Western-States-Scientific-Safety-Review-Workgroup-Meeting-Summary-04122022 Western States Scientific Safety Review Workgroup Meeting Summary - April 12, 2022

Western States Scientific Safety Review Workgroup Meeting Summary - April 12, 2022

Meeting #28 – Tuesday, April 12, 2022 – 5:00pm

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;
  • Rodney Hood, MD, Trustee, Alliance Healthcare Foundation;
  • 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)

State of Oregon

  • Louis Picker, MD, Associate Director of Oregon Health & Science University's Vaccine and Gene Therapy Institute

Workgroup Members Not Attending

  • Tomas Aragon, MD, Dr.PH, Director California Department of Public Health and State Health Officer;
  • Laura Byerly, MD, Chief Medical Officer, Virginia Garcia Health Center; 
  • Tony Lapiz, MPH, Health Policy Advisor, Office of Governor Kate Brown;
  • Kristy Zigenis, Contracted COVID-19 Vaccine Program Manager, CFCW

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. Dr. Pan reviewed the topics for discussion and noted that the agenda includes issues raised at the recent Vaccine Related Biologic Products Advisory Committee (VRBPAC) meeting of April 6, 2022, as well as additional topics of interest to state representatives. Today's meeting is discussion only. It is not expected that the Workgroup will develop a statement for public release. Dr. Reingold asked for additional input to the agenda from Nevada, Oregon, or Washington representatives.

State representatives weighed in that it is useful to have the expert group discuss topics as they arise and helpful to understand the various considerations of each state. Others commented that the discussions also are helpful to highlight and discuss the implications of available data.

Topics for Discussion

Arthur Reingold, MD, Chair

Erica Pan, MD, California State Epidemiologist

Rob Schechter, MD, Director, Immunization Branch, CDPH 

Discussion 1: Recommendations for 2nd booster (3rd dose) for Janssen/Johnson and Johnson (J&J) recipients aged 18-49 years old

Dr. Schechter introduced the topic. As a study investigator in the ten-state VISION Network, Dr. Klein reviewed data on the effectiveness of Janssen/Johnson and Johnson (J&J) and mRNA COVID- 19 vaccines against emergency department visits and hospitalizations during December 2021 – March 2022. This study compared unimmunized individuals against those receiving a one or two doses of J&J COVID-19 vaccine, one J&J and one mRNA COVID-19 vaccine dose or three mRNA doses. The vaccine effectiveness of J&J COVID-19 vaccine was higher with additional doses but lower than three doses of mRNA COVID-19 vaccine.

Dr. Schechter reviewed the current CDC-recommended COVID-19 vaccine schedule. Based on the limitations of the current Emergency Use Authorization (EUA) for J&J COVID-19 vaccine, a third dose is not recommended for healthy adults aged 18-49 years individuals who receive a first dose of J&J COVID-19 vaccine and a booster dose of MRNA vaccine. In contrast, an MRNA vaccine is recommended as a third dose for counterparts who received either two doses of J&J vaccine or an mRNA vaccine followed by J&J vaccine (Table).

Workgroup members discussed that, under current data, there are no known concerns to differentiate the recommendation for a third dose in adults aged 18-49 years old who are healthy. Workgroup members raised equity concerns related to this guidance, as the J&J COVID-19 vaccine was administered to many vulnerable communities and populations based on the convenience of

the single-dose initial series. One workgroup member noted that in the absence of concerns, equity should be an overriding consideration favoring offering a third dose to all. The Workgroup is not making a recommendation on this topic and continues to support CDC guidance. Clinicians and patients should make a decision that is best for them given available data.

Table: Current CDC guidance for Adults 18-49 years whose initial series includes Janssen vaccine 

StatusDose 1Dose 2Dose 3Dose 4
Healthy and ICJanssenJanssenmRNANot recommended
Healthy and ICmRNAJanssenmRNA or JanssenNot recommended
Healthy and ICJanssenmRNANot recommendedNot recommended
CompromisedJanssen
mRNA
mRNAmRNA

 

Discussion 2: Vaccine recommendations for children after the Omicron surge

Dr. Pan reported that questions have been raised about COVID-19 vaccine effectiveness and benefits vs risks for age 5-11 years old and age 12-17 years old. Dr. Schechter reviewed data on 64 confirmed pediatric deaths in California over the course of the pandemic through March 2022 (COVID Registry). Dr. Klein reviewed data from a VISION Network study published in March 2022 on hospitalizations among children. Vaccine effectiveness against hospitalization remains high with two doses of Pfizer vaccine for ages 12-17 years old.

Workgroup members affirmed their support for pediatric vaccination against COVID based on the available data on protection against severe COVID-19 caused by omicron variant and against Multisystem Inflammatory Syndrome in Children (MIS-C) caused by prior variants There are limited data so far on prevention of Long COVID. Also, it is premature to estimate the burden associated with future COVID-19 variants. Members commented that SARS CoV-2 is, or will soon be, endemic and the focus should remain on achieving high societal rates of recommended COVID-19 vaccinations.

The Workgroup noted the uncommon risk of myocarditis following COVID-19 vaccination. Initial research indicates a higher risk of severe myocarditis from infection than from vaccination. A Workgroup member referred to a recent meta-analysis comparing the risk of myocarditis following COVID-19 vaccine, smallpox vaccine and other vaccines.

Discussion 3: Duration of vaccine requirements in high-risk settings

California has requirements for COVID-19 vaccine boosters for employees in specific high-risk settings, such as health care. Some constituencies are calling for removing vaccination requirements given lower numbers of COVID-19 infections. Oregon conducted permanent agency rule-making procedures to require the COVID-19 vaccine primary series, but not boosters, for employees in schools and some high-risk settings. In California, while there are no state governmental mandates, employers in some high-risk settings require seasonal influenza vaccine. COVID-19 vaccine is provided by the federal government, making this an issue of public policy for states and counties, rather than employer policy. Workgroup members noted that given ongoing risks of COVID-19, it is too early to remove requirements for vaccination, particularly for high-risk settings such as health care and jails. It appears that COVID-19 vaccination rates would be lower without mandated COVID-19 vaccinations for health care workers. Equity is a particular concern in correctional facilities, since inmates do not have the choice to avoid unvaccinated staff.

Discussion 4: Timing of second booster doses in older adults

Workgroup members noted there are some reasons to consider delaying an additional booster for adults age 50 and older. During its April 6, 2022 meeting, VRBPAC members did not signal any urgency for recommending additional boosters at this time. Current rates of COVID-19 are relatively low, and it may be advantageous to receive a booster later in the year when COVID-19 cases are expected to surge. Another consideration is that more effective COVID-19 variant vaccines might become available over the next year. Finally, there are limited data about whether frequent and multiple boosts could ever diminish immune response. The durability of T-Cell responses are also unclear. More information might be presented at the Advisory Committee on Immunization Practices (ACIP) meeting scheduled for April 20.

On-Going Role of Western States Workgroup and Next Meeting – April 20, 2022

Arthur Reingold, MD, Chair

State's Public Health and Governors' Representatives 

The Western States Scientific Safety Review Workgroup is scheduled to meet on April 20, 2022. Members discussed the ongoing role for the Workgroup. All state representatives commented that input from the Workgroup is extremely valuable. There is a need for the group to continue to meet periodically until at least there is EUA for COVID-19 vaccines for children under age 5 years old. There has been high value in having both the ACIP and this Workgroup endorse recommendations. States have relied on the statements issued by the Workgroup, and state representatives believe that the Workgroup statements boost public confidence.