Western-States-Scientific-Safety-Review-Workgroup-Meeting-Summary-12222022 Western States Scientific Safety Review Workgroup Meeting Summary - December 19, 2022

Western States Scientific Safety Review Workgroup Meeting Summary - December 19, 2022

Meeting #36 – Monday, December 19, 2022 – 5:00pm

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
  • 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
  • Grace Lee, MD, Professor of Pediatrics and Associate Chief Medical Officer for Practice Innovation, Stanford Children’s Health
  • Bonnie Maldonado, MD, Professor and Chief of the Division of Infectious Diseases, Department of Pediatrics, Stanford Medicine;
  • 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 
  • Matt Zahn, MD, Medical Director, Communicable Disease Control Division, Orange County Health Care Agency.

State of 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
  • Kristy Zigenis, Contracted COVID-19 Vaccine Program Manager, CFCW

State of Oregon 

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

Workgroup Members Not Attending

  • Kyle Devine, Bureau Chief for the Bureau of Child, Family, and Community Wellness (CFCW)
  • John Dunn, MD, Medical Director for Preventive Care and Head of Immunization Program, Kaiser Permanente Washington
  • Rodney Hood, MD, Trustee, Alliance Healthcare Foundation
  • Nicola Klein, MD, Director, Kaiser Permanente Vaccine Study Center

Guest Attending 

  • Mark Ghaly, MD, Secretary California Health and Human Services
  • Umair Shah, MD, Secretary Washington State Department of Health 
  • Dean Sidelinger, MD, Health Officer and State Epidemiologist for the Oregon Public Health Division

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) and announced that this was the final meeting of the Workgroup. The topic for this meeting was to discuss the recent FDA action 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 six months through five years of age, and the subsequent supporting recommendation by CDC.

Before turning to the agenda topic, representatives from the participating states, California, Nevada, Washington, and Oregon, thanked members of the Workgroup for their service. Dr. Mark Ghaly, Secretary of Health and Human Services for California offered deep appreciation to Dr. Reingold, other Workgroup members, and the CDPH team for their important contributions. The Workgroup has been a critically important voice of highly-regarded regional experts to critically review national recommendations. Dr. Ihsan Azzam, Chief Medical Officer of the Division of Public and Behavioral Health for Nevada added his gratitude for the valuable and scientifically based discussions that were very helpful to Nevada. Dr. Dean Sidelinger, Health Officer and State Epidemiologist for the Oregon Public Health Division, offered a heartfelt thank you to Workgroup members and Bobbie Wunsch for grounding the discussion in considerations of equity, noting that Oregonians are better off from the work of the group. Dr. Umair Shah, Secretary of Health for the State of Washington, offered his thanks to the Washington state team and all members of the Workgroup. He noted the importance of the scientific foundation for the Workgroup’s statements, whose clarity and accuracy reflected the Workgroup’s expertise.

Workgroup Discussion

Arthur Reingold, MD, Chair

Dr. Schechter summarized the December 8, 2022 FDA authorization and subsequent CDC announcement December 9, 2022 to amend the Emergency Use Authorization (EUA) and expand the recommended use of the Moderna and Pfizer-BioNTech (Pfizer) COVID-19 bivalent BA.4/BA.5 variant vaccines to children 6 months through 5 years old:

  • Children 6 months through 5 years of age who received the original (monovalent) Moderna COVID-19 Vaccine are now eligible to receive a single booster of the updated (bivalent) Moderna COVID-19 Vaccine two months after completing a primary series with the monovalent Moderna COVID-19 Vaccine.
  • Children 6 months through 4 years of age who have not yet begun their three-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine or have not yet received the third dose of their primary series should now receive the updated (bivalent) Pfizer-BioNTech COVID-19 vaccine as the third dose in their primary series following two doses of the original (monovalent) Pfizer-BioNTech COVID-19 Vaccine.
  • Children 6 months through 4 years of age who have already completed their three-dose primary series with the original (monovalent) Pfizer-BioNTech COVID-19 Vaccine are not yet eligible for a booster dose of an updated bivalent vaccine. Children in this age group who already completed their primary series would still be expected to have protection against the most serious outcomes from the currently circulating omicron variant.

Dr. Lee noted that the Advisory Committee for Immunization Practice (ACIP) did not need to meet regarding the recent federal actions based on the breadth of its prior recommendations. She also noted that aspects of the recommendations, such as the current inability of children in this age group who have completed their primary series to receive boosters of Pfizer COVID-19 vaccine, are challenging to implement. Workgroup members reported that Pfizer clinical trials are ongoing.

There was consensus among Workgroup members to issue a statement that concurs with the FDA authorization and CDC announcement and recommendations. The Workgroup discussed potential messages for a statement to the Governors of the Western States’ members.

Members expressed the consensus view that the complexity of doses and changing recommendations may warrant a note of caution in the statement about careful attention to implementation. Workgroup members also noted that public perceptions regarding COVID-19 vaccines have shifted. While safety was a major concern in the early roll-out of the COVID-19 vaccines, people are now focused on different concerns. Recommendations will continue to evolve and likely become simplified as clinical trials are completed and additional data become available. Members noted that it will remain important to educate both providers and the public. Others stressed that maintaining a focus on the success of the COVID-19 vaccines in preventing hospitalizations and deaths will be needed to minimize complacency in the future.

Members suggested that the statement include comments about ongoing work of the FDA and CDC to monitor safety and review data, underscoring the confidence of this Western States Scientific Safety Review Workgroup in the work of the federal entities.

The Workgroup stressed the critical importance of ongoing attention to equity and access to COVID-19 vaccines and the need for vigilance on these topics, as the federal government reduces financial support for COVID-19 vaccinations. Members also stressed the importance of a continuing focus on assuring equitable access and utilization across all populations. The statement may be a good opportunity for the Workgroup to offer summary statements on equity and access.

In summary, members’ input for the statement included continued emphasis that:

  • COVID-19 vaccination is important for everyone at least 6 months of age.
  • COVID-19 vaccines may be co-administered with other vaccines, such as influenza vaccine.
  • The safety of COVID-19 vaccines should continue to be monitored.
  • Workgroup members are unanimous in their belief that the benefits of the COVID-19 bivalent booster outweigh any known risks for younger children, older children and adults.

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 before the weekend. Dr. Reingold indicated that a draft statement would be circulated for review and comment over the next two days for immediate distribution.

Final Meeting Closing Comments

All Members

Members offered appreciation for Dr. Reingold’s exemplary leadership of the Workgroup and his skill in soliciting contributions from all of its members. The group was created when it was critical to verify and clearly communicate the scientific basis for national recommendations, and it has accomplished its goal of increasing credibility for the public. The group produced 24 statements during its tenure. Thanks were also extended to Bobbie Wunsch for her highly effective facilitation of the Workgroup. Finally, California public health leaders recognized and thanked everyone for the willingness of so many experts across multiple disciplines from all four states on this workgroup.