COVID-19 Discussion at ACIP Meeting – Sarah Oliver (CDC)
Sarah provided an update from the ACIP meeting held on September 22. This was one in a series of “interim” meetings (i.e., between the routinely scheduled meetings) that have been held in preparation for the time a COVID vaccine(s) will be available in the U.S.
The ACIP meeting opened with an introduction from Beth Bell, MD, the COVID-19 workgroup (WG) chair. Dr Bell provided updates on the vaccines currently under development, as well as reviewing ACIP’s process for recommending any vaccine(s) over the next few months, as data begins to be available from Phase 3 clinical trials. Moderna and Pfizer mRNA vaccines are currently in Phase 3 trials. Moderna is nearing their goal enrollment of 30,000 people to participate in their trial. Pfizer is at almost 32,000 enrollees, and they have proposed expanding their population study size to 44,000. The AstraZeneca vaccine Phase 3 trial is currently on hold in the U.S. In addition, since the ACIP meeting, Janssen announced the Phase 3 trial of their adenovirus vector vaccine began on September 23. Unlike the other vaccines, which require two doses, the Janssen vaccine requires only one dose.
Dr. Bell also reviewed the path to COVID-19 vaccine recommendations. Currently the ACIP WG is meeting weekly. They are reviewing data as it becomes available and fine-tuning their structure for the upcoming data review. The ACIP WG will conduct an independent review of the safety and efficacy data as it becomes available and will present policy options to the full ACIP. After an FDA decision is announced, ACIP will conduct an “emergency” meeting. This will include a summary of the vaccine safety and efficacy data. Following that, ACIP will vote on recommendations for use of the vaccine, as well as populations for use. It is possible that these recommendations could be more targeted or detailed than the FDA conditions of use. The recommendations will then be sent to the CDC Director; if accepted, they will be published in the MMWR and become official CDC policy.
Two presentations highlighted vaccine safety. Dr. Grace Lee outlined the efforts to date of the Vaccine Safety Technical Subgroup which is focused exclusively on COVID-19 vaccine safety. Dr. Tom Shimabukuro discussed additional platforms (other platforms were highlighted at the August ACIP meeting) that will be developed to monitor COVID-19 vaccine safety in the future.
Dr. Janell Routh provided an overview on vaccine implementation, including a description of the COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations.
Dr. Megan Wallace presented information on disparities seen in COVID-19 epidemiology. She discussed racial and ethnic disparities seen among COVID-19 patients and deaths. She also highlighted CDC’s Social Vulnerability Index (SVI) and pointed out how this correlates with both COVID-19 cases and hotspots.
Dr. Oliver noted that she provided an overview on vaccine equity and prioritization frameworks during the ACIP meeting. Several frameworks have been published prior to this time. She reviewed how these frameworks have considered and applied issues of ethics and equity. This led into a discussion of ACIP’s plan for addressing ethics and equity in upcoming decisions related to vaccine allocation. The Committee has affirmed that all ACIP recommendations must be ethically principled, evidence based, and feasible for implementation. Potential priority groups for vaccine include healthcare workers, other essential workers, adults with high-risk medical conditions, and adults age 65 years and older. The Committee reviewed each of these four groups and discussed how applying the ethical framework with each group can assist in making future decisions.
The meeting ended with considerations for prioritization of Phase 1 vaccine. There was general broad approval that Phase 1a will be for healthcare personnel, using the broad definition of paid or unpaid workers in the healthcare setting. Phase 1b would include the other three groups mentioned above (previous paragraph.)
During the next scheduled meeting on October 28–29, ACIP will review any data available from various clinical trial phases. If Phase 3 data is available from the FDA prior to that time, ACIP could call an emergency meeting.
Dr. Oliver’s presentation was followed by a robust round of questioning from Summit partners, as outlined below.
When asked if there were any plans for clinical trials in pediatric age groups, she noted that FDA has said all manufacturers should have plans for pediatric clinical trials. It is expected that a vaccine will first be shown to be safe and effective in the adult population, and then move into pediatric trials. L.J asked if she anticipated there might be off-label use of any approved vaccine in older adolescents. She noted that this was difficult to answer, but she also pointed out that the Pfizer vaccine will now be tested down to age 16, so there might be safety and efficacy data for that age group that would not be off-label. At this time, the protocols for testing in various pediatric age groups are still being determined.
One Summit partner asked if ACIP planned to harmonize its recommendations If multiple vaccines are approved rather quickly. Dr. Oliver said that is the plan, but this may be impacted by information such as whether safety and efficacy data results in recommendations that highlight one group over another. This also is impacted by varying storage and handling requirements.
Information on timing of vaccine approval is not available at this time. In addition, Dr. Oliver could not provide specific information on how sub-prioritization might occur among healthcare workers. It is unlikely ACIP would make recommendations based strictly on race/ethnicity, but efforts will be made to reach vulnerable populations.
CPT codes for the vaccines have not yet been established but several groups are working on this.
Pharmacists will be allowed to administer COVID-19 vaccines.
Although some states have suggested they might establish their own vaccine review process, Dr. Oliver noted that everyone involved at the federal level is committed to transparency and fully sharing the process for all evidence-based decisions.
When asked whether healthcare institutions might mandate vaccine for their healthcare personnel, Dr. Oliver said it was her understanding that a vaccine cannot be allowed under an EUA. CDC does not mandate vaccines; this would occur at the jurisdiction level or by individual employer policy.
Some healthcare facilities are having people refuse flu vaccination under their condition of employment policies because these policies require that, in the absence of vaccination, the employee must wear a mask. Since they are now required to be masked anyway, some employees are turning down vaccination. Dr. Oliver said she needed to refer this question to others at CDC.
The Summit will follow up on two questions and provide information at a future meeting. (1) The Vaccine Finder doesn’t appear to be updating for vaccines available in pharmacies. (2) Although CDC has issued guidance for vaccination in the time of COVID, one partner wanted to determine if any states have issued similar information, particularly as it relates to use of PPE.
Announcements – L.J Tan (IAC)
- Summit Calls – The Summit has returned to its weekly schedule of holding a call each Thursday at 3 p.m. ET, unless partners receive prior notification that a call has been cancelled. The next call is scheduled for October 1.