Western-States-Scientific-Safety-Review-Workgroup-Meeting-Summary-04202022 Western States Scientific Safety Review Workgroup Meeting Summary - April 20, 2022

Western States Scientific Safety Review Workgroup Meeting Summary - April 20, 2022

Meeting #29 – Wednesday, April 20, 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; 
  • 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; 
  • Rodney Hood, MD, Trustee, Alliance Healthcare Foundation; 
  • 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:

  • 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; 
  • 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; 
  • Tony Lapiz, MPH, Health Policy Advisor, Office of Governor Kate Brown

Workgroup Members Not Attending

  • Oliver Brooks, MD, CMO, Watts Health Care; 
  • Louis Picker, MD, Associate Director of Oregon Health & Science University’s Vaccine and Gene Therapy Institute.

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 CDC Advisory Committee on Immunization Practices (ACIP) met today, April 20, 2022. ACIP discussed updates and reviewed COVID-19 vaccine safety data and vaccine effectiveness. The ACIP discussion focused on the benefit-risk of a second COVID-19 booster dose (4th total dose) for adults aged 50 years and older and aged 12 years and older who are immunocompromised. There was also discussion of the overall purpose of COVID-19 vaccinations. There is no new information about the timing for an Emergency Use Authorization (EUA) of COVID-19 vaccine for children age 5 years and younger. ACIP did not vote on any recommendations at the meeting and Dr. Pan suggested there is no expectation of a statement from the Workgroup.

Workgroup Discussion

Arthur Reingold, MD, Chair
Grace Lee, MD, ACIP Chair and Western States Members

Workgroup members recapped the ACIP discussion and commented that it was helpful to review and discuss various scenarios related to the benefit-risk of an additional (4th) COVID-19 booster dose. ACIP reviewed the vaccine effectiveness (VE) and safety data and observed there is a short-term, although diminishing benefit associated with COVID-19 boosters. There is evidence of waning VE against infection following three mRNA doses by 2-4 months after the last dose, and even lower rates of VE over time for recipients of Janssen/Johnson & Johnson COVID-19 vaccine. Myocarditis continues to be a risk consideration, although the risk appears to be lower following the first booster dose compared to the second dose. Additional data are needed about pericarditis following COVID-19 vaccination among older adults.


ACIP members did not indicate an urgency to strongly recommend an additional COVID-19 booster for everyone at this time. An additional (4th) COVID-19 vaccine dose is recommended for immunocompromised individuals age 12 and older. Workgroup members concur with this stance. Several factors surfaced in the discussion reflecting reasons to wait before voting to recommend an additional (4th) COVID-19 booster dose for everyone. Case rates remain at lower levels and the incremental benefit of another (4th) COVID-19 booster dose appears to be small. There is evidence of waning against infection by 2-4 months after the last dose and the issue of immune tolerance and impact on immune system’s ability to respond to new variants after multiple exposures to the same vaccine remains uncertain. Boosters every 3-4 months may be unsustainable and of limited benefit.

There are more data needed and unanswered questions remaining. This may be the right time to focus on gathering data, including data to understand the impact of recent COVID infection and to determine the extent to which declining vaccine effectiveness predicts waning effectiveness against hospitalization and death. In addition, additional studies among children aged 5-11 years old are needed.

Some members commented that their focus remains on getting the COVID-19 vaccine primary series and first booster to those who remain not fully vaccinated. Workgroup members agreed that vaccinating the unvaccinated against COVID-19 remains the chief objective and that the primary goal of COVID-19 vaccines is to prevent severe disease and death.

The Workgroup acknowledged that additional COVID-19 booster doses will very likely be needed in the future. Members discussed the practicalities surrounding communicating about and administering multiple and ongoing booster doses. While timing a recommendation for an additional COVID-19 booster dose to align to a surge in cases may be helpful, members voiced concern about the ability to move rapidly enough to vaccinate everyone once a surge or new variant appears.

The Workgroup agrees with a “permissive” recommendation for the additional booster rather than a strong recommendation for everyone to receive the additional (4th)COVID-19 booster dose. There are reasons in favor of receiving a second booster (4th dose) for individuals to consider and discuss with their healthcare provider. For example, older age groups are at greater risk of COVID-19, co-morbidities are an important consideration, and living in a geographic area with a higher case rates may all be factors that may make an additional booster the right individual choice.

One member voiced the need to emphasize equity considerations in the booster discussion to avoid widening the gap in vaccine rates in vulnerable communities. Members noted that clinics have had mixed experience so far. Some patients are coming forward asking for the additional (4th) COVID-19 vaccine dose. COVID-19 vaccine supply is not a barrier. Some noted that a recommendation for an additional COVID-19 dose could worsen the confusion and cause booster fatigue among individuals already reluctant to be vaccinated.

A question was raised about whether there should be encouragement for an additional COVID-19 dose in congregate care settings and prisons/jails. It takes months to deliver COVID-19 vaccine throughout these settings and it may be prudent to begin sooner rather than waiting.
There is high staff turn-over in many congregate care settings and this may signal a need for ongoing surveillance.

Workgroup members discussed the need for a strategic and holistic approach to dealing with COVID-19. Because circumstances have changed rapidly, new findings have resulted in a series of recommendations. Each specific question has been treated separately. Going forward, we are entering a period when there is benefit in discussing how to tackle COVID-19 overall with a public health strategy that is simpler, yet comprehensive.

Timing of Western States Statement and Next Steps

Arthur Reingold, MD, Chair
There will not be a statement issued following this meeting. Exact timing for the next meeting is not known. There are a series of items ready to go to FDA and it is likely there may be a continuing series of meetings over the summer.