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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 July 19, 2022, the Western States Scientific Safety Review Workgroup thoroughly reviewed the evidence concerning the safety, immunogenicity and efficacy of the Novavax COVID-19 vaccine in those ≥ 18 years of age presented to the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) on the same day and considered the committee’s discussions. The Workgroup noted the substantial numbers of cases of COVID-19, as well as COVID-19- related hospitalizations and deaths that are continuing to occur in the United States, and the fact that large numbers of individuals ≥ 18 years of age remain unvaccinated against COVID-19, some of whom have reservations about other COVID-19 vaccines. 

The Workgroup carefully assessed the safety data for the Novavax COVID-19 vaccine presented to the ACIP, noting the absence of 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 using mRNA COVID-19 vaccines or after other routine immunizations. The Workgroup noted the vaccine’s high efficacy in the pre-Omicron era against symptomatic COVID-19 disease in those ≥ 18 years of age. 

Based on its review, the Workgroup concluded the Novavax COVID-19 vaccine is safe and effective in this age group. Because substantial numbers of adults remain at risk of COVID-19 illness and its complications, including hospitalization and death, the Workgroup is confident that the benefits of the Novavax Covid-19 vaccine for those ≥ 18 years of age substantially outweigh any known or likely risks. Therefore, the Workgroup supports the use of the Novavax Covid-19 vaccine under Emergency Use Authorization (EUA) as a two-dose primary series of 5 µg of antigen and 50 µg of adjuvant for those ≥ 18 years of age who have not received any prior COVID-19 vaccinations, with doses given three to eight weeks apart (three weeks apart for people who are moderately or severely immunocompromised). 

 With the multiple types of COVID-19 vaccines now available, the Workgroup notes the increased potential for administration errors in COVID-19 immunization that may accompany the introduction of an additional vaccine option. To promote safe and effective immunization, the Workgroup recommends that providers consult with clinical guidelines from CDC, including the recommendation that, in general, the same COVID-19 vaccine product should be used for all doses in the primary series. 

The Workgroup will continue to assess the findings from the rigorous ongoing national safety surveillance of COVID-19 vaccines, including monitoring for reports of myocarditis or pericarditis in recipients of the Novavax COVID-19 vaccine. The Workgroup strongly advises registration in the V-safe system and urges that all suspected adverse events following receipt of any COVID-19 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 July 19, 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 (not in attendance at the July 19, 2022 Western States meeting)
  

• 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
  

• 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

• Kristy Zigenis, COVID-19 Vaccine Manager

Oregon Members:

• Laura Byerly, MD, Virginia Garcia Memorial Health Center (not in attendance at the July 22, 2022 Western States meeting)
  

• Louis J. Picker, MD, OHSU Vaccine and Gene Therapy Institute (not in attendance at the July 22, 2022 Western States meeting)
  

Washington Members:

• John Dunn, MD, MPH, Kaiser Permanente Washington

• Edgar K. Marcuse, MD, MPH, University of Washington School of Medicine