Confusion spreads over system to determine priority access to Covid-19 vaccines

As manufacturers around the world race to develop Covid-19 vaccines, a parallel effort has begun to figure out who in the United States should get them first — and how those doses should be distributed.

But already the effort is being complicated by tensions over who gets to make those critical decisions, with some groups feeling sidelined and multiple new actors crowding the stage.

On Tuesday, the National Academy of Medicine, tasked by top U.S. health officials, named an expert panel to develop a framework to determine who should be vaccinated first, when available doses are expected to be scarce. But that panel is ostensibly encroaching on the role of the Advisory Committee on Immunization Practices, a panel that has made recommendations on vaccination policy to the Centers for Disease Control and Prevention for decades, including drawing up the vaccination priority list during the 2009 H1N1 flu pandemic.

There is also the matter of Operation Warp Speed, the government’s vaccine fast-tracking program that has claimed authority over, among other things, distribution decisions when it comes to Covid-19 vaccines.

Amid so many players, public health experts are expressing concern and confusion.

“It seems to me like we’ve just assigned four different air traffic control towers to land the same plane,” said Michael Osterholm, director of the University of Minnesota’s Center for Infectious Diseases Research and Policy. “Between ACIP, and this new committee, the group working within Operation Warp Speed and just in terms of input from the general community, it’s not clear to me who will make the final decision and how that process will unfold.”

The health of untold numbers could hang in the balance, given that initial batches of vaccine are likely to be available only for a sliver of the population. Additionally, most vaccines will probably be given in two-dose regimens, meaning any figure of available doses would have to be divided in half to see how many people could be vaccinated.

There is no doubt that health care workers will be offered vaccines first. But after that, tough decisions will have to be made about the order in which other frontline workers — which? how many? — are offered priority access to vaccine and who will follow, in what order.

Normally, such decisions would fall to ACIP, which months ago set up a working group to monitor the evolving science on Covid-19 and the vaccines being developed to protect against it. But it’s not clear what task ACIP will be handed here.

“We haven’t been given a firm answer as to what our role will be. We are continuing with our routine planning and discussion, and we will come up with what we think are appropriate guidelines for prioritization. But that we’ve not been given assurances that we will actually be contributing to that,” said José Romero, the panel’s chairman.

Romero told STAT he even had applied to be on the National Academy’s panel after the academy urged people who were interested to nominate themselves. Romero said he never heard back. The agenda for the first public meeting of the panel, scheduled for Friday, states Romero has been invited to speak to the kickoff session. He said late Monday he hadn’t received an invitation.

ACIP member Beth Bell, who chairs its Covid-19 vaccines work group, is also concerned about the National Academy panel working on vaccination priorities before ACIP.

“Hopefully it won’t be a parallel process and it’ll be something which can complement the work of the ACIP,” said Bell, a professor of global health at the University of Washington and a former director of the CDC’s national center for emerging and zoonotic infectious diseases.

She seemed to take some solace from the fact that former CDC director Bill Foege — one of the architects of the smallpox eradication program and a revered figure in public health circles — has been named co-chair of the new panel.

Foege will share chairing duties with Helene Gayle, president and CEO of Chicago Community Trust. Gayle previously worked at the CDC for 20 years on HIV/AIDS and at the Bill and Melinda Gates Foundation. In addition to the co-chairs, the 15 panelists include vaccine experts, ethicists, experts in vaccine hesitancy, global health, health policy, risk communications, and the delivery of health care to low-income populations.

Francis Collins, director of the National Institutes of Health, first asked National Academy of Medicine President Victor Dzau to create the new panel, even though setting vaccination priorities is a public health role — traditionally on the CDC’s turf, not the NIH’s. Later a letter formally requesting that the panel be struck came from Collins and Robert Redfield, the CDC director.

In an interview, Collins seemed puzzled as to why ACIP members might be concerned about the creation of the expert panel. He said the decision-making framework the panel designs “will make their job, I think, a lot more straightforward and less likely to be attacked as being capricious.”

“This is a discussion which is potentially going to be contentious and we want to try to minimize that,” Collins told STAT.

“There are certainly parts of society that are suspicious of what the government is doing, no matter what it is,” he added. “And this takes it out of that framework and provides an opportunity for whose sort of wisest big thinkers to gather and make this kind of a judgment about what those priorities ought to look like,” he said.

“What’s not to love about this?” he said.

Some vaccine developers have embraced the idea of the National Academy’s involvement, which the body suggests will set a priorities framework that can be used in the United States and beyond.

