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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 December 16, 2021, the Western States Scientific Safety Review Workgroup carefully reviewed the data presented at the U.S. C.D.C. Advisory Committee on Immunization Practices (ACIP) meeting held the same day concerning the risk of Thrombosis with Thrombocytopenia Syndrome (TTS) and Guillain- Barré Syndrome (GBS) following the receipt of the Janssen (Johnson and Johnson) COVID-19 vaccine.

The data presented to ACIP show that COVID-19 mRNA vaccines have higher effectiveness and are associated with fewer severe adverse events than the Janssen (Johnson & Johnson) COVID-19 vaccine, receipt of which continues to be associated with an elevated risk of TTS and a substantially higher risk of GBS. The Workgroup concurs with the decision of ACIP to give a preferential recommendation to the COVID-19 mRNA vaccines produced by Pfizer-BioNTech and Moderna for those ages 18 years and older, given their greater effectiveness and stronger safety profile. Specific guidance related to this recommendation will be forthcoming from the CDC. Ensuring accurate information concerning the preferential recommendation for mRNA COVID-19 vaccines is available in multiple languages and communicated effectively to those seeking vaccination against COVID-19 should be a high priority. It is also important to ensure the availability of adequate supplies of mRNA vaccine supplies, including in settings that serve hard-to-reach populations.

The Workgroup recognizes some individuals have valid medical contraindications to the COVID-19 mRNA vaccines and others may simply prefer the Janssen (Johnson & Johnson) COVID-19 vaccine. The Workgroup believes vaccine providers should continue to make the Janssen (Johnson & Johnson) COVID-19 vaccine available to such individuals after they have been educated about the vaccine’s risks, as the benefits of receiving the vaccine outweigh the known risks compared to not receiving a COVID-19 vaccine.

The Workgroup also reviewed the data presented at the December 16, 2021 ACIP meeting concerning reports of adverse events among children 5-11 years of age who received a COVID-19 vaccine. Although the number of such children is limited, and only a small number have received second doses of the vaccine, the Workgroup was reassured by these data on the safety of the vaccine in younger children. The Workgroup recognizes the important contributions of various U.S. systems for monitoring the safety of vaccinations, including COVID-19 vaccination safety, and their central role in guiding vaccination policy. The Workgroup continues to urge all healthcare providers and vaccine recipients to report any suspected adverse events following receipt of a COVID-19 vaccine to the Vaccine Adverse Events Reporting System (VAERS).

The Workgroup calls on our states to continue to provide COVID-19 vaccines to those who have not yet been vaccinated and to provide booster doses of a COVID-19 vaccine to all who have received an initial COVID-19 vaccination series, in accordance with ACIP and FDA recommendations and CDC guidance.

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 present at Western States meeting on December 16, 2021)

• 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 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 (not present at Western States meeting on December 16, 2021)
• Karissa Loper, MPH, Health Bureau Chief, Nevada Department of Health and Human Services

Oregon Members:

• Laura Byerly, MD, Virginia Garcia Memorial Health Center (not present at Western States meeting on December 16, 2021)

• 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