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HomeMy WebLinkAbout12.21.20 FW_ SYASL COVID-19 Update From:Ring, Brian To:Alpert, Bruce;Bennett, Robin;Clerk of the Board;Connelly, Bill;Cook, Holly;Kimmelshue, Tod;Lambert, Steve; Lucero, Debra;McCracken, Shari;Paulsen, Shaina;Pickett, Andy;Ring, Brian;Ritter, Tami;Rodas, Amalia; Sweeney, Kathleen;Teeter, Doug Cc:Pickett, Andy;Snyder, Ashley Subject:FW: SYASL COVID-19 Update Date:Monday, December 21, 2020 4:49:07 PM Attachments:SYASL COVID-19 Update 12.21.20.pdf FYI – update from our State lobbyist on the State’s response to COVID. Brian Ring Assistant Chief Administrative Officer Administration 25 County Center Drive, Oroville, CA 95965 T: From: SYASL County Info <SYASLCountyInfo@SYASLpartners.com> Sent: Monday, December 21, 2020 4:47 PM To: SYASL County Info <SYASLCountyInfo@SYASLpartners.com> Subject: SYASL COVID-19 Update ATTENTION: This message originated from outside Butte County. Please exercise judgment before opening .. attachments, clicking on links, or replying. To: County Administrative Officers and Interested Parties From: Paul J. Yoder and Karen Lange Date: December 18, 2020 RE: SYASL COVID-19 Update Please find attached our daily SYASL COVID-19 update. -Paul and Karen COVID-19 Updates www.covid19.ca.gov December 21, 2020 Newsom Administration - Resources / Mutual Aid / Executive Orders Today, Governor Newsom reported hospitalization and ICU numbers continue to increase and that the State has requested continued staffing relief from the federal government and DOD as well as an extension of existing staffing through January. Over the weekend, the Western States Scientific Safety Review Group completed its review and concluded the Moderna COVID-19 vaccine is safe and efficacious for use in the Western States. The Workgroup provided its confirmation to the Governors of California, Nevada, Oregon, and Washington Sunday morning, making the Moderna vaccine the second COVID-19 vaccine supported for use in these states. Shipments are expected early this week. The Community Vaccine Advisory Committee will meet from 2-4pm on December 23 to discuss Phase 1B of the vaccine distribution prioritization and tiers. View here for details. Per Governor Newsom, 70,258 doses were administered during week one. Dr. Ghaly reported that the State is keeping a close eye on various strains of covid and do not have any evidence that the latest strain reported in the United Kingdom has arrived in California or in the United States. Governor Newsom and Dr. Ghaly did indicate that based on trending numbers, they anticipate regions currently under Stay-at-Home orders will likely have those orders extended beyond the three-week time frame. The Administration is currently preparing to decide at the end of this week or the beginning of next. They noted they will not make that call until it is time to do so, and they will base the decision on real-time data. You may view slides from todays briefing here and SYASL staff notes here. Governor Newsom has announced the appointment of Jim DeBoo as Executive Secretary. This position was previously held by Ann OLeary. Please visit the California Department of Public Health website for the latest guidance documents. BSCC Seeks County Input on DJJ Realignment Grant On December 18, the Board of State and Community Corrections, the administering entity for the Regional Youth Programs and Facilities Grant Program (RYPFGP), issued a Request for Information (RFI) to solicit information from counties to inform its decision making and identify potential funding priorities. The RFI ressing the needs of the realigned population, including infrastructure needs, whether the county intends to consider out-of-county placement options, and if the county is planning to accept youth from other counties. Responses to the RFI should be submitted by January 11, 2021. (Note that a single, coordinated response from each county is requested.) Questions on the RFI can be sent here, or direct outreach can be made to John Prince, BSCC Deputy Director, at (916) 445-2014. 1 December 20, 2020 To: Governors of California, Nevada, Oregon, and Washington State Governor Gavin Newsom, California Governor Steve Sisolak, Nevada Governor Kate Brown, Oregon Governor Jay Inslee, Washington From: Arthur Reingold, MD, Chair Western States Scientific Safety Review Workgroup Summary of Findings: The Western States Scientific Safety Review Workgroup, after its thorough review, Recommends unanimously that the Moderna COVID-19 vaccine be used in our states, as we conclude that the vaccine is safe and efficacious; Endorses the transparency and objectivity of the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) and the CDC Advisory Committee on Immunization Practices (ACIP) review processes and the rigor, validity and reliability of their analyses; Concludes that equity has been considered appropriately in the clinical trials and urges that equity continue to be a guiding principle in immunization implementation, monitoring and communication; and Recommends that our states use the Moderna COVID-19 vaccine, in addition to the Pfizer BioNTech COVID-19 vaccine, to expand our