- ACIP Update – Sara Oliver (CDC)
- NVAC Update – Ann Aiken (CDC)
- VRBPAC Update – David Kim (OASH)
- Announcements – L.J Tan (IAC)
ACIP Update – Sara Oliver (CDC)
Sara provided a brief overview of the extremely busy three-day ACIP meeting held on October 28–30. While the first two days covered non-COVID vaccine topics, the third day was devoted entirely to COVID vaccine updates. Because this currently is the area of greatest interest, Sara’s presentation focused on this final day of the meeting. (Note: Slides for the majority of ACIP presentations are/will be available on the meeting website. However, some presentations are temporarily unavailable while the slides are being modified to ensure compliance with Section 508 standards.)
Topics addressed during the COVID sessions of the ACIP meeting included updates from the October 22 meeting of the Vaccines and Related Biologic Products Advisory Committee (VRBPAC), overviews of two COVID vaccine candidates (Novavax and Janssen), discussions of implementation issues and vaccine safety, an overview of COVID-19 epidemiology and vaccine modeling and allocation strategies, and a summary of the ACIP COVID Workgroup’s interpretation of the data and policy questions to be discussed in the future.
At the time of the meeting, four vaccine candidates (produced by AstraZeneca, Janssen, Pfizer/BioNTech, and Moderna) were in Phase 3 clinical trials. (For additional details, see slide #3 of Sara’s presentation.)
In considering diversity of study participants, Pfizer noted that 30% of U.S. participants had “diverse backgrounds. Data from Moderna indicate ~63% of study participants were white, 20% were Hispanic/Latinx, and 10% were Black. Approximately 8,000 of the 30,000 study participants were age 65 years and older, and 27% had an underlying medical condition such as diabetes, heart disease, lung disease, and obesity.
ACIP discussed several issues in preparation for when recommendations will need to be made. Following an update on the current epidemiology of COVID-19, the workgroup emphasized the importance of awaiting data from Phase 3 trials to assess for any possible vaccine-associated enhanced disease or reactogenicity after prior infection. They also noted that, in the absence of concerning data from Phase 3 trials, a history of a positive PCR, antibody, or antigen test likely would not be a contraindication to receipt of COVID-19 vaccine. It was acknowledged that any vaccine recommendations that relied on knowledge of prior immunity/antibody testing would be difficult to implement.
ACIP is very likely to recommend that healthcare personnel will be Phase 1a for vaccine allocation. Because women make up 75% of the healthcare workforce, it is estimated that 300,000 or more of this group could be pregnant or postpartum. Therefore, ACIP wanted to understand the potential risk for this group as it related to COVID-19 disease and vaccination. This data is contained in a recently published MMWR report. While the absolute risk of severe disease is low, it does appear that pregnant women are at risk for severe disease when compared with non-pregnant women. When discussing the possible implications of this information, the workgroup felt that breastfeeding would not be a contraindication to receipt of a COVID-19 vaccine. However, this will need to be evaluated for each vaccine. Limited data on pregnancy are expected from Phase 3 trials. Although the workgroup did not reach a consensus, the majority felt that if a woman is recommended to receive the vaccine in an early allocation phase, pregnancy should be a precaution (not contraindication). The group emphasized the importance of allowing women to make an informed decision. The majority of the group also felt that, in the instance of pregnancy being diagnosed after receipt of the first dose of COVID-19 vaccine, the second dose could be given at the recommended interval.
Sarah gave an overview of the major highlights from modeling presentations provided at the meeting. Modelers assumed that phase 1B vaccine will initially be directed to persons age 65+, high risk adults, and essential workers. The biggest impact on all 3 groups was when the vaccine was introduced in relation to whether this was before incidence rises, as incidence is rising, or as incidence falls. The overall difference among the three strategies was minimal. Therefore, ethical principles and implementation considerations may greatly contribute to selecting the optimal sequence in Phase 1b. the largest impact in averted deaths and infections is the timing of vaccine introduction.
The group reviewed the clinical trial data from Novavax and Janssen. Novavax is expected to begin Phase 3 clinical trials in the U.S. relatively soon. Both platforms have prior experience from other vaccines. For the current Phase 3 clinical trials, the workgroup also discussed issues such as a focus on enrolling diverse study participants, the importance of harmonizing safety and efficacy endpoints across all Phase 3 trials, the need to report maternal and fetal outcomes for women who become pregnant during the clinical trials, and support for FDA’s guidance to conduct ongoing assessment of long-term vaccine safety and efficacy.
Finally, ACIP discussed the pathway to vaccine recommendation. Following FDA approval (either through licensure, EUA, or expanded access routes), the group will consider two questions, i.e., whether a vaccine should be recommended and to whom early allocations of the vaccines should be recommended. In making this decision, the workgroup will consider population, intervention, comparison, and outcomes (PICO). The group will continue to hold discussions on these two questions and the principles that should be used in making these decisions.
NVAC Update – Ann Aiken (CDC)
Ann gave an update on the October 16 meeting of the National Vaccine Advisory Committee (NVAC). The purpose of the meeting was to work on a charge received from Assistant Secretary of Health Admiral Brett Giroir. He asked the committee to consider 3 questions: how to support communications to enhance decision-making before/during/after COVID-19 vaccination campaigns; enhancing vaccination of diverse populations, including the best approach for proceeding with childhood vaccinations and during pregnancy; and developing new and improved vaccines. NVAC is currently writing a report addressing all 3 questions.
The next meeting will be held on December 4. Ann reported the committee was likely to have final discussion and take a vote on the report at this meeting. The committee also has two very active sub-committees working on vaccine confidence and immunization equity issues. Reports from these groups probably will be voted upon in 2021.
VRBPAC Update – David Kim (OASH)
David reported on the October 22 meeting of the FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC). In particular, he highlighted a presentation given by Dr. Doran Fink, who discussed clinical considerations for vaccine licensure or emergency use authorization. The meeting included overviews on COVID-19 epidemiology, and update on activities of the Biological Advanced Research and Development Authority (BARDA), and CDC’s evaluation of vaccine safety for vaccines under an EUA. CDC discussed the operational aspects of COVID-19 vaccine distribution and tracking, as well as vaccine confidence. The committee held a robust discussion on potential COVID-19 vaccines.
Announcements – L.J Tan (IAC)
- L.J shared that the American Nurses Association wished to remind Summit partners that the organization has multiple COVID-19 resources available on its website.
- David Kim noted that the comment period is now open for the Agency for Healthcare Research and Quality’s report, Safety of Vaccines Used for routine Immunization in the United States: An Update. Comments are highly encouraged. The deadline is November 23. A draft of the National Vaccine Plan update is also available for public comment at this time.
- Carolyn Bridges reminded partners that it’s not too late to vaccinate against influenza. The Influenza Vaccine Availability Tracking System (IVATS) site is available for partners who may be looking for additional vaccine.
Summit calls are held each Thursday at 3 pm ET, unless cancelled. The next Summit call, scheduled for November 12, will include a surveillance update and a presentation from the American Lung Association on their MyShot campaign. Summit partners wishing to provide announcements on upcoming calls should contact L.J Tan or Joanna Hill to be added to the agenda.