Western-States-Scientific-Safety-Review-Workgroup-Meeting-Summary-06182022 Western States Scientific Safety Review Workgroup Meeting Summary – June 18, 2022

Western States Scientific Safety Review Workgroup Meeting Summary – June 18, 2022

Meeting #31 - Saturday, June 18, 2022 – 4:00pm

California Health and Human Services Agency (CHHS)

 California Department of Public Health (CDPH)

Workgroup Members Attending

State of California

  • 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

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:

  • Laura Byerly, MD, Chief Medical Officer, Virginia Garcia Health Center, Oregon
  •  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
  •  Ihsan Azzam, MD, Chief Medical Officer, Division of Public and Behavioral Health, Nevada
  • Rodney Hood, MD, Trustee, Alliance Healthcare Foundation
  • Louis Picker, MD, Associate Director of Oregon Health & Science University’s Vaccine and Gene Therapy Institute
  • Arthur Reingold, MD, School of Public Health Division Head of Epidemiology and Biostatistics, University of California, Berkeley; Matt Zahn, MD, Medical


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

Welcome and Setting Stage for Today's Discussion Topics

Mark Sawyer, MD

Bobbie Wunsch, Pacific Health Consulting Group

Dr. Sawyer began by asking Dr. Pan whether she had any specific questions or concerns for the workgroup to address. Dr. Pan thanked the workgroup and said the main question is whether the group supports and endorses the recommendations made by the FDA and ACIP.

Workgroup Discussion

Mark Sawyer, MD

Dr. Sawyer summarized the FDA and ACIP meetings, which he attended. After much discussion at both meetings, the final conclusion was a straightforward endorsement of both COVID-19 vaccines for children 6 months through 4 or 5 years of age. Dr. Sawyer noted that continued surveillance of COVID-19 vaccine safety in children is needed given the limited data from the trials to date. He is reassured that the CDC is well aware of this issue and has programs in place like the VSD to monitor for side effects, including after concomitant administration of COVID-19 vaccines with other routine infant and childhood vaccines. Both group statements strongly endorse the concomitant administration of COVID-19 vaccines with other infant and childhood vaccines.

Dr. Sawyer offered the group a chance to comment and ask questions.

Dr. Brooks noted that the primary study of the Pfizer vaccine received a Grade 4 (the lowest grade). Similar to COVID-19 vaccine, other routine children’s vaccines have been approved based on immunobridging data, and have been later confirmed to be clinically effective, which gives him more comfort. He posed the question of whether there had been correlates of protection in the past, given that there were none in these studies. One safety concern is that the Pfizer study did not include long follow-up. Dr. Brooks’ recollection is that there was only one febrile seizure in the studies.

Dr. Sawyer clarified that there was a febrile seizure discussion at VRBPAC and that 15-20% of children given the Moderna COVID-19 vaccine had a fever, including a few who had a high fever, and therefore when given with other vaccines that, can cause fever, seizures could be a risk.

Dr. Klein said this has been known for months and that a primary issue of concern is the two vaccines being so different with different timing and dosing. This will make safety monitoring much more complicated.

Dr. Maldonado noted that febrile seizures are a concern mainly for young infants and that the febrile infant guidelines published by the AAP are focused on those under 30 days of age. Because the Moderna COVID-19 vaccine is being given at 6 months of age, Dr. Maldonado is concerned that the discussions at ACIP focused on available data at older ages, which might overestimate the actual risk to young children. Given potential age differences in reactions, Dr. Maldonado would like to see data comparing the adverse events to persons 5 years and older between Moderna vaccine and non-COVID vaccines previously approved by ACIP. She noted this level of surveillance for adverse events following immunization is rare and that 8,000 children is a reasonable sample size. She is concerned about a disproportionate focus on safety rather than the robust results concerning efficacy, compared to reviews of other vaccines, and that an unbalanced focus on adverse events might increase concerns about other childhood vaccines. Dr. Maldonado thinks communications need to be ramped up quickly to anticipate and minimize these concerns.

