Oct. 19, 2020 -- As the promise of a COVID-19 vaccine inches ever closer, states and U.S. territories are finalizing plans on what happens when it arrives.
The CDC had set a deadline of this past Friday for all 50 states, nine territories, and five large cities to submit their draft plans to distribute the vaccine.
“We all know that the goal is not to have a safe vaccine sitting on the shelf, but to have a program to administer the vaccine safely and effectively as another tool to end the pandemic,” Nancy Messonnier, MD, director of the CDC’s COVID-19 vaccine planning unit, said on an Oct. 5 CDC planning call.
The CDC will review the draft vaccination plans and provide technical assistance.
“There are things about COVID-19 that make this a daunting task -- it’s a complex and evolving landscape. There are six vaccines being developed in the U.S., and they are not interchangeable -- there are differences in doses, adverse events for different populations, and storage requirements,” Messonnier said.
The key components are a phased approach to distributing vaccines, educating health care providers and consumers, recruiting providers to give the vaccine, proper storage and handling, and information systems to track vaccine inventory and ordering, when people get first doses, and adverse events.
“Most of the state and local plans focus on the initial stages -- how the vaccine will be prioritized, teasing out who those priority populations are and how to reach them,” says Claire Hannan, executive director of the Association of Immunization Managers in Rockville, MD.
A major piece of the broader planning is getting “enough [licensed and credentialed] providers enrolled and on board for when the vaccine supply is more robust” so they can administer it widely, says Hannan.
The CDC has already sent the 64 jurisdictions a total of $200 million to help develop vaccination plans and published a 57-page COVID-19 playbook describing what the vaccination plans should cover.
The federal government is contracting directly with providers such as hospitals and clinics to ship supplies of vaccines to. Providers have to sign a contract agreeing to “accept the vaccine without charging for it, and to administer and give it properly,” says Hannan.
This is a big change from the usual private sector vaccine market, where providers buy their own vaccines, store them in their refrigerators, and charge patients to be vaccinated, she says.
Public health departments will not be solely responsible for distributing the vaccines but will be one of the contracted vendors.
Rural areas face more challenges when it comes to distributing, handling, and storing certain vaccines. “There is a really big difference between a vaccine that comes in a minimum of a 975-dose box and one that comes in a 100-dose box when it comes to distributing the vaccine to rural areas,” says Hannan.
A successful vaccination campaign in rural areas involves taking the vaccine to health care workers. “It’s fine to hold a clinic for 975 health care workers in a large city, but in rural areas, it’s not practical and would result in wasted vaccine or forcing some workers to travel distances to a central location,” she says.
It’s also difficult to train people for such a complicated requirement. “Providers are used to taking the vaccine out of the refrigerator and using it,” says Hannan. The vaccine has to be stored at -94 F and comes in a package with dry ice. To break up the package into smaller amounts would require packaging again with dry ice and maintaining -94 F, which is very hard.
The CDC has pushed vaccine maker Pfizer to continue to look at how long its vaccine is viable and stable after it has thawed. The company says now that is 5 days, compared to 1 day before.
Several groups, including the Association of Immunization Managers, have told the CDC that the vaccine’s requirements make it challenging for their members. “The CDC is worried about this, too, and has told the states that they don’t want them buying ultra-cold storage or repackaging it, but to use it right way. That’s the best way to ensure the vaccine’s viability. The more you try to store, handle it, the greater the risk of doing something wrong,” says Hannan.
States also need information systems that can track vaccine management and send out reminders. “That’s an IT issue that we’re concerned about because a lot of state vaccine registries are not as robust as states would like, and they don’t communicate across states either. A lot needs to be fixed, although we have some time,” says Marcus Plescia, MD, chief medical officer for the Association of State and Territorial Health Officials in Arlington, VA.
Immunization information systems are designed to serve individual states and not to be a national reporting system in real time, says Hannan. “We need to ensure they report and connect to each other and share data.”
The CDC recommends that health care workers be the first group to receive any COVID vaccine, followed by essential workers and vulnerable populations such as the elderly and people with other conditions.
But the agency cautions that its advice could change after the vaccines become available, depending on their characteristics and supply, how the epidemic is spreading, and local community factors, all of which could affect its priorities.
“The CDC is uncomfortable releasing its full prioritization plan until it knows how the vaccine [candidates] will perform based on evidence from the current trials, which makes planning more challenging. For example, the second round of shipments will go to nursing homes, but what if the vaccines don’t perform well in older populations or there are side effects?” Plescia says.
Although the states laid the groundwork for vaccinating their health care workers, “they can’t actually know how it will work because they don’t know which vaccine and how many doses they will get, how it needs to be stored and handled, and whether they will need one central, large location or be able to move it around to different locations,” says Hannan.
The CDC playbook includes two “hypothetical” vaccine scenarios and assumptions. They show different cold storage requirements, available doses, and days between doses. “The strategy for how to use the vaccine will be different, depending on whether you get 100,000 doses of a refrigerated, stable product or 50,000 doses of an ultracold product that comes on dry ice,” she says.
The nation’s governors have many concerns. A group of Republican and Democratic governors have submitted dozens of questions to the White House about how the vaccine project will work.
“The distribution and implementation of the vaccine is a massive undertaking that cannot be managed without significant logistical coordination, planning and financial assistance between states and the federal government,” the governors said in a letter to the White House, released by New York Gov. Andrew Cuomo, the chairman of the National Governors Association. “The list of questions -- which were submitted from Republican and Democratic governors from around the country -- covers funding for the administration of a vaccine, allocation and supply chain, and communication and information requirements.”
Among those questions: Is more money coming? How will the government decide which states get which -- and how many doses -- of vaccines? What are the states’ roles in keeping up with safety and side effects? Is the federal government stockpiling dry ice for shipment and storage?
Not Enough Funds
The Association of State and Territorial Health Officials and the Association of Immunization Managers are concerned that the $200 million the CDC sent the 64 jurisdictions to develop their plans isn’t enough to cover costs. “Congress has to get on this -- if jurisdictions do not have the resources to implement their plans, there is only so much they can do. We don’t want only the affluent states who can react well and administer vaccines efficiently to have access to them,” says Plescia.
Although the funds helped with early planning, including IT and outreach, and enrolling providers, more staff will be needed to order and give daily vaccinations, says Hannan. “Whether you’re getting 500 doses a week or 5 million, you need to be managing them and directing them and making sure they are getting successfully administered.”
In addition, local health departments didn’t receive any of the total $200 million from the CDC.
“They’re already spread thin working on contact tracing and will have to coordinate and run mass vaccination clinics with state health departments,” says Hannan.
Now that the states have written their plans, the next steps will be “to look around the region and reach out to neighboring states to share information, make decisions, and put policies in place,” says Hannan.