To: Governors of California, Nevada, Oregon, and Washington State
- Governor Gavin Newsom, California
- Governor Steve Sisolak, Nevada
- Governor Kate Brown, Oregon
- Governor Jay Inslee, Washington
From: Arthur Reingold, MD, Chair, Western States Scientific Safety Review Workgroup
At its meeting on October 12, 2022 the Western States Scientific Safety Review Workgroup reviewed the information summarized by the U.S. Food and Drug Administration (FDA) in its amendment of the Emergency Use Authorization (EUA) of the Moderna and Pfizer-BioNTech COVID-19 bivalent BA.4/BA.5 variant vaccines to include children aged five years and older dated October 12, 2022, as well as the announcement by CDC Director Dr. Rochelle Walensky on the same day.
To sustain protection against COVID-19, the Workgroup concurs with the 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. The Moderna COVID-19 bivalent vaccine is authorized for administration at least two months following completion of primary or booster vaccination in children down to six years of age, and the Pfizer-BioNTech COVID-19 bivalent booster is authorized for administration at least two months following completion of primary or booster vaccination in children down to five years of age. Guidance for spacing of a bivalent booster vaccine following SARS-CoV-2 infection is the same as with prior booster recommendations.
Given the anticipated burden of COVID-19 infections and related illnesses this fall/winter season, the Workgroup believes that the benefits of bivalent booster doses that more closely match currently circulating SARS-CoV-2 variants will sustain protection against COVID-19-related hospitalizations and deaths in young children and substantially outweigh any potential risks. Provision of bivalent booster doses should not impede efforts to vaccinate those who have not yet received an initial series of a COVID-19 vaccine, as unvaccinated persons remain at much higher risk of COVID-19 infection than those who have received COVID-19 vaccines. To control the pandemic, the Workgroup urges vaccination against COVID-19 for everyone who is eligible.
Evidence available to date supports the safety of authorized and licensed COVID-19 vaccines, with over 640 million doses administered in the U.S. However, the Workgroup continues to be concerned about the potential for errors in the administration of the various COVID-19 vaccines, given that formulations for different age groups look alike. To minimize the frequency of such errors, which should be reported to VAERS, it is imperative that clear COVID-19 vaccination guidelines be disseminated to all vaccine providers. The Workgroup reiterates the importance of reporting to VAERS any suspected adverse events following receipt of a COVID-19 vaccine, whether as part of an initial series or as a booster dose and continued national safety surveillance efforts.
A bivalent COVID-19 booster dose can be co-administered with other vaccines, including influenza vaccines.
The Workgroup reiterated its earlier calls for concerted efforts to ensure equal access to COVID-19 vaccinations and for careful monitoring of vaccine utilization across all populations.
Members of the Western States Scientific Safety Review Workgroup: Arthur Reingold, MD, Chair, UC Berkeley School of Public Health
- Tomás J. Aragón, MD, DrPH, California Department of Public Health and State Health Officer
- Oliver Brooks, MD, Watts Healthcare Corporation
- Eric Goosby, MD, UCSF School of Medicine
- Rodney Hood, MD, UC San Diego Alumnus and National Medical Association (not present at the October 12, 2022 Western States Workgroup meeting)
- Nicola Klein, MD, Ph.D., Kaiser Permanente Northern California
- Grace M. Lee, MD, MPH, Stanford Children’s Health and Stanford University School of Medicine
- Bonnie Maldonado, MD, Stanford University School of Medicine and Stanford Children’s Health (not present at the October 12, 2022 Western States Workgroup meeting)
- Mark H. Sawyer, MD, UC San Diego School of Medicine and Rady Children’s Hospitals
- Robert Schechter, MD, California Department of Public Health
- Peter G. Szilagyi, MD, MPH, UCLA Health and David Geffen School of Medicine
- Matt Zahn, MD, Orange County Health Care Agency (not present at the October 12, 2022 Western States Workgroup meeting)
- Ihsan Azzam, MD, Ph.D., Chief Medical Officer, State of Nevada (not present at the October 12, 2022 Western States Workgroup meeting)
- Kyle Devine, Bureau of Child, Family and Community Wellness
- Kristy Zigenis, COVID-19 Vaccine Manager
- Laura Byerly, MD, Virginia Garcia Memorial Health Center
- Louis J. Picker, MD, OHSU Vaccine and Gene Therapy Institute (not present at the October 12, 2022 Western States Workgroup meeting)
- John Dunn, MD, MPH, Kaiser Permanente Washington
- Edgar K. Marcuse, MD, MPH, University of Washington School of Medicine