Western-States-Scientific-Safety-Review-Workgroup-Meeting-Summary-12162021 Scientific Safety Review Workgroup Meeting Summary - December 16, 2021

Scientific Safety Review Workgroup Meeting Summary - December 16, 2021

California Health and Human Services Agency (CHHS)

California Department of Public Health (CDPH)

Western States Scientific Safety Review Workgroup

Meeting #24 – Thursday, December 16, 2021 – 7:00pm

Meeting Summary

Workgroup Members Attending


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; 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.



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



Karissa Loper, MPH, Health Bureau Chief, Nevada Department of Health and Human Services

STATE OF OREGON Louis Picker, MD, Associate Director of Oregon Health & Science University's Vaccine and Gene Therapy Institute


Workgroup Members Not Attending

Ihsan Azzam, MD, Chief Medical Officer, Division of Public and Behavioral Health; Laura Byerly, MD, Chief Medical Officer, Virginia Garcia Health Center; Rodney Hood, MD, Trustee, Alliance Healthcare Foundation



Bobbie Wunsch, Founder and Partner, Pacific Health Consulting Group

Welcome and Review of Agenda

Arthur Reingold, MD, Chair

Dr. Reingold welcomed members. He commented that the agenda for the call will include review of data on Thrombosis with Thrombocytopenia Syndrome (TTS) and Guillain-Barré syndrome (GBS), discussion of updated recommendations for use of the Janssen COVID-19 vaccine, and COVID-19 vaccine safety surveillance data for children 5-11 years of age. Dr. Pan requested that the Workgroup include a short discussion to consider the implications of language usage related to “fully vaccinated” and “up to date”.

Updated COVID-19 Vaccine Recommendation

Arthur Reingold, MD, Chair
Grace Lee, MD, Stanford Children’s Health

Dr. Lee and Workgroup members presented data, including data from the Vaccine Adverse Event Reporting System (VAERS) and summarized key information from the CDC Advisory Committee on Immunization Practice (ACIP) meeting held earlier today, December 16, 2021. Workgroup members discussed recent data indicating higher incidence of TTS and GBS in recipients of the Janssen COVID-19 vaccine compared to recipients of mRNA COVID-19 vaccines.
Dr. Lee reported there was a unanimous vote by ACIP to recommend that mRNA COVID-19 vaccines be preferred over the Janssen COVID-19 vaccine for the prevention of COVID-19 for all those ≥18 years of age.

Dr. Lee noted that clinical considerations are not voted on by ACIP. They are developed by the CDC from the ACIP discussion and reviewed by members prior to being posted. Generally, clinical guidance is available within two days of the ACIP recommendation. In this case, two circumstances in which the Janssen COVID-19 vaccine might be used include when an individual has had an anaphylactic reaction to an mRNA vaccine or myocarditis following receipt of an mRNA vaccine or when a patient strongly prefers the Janssen COVID-19 vaccine after receiving information about the risks and benefits. The intent is to ensure multiple vaccines are available to all populations.

The Workgroup also reviewed safety data for children 5-11 years of age who have received COVID-19 vaccination. Although the number of such children is limited, and only a small number have received a second dose of the vaccine, the Workgroup was reassured by the data on the safety of the vaccine in younger children available to date.

Dr. Reingold asked members to offer comments on their support of a statement to recommend that mRNA COVID-19 vaccines be preferred over the Janssen COVID-19 vaccine for the prevention of COVID-19 for all those ≥18 years of age. There was unanimous agreement for this recommendation based on the data presented.
Workgroup members discussed potential messages and surrounding information for the statement.

  • mRNA COVID-19 vaccine is preferred but both the mRNA and Janssen (Johnson and Johnson) vaccines should be available at all vaccination sites.
  • Communicate that the Janssen COVID-19 vaccine can still be administered; its Emergency Use Authorization is not withdrawn by this recommendation.
  • Janssen COVID-19 vaccine should be considered when a person has clinical contraindications to an mRNA vaccine (e.g. myocarditis following a dose of the vaccine) or a person has a strong preference for the Janssen COVID-19 vaccine after education about its benefits and risks.
  • Unless there is a clinical contraindication or strong personal preference for the Janssen COVID-19 vaccine, an mRNA COVID-19 vaccine is preferred.
  • Ensure equitable education concerning the benefits and risks of the vaccines in multiple languages.
  • Include a message that preliminary VAERS data for youth 5-11 years of age are reassuring with regard to the safety of the vaccines in this age group.
  • Continue to emphasize that COVID-19 vaccination and boosters are essential.
Workgroup members commented that ensuring adequate education in mass vaccination sites is more challenging; however most states rely less on such sites now. Many public vaccine sites have moved to appointment-only vaccination and do not accommodate walk-ups, to ensure adequate time for patient education prior to administering vaccine.

The Workgroup had a short discussion on the clarity and usefulness of public messaging regarding terminology of “fully vaccinated” vs “up to date” on COVID-19 vaccination. There is growing interest in moving to language of “up to date,” because what it means to be “fully vaccinated” changes over time. The changing terminology makes it difficult to know what standard “fully vaccinated” is referencing. For example, the CDC current clinical recommendation for fully vaccinated for college entry means two doses of an mRNA COVID-19 vaccine or one dose of J&J COVID-19 vaccine. The general agreement is that the shift in language is an important emerging topic; however, it is not yet fully endorsed or used routinely. It would be confusing to introduce different language at this time.

Timing of Statement and Next Steps

Arthur Reingold, MD, Chair

A draft statement will be distributed to the Workgroup for review and comment to be finalized tomorrow, December 17, 2021 to the Western States’ Governors.