Western-States-Scientific-Safety-Review-Workgroup-Meeting-Summary-05192022 Western States Scientific Safety Review Workgroup Meeting Summary - May 19, 2022

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

​Meeting #30 – Wednesday, May 19, 2022 – 5:30pm 

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;
  • 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;
  • 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:

  • 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

  • Tony Lapiz, MPH, Health Policy Advisor, Office of Governor Kate Brown;
  • Louis Picker, MD,  Associate Director of Oregon Health & Science University's Vaccine and GeneTherapy Institute.

Workgroup Members Not Attending

  • Ihsan Azzam, MD, Chief Medical Officer, Division of Public and Behavioral Health, Nevada;
  • Laura Byerly, MD, Chief Medical Officer, Virginia Garcia Health Center, Oregon;
  • Eric Goosby, MD, Distinguished Professor of Medicine and Director of the Center for Global Health Delivery, University of California, San Francisco;
  • Rodney Hood, MD, Trustee, Alliance Healthcare Foundation;
  • Bonnie Maldonado, MD, Professor and Chief of the Division of Infectious Diseases, Department of Pediatrics, Stanford Medicine.

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 safety and effectiveness data and advise on the recommendation for children ages 5–11 years old to receive a Pfizer-BioNTech COVID-19 vaccine booster dose at least 5 months after completion of the primary series.

Dr. Reingold asked state representatives to offer input on the timing of issuing a statement following the meeting. Dr. Aragon indicated that California would appreciate a statement tomorrow (Friday May 20, 2022), if possible. He acknowledged the need for both careful review of available data and a rapid turnaround. Oregon, Washington and Nevada representatives agreed that a quick turnaround for a statement by tomorrow morning, if possible, would be extremely helpful.

Workgroup Discussion

Arthur Reingold, MD, Chair

Grace Lee, MD, ACIP Chair and Western States Members

Dr. Lee and other members reviewed information from the CDC Advisory Committee on Immunization Practices (ACIP) meeting discussion today, May 19, 2022, of Pfizer-BioNTech COVID- 19 vaccine recommendations for children ages 5-11 years old. The current recommendations for COVID-19 vaccine for children ages 5-11 years old include a primary series of two doses (three week interval) for children ages 5-11 years old who are not immunocompromised and a primary series of three doses (three week interval for dose two and four week interval for dose three) for children ages 5-11 years old who are immunocompromised.

On May 17, 2022, the FDA amended the emergency use authorization (EUA) for the Pfizer- BioNTech COVID-19 vaccine to authorize the use of a single booster dose in children ages 5 - 11 years old at least five months after completion of a primary series with the Pfizer-BioNTech COVID19 vaccine. Only the Pfizer-BioNTech COVID-19 vaccine is currently authorized for administration to children ages 5-11 years old.

The Western States Workgroup reviewed safety and vaccine effectiveness data for a Pfizer- BioNTech COVID-19 vaccine booster dose in children ages 5-11 years, as well as the epidemiologic data concerning COVID-19 illnesses and hospitalizations among children in this age group. Key points from the meeting included:

  • The two-dose vaccine effectiveness declines quickly in children and adolescents, following a pattern similar to that seen in adults during the Omicron surge, and a booster dose in adolescents significantly improved vaccine effectiveness at least six weeks-three months after the third dose
  • Reporting rates of myocarditis for males ages 5–11 years old after dose one of the Pfizer COVID-19 vaccine and for females after either dose one or dose two are not elevated above background rates (using a 0–7-day risk interval).
  • Children ages 5-11 years are at risk of severe illness from COVID-19, with more than 4.8 million reported cases and 15,000 hospitalizations in this age group to date.
  • In 2020, COVID-19 was a leading cause of death in children ages 5 – 11 years old. Children who have received a COVID-19 vaccine primary series have better outcomes than children who are unvaccinated, particularly with regard to severe illness.
  • Only 29% of children ages 5-11 years old have completed their primary series of Pfizer COVID-19 vaccine.

The ACIP voted to recommend that a Pfizer-BioNTech COVID-19 vaccine booster (3rd dose) should be administered at least five months after the primary COVID-19 vaccine series for non- immunocompromised and a Pfizer-BioNTech COVID-19 vaccine booster (4th dose) should be administered at least three months after the primary COVID-19 vaccine series for immunocompromised children ages 5-11 years old.

Workgroup members discussed several topics related to immunogenicity, effectiveness and safety of the booster doses of the Pfizer COVID-19 vaccine. Members commented on the significance of data from the clinical trial of 400 children in which antibody testing post-vaccination dose two showed a significant drop in antibody levels by seven months post vaccination. The clinical trial safety data for children ages 5-11 years old are reassuring. There were no reports of myocarditis or serious adverse events and the overall safety profile was similar to that in other age groups for other systemic reactions. Members noted that effectiveness (decreased hospitalization and death) following a booster has been seen in all other age groups, offering confidence that children ages 5-11 years old will also benefit from a booster.

The Workgroup discussed several additional topics, including the low COVID-19 vaccination coverage in children ages 5-11 years old and the disparities in vaccine coverage across geography and ethnicity/race. Nationally, only 29% of children ages 5-11 years old have completed the two dose primary series of COVID-19 vaccination and only 35% have had one dose. In California, the COVID-19 vaccination coverage for children ages 5-11 years is slightly higher than national coverage, with 35% having completed the primary series of COVID-19 vaccination. In Oregon, among children ages 5-11, COVID-19 vaccination coverage is 36% for two doses and 41% for at least one dose, while in Washington state COVID-19 vaccination coverage is 37% complete (two doses) and 32% with first dose only. There is high variability in vaccine coverage across counties in California, from 84% of children ages 5-11 years old with one dose in Marin County to only 4% of children ages 5-11 years old with one dose in Modoc and Lassen counties.

The results of a recent national survey showed that 40% of rural parents reported that clinicians did not recommend COVID-19 vaccination, while only 8% of urban parents reported that clinicians did not recommend COVID-19 vaccination. Many providers report not stocking the COVID-19 vaccine in their offices. In California, a recent survey of providers indicated that the decision by providers to stock COVID-19 vaccine was driven by concerns about wasting doses and the availability of vaccines elsewhere in the community. There is a national campaign encouraging pediatricians to provide COVID-19 vaccination.

Workgroup members noted that the recommendation for a booster dose of COVID-19 vaccine in children ages 5-11 years old makes the communication regarding boosters consistent across youth >5 years of age which will help reduce confusion that could result from differing recommendations in different age groups. The incidence of myocarditis following receipt of COVID-19 vaccine appears to be even lower among children ages 5-11 years old than among adolescents, and there is already a recommendation for a booster in those >11 years of age.

There was unanimous agreement among Workgroup Members that the available data support the conclusion that the benefits of giving a booster dose of the Pfizer BioNTech COVID-19 vaccine to those ages 5-11 years of age substantially outweigh any known risks, particularly in light of the data presented to ACIP concerning the significant but often unappreciated burden of COVID-19- related illnesses, hospitalizations and deaths in children in this age group. Several members mentioned that a statement should highlight the incidence of serious COVID-19 related disease and death in this age group. Others suggested including a message to encourage completion of the COVID-19 primary vaccination series for children ages 5-11 years old.

Timing of Western States Statement and Next Steps

Arthur Reingold, MD, Chair

A statement will be circulated for review tonight following the meeting, May 19, 2022. Please send comments and edits by 8 AM tomorrow, May 20, 2022, so the statement can be finalized and released May 20, 2022. Western State representatives expressed great appreciation for the Workgroup and its rapid turnaround of a statement.