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 August 13, 2021, the Western States Scientific Safety Review Workgroup reviewed the evidence presented at the meeting of the CDC Advisory Committee on Immunization Practices (ACIP) on August 13, 2021 concerning the safety and efficacy of an additional dose of mRNA COVID-19 vaccines given to individuals with moderate to severe immunosuppression.
Noting the continued increase in the incidence of COVID-19 illnesses and the widespread prevalence of the Delta variant of SARS-CoV-2, the Workgroup remains concerned about the vulnerability to severe COVID-19 of individuals with moderate to severe immunosuppression, who in some settings have represented over 40% of persons recently hospitalized for COVID-19.
To provide maximal protection to this vulnerable population, the Workgroup reiterates its recommendation that all persons 12 years and older, especially those with moderate to severe immunosuppression and those who are in close contact with them, receive an initial complete series of an authorized COVID-19 vaccine. Moreover, persons with moderate to severe immunosuppression who have received a complete series should receive an additional dose of an mRNA COVID-19 vaccine, based on current limited data on the safety and immunogenicity of an additional dose.
To monitor the safety of additional doses, the Workgroup continues to encourage all recipients of COVID-19 vaccine with access to a smartphone to participate in the v-safe program.
The Workgroup recommends that individuals and care providers discuss the benefits and risks of an additional dose of an mRNA COVID-19 vaccine. An individual's medical care team is best positioned to determine the degree of immunocompromise in relation to the recommended COVID-19 vaccination schedule.
As current data indicate that an additional dose of an mRNA COVID-19 vaccine does not result in seroconversion in all persons with moderate to severe immunosuppression, the Workgroup continues to recommend that these individuals continue to take other measures to prevent infection with SARS-CoV-2, such as wearing a well-fitted, multi-layer mask and avoiding crowds and poorly ventilated indoor spaces. The Workgroup emphasizes that all persons 12 years of age and older, especially close contacts of immunosuppressed persons, should be vaccinated against COVID-19 to protect immunosuppressed contacts.
The Workgroup recognizes that current federal authorization and guidance for an additional dose of an mRNA COVID-19 vaccine are limited to persons who have received an mRNA vaccine, and that immunosuppressed persons who instead have received the Janssen COVID-19 vaccine might still be vulnerable to becoming severely ill if infected with SARS-CoV-2. The Workgroup supports expedited efforts to better protect immunosuppressed persons who have received the Janssen COVID-19 vaccine.
The Workgroup recognizes that the ACIP did not provide guidance for similarly immunosuppressed patients who received the Janssen COVID-19 vaccine. The Workgroup also recognizes that for vaccines authorized under an EUA there is no pathway for "off label use," as there is for vaccines approved under a Biologic License Application.
The Workgroup noted that expert guidance is most needed when the information and data available are insufficient to guide practice. Therefore, the Workgroup advises individuals whose immune systems are moderately to severely compromised and who received the Janssen COVID-19 vaccine to consult with their health care providers. The Workgroup believes clinicians should weigh the potential risk of COVID 19 infection and the unknown potential risks and benefits of a dose of an mRNA vaccine for each such patient and also consider the potential organizational and professional risks of the unauthorized administration of a supplementary dose of an mRNA vaccine. Should a clinician choose to recommend the patient consider a supplementary dose of an mRNA vaccine in these circumstances, the patient should be informed that the recommendation exceeds current FDA and CDC guidance and is based on the clinician's individualized medical judgment.
The Workgroup reiterates its strong recommendation for the immunization against COVID-19 of pregnant and recently pregnant women, who if unimmunized remain at increased risk for severe COVID-19. An increasing body of data indicates the safety of COVID-19 vaccine for pregnant or lactating women.
The Workgroup notes that there is currently no evidence that any vaccines, including COVID-19 vaccines, adversely affect fertility and that many women have become pregnant after receiving COVID-19 vaccine.
The Workgroup continues to support monitoring of immunization safety in women of childbearing age.
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
- Eric Goosby, MD, UCSF School of Medicine
- Rodney Hood, MD, UC San Diego Alumnus and National Medical Association
- Nicola Klein, MD, Ph.D., Kaiser Permanente Northern California (not present at August 13, 2021 Western States Workgroup meeting)
- 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 (not present at August 13, 2021 Western States Workgroup meeting)
- Matt Zahn, MD, Orange County Health Care Agency
- Ihsan Azzam, MD, Ph.D., Chief Medical Officer, State of Nevada
- Karissa Loper, MPH, Health Bureau Chief, Nevada Department of Health and Human Services (not present at August 13, 2021 Western States Workgroup meeting)
- Laura Byerly, MD, Virginia Garcia Memorial Health Center (not present at August 13, 2021 Western States Workgroup meeting)
- 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