Western-States-Scientific-Safety-Review-Workgroup-Meeting-Summary-09012022 Western States Scientific Safety Review Workgroup Meeting Summary - September 1, 2022

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Western States Scientific Safety Review Workgroup Meeting Summary - September 1, 2022

October 11, 2022

ā€‹ā€‹ā€‹Meeting #34 ā€“ Thursday, September 1, 2022 ā€“ 7:00pm

California Health and Human Services Agency (CHHS)

California Department of Public Health (CDPH)

Workgroup Members Attending

State of California

  • Tomas Aragon, MD, Dr.PH, Director California Department of Public Health and State Health Officer
  • Nicola Klein, MD, Director, Kaiser Permanente Vaccine Study Center
  • Grace Lee, MD, Professor of Pediatrics and Associate Chief Medical Officer for Practice Innovation, Stanford Childrenā€™s Health
  • Arthur Reingold, MD, School of Public Health Division Head of Epidemiology and Biostatistics, University of California, Berkeley 
  • Matt Zahn, MD, Medical Director, Communicable Disease Control Division, Orange County Health Care Agency.

State of Washington

  • John Dunn, MD, Medical Director for Preventive Care and Head of Immunization Program, Kaiser Permanente Washington
  • Edgar K. Marcuse, MD, MPH, FPIDS, Emeritus Professor, Pediatrics, University of Washington

State of Nevada

  • Ihsan Azzam, MD, Chief Medical Officer, Division of Public and Behavioral Health, Nevada; Kyle Devine, Bureau Chief for the Bureau of Child, Family, and Community Wellness (CFCW)
  • Kyle Devine, Bureau Chief for the Bureau of Child, Family, and Community Wellness (CFCW)

State of Oregon 

  • Laura Byerly, MD, Chief Medical Officer, Virginia Garcia Health Center, Oregon
  • Louis Picker, MD, Associate Director of Oregon Health & Science Universityā€™s Vaccine and Gene Therapy Institute

Workgroup Members Not Attending

  • Oliver Brooks, MD, CMO, Watts Health Care
  • Eric Goosby, MD, Distinguished Professor of Medicine and Director of the Center for Global Health Delivery, University of California, San Francisco 
  • Rodney Hood, MD, Trustee, Alliance Healthcare Foundation; Bonnie Maldonado, MD, Professor and Chief of the Division of Infectious Diseases, Department of Pediatrics, Stanford Medicine
  • Rob Schechter, MD, Chief, California Department of Public Health, Immunization Branch
  • Peter Szilagyi, MD, Professor and Vice Chair for Clinical Research, Department of Pediatrics and Mattel Children's Hospital
  • Mark Sawyer, MD, Infectious Disease Specialist, Rady Children's Hospital; Kristy Zigenis, Contracted COVID-19 Vaccine Program Manager, CFCW

Consultant

  • Bobbie Wunsch, Founder and Partner, Pacific Health Consulting Group

Welcome and Setting Stage for Today's Discussion Topics

Arthur Reingold, MD, Chair 

Dr. Reingold welcomed members of the Western States Scientific Safety Review Workgroup. The topic for this meeting is to review the evidence concerning booster doses of the Moderna and Pfizer-BioNTech COVID-19 bivalent BA.4/BA.5 variant vaccines for individuals in age groups currently recommended to receive a COVID-19 vaccine booster.


Dr. Lee summarized information from the CDC Advisory Committee on Immunization Practices (ACIP) meeting discussion, September 1, 2022. In recommending the BA.4/BA.5 bivalent vaccine, ACIP reviewed clinical trial data from Moderna and Pfizer-BioNTech (Pfizer) for the COVID-19 bivalent booster with BA.1 Omicron variant-modified vaccine administered to over 1400 individuals. Data related to adverse events for COVID-19 bivalent booster vaccines reported through V-safe, Vaccine Adverse Events Reporting System (VAERS) and Vaccine Safety Datalink (VSD) were reviewed. There were no new safety concerns identified. The risk of myocarditis following the COVID-19 bivalent booster dose is unknown. There will be continued close monitoring of safety data. ACIP also reviewed pre-clinical studies in mice of the COVID-19 bivalent BA.4/BA.5 vaccine, for which there are no human clinical trial data to date.

In addition to discussion of vaccine efficacy, safety, and clinical considerations related to COVID-19 bivalent boosters, ACIP reviewed in detail the current epidemiology of COVID-19. In a new approach for ACIP, questions related to equity were considered for each domain in the Evidence to Recommendation framework, reflecting the disproportionate burden of COVID-19 illness, hospitalization, and death in people of racial and ethnic minority groups.

The ACIP voted 13-1 that individuals ages 12 years and older be recommended to receive an age-appropriate COVID-19 bivalent BA.4/BA.5 mRNA booster dose at least two months after receipt of a primary series or prior monovalent booster dose. Either Pfizer-BioNTech COVID-19 bivalent BA.4/BA.5 vaccine (12 years and older) or Moderna COVID-19 bivalent BA.4/BA.5 vaccine (18 years and older) can be used, based on the patient's age at time of administration. Consistent with the FDA action, ACIP action repeals its previous recommendations for administration of monovalent vaccine boosters for persons ages 12 years and older. The COVID-19 BA.4/BA.5 bivalent booster recommendation replaces previous booster recommendations for this age group. For children 5 through 11 years of age, the previous ACIP recommendation for a monovalent booster remains unchanged.

Workgroup Discussion

Arthur Reingold, MD, Chair

Workgroup members discussed the recommended interval language of at least two months after receipt of a primary series or prior monovalent booster dose. Clinical guidance includes additional detailed information and considerations about the recommended interval for specific circumstances, such as recent infection. Workgroup members preferred that any statement to be issued use language consistent with CDC to reduce confusion, as long as Workgroup agrees with the recommendation
Workgroup members commented that the modeling data presented to ACIP were useful and indicated that more than 100,000 hospitalizations may be prevented with prompt implementation of the COVID-19 bivalent BA.4/BA.5 vaccine booster.

Workgroup members noted that although the overall number of COVID-19 cases is smaller in children than adults, COVID-19 is one of the leading causes of hospitalization and death among children in the U.S. Communications to increase vaccination rates in youth may benefit from highlighting that COVID-19 vaccination can reduce the burden of COVID-19 on families, schools, and communities, in addition to reducing the burden of disease among youth.

There was consensus among Workgroup members to recommend the use of COVID-19 bivalent BA.4/BA.5 vaccine booster doses for those individuals in age groups currently recommended to receive a COVID 19 vaccine booster.

Timing of Western States and Next Steps

Arthur Reingold, MD, Chair

Dr. Reingold requested input about timing for a Western States Scientific Safety Workgroup statement to Governors. State representatives weighed in that it would be important to have a statement over the weekend, if possible. Dr. Reingold indicated that a draft statement will be circulated for review and comment by mid-day Friday for final distribution over the weekend.