LAC DPH Health Advisory: COVID-19 Vaccine Update December 4, 2020 California Department of Public Health, Centers for Disease Control, Coronavirus, COVID-19, Emergency Use Authorization, Food and Drug Administration, Healthcare Personnel, Long-Term Care Facility, Los Angeles County Department of Public Health, Moderna, Pfizer, Vaccination, Vaccine 1598 Key Messages It is anticipated that one or more COVID-19 vaccine(s) will receive Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) and will be recommended by the Advisory Committee Immunization Practices (ACIP) this month. LAC DPH is working closely with the California Department of Public Health (CDPH) and the CDC to plan the allocation, distribution, and administration of COVID-19 vaccine. The new LAC DPH COVID-19 Vaccine Provider Information Hub will host local, state, and national resources related to COVID-19 vaccination. As information about the COVID-19 vaccination program is changing rapidly, healthcare providers are encouraged to check this website often for the most up-to date local information. LAC DPH is conducting a COVID-19 Vaccine Healthcare Worker Outreach Survey to assist with planning efforts. All healthcare personnel are encouraged to provide their input. The survey takes less than 5 minutes and is open until Friday, 12-11-20. Please help us by clicking here to learn more and to take the survey. Situation As reported by Operation Warp Speed, as many as 40 million doses of COVID-19—enough to vaccinate about 20 million people in the United States—will be available by the end of December. In early 2021, the number of available doses is expected to increase to about 35 million—enough to vaccinate about 18 million additional people. COVID-19 vaccines will be allocated pro rata by population to local health jurisdictions. As there will be a constrained supply for some months, a phased approach to vaccine allocation will be used. Health care personnel and residents of long-term care facilities (LTCF) will be the first groups to be vaccinated (the 1a “jump start” phase). See Vaccine Prioritization below. The U.S. government is committed to making COVID-19 vaccines available to all persons who want them as soon as possible. COVID-19 Vaccine Summary Both Pfizer and Moderna have requested EUA from the FDA for their COVID-19 vaccines. The data submitted for the EUAs showed both the vaccines to be highly efficacious against COVID-19 disease (>94% for both) and no serious adverse events were reported in more than 36,000 vaccine recipients across a diverse range of ages (age 18 and older) and racial/ethnic backgrounds. To create these vaccines, the traditional phases of vaccine development were completed, including clinical development phases 1,2, and 3. Their rapid development was made possible through years of prior coronavirus research, mRNA vaccine development for other indications, and the overlapping of certain phases including large-scale manufacturing. No development or testing stages were skipped. The FDA Vaccines and Related Biological Products Advisory Committee is meeting to discuss the EUAs on: Pfizer-BioNTech 12/10/20 Meeting information Moderna 12/17/20 Meeting information FDA intends to make background material available to the public on this page no later than 2 business days before each meeting. The meetings will be broadcast live and the public can submit comments several days before the meetings. To read the vaccine trial data see: Pfizer Walsh et al. Safety and immunogenicity of two RNA-Based COVID-19 vaccine candidates. NEJM 2020; online publication Oct 14. Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints Press Release 11-18-20 Moderna Jackson et al. An mRNA Vaccine against SARS-CoV-2-Preliminary report. NEJM 2020;20:1920-1931. Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate Press Release 11-30-20 Vaccine Prioritization It is anticipated that vaccine will be made available to individuals in three phases. Within the phases, sub-phases and tiered sub-prioritization are being planned until larger vaccine supplies become available. Allocation policies will be dynamic and will be adapted based on vaccine performance, vaccine supply and demand, and other factors. On 12-1-20, the ACIP COVID-19 Vaccines Work Group voted to recommend that health care personnel and residents of LTCFs be the first groups to be vaccinated (the 1a “jump start” phase). In addition, they proposed groups for phases 1b and 1c, however the ACIP has not voted on these phases yet. For more information on the 12-1-20 ACIP recommendation, see The Advisory Committee on Immunization Practices’ Interim Recommendation for Allocating Initial Supplies of COVID-19 Vaccine — United States, 2020. CDPH formed a Scientific Safety Review Workgroup to assess the ACIP recommendations in order to develop vaccine prioritization and allocation guidance for California. On 11-30-20, this group presented a framework for tiered sub-prioritization within ACIP recommended Phase 1a to match the level of available supplies with demand. ACIP Recommended Phase 1a Healthcare Personnel: hospitals, long-term care facilities, outpatient clinics, home health care, pharmacies, emergency medical services, public health. Health care personnel are defined as paid and unpaid persons serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials. Long-Term Care Facility (LTCF) Residents: skilled nursing facilities, assisted living facilities and other residential care. Long-term care facility residents are defined as adults who reside in facilities that provide a variety of services, including medical and personal care, to persons who are unable to live independently. ACIP Proposed Phase 1b and 1c 1b: Essential workers (examples: Education Sector, Food & Agriculture, Utilities, Police, Firefighters, Corrections Officers, Transportation) 1c: Adults with high-risk medical conditions and Adults 65+ Becoming a Vaccine Provider CDPH is overseeing the registration for the COVID-19 vaccination program in California. In order for healthcare provider facilities to participate (receive and/or administer vaccine) they must: be registered with CDPH via COVIDReadi and be enrolled in the California Immunization Information System or IIS (CAIR). Currently CDPH is not registering facilities unless they have already been assigned as a pre-positioned site given their ultra-low temperature storage capability and/or as an acute care hospital. Providers or organizations interested in receiving and administering the COVID-19 vaccine are encouraged to enroll or update their information in CAIR now. Visit http://cairweb.org/enroll-now for information about how to enroll. Providers or organizations that are already enrolled in CAIR will be asked to provide their organizational IIS ID during the registration process. For any questions about enrollment contact the local CAIR representative or the CAIR Help Desk. As vaccine supplies improve, CDPH will open registration to support vaccination of individuals who are identified to be in Phase 1a. We do not know when CDPH anticipates making this announcement, but information and registration links will be posted on the COVIDReadi website and the LAC DPH Vaccine Provider Information Hub as soon as they are available. Visit CDPH California COVID-19 Vaccination Program for more information on vaccine distribution, availability, enrollment and training requirements, and planning questions and answers. National and State Planning Resources Centers for Disease Control (CDC) COVID-19 Vaccination main website 10 Things Healthcare Professionals Need to Know about U.S. COVID-19 Vaccination Plans webpage COVID-19 Vaccination Training Programs and Reference Materials for Healthcare Professionals. This PDF document provides a list of immunization training and educational materials, including basic and COVID-19-specific information. California Department of Public Health (CDPH) COVID-19 Vaccination Program main website COVID-19 Vaccination Planning webpage Vaccine Planning Questions and Answers Q&A ACIP COVID-19 Vaccines-December 1, 2020 slides Recent and Upcoming Webinars CDC/IDSA COVID-19 Clinician Vaccine Update and Q&A. Saturday December 5, 12 PM PST. Learn more and register COVID-19 Vaccination Implementation and the "Vaccinate with Confidence Strategy" with CDC speakers. Recorded webinar from live event on 12-3-20. View free webinar Talking to Patients As patients’ most-trusted source of information on vaccines, healthcare providers play a critical role in helping patients understand the importance of COVID-19 vaccination, as well as if and when it is likely to be recommended for them. Your strong vaccine recommendation is a key part of the conversation. While much is still unknown, you can start laying the groundwork now for when vaccines are available. See CDC’s webpages Engaging in effective COVID-19 vaccine conversations (which offers techniques and resources for discussing vaccination with patients even before vaccines are widely available), and Answering Patients’ Questions (which outlines likely questions and provides tips and examples of how to answer them). Information for patients CDC Frequently Asked Questions about COVID-19 for patients FAQs DPH vaccine information for the public webpage FAQs - Available in multiple languages. DPH COVID-19 Provider Vaccine Information Call Line This call line is to answer questions from the health care community (e.g., providers, hospitals, pharmacies) about registering to receive the vaccine and to answer questions related to vaccine distribution, storage, and handling. Note that CDPH is not currently registering facilities unless they have already been assigned as a pre-positioned site. Monday through Friday 8:00am- 5:00pm Call 833-505-0761 or email COVIDVaccineReq@ph.lacounty.gov. For clinical questions regarding the vaccine, please call the COVID-19 Provider Call Line. Visit the LAC DPH COVID-19 Healthcare Provider websites for up-to-date resources and guidance COVID-19 Vaccine information COVID-19 information This communication was provided by Dr. Claire Jarashow, Director, Vaccine Preventable Disease Control, Los Angeles County Department of Public Health.