states’ ability to respond to the COVID-19 pandemic, including in underserved communities. WESTERN STATES SCIENTIFIC SAFETY REVIEW WORKGROUP 2 The Western StatesScientific Safety Review Workgroup was establishedby the Governors of California, Nevada, Oregon and Washington, to independently review and assess data on U.S. candidate COVID-19 vaccines and the processes of federal advisory committees and agencies considering approval of these vaccines prior to their introduction in the United States. The Workgroup includes members with diverse relevant expertise, many of whom have participated in multiple prior VRBPAC and ACIP vaccine reviews. The Workgroup held two virtual meetings on December 17, 2020 and December 19, 2020 to review the available evidence concerning the safety, immunogenicity, and efficacy of the Moderna COVID-19 vaccine. The Workgroup’s deliberations are guided by four considerations: assuring the safety and efficacy of COVID-19 vaccines that might be used in our states; assessing the transparency and objectivity of the FDA VRBPAC and CDC ACIP review processes and the rigor, validity and reliability of their data analyses; ascertaining whether equity has been considered appropriately in the design, implementation and analysis of the clinical trials; and avoiding any undue delay in making available to our states’ residents COVID-19 vaccines deemed by the FDA and CDC to be safe and efficacious. WESTERN STATES SCIENTIFIC SAFETY REVIEW WORKGROUP 3 Wehave focused our review onthe data presented to VRBPAC and ACIP and the processes and deliberations of those committees. Phase 3 trial data concerning the safety, immunogenicity, and efficacy of the Moderna COVID-19 vaccine were presented in open meetings to VRBPAC on December 17, 2020 and to the ACIP on December 19, 2020. Multiple members of our Workgroup either directly participated or observed the VRBPAC meeting on December 17, 2020 and the ACIP meeting on December 19, 2020. These presentations and discussions were reviewed and discussed by our Workgroup on December 17, 2020 and December 19, 2020. Data reviewed by the Workgroup demonstrated that the Moderna COVID-19 vaccine had an efficacy of 94.1% (95% confidence interval: 89.3% - 96.8%) against COVID-19 disease of any severity. The data presented did not reveal any differences in efficacy in various subgroups of the population. Safety data from a two-month follow-up of participants in the Phase 3 trial of the Moderna COVID-19 vaccine were reviewed by FDA and CDC staff, VRBPAC and ACIP. Given the escalating rate of COVID-19 hospitalizations and deaths throughout the U.S., the Workgroup agreed that the two-month review supports distribution and use according to ACIP recommendations of the Moderna COVID- 19 vaccine under an FDA EUA. Confirming the safety of COVID-19 vaccines by continued close monitoring and surveillance of vaccine recipients for adverse health events is of paramount WESTERN STATES SCIENTIFIC SAFETY REVIEW WORKGROUP 4 importance to gain and sustain the public acceptance of COVID-19 vaccination. The CDC and FDA have implemented multiple systems to rapidly obtain and investigate reports of adverse health events following receipt of COVID-19 vaccines. The Workgroup endorses these efforts and encourages our states to support active and regular reporting to these systems, which are already yielding valuable results. At the December 19, 2020 ACIP meeting, CDC noted that it is investigating reports of anaphylactic reactions in six recipients of the Pfizer BioNTech vaccine. Pfizer BioNTech reported at the FDA VRBPAC meeting on December 10, 2020 that such reactions had not occurred in any of the 18,000 Phase 3 clinical trial participants who received the Pfizer BioNTech COVID-19 vaccine. Moderna reported to ACIP on December 19, 2020 that one participant in the Phase 3 clinical trial had an episode of anaphylaxis 63 days after immunization. The Scientific Safety Review Workgroup wants to underscore the importance – as with any vaccine – of providing COVID-19 vaccines in locations that are prepared to treat anaphylactic reactions or any other unexpected reactions, as noted in standard guidance from CDC. CDC has produced enhanced guidance to ensure that appropriate equipment is available in all locations where COVID-19 vaccines are being administered and that vaccine recipients be monitored for 15 - 30 minutes after vaccination. The Workgroup noted that several important attributes of the Moderna COVID-19 vaccine remain to be defined, including the duration of vaccine-induced WESTERN STATES SCIENTIFIC SAFETY REVIEW WORKGROUP 5 protection;the efficacyof vaccinationin preventingasymptomatic infection;and the efficacy and safety of the vaccine in pregnant women and children. Efficacy and safety of the Moderna COVID-19 vaccine were observed to be consistent across age, gender, race and ethnicity subgroups in the Phase 3 clinical trial. Ongoing monitoring of the efficacy and safety of the Moderna COVID-19 vaccine in diverse subgroups of the population, especially by race, ethnicity, age, and underlying disease status, will be crucial to ensuring confidence in and high acceptability of the vaccine by a