“It is the CDC’s responsibility, the ACIP that makes decisions about allocation, but in this very special case, I have personally — and I think many of us have — called for the National Academy of Medicine to create a mechanism to look at health equity and make sure that the allocation is fair,” Julie Gerberding, the chief patient officer at Merck, told a House subcommittee on Tuesday.

Others acknowledge there is confusion about who is doing what — and most importantly, who will make the final decisions.

Osterholm, the University of Minnesota expert, called the composition of the National Academy panel “outstanding. … They couldn’t find two better chairs than Bill and Helene.”

But the excellence of the panel doesn’t negate the fact there isn’t much clarity about roles, he said.

Ultimately the administration in power when vaccine is approved for use will likely dictate who stands where in the vaccine priority line. The current administration’s past decisions about distribution of desperately needed protective equipment for health workers and scarce supplies of the antiviral drug remdesivir don’t instill confidence that the painstakingly crafted recommendations of the National Academy group, or of the ACIP, will be followed to the letter.

“In the end it will be decided by the U.S. government,” Osterholm said. “Look at how the remdesivir situation unfolded nationally. That was a terrible situation.”

The task of setting priority groups won’t be an easy one.

Older adults are most at risk of dying if they become infected. But essential workers in food production and distribution may be at higher risk of contracting the virus. Who should move to the front of the line? Should the vaccination program prioritize people of color, who have contracted and died from Covid-19 in disproportion numbers? At the June meeting of the ACIP, at least one member suggested that should be considered. One of the charges to the National Academy panel is to advise on how communities of color can be assured equitable access to the vaccines.

Other questions asked of the National Academy panel include what criteria should be used to set priorities for equitable allocation of vaccines — for example, how to weigh individual risk, due to age, underlying health conditions, or occupation, versus group risks posed by being in prison, being homeless or being a resident of a long-term care facility. The panel is also being asked to provide input on how to communicate vaccine priority decisions to the wider public, and how to address vaccine hesitancy, especially in high-risk populations.

Collins said the panel has been asked to come up with interim recommendations by Labor Day, which would then be subject to a short period of public comment. Dzau, the academy president, said last week that the final recommendations would probably take about three months to deliver, which would mean early October.

Dzau strenuously refuted the idea that the new panel might be driving in someone else’s lane. The group will create scenarios, he said, of how to deal with the variety of circumstances the country might face, for instance starting to vaccinate with 10 million doses, or 60 million, or 100 million.

“I think our job will be to look at the evidence and the strategy of who should get what and how. … Some kind of priority list and the rationale for that,” Dzau said.

The time frame he and Collins envisage may leave the ACIP with little time to fine-tune the framework the National Academy panel devises. Some of the most aggressive manufacturers have stated they may have enough evidence to support the issuance of an emergency use authorization from the Food and Drug Administration by October.

Beyond questions of priority-setting, there are also concerns about how vaccines will be distributed.

Those concerns were first triggered by the press release announcing the formation of Operation Warp Speed, which claimed distribution as one of the project’s responsibilities.

Four organizations representing professionals who make up the last mile of a vaccine’s journey into arms in the United States wrote to the leaders of Operation Warp Speed on June 23, asking if the project intended to use existing vaccine delivery infrastructure to get Covid-19 vaccines into Americans. They still haven’t received a reply.

“If your job is logistics and you don’t know that there’s a system out there already, it might be easy for you to start planning things down a different path,” said Claire Hannan, executive director of the Association of Immunization Managers, one of the groups. “And we don’t want that to happen.”

Another group that signed the letter, the Association of State and Territorial Health Officials, has since had a discussion with Lt. Gen. Paul Ostrowski, from Operation Warp Speed, said Jim Blumenstock, the organization’s chief program officer for health security. Blumenstock said that after the conversation, he felt more confident that traditional vaccine distribution networks would play a part in the roll out of Covid-19 vaccines.

“The proof is always in the pudding,” he said, recounting that Ostrowski told him that “micro-planning” for vaccine distribution would start in the next two to three weeks.

STAT asked Operation Warp Speed for interviews about these issues. The requests were neither turned down nor granted — they were merely acknowledged.

Hannan, who hadn’t heard anything from Operation Warp Speed as of Monday, remains unsettled.

“I am still very concerned about how distribution will be carried out and about the lack of planning with state and local public health agencies,” she told STAT.  “We have received no assurance that existing vaccine allocation, distribution, and tracking systems will be used.”

Damian Garde contributed reporting