ACIP Mulls Priority Groups for COVID-19 Vaccines

Members of the the CDC’s Advisory Committee on Immunization Practices (ACIP) meeting Tuesday appeared to agree that healthcare workers should be first in line to receive a COVID-19 vaccine when one is approved, followed by some combination of essential workers, those with high-risk medical conditions, and older adults.

However, with no formal vote taken — that won’t happen until one or more vaccines are authorized or approved by the FDA for clinical use — it’s not yet official policy, and not much was settled about priorities for later rounds of immunizations.

ACIP chair José Romero, MD, said once data is available from phase III clinical trials, an ACIP work group will conduct an independent review of its safety and efficacy.

“If and when the FDA authorizes or approves vaccines, ACIP will have an emergency meeting and then vote on recommendations and populations for use,” he said.

Perhaps with an eye towards the FDA’s planned Oct. 22 vaccines advisory committee meeting — at this point, no specific products are on the agenda for that discussion either — the ACIP discussed a proposed framework for vaccination recommendations.

Phase 1a, the first round of vaccinations, would go to paid and unpaid persons who have the “potential for direct or indirect exposure to patients or infectious materials” — such as those working in hospitals, long-term care facilities, outpatient, home health care, pharmacies, emergency response, and public health.

CDC experts laid out the framework for their recommendations, based not only on previous recommendations from the National Academies, but also the Johns Hopkins University Bloomberg School of Public Health and the World Health Organization’s SAGE group. These principles included maximizing benefits, equity, justice, fairness, and transparency.

For example, vaccinating healthcare professionals (HCPs) first may reduce COVID-19 morbidity as well as transmission (“maximize benefits”). Racial/ethnic minority groups and lower income earners are overrepresented in some healthcare fields, with higher seroprevalence of SARS-CoV-2 among Hispanic and non-Hispanic Black workers, and a larger proportion of staff at long-term care facilities who were both women and non-Hispanic Black (“equity”).

But ACIP also grappled with how to define the groups to be included in phase 1b, likely including essential workers such as those in food and agriculture, transportation, education, and law enforcement. Also on most lists for phase 1b are the elderly and people with high-risk medical conditions.

Kathleen Dooling, MD, of the CDC, discussed the potential “short period of time where administration might be limited” and asked the committee what they would want to know in setting priorities. Specifically, she noted areas where phase 1b groups overlap (essential workers with high-risk conditions, or older adults who are essential workers, for example).

ACIP member Peter Szilagyi, MD, of the University of California Los Angeles, emphasized the importance of identifying risk of “serious COVID infection and death” as an outcome, separate from mere COVID infection.

“For example, many essential workers who do not have chronic conditions or are younger may have a high likelihood of infection,” but not necessarily mortality, he noted.

Some ACIP members brought up the idea of targeting geographic hotspots, but the CDC’s Nancy Messonnier, MD, pointed out that may not be a feasible short-term strategy for controlling an outbreak.

“I’m a little troubled by the idea we can use hotspot analysis to make decisions about how to target vaccines, given that unfortunately our hotspot analysis does not predict that far out and may not predict past the second dose of vaccine,” she said.

Dooling also asked about the “correct balance” between national guidance and local flexibility, and members were split on this as well.

ACIP member Robert Atmar, MD, said he would argue for more national guidance, because at this level, it has “the greatest transparency.” When it “trickles down to intermediate and local control, transparency isn’t always as great,” he said.

But liaison member Matthew Zahn, MD, of the National Association of County and City Health Officials, argued for more flexibility within local health departments.

“It really is appropriate to be aware of what’s going on in your community, that reality has to drive the response in a community [and] local public health has to be given the flexibility to react that way,” he said.

In any event, if and when a vaccine is approved, CDC officials let the ACIP know states will be ready to distribute it. A jurisdictional “playbook” was released by CDC on Sept. 16 about programmatic implications of vaccination programs. Officials said they asked states to have their plans finalized by October 16.

ACIP member Helen Keipp Talbot, MD, of Vanderbilt University brought up the potential of states having a plan in place when it’s possible there will not be adequate data by that time, calling it “somewhat premature.”

But Messonnier noted this came from Operation Warp Speed, leaders of which expected a vaccine as early as November.

“Our goal is to be ready on the first day we can actually distribute a vaccine. We need to be ready, so there’s no delays,” she said.