majority of residents in our states. At its meeting on December 19, 2020, the Workgroup unanimously concluded that, based on our review of the data submitted to the FDA by the manufacturer and the VRBPAC and ACIP analyses of the data, the COVID-19 vaccine made by Moderna meets or exceeds FDA standards for safety, immunogenicity, and efficacy. Its widespread use in our respective states at this time under an EUA is justified. Furthermore, our conclusion is that VRBPAC and ACIP adherence to their usual standards of transparency and evidence-based decision making warrants full confidence in the recommendations made by these independent advisory committees for the use of the Moderna COVID-19 vaccine at this time. The Western States Scientific Safety Review Workgroup recommends that our states make available to our states’ residents the Moderna COVID-19 vaccine deemed by the FDA and CDC to be safe and efficacious. We believe that this vaccine will expand our states’ ability to respond as quickly as possible to the WESTERN STATES SCIENTIFIC SAFETY REVIEW WORKGROUP 6 COVID-19 pandemic and will –along with the Pfizer BioNTech COVID-19 vaccine – expand access in underserved communities. We will perform similar assessments of additional COVID-19 vaccine candidates as they are presented for possible authorization or approval for use in the U.S. Respectfully submitted: Members of the Western States Scientific Safety Review Workgroup: Arthur Reingold, MD, Chair, UC Berkeley School of Public Health California Members: Tomás J. Aragón, MD, DrPH, City and County of San Francisco Eric Goosby, MD, UCSF School of Medicine Rodney Hood, MD, UC San Diego Alumnus and National Medical Association Nicola Klein, MD, Ph.D., Kaiser Permanente Northern California Grace M. Lee, MD, MPH, Stanford Children’s Health and Stanford University School of Medicine Bonnie Maldonado, MD, Stanford University School of Medicine and Stanford Children’s Health Mark H. Sawyer, MD, UC San Diego School of Medicine and Rady Children’s Hospital Robert Schechter, MD, California Department of Public Health Peter G. Szilagyi, MD, MPH, UCLA Health and David Geffen School of Medicine Matt Zahn, MD, Orange County Health Care Agency Nevada Members: Ihsan Azzam, MD, PhD, Chief Medical Officer, State of Nevada Candice McDaniel, MS, Nevada Department of Health and Human Services WESTERN STATES SCIENTIFIC SAFETY REVIEW WORKGROUP 7 Oregon Members: Laura Byerly, MD, Virginia Garcia Memorial Health Center Louis J. Picker, MD, OHSU Vaccine and Gene Therapy Institute Washington Members: John Dunn, MD, MPH, Kaiser Permanente Washington Edgar K. Marcuse, MD, MPH, University of Washington School of Medicine WESTERN STATES SCIENTIFIC SAFETY REVIEW WORKGROUP DDb ƦķğƷĻͲ 5ĻĭĻƒĬĻƩ ЋЊͲ ЋЉЋЉ GGN I am back in my home office in a 10-day quarantine We continue to fill hospitals and ICUs Currently, 607 state staff deployed in 75 facilities We are trying to extend DMAT staffing who are due to be deployed elsewhere in the US had a call with he VP to have extended through January We have specifical asks out to DOD for 10 teams of 20 (200 personnel) Working with HHS re monoclonal antibodies program Alternative Care Sites we have 11 sites 62 patients currently in state alternative care sites decompressing hospitals statewide 37,892 cases December 20 43,901 7-day average May be seeing a very modest decrease in growth rate but we are not reading into that, it is still too early to tell 329,766 7-day average tests performed 83 deaths December 20, 233 7-day average, 2,741 14-day average This disease remains deadly Weekend reporting periods often lag 2.5% statewide current ICU capacity When in 0% - that means that region is in surge status Northern CA is the only region not in Stay at Home order Based on current trends, current stay at home orders will likely be extended in some regions FDA approved Moderna As of this moment, 21 sites have received doses 672,600 Moderna doses for CA this week 560,625 Pfizer doses have arrived 327,600 received in San Diego, Redding, Stockton Eureka, Sacramento, and Fresno A second allocation is anticipated Week 1: 70,258 doses administered Upcoming meetings: o Today: Drafting Guidelines Workgroup o December 23: Community Vaccine Advisory Committee Public meeting 2-4pm Covid19.ca.gov Please tune in and listen to the discussion on plan 1B Federal covid relief bill, $900 billion in total Please note these are initial estimates Most significant is it is money directly to people A half a billion in grants and sales tax floats, hiring tax credits etc., will also have some very significant small biz support, this is in addition to all of that We have all been waiting for rental assistance, this is not as bog and bold as we hoped for but it is significant We cant get people back to work without childcare We talk a lot about broadband, we will be talking even more about it It is at the top of our priorities and the legislatures in January Federal funding will help with our efforts The new covid strain we are reading about coming out of the UK no evidence of this strain in CA, and to our knowledge, the US Underscores the importance of continued surveillance to detect such