Dr. Lee noted that the purpose of the ACIP is to focus on the science and data in detail. She is concerned that the information was not fully available until just before the June 18 meeting. She noted that there was strong endorsement of using the Moderna COVID-19 vaccine in children under age 5 years, and no dissent, but that safety questions will undoubtably come to providers, and educating the provider community is an important part of the ACIP’s role.

Dr. Maldonado agreed with the importance of transparency and added that transparency when comparing COVID-19 vaccines to other vaccines needed to be increased, including comparing the initial and updated grading and evidence for other childhood vaccines which have been safe and effective over time.

Dr. Sawyer noted that these COVID-19 vaccines are being reviewed under an EUA and therefore there is much less information concerning safety and efficacy than there would be for a BLA. Dr. Klein stated that there are plenty of data to compare and contrast with other vaccines.

Dr. Sawyer shared that there is a potential for error and confusion when administering COVID-19 vaccines to infants and young children given different age cutoffs, cap colors, vial labels, etc. Providers need to be very diligent in their initial and ongoing use; health departments and the AAP will need to advise providers about what to do in case of errors. Dr. Marcuse agreed that implementation would be a huge challenge, especially in smaller and rural practices. He also noted that how we craft the statement will be challenging. Abundant data clearly demonstrate the extent of COVID-19 disease in those under age 5, and there is no question about the immunogenicity of this vaccine or that it will have comparable efficacy to vaccines in older age groups. There is every reason to believe the Moderna COVID-19 vaccine will prevent severe COVID-19 disease, but it will not prevent many SARS-CoV-2 infections.

There was a discussion about the timing of giving a COVID-19 vaccine after a bout of COVID-19. Dr. Sawyer noted that neither the VRBPAC nor ACIP data presented shed any light on the amount of time to wait between natural infection and administration of vaccine. The current CDC statement suggests waiting 90 days between COVID-19 and administration of COVID-19 vaccination because there is likely protection for 3 months after infection. Dr. Marcuse noted that early immunization after infection might blunt the response to the vaccine, although there are no data on which to base recommendations. This interval may be outside the scope of the group’s statement, and the CDC will likely suggest that parents consult with their children’s physicians.

Dr. Lee shared this guidance:

“[p]eople who recently had SARS-CoV-2 infection may consider delaying a primary series dose or their first or second COVID-19 vaccine booster dose by 3 months from symptom onset or positive test (if infection was asymptomatic). Studies have shown that increased time between infection and vaccination may result in an improved immune response to vaccination. Also, a low risk of reinfection has been observed in the weeks to months following infection. Individual factors such as risk of COVID-19 severe disease, COVID-19 community level, or characteristics of the predominant SARS-CoV-2 strain should be taken into account when determining whether to delay getting a COVID-19 vaccination after infection.”

Source: https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html#infection

Dr. Sawyer asked the other states to share their perspectives.

  • Oregon said they would review the draft statement. Dr. Byerly noted that the presence of COVID-19 disease in this age group and evidence of protection by the vaccine will really help with messaging.
  • Nevada noted that implementation would be very challenging, given the nuances specific to each product, and requested maximum clarity in the statement for providers. Kyle added that vaccine uptake would likely be low and that it would be critical to get the most information possible to providers and parents.

Ms. Wunsch added that Dr. Reingold wants the workgroup statement to urge states to actively educate providers and parents about the need for this vaccine. Dr. Marcuse agreed that this was a real opportunity to share extensive data on serious COVID-19 disease in this age group and that there is every reason to believe the effectiveness of the COVID-19 vaccine in this age group will be comparable to that in other age groups. He shared the sobering forecast about the low proportion of parents planning to have their children vaccinated for COVID-19. It is clear that this vaccine will save lives and that should be the main message.

Dr. Maldonado noted that the AAP has already drafted statements and FAQs for providers to give families. She will share these with the group.

