States Face Monumental Challenges Readying Vaccine Distribution

(Bloomberg) -- As states race the clock to ready their plans to vaccinate millions of people by an Oct. 16 federal deadline, they are pushing ahead with the health planning equivalent of wearing blindfolds.

State health officials, under intense time pressure, are grappling with a multitude of logistical hurdles, yet they haven’t a clue which vaccine they will be distributing nor when — or even if — a vaccine will be forthcoming.

That’s a problem. Even as President Donald Trump has ceded much of the job of readiness to local leaders for distribution of Covid-19 vaccines, it’s been impossible for states to fully prepare when, for instance, safe storage and transportation requirements will differ vastly depending on which of the four frontrunner vaccines now in contention will be approved.

“It's an extremely stressful time trying to pack a very enormous planning task into 30 days,” said Claire Hannan, executive director of the Association of Immunization Managers, whose members include state health officials focused on vaccinations.

Distributing a vaccine on a national scale has never been an easy task. Now, in the fog of the pandemic and with political pressure from the White House to pick up the pace ahead of the Nov. 3 election, the job has become mindboggling for state planners. Among the myriad of decisions they must quickly resolve: directing transport from manufacturer to hospitals, physician practices and clinics; determining who will receive the first doses; and coming up with a strategy to convince increasingly skeptical citizens the shots are safe, all with little guidance from Washington.

“Different states are doing 50 different training programs and 50 different messagings on why the vaccine is critical,” Hannan said. “We really need that from the top.”

State and local health departments are veterans of vaccine campaigns. They played a crucial role in the 2009 H1N1 pandemic and they help protect residents from the flu every year. But this operation provides a whole new level of complexity.

Bottom-Up Delivery

Demands from a myriad of agencies, under the federal Operation Warp Speed initiative, are challenging states’ ability to comply. “The federal government is insisting on strict requirements that states must meet,” without doing much to help local leaders get the job done, said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota who is advising the state on its preparations.

“The issue here is trying to merge a federal top-down direction with what is largely a bottom-up delivery system,” Osterholm said. “That's the conflict you're seeing right now.”

States, for instance, are already strategizing whom to vaccinate first though they have no final recommendations from the federal government.

A panel of immunization experts that advise the Centers for Disease Control and Prevention will make recommendations for who should first receive a Covid-19 vaccine once a shot is authorized by the Food and Drug Administration. The panel has met to discuss the potential scenarios but won't vote on the recommendations until a Covid-19 vaccine has FDA clearance.

The panel, known as the Advisory Committee on Immunization Practices, will convene an emergency meeting as soon as the FDA moves on a vaccine, José Romero, chairman of the ACIP, said in an interview.

“That emergency meeting can occur as early as the evening of the announcement date or the next day,” Romero, chief medical officer at the Arkansas Department of Health, said.

States are planning ahead based on recommendations from the National Academies of Sciences, Engineering and Medicine, which call for starting with frontline health-care workers. That sounds easier than it is, said Bob Swanson, director of the division of immunization at the Michigan Department of Health and Human Services.  

“You have your hospital health-care workers, your private clinic health-care workers, you have your pharmacists, your urgent care, your local health department health-care workers, long-term care health-care workers,” he said. “You need to figure out how you’re going to get the vaccine to” all those groups, he said.

Essential workers are also near the front of line, a definition that can vary greatly by state.

“That might be different in New York where it might be transportation workers,” said Dr. Jennifer Dillaha, Arkansas’ state epidemiologist and medical director for immunizations. “In a rural state like Arkansas it might be poultry processing plants.”

Below Zero

Getting the vaccine to those workers will be no easy task. Pfizer Inc. and BioNTech SE’s candidate, one  of the vaccines furthest along in clinical trials, needs to be kept about 94 degrees below zero. The company plans to ship temperature-controlled containers filled with at least 1,000 shots directly to providers, solving a storage issue yet posing a problem for rural states who need to spread those doses out.

“Either you can't send them to rural areas or we'll have to figure out how to break apart shipments,” Molly Howell, North Dakota immunization program manager, said.

States are responsible for tracking who receives which vaccine, when and where. Most of the leading candidates require two doses weeks apart, adding another layer of complexity to the already challenging effort.

The CDC is offering an app that Deloitte is developing. Some states are wary of using it because they haven’t been able to test it themselves or have already invested in their own systems, Hannan said.

It’s a virtual certainty at this point that there will be no vaccine approved before Election Day, despite Trump’s promises. The FDA wants a median of two months of safety data after a final shot is given and only then will it seek input from its advisory committee, according to guidelines published earlier this month.

For the states, at least, that means a bit more time to get ready.

©2020 Bloomberg L.P.