mutations We encourage people to active CA Notify on their phones Dr. Ghaly We know that viruses are prone to mutations The new mutated covid virus seems to enter the cell more easily Exposure may mean you are more likely to become infected than you would be if you were exposed to the current strain it seems to infect more easily On a daily basis over the course of months we check thousands of strains We are concerned because of the unknowns We will continue to watch and update as info becomes available Press (Could not hear the reporters question) GGN I think the question was around localism and making sure health professionals are held accountable regarding the prioritization of distribution Dr. Ghaly The fundamental platform is prioritization Priority Group 1A: healthcare workers and residents at LTC facilities Some professionals on frontlines are on tier one and some are in tier three We are working to make sure people get the vaccine in the order that we believe makes sense in CA We are watching closely so we can act swiftly if there is any flagrant misuse or people cutting the line We are working with counties and partners how we expect to monitor and watch If there are cases where we are worried about that, we will reach out to community and county partners and if follow up action is necessary we will move swiftly GGN It is important to know we have Plan 1A, and within the tiers there is subpopulations When it gets to the site, there is some autonomy at each level so support staff and those who are essential to ICU operations are included There is room for a judgment call AP Projecting 99k hospitalizations by mid-January is this really possible? GGN We are requesting another full field medical station We are anticipating a substantial surge We are looking to support staffing at alternative care sites and set up more care sites Dr. Ghaly We believe 12% of todays cases will be hospitalized two weeks from now and 12% of those will end up in ICU We have a well-exercised mutual aid system between counties and regions that we will always invoke for those needed s we can work across the entirety of CA We continue to build up hospital capacity We work hard to make sure systems are in place and we also work hard to make sure those systems hopefully have to be used GGN We have been preparing for months for a significant surge and looking to expand the healthcare delivery system within itself The primary issue today and the immediate future is staffing which is why we are being aggressive in our asks Are we pursuing the USNS Mercy? Currently, we are not but we are looking for personnel who would be staffed on the ship to meet our immediate needs SF Chron Are regions still transferring patients? We are hearing some accepting transfers Dr. Ghaly We continue to work on making sure those transfers happen in a timely way We continue to make sure supplies are also furnished as people are deeply impacted We know it will get harder to move patients between regions due to hospitals having their own surge The number on strategy is to support hospitals where they are now and expand their existing footprint GGN We have agency and are not just victims of fate LA Daily News What is the States position on the 2021 Rose Bowl game being moved? GGN I love this tradition but when we have zero ICU capacity, we cannot proceed with a gathering like this We are disappointed we had to make that call LA Times Can you talk about what exposure you have to staff and what the rules and procedures are? How long will the stay at home orders be extended? GGN We all wear masks; many are teleworking Very few people in our staff environment have had contact to one another We wish a speedy recovery to the person who tested positive We are quarantining and the following protocol Dr. Ghaly We are preparing this week to roll out how those determinations will be made so we can roll them out the beginning of next week We have tools to make projections We will look at current ICU capacity, the number of new cases over 7-day period, ow fast the transmission rate is accelerating or decelerating it is a lot about the individual changes in behavior that affect the decision, not just the ICU numbers We will look at all the factors and socialize it with many, starting with San Joaquin Valley and then the Southern CA region At the moment, none of our projections indicate regions will be exiting the stay at home order but we will reassess when the time is right KCRA What would be your takeaway to businesses? Are you quarantining separate from your family? Are you taking vacation? Traveling? GGN I am separate from my family in a different room There will be no vacations We will try and create conditions where this can be as normal as possible for all families around the holidays Thank you to Speaker Pelosi for not taking your eye off the ball over the many, many months We will continue to update you in the coming days on the new strain, any additional federal supports, vaccines etc. rd I encourage people to tune in on the 23 to the planning for vaccination distribution I look forward to updating you tomorrow and Wednesday and Thursday. I may spare you on Friday.