Western-States-Scientific-Safety-Review-Workgroup-Meeting-Summary-10122022 Western States Scientific Safety Review Workgroup Meeting Summary - October 12, 2022

Western States Scientific Safety Review Workgroup Meeting Summary - October 12, 2022

​​Meeting #35 – Wednesday, October 12, 2022 – 5:30pm

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
  • 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
  • Nicola Klein, MD, Director, Kaiser Permanente Vaccine Study Center
  • Grace Lee, MD, Professor of Pediatrics and Associate Chief Medical Officer for Practice Innovation, Stanford Children’s Health
  • Arthur Reingold, MD, School of Public Health Division Head of Epidemiology and Biostatistics, University of California, Berkeley
  • Mark Sawyer, MD, Infectious Disease Specialist, Rady Children's Hospital
  • 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 

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

  • Kyle Devine, Bureau Chief for the Bureau of Child, Family, and Community Wellness (CFCW)
  • Kristy Zigenis, Contracted COVID-19 Vaccine Program Manager, CFCW

State of Oregon 

  • Laura Byerly, MD, Chief Medical Officer, Virginia Garcia Health Center, Oregon

Workgroup Members Not Attending

  • Ihsan Azzam, MD, Chief Medical Officer, Division of Public and Behavioral Health, Nevada
  • Rodney Hood, MD, Trustee, Alliance Healthcare Foundation
  • Bonnie Maldonado, MD, Professor and Chief of the Division of Infectious Diseases, Department of Pediatrics, Stanford Medicine
  • Louis Picker, MD, Associate Director of Oregon Health & Science University’s Vaccine and Gene Therapy Institute 
  • Matt Zahn, MD, Medical Director, Communicable Disease Control Division, Orange County Health Care Agency

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 (Workgroup). The topic for this meeting is to review the safety data and other evidence summarized in the FDA decision to amend the Emergency Use Authorization (EUA) of the Moderna and Pfizer-BioNTech (Pfizer) COVID-19 bivalent BA.4/BA.5 variant vaccines for children aged five years and older.

Dr. Schechter summarized the supporting data for the October 12, 2022, FDA announcement to amend the EUA and CDC announcement to expand the recommended use of the Pfizer and Moderna COVID-19 bivalent vaccine to children aged 5-11 years old.

The supporting data cited for the Pfizer COVID-19 vaccine were presented over previous months.

Data for the Moderna COVID-19 bivalent vaccine for younger ages were summarized by the FDA, although some data were not yet publicly posted. The Advisory Committee for Immunization Practices (ACIP) met September 1-2, 2022, and reviewed safety data and immunobridging information for adult COVID-19 bivalent BA.4/BA.5 variant vaccines that was subsequently published in the New England Journal of Medicine and cited in the FDA announcement.

Workgroup members who have continued to review data are not aware of any new safety signals reported through V-safe, Vaccine Adverse Events Reporting System (VAERS) and Vaccine Safety Datalink (VSD) or any efficacy data that would alter the benefit-risk balance assessment or change recommendations made in the September 1-2, 2022, ACIP meeting. Members also noted that VSD has not detected any myocarditis cases following COVID-19 vaccine booster doses in children aged 5-11 years old.

Workgroup Discussion

Arthur Reingold, MD, Chair

Workgroup members posed questions related to the announcement. Dr. Schechter clarified that the dose and formulation for younger ages will remain the same as recommended for older age youth. In addition, he clarified that clinical guidance continues unchanged that COVID-19 and other routine vaccines can be co-administered.

Workgroup members discussed additional considerations for the amended EUA, such as concerns about potential increases in SARS-COV 2 infection over the winter months, the fact that schools are in session with in-person attendance as well as wanting to protect younger age children from hospitalization and death due to COVID-19.

There was consensus among Workgroup members to issue a statement that concurs with the FDA announcement and CDC recommendation to give a single booster dose of an updated bivalent BA.4/BA.5 COVID-19 vaccine to younger children who have completed a primary COVID vaccine series to sustain protection against COVID-19. The Moderna COVID-19 bivalent vaccine is authorized down to six years of age, and the Pfizer-BioNTech COVID-19 bivalent vaccine is authorized down to five years of age. Both are authorized for administration at least two months following completion of primary or booster vaccination.

The Workgroup discussed potential messages for inclusion in a statement to the Governors of the Western States’ members. The statement should include:
  • Concern about the potential for errors in the administration of the various COVID-19 vaccines due to the fact that formulations for different age groups appear alike.
  • Continuing to emphasize the importance of COVID-19 vaccination for everyone.
  • Information that COVID-19 and other vaccines, including flu vaccine, can be co-administered.
  • Emphasizing that safety monitoring will continue and that Workgroup experts agree the benefit of COVID-19 bivalent booster significantly outweighs risk for younger children.

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 expeditiously. Dr. Reingold indicated that a draft statement will be circulated for review and comment immediately following the meeting for final distribution tomorrow.