, 2020 No Disclosures In compliance with ACCME Standards for Commercial Support of CME activities… – I have no relevant financial relationships to disclose. – Some slides are from CDC experts (acknowledgements in footnotes) ACIP’s Principles in Allocating COVID-19 Vaccines-Phase 1

• Disease burden from SARS-CoV-2 • Balance of benefits/harms from vaccine

• Feasibility • Values of target group • Maximize benefits & minimize harms • Promote justice • Mitigate health inequities • Promote transparency Key Groups for Phase 1 Allocation and Sequence

Proposed Groups Possible Sequence

Modeling: Potential Impact on Preventing Infections & Deaths: By initially allocating to one of the groups in Phase 1b

Vaccinating high-risk adults or essential workers first: Vaccinating >65yr olds first: Averts up to 3% more infections Averts up to 2% more deaths From: K. Dooling, Dec. 1 2020 ACIP Meeting Key points from modeling the differences in prioritizing: Essential workers vs. Those with chronic conditions vs. >65y . Differences among prioritizing the 3 groups are minimal

. The largest impact on averting infections and death is timing of vaccinations

. Other key factors play a role: – Vaccine effectiveness in older adults – Whether the vaccine can prevent asymptomatic infection and transmission – Wearing a mask and social distancing across the 3 groups

. Thus ethical principles and decisions must play a major role Healthcare Personnel and Long-Term Care Facility Residents Ethics

From: K. Dooling, Dec. 1 2020 ACIP Meeting The Other 3 Risk Groups: Ethics

Dark Green = Strongest Gray = Weakest From: K. Dooling, Nov 23 2020 ACIP Meeting Will target groups be willing to be vaccinated?

. National survey of US residents: The Understanding America Study – Probability-based internet panel, October 14 – November 9, 6,007 respondents

. We asked: – “If a vaccine against the coronavirus becomes available, do you plan to get vaccinated?” • Responses: Yes ASAP, Yes but wait and see, No but wait and see, No, Unsure)

– How much do you trust (fully, mostly, somewhat, do not trust): • The governmental approval process to ensure the COVID-19 vaccine is safe? • The process in general (not just for COVID-19) to develop safe vaccines for the public?”

Szilagyi et al. (submitted) Do you plan to get vaccinated or not? (Oct. 14-Nov. 9) Percent Yes ASAP Yes Wait and See No Wait and See No Unsure 100

0 All F M 18-4950-64 65+ CD Wh Lat Bl AS HCWOther No Yes No College Degree Race/Ethnicity Essential Worker Chronic Female/Male Age (CD) White/Latino/Black/Asian HCW=Health Care Disease Do you trust the governmental approval process? (Oct. 14-Nov. 9)

Percent Fully Trust Mostly Trust Somewhat Trust Do Not Trust 100

0 All F M 18-4950-64 65+ CD Wh Lat Bl AS HCW Other No Yes No College Degree Race/Ethnicity Essential Worker Chronic Female/Male Age (CD) White/Latino/Black/Asian HCW=Health Care Disease Election Will target groups be willing to be vaccinated?

. Currently, there is much hesitancy and also “wait and see” . Trust is the key underlying factor . Effective communication strategy is critical – Coordinated – Culturally tailored – Role of safety workgroups: E.g., the Western States Safety Review Workgroup, Health Systems workgroups – Key role of the primary care physician – Respected and public figures, leading by example . COVID-19 vaccine hesitancy is mutable (but we don’t know how much) . Since many in risk groups will decline, the next risk group might start earlier than planned Key Groups for Phase 1 Allocation and Sequence Proposed Sequence Key Groups for Phase 1 Allocation and Sequence Possible Timing

12/15 1/18 2/22 3/29 5/3 Key Groups for Phase 1 Allocation and Sequence

Proposed Sequence Possible Timing

12/15 1/18 2/22 3/29 5/3 Early Implementation Phase of COVID-19 Vaccines

From: CDC COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations, V1.0, Sept. 16,2020

CA COVID-19 Vaccine Implementation Program

First Two Allocations . 1st allocation of 327,000 doses going to local health departments to allocate

. 2nd allocation from CDC: end of December – Perhaps up to 1.7 million doses – To be allocated to: • Local HDs • Multi-county entities (e.g., Kaiser, Sutter, Tenet, Dignity, AHMC, Adventist, UC Health)

Subprioritization for Phase 1a . Tier 1: – Acute care, psychiatric, correctional facility hospitals – SNFs, assisted living, similar settings – Paramedics, EMTs; Dialysis centers . Tier 2 – Intermediate care facilities – Home health care – Community health workers, – Public health field staff – Primary care clinics . Tier 3 – Specialty clinics , Lab workers – Dental and health clinics – Other Pharmacy staff Subprioritization for Phase 1a

. If insufficient doses within a facility, prioritize to facilities serving the greatest % vulnerable persons in their catchment area – California Healthy Places Index (HPI) or – Comparable health department knowledge Subprioritization for Phase 1a

. If insufficient doses within a facility, Health Departments may allocate doses for facilities to protect workers at highest risk of occupational exposure to SARS-CoV-2 first – Occupational age – Descending age: • 65 years and older • 55-64 years • Younger than 55 years – Other attributes including: • Underlying medical conditions • Race/ethnicity University of California’s Priority Allocation Plan Healthcare Workers: DRAFT

Group 1 Front-line facing with close, prolonged, repeated exposure to (Highest Risk) patients with COVID-19, or unknown COVID status Group 2 Front line clinical staff, without prolonged and repeated (High Risk) close contact Group 3 Front-line, with some risk, essential services to patient care (Moderate risk) Group 4 Front-line, some risk –high traffic areas or other essential (Other risk) services

Key Considerations in Allocation of Vaccines

General Considerations Additional Considerations

. Sub-prioritization within categories . Outreach to high-risk populations . Health equity metric to address disparities . Preventing gaming of vaccine allocation . Vaccine provider recruitment, locations . Phase 2 (younger adults) . Vaccine storage and handling . Changing guidelines as new data come in . Vaccination second-dose reminders . New populations- Adolescents, Children . Communication . Public behavior (masks, social distancing) . Safety monitoring of vaccine recipients . Impact on vaccination delivery in general . Monitoring of the state’s program Thank You Evaluation

• At the end of this webinar an Evaluation will pop up on your screen. • The evaluation should take approximately 5 minutes to complete. • CIC utilizes the evaluation from our COVID Conversations to guide us in future endeavors as well as sharing the performance with our panelists. COVID Conversations Program #2

Wednesday, January 13th 6:00 pm – 7:00 pm (pst)

Featured Speaker: Oliver Brooks MD, Chief Medical Officer, Watts HealthCare Corporation

Featured Speaker: Robert Schechter MD, Branch Chief, California Department of Public Health Immunization Branch Thank you for your support and your participation!