Vaccine Trial Raises Hopes, But Distribution Will Challenge States

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States have worked vigorously for months on their COVID-19 vaccine plans but still face a long list of substantial uncertainties, even as hopes rise that the first vaccines could receive federal approval before the end of the year.

Despite the unknowns and the enormity of the task ahead — vaccinating a population of 330 million — state public health officials feel more confident in working with the federal government on vaccines than other matters such as testing, contact tracing and the production and distribution of medical supplies. On Monday, President-elect Joe Biden announced his pandemic response task force, and Pfizer announced that its vaccine candidate has shown in an early analysis to be more than 90% effective.

Nonetheless, states are well aware of the momentous challenge facing them. “This is the largest mass vaccination campaign I’ve ever faced in my career, and that goes back 30 years,” said Dr. Karen Landers, Alabama’s assistant medical officer.

The federal vaccine program was “slow and delayed in starting, but, when it did start in early August and September, it was very aggressive and very inclusive with a whole community approach,” said James Blumenstock, head of the pandemic response with the Association of State and Territorial Health Officials (ASTHO).

Named Operation Warp Speed, the federal program is aimed at spurring and coordinating the development and production of the vaccine and paying for doses for all Americans. Under COVID-19 legislation passed earlier this year, all health plans including Medicaid and Medicare must provide the vaccine at no cost to patients. Congress also made provisions to pay for vaccines for the uninsured.

“There are still many unknowns and issues that have to be worked through on a day-to-day basis,” Blumenstock said, “but the collaboration, information exchange and transparency has been good.”

Still, the work ahead for states comes after exhausting, often demoralizing months of fighting the coronavirus with depleted resources and in the face of an often-resistant public.

“And now they are being asked to put up a mass vaccination program that has not been done at these volumes for decades and never at this speed,” said Dr. Wilbur Chen, an infectious disease specialist at the University of Maryland, an adviser on Maryland’s COVID-19 task force and an incoming member of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

While the federal government will pay for the vaccines, states will play a key role in arranging for the distribution and safe storage of large but unknown quantities of vaccines. (Some will go directly to pharmacies, health systems and nursing homes.) States will be responsible for enrolling doctors as COVID-19 vaccinators and educating them in the use and handling of the drugs.

States are setting priorities for who gets the vaccines when and assuring they are distributed equitably. They will be responsible for promoting vaccinations despite the hesitancy that polls show many Americans feel about vaccines developed at breakneck speed and against a backdrop of intense political acrimony.

But before any of that can happen, there are a lot of questions that can only be answered in the ongoing clinical trials.

Which vaccines will be first to win approval from the U.S. Food and Drug Administration, for what kinds of patients and with what handling requirements? In what volume will they be produced and delivered? How will they be tracked to ascertain who has received them and whether any people are experiencing adverse reactions or failing to get vaccinated? How many doses will people need?

For states one more consequential question looms: Will there be federal money to help cash-depleted states pay for all the tasks the vaccine will impose?

Congress and the Trump administration have sent $340 million to the states for vaccine preparation, but that is a fraction of what state public health officials say is required.

“State and local public health is going to need more,” said Dr. Rachel Levine, Pennsylvania’s secretary of health and the current ASTHO president. ASTHO and other public health organizations have asked Congress for $8.4 billion to help states run their vaccination programs.

Money remains the biggest worry about pulling off a successful COVID-19 vaccine operation, said Alabama’s Landers. “We have a lot of concerns related to funding, but that can’t deter us from our responsibility to our citizens.”

Nevertheless, she expressed confidence. “We have concerns, but we also believe that based on the way we are doing it now, we are moving in a systematic, thoughtful, organized manner.”

Which Vaccine?

Eleven COVID-19 vaccines are in late-stage trials, including four in the United States. Candidates will need FDA approval before they could be distributed for widespread administration. The most basic questions are: Which vaccine will be the first out of the gate, and for which groups will it be appropriate? For example, some vaccine candidates may be more or less effective for the elderly or for children. Those variables could affect state priority plans. 

