Western-States-Scientific-Safety-Review-Workgroup-Meeting-Summary-02042022 Western States Scientific Safety Review Workgroup Meeting Summary - February 4, 2022

Western States Scientific Safety Review Workgroup Meeting Summary - February 4, 2022

Meeting #26 – Friday, February 4, 2022 – 6:00pm

California Health and Human Services Agency (CHHS)

California Department of Public Health (CDPH)


Workgroup Members Attending

State Of California

  • 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; 
  • Grace Lee, MD, Professor of Pediatrics and Associate Chief Medical Officer for Practice Innovation, Stanford Children's Health; 
  • 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
  • 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

  • Laura Byerly, MD, Chief Medical Officer, Virginia Garcia Health Center
  • Louis Picker, MD, Associate Director of Oregon Health & Science University's Vaccine and Gene Therapy Institute
  • Tony Lapiz, MPH, Health Policy Advisor, Office of Governor Kate Brown

Workgroup Members Not Attending

  • Tomas Aragon, MD, Dr.PH, Director California Department of Public Health and State Health Officer;
  • Rodney Hood, MD, Trustee, Alliance Healthcare Foundation

Consultant

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

 

Welcome and Review of Agenda

Arthur Reingold, MD, Chair

Dr. Reingold welcomed members of the Western States Scientific Safety Review Workgroup, including two new members from Nevada. Kyle Devine and Kristy Zigenis introduced themselves and offered information about their background and roles in Nevada.

Today's meeting agenda will focus on a review of the evidence and discussion of the biologics license application (BLA) for Moderna COVID-19 vaccine in adults 18 years and older included in the CDC Advisory Committee on Immunization Practice (ACIP) meeting February 4, 2022. The Workgroup also will review the discussion and data from ACIP about dose intervals for mRNA COVID-19 vaccines, as well as 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. Dr. Pan also requested that the Workgroup offer input on the issue of the optimal interval for mRNA COVID-19 vaccination after COVID-19 infection.

Updated Recommendations

Arthur Reingold, MD, Chair

Grace Lee, MD, Stanford Children's Health

Dr. Grace Lee offered an overview of the meeting today of the CDC Advisory Committee on Immunization Practice (ACIP). First, the Workgroup thoroughly reviewed the evidence concerning the Moderna COVID-19 vaccine -Spikevax. On January 31, 2022, the FDA approved the Moderna COVID-19 vaccine (Spikevax) for individuals 18 years of age and older. The FDA biologics license application (BLA) approval for Spikevax builds upon the data and information that supported the EUA, such as preclinical and clinical data. The Moderna COVID-19 vaccine remains under EUA for specific indications, such as the third primary series dose for individuals 18 years of age and older who have conditions of immunocompromise.

Dr. Lee reported that the ACIP voted unanimously in favor of the policy question, 

Should vaccination with the Moderna COVID-19 vaccine (Spikevax, 2-dose primary series) be recommended for persons 18 years of age and older?


Highlights of information presented to ACIP and discussed by the Workgroup included:

  • As of January, COVID-19 cases, hospitalizations, and deaths have increased – In November 2021, unvaccinated adults ages 18 years and older had 4X risk of testing positive and 15X risk of dying from COVID-19 compared to fully vaccinated adults
  • Increasing cases are taxing healthcare resources, with many states facing ICU bed shortages again
  • Over 212 million people (63.9%) are fully vaccinated in the United States; however, vaccination coverage varies by age and geographic region
  • Safety and efficacy of Moderna COVID-19 vaccine from the Phase III clinical trial
  • Meta-analysis for global real-world effectiveness data for Moderna COVID-19 vaccine

Workgroup members reviewed ACIP meeting presentations and discussion related to 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. The Workgroup was supportive of the recommendation for 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 also supported changes to the clinical guidance with regard to timely COVID-19 vaccine administration following anti- SARS-CoV-2 antibody treatment or prophylaxis.

The Workgroup reviewed safety updates for PfizerBioNTech and Moderna COVID-19 vaccines and data concerning the risk of myocarditis after mRNA COVID-19 vaccines reported through the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink. Specifically, at 90 days post-diagnosis of myocarditis following COVID-19 mRNA vaccination, most patients reported no impact on their quality of life, and most did not report missing school or work. CDC analysis of the data concluded that the benefits of the Moderna COVID-19 vaccine continue to far outweigh any possible vaccine-associated risks.

The Workgroup discussed research presented to ACIP from Canada and Europe on the relative efficacy and safety of extending the interval between doses 1 and 2 of COVID-19 mRNA vaccines from the current 3-4 weeks to a longer, 8-week interval. Members discussed whether 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.

Dr. Reingold asked the Workgroup to weigh in on information for a statement to the Western States' Governors. There was Workgroup consensus for endorsing the BLA approval for the Moderna COVID-19 vaccine (Spikevax) for recipients 18 years of age or older. The Workgroup also discussed and reached consensus that it would be useful to point to the evidence presented to ACIP regarding a change in the recommendation for mRNA vaccine intervals. Although CDC has not issued new clinical considerations on this topic, the Workgroup agrees with the comments voiced during the ACIP discussion for provider flexibility to consider extending the interval between doses 1 and 2. The Workgroup will continue to monitor this topic and review forthcoming CDC clinical considerations.

Finally, the Workgroup discussed the issue of clinical guidance with regard to the interval between COVID-19 infection and vaccination. The CDC guidance to wait 90 days after COVID- 19 infection before administering vaccines is no longer in effect, based on analysis of available data; however, new guidance has not been issued. Workgroup members discussed the factors influencing what an optimal interval might be for vaccine following COVID-19 infection. There are no known clinical data that strongly indicate harm or clear benefit to guide the recommended interval, and many clinicians are proceeding with COVID-19 vaccination once symptoms of COVID-19 infection have ended. Workgroup members agreed that without data, there cannot be definitive guidance.

Timing of Statement and Next Steps

Arthur Reingold, MD, Chair

 

A draft statement will be distributed to the Workgroup Monday February 7, 2022 for review and comment to be finalized by end of day and forwarded to the Western States' Governors.