Issued February 7, 2022
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 Spikevax, the Moderna COVID-19 vaccine, which was granted a BLA by the U.S. Food and Drug Administration on January 31, 2022, including data presented to the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunizations Practices (ACIP) at its meeting on February 4, 2022.
The Workgroup members also followed closely the discussions and presentations at the February 4, 2022 ACIP meeting concerning anticipated changes to CDC's clinical considerations regarding use of COVID-19 vaccines in individuals with moderate or severe immunocompromise and in individuals who have recently received anti-SARS-CoV-2 antibody treatments. In addition, the Workgroup carefully reviewed and discussed the updated information concerning the risk of myocarditis/pericarditis following receipt of either the Moderna or the PfizerBioNTech mRNA COVID-19 vaccines and the effects of the length of the interval between first and second doses of these vaccines and both the risk of myocarditis/pericarditis and the efficacy, effectiveness, and immune responses.
Based on its review, the Workgroup concluded that the Moderna COVID-19 vaccine continues to be safe and effective in those 18 years of age and older. Because substantial numbers of individuals 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 this vaccine for those 18 years of age and older substantially outweigh any known or likely risks. Therefore, the Workgroup supports its continued use under the newly granted BLA.
With regard to anticipated changes to CDC's clinical considerations concerning use of COVID-19 vaccines for individuals who have moderate or severe immunocompromise, the Workgroup was supportive of an additional primary dose ≥28 days for Janssen vaccine recipients and a booster dose ≥2 months later. In addition, the Workgroup agreed that healthcare providers should have the flexibility to administer a booster dose ≥3 months after completing a 3-dose primary series for mRNA vaccine recipients with moderate to severe immunocompromise. The Workgroup was also supportive of changes to the clinical guidance with regard to timely COVID-19 vaccine administration among recipients of anti-SARS-CoV-2 antibody treatment or prophylaxis.
The Workgroup also concurred with the view, voiced by several members of the ACIP and its COVID-19 Vaccine Workgroup, that an extended interval of 8 weeks between the first and second doses for either mRNA COVID-19 vaccine may improve immunogenicity and vaccine effectiveness and might also reduce the risk of myocarditis/pericarditis following the second dose of the vaccine. While awaiting CDC guidance on possible extension of the interval, the Workgroup believes vaccine providers and recipients should consider the potential benefits of an increased interval between the first and second doses of an mRNA COVID-19 vaccine and weigh them against the risk of developing COVID-19 during the interval between receipt of the first and second doses of vaccine.
The Workgroup will continue to monitor the results of the rigorous ongoing national safety surveillance of all COVID-19 vaccines. The Workgroup strongly advises vaccine recipients to register 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
- Tomás J. Aragón, MD, DrPH, California Department of Public Health and State Health Officer (not in attendance at Western States meeting on February 4, 2022)
- 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 Western States meeting on February 4, 2022)
- 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
- 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
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
- Laura Byerly, MD, Virginia Garcia Memorial Health Center
- Louis J. Picker, MD, OHSU Vaccine and Gene Therapy Institute
- John Dunn, MD, MPH, Kaiser Permanente Washington
- Edgar K. Marcuse, MD, MPH, University of Washington School of Medicine
Originally published on February 8, 2020