Friday marks the deadline for state health officials across the U.S. to submit plans to the federal government on how they will inoculate hundreds of millions of Americans against Covid-19 once a vaccine is approved.
States have about two weeks to set up distribution centers across the country to meet the Nov. 1 deadline set by the Centers for Disease Control and Prevention — a monumental undertaking made even more difficult by the fact that a vaccine hasn’t been cleared by the Food and Drug Administration and clinical trials of two of the four leading candidates have been halted.
Most of the potential vaccines require two doses, although Johnson & Johnson’s requires just one shot, and some of them need to be transported and stored at varying and specific temperatures.
“Everybody needs to realize it’s not going to be seamless,” said Dr. Marcus Plescia, chief medical officer at the Association of State and Territorial Health Officials. “This is an ambitious undertaking, but we will get there and I think the fact that we have an opportunity to get a little bit in front of something and plan for it is going to make a difference.”
Operation Warp Speed
Once a vaccine is approved, U.S. officials will need to figure out how many doses go to each state or region. States will then be responsible for disbursing the doses to local providers, according to the CDC’s guidelines.
“Government does not do these large operational complex functions easily or well,” New York Gov. Andrew Cuomo, a Democrat, told reporters on a conference call Thursday. “And the federal government has shown that it doesn’t have the operational capacity to do these things. That’s why the federal government at the beginning of Covid just delegated it all to the states.”
The federal government is in the process of “actively engaging tens of thousands of provider outlets for these vaccines,” Paul Mango, deputy chief of staff for policy in the Department of Health and Human Services, told reporters on an Oct. 9 call. The CDC is also in the process of helping native tribes decide on the best option for vaccine allocation, the agency’s deputy director for infectious diseases, Jay Butler, told reporters on the same call.
Mango added that the U.S. currently has assembled 40 million-plus vaccination kits with the bottles, needles and other items needed for the shots.
“All of those are in warehouses ready to go, so that’s a big logistical task or undertaking,” he said. Supplies, such as needles and syringes, will be automatically ordered in amounts to match vaccine orders.
However, storage and handling of the vaccine will depend on “which vaccines become available and what amount and when,” Butler said.
Because Pfizer’s vaccine needs to be stored at 94 degrees below zero, requiring special storage equipment and transportation, the company’s only shipping about 500 to 1,000 doses at a time. The longer it sits on a shelf, the greater a chance it will go bad, Butler said. By comparison, Moderna’s vaccine candidate will need to be stored at 4 degrees below zero.
There are already tens of thousands of potential vaccination centers in the U.S., but not all of them will have the ultra-cold freezers required for some of the vaccines.
So far the CDC has allocated $200 million to jurisdictions for Covid-19 vaccine preparedness, though much of that funding hasn’t trickled down to the local level, said Lori Freeman, CEO of the National Association of County and City Health Officials.
In many instances, local health departments haven’t received any funds for vaccine distribution. Many of them are already strapped for cash and lack the critical data reporting infrastructure and staffing to carry out a vaccine campaign on this scale, Freeman said. The data systems will be critical for understanding what percentage of the population has been inoculated, she said.
“When you’re talking about executing a mass immunization program on the ground with all the money sitting at higher levels of government, it doesn’t make any sense,” Freeman said.
Plescia, who represents state health officials, said ASTHO has asked the federal government for an additional $8.4 billion in funding to carry out vaccine distribution. That funding would largely go toward filling staffing shortages and ensuring health-care workers have adequate personal protective equipment, he said.
“The No. 1 issue that we are trying to be very clear about is the states are going to need more funding,” he said.
Dr. Janis Orlowski, chief health-care officer at the Association of American Medical Colleges, said public health departments across the country “continue to be underfunded.” Health departments will either need more resources and staff to roll out the vaccine or massive assistance from hospital systems and private contractors, she said.
Distributing the vaccine will be “very expensive” and complicated, Cuomo said.
“How do we administer 20 million vaccines in the state of New York? And how do you do that quickly and how do you do that safely? How do you do the vaccines all across the country?” Cuomo said. “It’s clear that the states won’t be able to do it on their own … we need to know what is the plan.”
Logistical challenges loom
In mid-September, the CDC released a 57-page “playbook” to help state health authorities create their own plans for distributing a Covid-19 vaccine. In the playbook, the CDC said it anticipates a coronavirus vaccine will initially be granted an emergency use authorization before earning full formal approval.
Even with these guidelines, experts warn the plans submitted on Friday will likely be a rough draft and will vary from state to state as officials scramble to arrange the infrastructure to deliver and store vaccines at below-arctic-cold temperatures and to ease people’s potential safety concerns.
“We need national guidance. This is going to be a challenge, because states won’t know if they’ll have enough vials or enough trained people to administer vaccines — and some are two shots,” said Arthur Caplan, professor of bioethics at New York University Langone Medical Center.
Orlowski, who said she’s been briefed by federal officials running the vaccine program, said “half of the work is done” because states run large immunization campaigns for the flu and other vaccines every year.
But many of the Covid-19 vaccines will require two shots, which raises a big question of how the government plans to track the immunizations to know when someone needs their booster shot.
“The CDC has not been clear,” she said of whether the vaccine registry will be a federal or state-by-state effort. “I suspect that they’re planning for federal registration, but I don’t know how they’re going to do it. What they have told us is that they’ll have more details next week.”
Who gets vaccinated first?
The vaccine will likely be distributed in four phases, with health-care workers, the elderly and people with underlying health conditions getting it first. Essential workers, teachers and people in homeless shelters as well as prisoners would be next on the list, followed by children and young adults.
However, the vaccine hierarchy remains complex and who’s included in those groups will differ depending on where someone lives, said Freeman, whose organization represents more than 2,800 local publich health organizations.
“It can’t be sort of this rubber-stamping approach. That hierarchy guidance is really important to come from the federal level, but it still has to be tailored to the community because a rural community might look extremely different from a suburb or an urban community,” Freeman said.
Local health departments have the expertise to provide outreach to those priority groups, identify ideal vaccination sites and assuage fears over the drug’s safety, but Freeman said she’s worried county and city health officials haven’t been fully engaged in the vaccine distribution planning process.
“Our local health departments are doing the best they can to rely on everything that they’ve done in the past regarding mass vaccination planning and execution, they know how to do this,” she said. “Our worry is that they might be left out of it.”
Rural states could struggle
Getting the vaccine to people in poorer or more rural areas of the country may also prove difficult.
That’s because many states lack the adequate infrastructure to ensure the safe and effective delivery of Covid-19 vaccines that will require special refrigeration, said Lawrence Gostin, a professor of global health law and director of the O’Neill Institute for National and Global Health Law at Georgetown University.
“We have procured some ultra cold chain freezers and transport freezers. Dry ice is still on the table and in the works,” said Molly Howell, North Dakota immunization program manager, said. “Because we’re such a rural state, we want to make sure we’re able — if that’s the only vaccine that’s available — we want to make sure that we can get it to the rural areas.”