Dr. Klein suggested that the statement emphasize the added benefit of COVID-19 vaccine after infection and the fact that COVID-19 disease does not produce reliable protection against future disease. All agreed to include this.

The group then considered whether the statement should include advice to provider offices to use COVID-19 vaccine from a single manufacturer. Most felt the statement should not address this level of implementation; however, it could advise due diligence when ordering and administering vaccines. Dr. Lee regrets that the cap colors may be difficult to differentiate.

Dr. Pan asked whether and how to message about the two COVID-19 vaccine options for infants and children in this age group. The Workgroup noted that the available data are not adequate to support a preferential recommendation for either COVID-19 vaccine. Dr. Klein suggested using similar language to that in other ACIP recommendations, as there is rarely a preference for one vaccine over another.

Equity Issues

Mark Sawyer, MD

Dr. Marcuse suggested that we should emphasize the disproportionate impact of COVID-19 morbidity on non-White and disadvantaged populations. The best hope to reduce these disparities is through broad vaccine efforts to encourage and provide COVID-19 vaccines in a wide range of settings.

Dr. Byerly asked whether the statement could mention supporting parents’ time off from work to get their kids vaccinated or be included as a consideration for states.

Dr. Brooks noted the significance of approving a COVID-19 vaccine for a new age group of 18.7 million children, and that parents tend to protect their young children more cautiously than their older children and teens.

Dr. Sawyer suggested that the statement say that now, just like influenza, this vaccine has been recommended for everyone 6 months of age and older. Others liked this simple framing.

Guidance on Novavax and Moderna COVID-19 Vaccines

Bobbie Wunsch, Pacific Health Consulting Group

Ms. Wunsch asked the state representatives whether they wanted the workgroup to make a statement on the recent approval of the Novavax COVID-19 vaccine.

Dr. Pan noted that the Novavax COVID-19 vaccine would not be available for several months, but that it would still be helpful to include a statement about the vaccine if possible.

Dr. Lee noted that the Novavax COVID-19 vaccine would be considered by ACIP in the near future.

Dr. Sawyer stated that he would prefer to wait until the ACIP deliberation, following the typical pattern of these meetings. There is a benefit to avoid diluting the main message about the availability of and recommendations concerning COVID-19 vaccines for young children.

Dr. Schechter added that ACIP would be reviewing the EUA for the Moderna COVID-19 vaccine in 6–17-year-olds in one week, and asked whether that would merit a Western States Workgroup meeting. Dr. Brooks thinks it does, as the vaccine has not been approved for use in this age group and gives another alternative for this age group. Dr. Sawyer noted that myocarditis is more important in this age group, so it makes sense for the group to weigh in on any unique concerns.

Others agreed that this would be consistent with all other meetings and authorizations following COVID-19 vaccines and agreed NOT to include anything about the Novavax COVID-19 vaccine in the current statement.

Dr. Klein asked if there were booster doses for adolescents included in the EUA for Moderna. Dr. Brooks responded that the EUA does not include adolescents. Dr. Sawyer shared that the VRBPAC discussion did not include boosters, only the primary two-dose series. The FDA did note that children who are immunocompromised could get a third dose as part of the primary series.

The ACIP meeting to discuss the Moderna COVID-19 vaccine EUA for children and adolescents 6-17 years of age is on June 23.

Timing of Western States Statement and Next Steps

Bobbie Wunsch, Pacific Health Consulting Group

Dr. Sawyer was pleased to see the accolades given to the CDC and FDA staff for their hard work to promptly review these vaccines for authorizations and recommendations.

Dr. Reingold and Ms. Wunsch will send a draft statement to the workgroup tonight and all agreed to give feedback by Sunday June 19 at noon. A revised statement will go to the states by the end of day Sunday. The state representatives noted that they wouldn’t receive doses of the Moderna COVID-19 vaccine for infants and young children until Monday at the earliest.