Western-States-Scientific-Safety-Review-Workgroup-Meeting-Summary-07192022 Western States Scientific Safety Review Workgroup Meeting Summary - July 19, 2022

Western States Scientific Safety Review Workgroup Meeting Summary - July 19, 2022

​​Meeting #33 – Tuesday, July 19, 2022 – 5:00pm

California Health and Human Services Agency (CHHS)

California Department of Public Health (CDPH)

Workgroup Members Attending

State of California

  • Tomas Aragon, MD, Dr.PH, Director California Department of Public Health and State Health Officer
  • Oliver Brooks, MD, CMO, Watts Health Care
  • Eric Goosby, MD, Distinguished Professor of Medicine and Director of the Center for Global Health Delivery, University of California, San Francisco
  • Nicola Klein, MD, Director, Kaiser Permanente Vaccine Study Center
  • Bonnie Maldonado, MD, Professor and Chief of the Division of Infectious Diseases, Department of Pediatrics, Stanford Medicine
  • Arthur Reingold, MD, School of Public Health Division Head of Epidemiology and Biostatistics, University of California, Berkeley 
  • Mark Sawyer, MD, Infectious Disease Specialist, Rady Children's Hospital
  • Rob Schechter, MD, Chief, California Department of Public Health, Immunization Branch
  • Peter Szilagyi, MD, Professor and Vice Chair for Clinical Research, Department of Pediatrics and Mattel Children's Hospital
  •  Matt Zahn, MD, Medical Director, Communicable Disease Control Division, Orange County Health Care Agency.

State of Washington

  • John Dunn, MD, Medical Director for Preventive Care and Head of Immunization Program, Kaiser Permanente Washington
  • Edgar K. Marcuse, MD, MPH, FPIDS, Emeritus Professor, Pediatrics, University of Washington

State of Nevada

  • Ihsan Azzam, MD, Chief Medical Officer, Division of Public and Behavioral Health, Nevada; Kyle Devine, Bureau Chief for the Bureau of Child, Family, and Community Wellness (CFCW)
  • Kristy Zigenis, Contracted COVID-19 Vaccine Program Manager, CFCW

State of Oregon

Representatives were not available to attend

Workgroup Members Not Attending

  • Laura Byerly, MD, Chief Medical Officer, Virginia Garcia Health Center, Oregon; Rodney Hood, MD, Trustee, Alliance Healthcare Foundation
  • Tony Lapiz, MPH, Health Policy Advisor, Office of Governor Kate Brown; Grace Lee, MD, Professor of Pediatrics and Associate Chief Medical Officer for Practice Innovation, Stanford Children’s Health
  • Louis Picker, MD, Associate Director of Oregon Health & Science University’s Vaccine and Gene Therapy Institute.

Consultant

  • Bobbie Wunsch, Founder and Partner, Pacific Health Consulting Group

Welcome and Setting Stage for Today's Discussion Topics

Arthur Reingold, MD, Chair 

Dr. Reingold welcomed members of the Western States Scientific Safety Review Workgroup. The topic for this meeting is to review the immunogenicity, safety and efficacy of the two dose Novavax COVID-19 vaccine (Novavax) primary series for administration to individuals ages 18 years and older. On July 13, 2022, the FDA granted emergency use authorization for the Novavax COVID-19 vaccine.

Dr. Reingold summarized information from the CDC Advisory Committee on Immunization Practices (ACIP) meeting discussion today, July 19, 2022, pertaining to the two dose Novavax COVID-19 vaccine (Novavax) primary series for administration to individuals ages 18 years and older. Presentations to ACIP showed high efficacy in the pre-Omicron era against severe COVID-19 disease in those ≥ 18 years of age and an excellent safety profile in keeping with other COVID-19 vaccines. Presentations also included several related topics for the Workgroup’s consideration:

  • COVID-19 continues to pose a significant public health problem and COVID-19 vaccines continue to mitigate case rates, hospitalizations, and deaths.
  • About 26–37 million US adults have not yet received any COVID-19 vaccine.
  • An additional COVID-19 vaccine, utilizing established vaccine technology, will provide an additional option for unvaccinated individuals.
  • Benefits of Novavax COVID-19 vaccine outweigh risks.

The ACIP voted unanimously to recommend a two-dose Novavax COVID-19 vaccine as an option for the COVID-19 vaccine primary series for persons ages 18 years and older under the EUA issued by FDA.

Workgroup Discussion

Arthur Reingold, MD, Chair

The Western States Workgroup reviewed data presented to ACIP on COVID-19 epidemiology, including case rates and trends, hospital admissions and deaths due to COVID-19. The Workgroup also reviewed data related to the relative risk of COVID-19 infection by vaccination status and opportunities to increase vaccination rates among the 27-36 million Americans who have not yet received a COVID-19 vaccine.

Workgroup members also highlighted that the Novavax COVID-19 vaccine is not recommended for individuals who have already received an mRNA COVID-19 vaccine or used in a mixed regimen with an mRNA COVID-19 vaccine. Also, the Novavax COVID-19 vaccination is not intended as a

booster following mRNA COVID-19 vaccine primary series. This information will be detailed in CDC guidance on Use of COVID-19 Vaccines in the United States - Interim Clinical Considerations. Workgroup members noted that the primary target for this vaccine is the unvaccinated population.

The Workgroup discussed several additional topics, including follow up data from the Vaccine Adverse Events Reporting System (VAERS) and Vaccine Safety Datalink (VSD) on myocarditis or pericarditis following COVID-19 vaccination. As seen after the widespread use of mRNA COVID-19 vaccines, there were rare cases of myocarditis or pericarditis following receipt of Novavax COVID-19 vaccine during clinical trials. Continued monitoring post-authorization of the Novavax COVID-19 vaccine for both vaccine effectiveness and safety will be important.

The Workgroup emphasized that the high number of individuals not yet vaccinated remains a concern and a key priority. There was also discussion of the continuing disparities in receipt of COVID-19 vaccinations and how the authorization of Novavax may impact this. According to the December 2021 U.S. Census Bureau Household Pulse Survey (HPS), individuals not receiving COVID-19 vaccination are more likely to be younger, non-White and married, as well as reporting lower levels of education, economic disadvantage and having a disability. Survey data are mixed as to whether the availability of a COVID-19 vaccine not based on mRNA technology, such as the Novavax COVID-19 vaccine, will improve vaccination inequities. When asked in early 2022, 16% of unvaccinated respondents “probably” or “definitely” would get an adjuvanted protein-based COVID-19 vaccine, however, 77% of unvaccinated adults said they wouldn’t get a traditional protein-based COVID-19 shot if one were authorized for use in the United States.

The Workgroup discussed Novavax COVID-19 vaccine implementation and logistics. Novavax COVID-19 vaccine labels will be changed going forward to reflect expiration dates, which are not currently noted. There may be wastage due to the requirement that Novavax COVID-19 vaccine vials must be disposed six hours after a first dose is withdrawn. The Workgroup noted the increased potential for administration errors in COVID-19 immunization that may accompany the introduction of an additional vaccine option.

Based on its review, the Workgroup concluded the Novavax COVID-19 vaccine is safe and effective for adults age 18 years or older and that benefits outweigh any risks. The Workgroup also noted that continued monitoring through the established national safety surveillance systems is important for all COVID-19 vaccines.

Timing of Western States and Next Steps

Arthur Reingold, MD, Chair

State representatives weighed in that distribution of a statement would be useful within the next several days. Dr. Reingold indicated that a statement will be circulated for review and comment by Workgroup members for final distribution by Friday, July 22, 2022.