āTo: 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 December 19, 2022 the Western States Scientific Safety Review Workgroup reviewed the information summarized by the U.S. Food and Drug Administration (FDA) in its announcement of December 8, 2022 concerning 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 down to six months of age, as well as the announcement by CDC Director Dr. Rochelle Walensky on December 9, 2022.
To sustain protection against COVID-19, the Workgroup concurs with the latest recommendation from FDA and CDC to give a single booster dose of the Moderna COVID-19 bivalent vaccine to children six months through five years of age as a single booster dose at least two months after completion of primary vaccination with the monovalent Moderna COVID-19 vaccine. The Workgroup also concurs with the prior recommendation to give a single booster dose of the Moderna COVID-19 bivalent vaccine to individuals six years of age and older at least two months after completion of either primary vaccination of any authorized or approved COVID-19 vaccine or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.
The Workgroup also concurs with the recommendation that children six months through four 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 does of their primary series should 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 in this age group who have already completed their three dose primary series with the original monovalent Pfizer-BioNTech COVID-19 vaccine are not eligible for a booster dose of an updated bivalent COVID-19 vaccine at this time.
Given the anticipated burden of SARS-CoV-2 infections and related COVID-19 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 help 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 illness 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 660 million doses administered in the U.S. However, the Workgroup continues to be very concerned about the potential for errors in the administration of the various COVID-19 vaccines, given that formulations for different age groups look alike and given the complexity of the recommendations regarding the use of booster doses of COVID-19 vaccines. To minimize the frequency of such errors, 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 administration errors or 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.
US FDA recently announced that a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) scheduled for January 26, 2023 will discuss future COVID-19 vaccination regimens. The Workgroup calls on the states to carefully monitor and incorporate any future changes in FDA and CDC recommendations regarding COVID-19 vaccines.
The Workgroup strongly reiterated its ongoing calls for concerted efforts to ensure equal access to COVID-19 vaccinations and for careful monitoring of vaccine utilization across all populations, given current reductions in federal financial support of COVID-19 vaccination efforts, which are likely to hamper efforts to vaccinate hard-to-reach populations.
Respectfully submitted:
Members of the Western States Scientific Safety Review Workgroup: Arthur Reingold, MD, Chair, UC Berkeley School of Public Health
California Members:
- TomĆ”s J. AragĆ³n, 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 December 19, 2022 Western States Workgroup meeting)
- Nicola Klein, MD, Ph.D., Kaiser Permanente Northern California (not present at the December 19, 2022 Western States Workgroup meeting)
- Grace M. Lee, MD, MPH, Stanford Childrenās Health and Stanford University School of Medicine
- Bonnie Maldonado, MD, Stanford University School of Medicine and Stanford Childrenās Health
- Mark H. Sawyer, MD, UC San Diego School of Medicine and Rady Childrenās 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
Nevada Members:
- Ihsan Azzam, MD, Ph.D., Chief Medical Officer, State of Nevada
- Kyle Devine, Bureau of Child, Family and Community Wellness (not present at the December 19, 2022 Western States Workgroup meeting)
- Kristy Zigenis, COVID-19 Vaccine Manager
Oregon Members:
- Laura Byerly, MD, Virginia Garcia Memorial Health Center
- Louis J. Picker, MD, OHSU Vaccine and Gene Therapy Institute
Washington Members:
- John Dunn, MD, MPH, Kaiser Permanente Washington (not present at the December 19, 2022 Western States Workgroup meeting)
- Edgar K. Marcuse, MD, MPH, University of Washington School of Medicine