The various vaccines, contained in small glass vials, also will have different storage requirements. For example, the vaccine Pfizer is developing needs to be stored at temperatures as low as minus 112 degrees Fahrenheit. Another candidate, this one being developed by Moderna, would need to be stored at minus 4 degrees Fahrenheit. The other vaccine candidates can be stored conventionally.

The Centers for Disease Control and Prevention has told states to hold off acquiring cold storage facilities, although states are nevertheless making contingency plans.

“We here in the state have been working to identify facilities that have capacity to store at ultra-cold temperatures and with hospital systems working try to come up with agreements with dry ice providers,” said Kurt Seetoo, program manager of the Maryland Department of Health’s Center for Immunization.

“The biggest unknown is the supply and timing,” said Claire Hannan, executive director of the Association of Immunization Managers. “States have no idea. Are they going to get 5 million doses in the first week of December or 40 million in the last week of December? It makes planning very difficult.”

The uncertainty complicates determinations about who would get immunized first. States, following CDC guidelines, have prioritized health workers, the elderly and those with preexisting conditions, followed by other groups, such as essential workers. States are now reaching out to health care systems, nursing homes and others to locate and quantify those priority populations.

States submitted preliminary but detailed plans to the CDC last month; the agency reviewed them and, in some cases, suggested refinements. All states expect to make revisions as answers to outstanding questions are addressed.

Some states have been more specific about targeted populations. Virginia, for example, has identified as priorities groups at increased risk of infection, such as racial and ethnic minorities, prisoners, the homeless and college students.

Colorado Gov. Jared Polis, a Democrat, at a recent news conference stressed the need to get early vaccines to certain areas in rural parts of the state. “If you look at some of the outbreaks in rural areas, meatpacking, congregate housing in agriculture, prison guards,” he said, “those are all priority categories that have disproportionately impacted rural areas and will be one of the first areas to receive the vaccine.”

But if the initial volumes of the vaccine are limited, as is expected, there won’t be enough to cover everyone in those priority groups. In that case, states will have to adopt a more targeted approach to develop, as Levine said, “priority lists within priority lists.”

“It’s easy to say everyone in one category is entitled to it first,” Blumenstock said, “but if there’s not enough vaccines to do that full cohort you have to get into a subpopulation scheme, one that is fair, equitable and accessible.”

He added that population priorities in turn affect another task the states face, which is enrolling doctors and health clinics in the vaccination program, educating them on the vaccine and assuring that they can store the vaccines safely.

“If we don’t know if and when a vaccine is approved for children or pregnant women,” he said, “it doesn’t make sense for states to expend a lot of effort now in enrolling pediatricians or gynecologists.”

Tracking the Vaccine

States also will have to track who gets the vaccines. All states track childhood immunizations, and some also track adult vaccinations.

The national data collection will help public officials quickly identify adverse reactions and regions where not enough people are getting vaccinations, which may prompt different outreach approaches.

“You’d be looking for any signal that might indicate that something that happened in, say, California is happening in New York as well,” Hannan said.

Some of the vaccine candidates will require a second dose, and the timing for that dose varies among the brands. The data will be instrumental in reminding patients it is time for a second dose and would help assure that the second dose is the same brand as the first.

States also are reconfiguring data systems to talk across state lines should residents move between states.

The states also will play a leading role in communicating with the public about the vaccine. That will include cautioning people that it is likely to take months before the vaccine reaches everyone and that the vaccine, like many others, will not be 100% effective. States must also overcome public skepticism by using advertising campaigns and targeted messaging.

In that regard, said Levine, Pennsylvania’s health secretary, the federal government didn’t do public health any favors when it named the vaccine-development project Operation Warp Speed, a sobriquet that she said might suggest corners are being cut in an unsafe manner.

She wrote a message in September as president of ASTHO insisting that safety rather than politics dictate the vaccine timeline.

Since then, Levine said she has been reassured by the federal government’s performance on the vaccine. “We’ve had a very robust response from HHS [the U.S. Department of Health and Human Services],” she said. “I have felt much better about this process that it’s not going to be politicized.”