​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

The Western States Scientific Safety Review Workgroup thoroughly reviewed the evidence concerning the safety, immunogenicity and efficacy of the Moderna COVID-19 vaccine in children and adolescents ages 6 – 17 years presented to the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) on June 23, 2022 and considered the committee's discussions. The Workgroup noted the substantial numbers of cases of COVID-19 (more than 10 million) and COVID-19-related deaths (more than 600) in this age group, as well as the large number of children and adolescents in all racial and ethnic groups who remain unvaccinated against COVID-19 in the United States – 65% of 5-11 year olds and 30% of 12-17 year olds.

The Workgroup carefully assessed the safety data for this vaccine, noting the absence of any severe adverse events among vaccine recipients in the clinical trial. Reactions were mild, self-limited, and similar to those seen after immunization against COVID-19 at older ages or after other routine immunizations at any age. The Workgroup noted the vaccine's efficacy in the pre- Omicron era against symptomatic COVID-19 disease in these age groups. Therefore, the Workgroup supports the use of the Moderna Covid-19 vaccine under Emergency Use Authorization (EUA) as a two-dose primary series of 50 µg for ages 6-11 years and 100 µg for ages 12-17 years, with doses given four to eight weeks apart.

Expanding the number of COVID-19 vaccines available for use in children and adolescents 6-17 years of age will allow them to more safely engage in educational and other activities important to their health and development; give parents a means of further protecting their children; and contribute to control of the COVID-19 pandemic in our states. The Workgroup strongly urges that states make every effort to reduce or eliminate disparities in the availability and uptake of COVID-19 vaccines in children and adolescents 6-17 years of age, as well as in infants, all younger children 6 months – 5 years of age, and adults.

Based on this review, the Workgroup concluded the Moderna COVID-19 vaccine is safe and effective in this age group. Because substantial numbers of children of this age remain at risk of COVID-19 illness and its complications, including hospitalization and death, the Workgroup is confident that the benefits of the Moderna Covid-19 vaccine for children and adolescents 6-17 years of age substantially outweigh any known or likely risks.

The Workgroup notes the increased potential for administration errors in COVID- 19 immunization, given the differences by manufacturer and age group. To promote safe and effective immunization, the Workgroup recommends that providers consult with clinical guidelines from CDC .

The Workgroup will continue to monitor the rigorous ongoing national safety surveillance of COVID-19 vaccines. The Workgroup strongly advises parents and caregivers to register their children in the V-safe system and urges that all suspected adverse events following receipt of the vaccine be reported to the Vaccine Adverse Event Reporting System (VAERS).

Respectfully submitted:

Members of the Western States Scientific Safety Review Workgroup: Arthur Reingold, MD, Chair, UC Berkeley School of Public Health

California Members:

• Tomás J. Aragón, MD, DrPH, California Department of Public Health and State Health Officer
• Oliver Brooks, MD, Watts Healthcare
• Eric Goosby, MD, UCSF School of Medicine
• Rodney Hood, MD, UC San Diego Alumnus and National Medical Association (not in attendance at the June 23, 2022 Western States 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
• Mark H. Sawyer, MD, UC San Diego School of Medicine and Rady Children's Hospital (not in attendance at the June 23, 2022 Western States meeting)
• 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 (not in attendance at the June 23, 2022 Western States meeting)
• Kyle Devine, Bureau of Child, Family and Community Wellness
• Kristy Zigenis, COVID-19 Vaccine Manager

Oregon Members:

• Laura Byerly, MD, Virginia Garcia Memorial Health Center (not in attendance at the June 23, 2022 Western States meeting)
• Louis J. Picker, MD, OHSU Vaccine and Gene Therapy Institute

Washington Members:

• John Dunn, MD, MPH, Kaiser Permanente Washington
• Edgar K. Marcuse, MD, MPH, University of Washington School of Medicine