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The COVID-19 Vaccine: Who Gets It—and How?

by Dec 1, 2020COVID-19, Healthcare, Magazine

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Alaska’s healthcare and logistics professionals are collaborating to formulate a plan for distribution

As scientists and medical experts work to develop a COVID-19 vaccine, the conversation has grown to include not just the safety and efficacy of a potential vaccine but the logistics surrounding its distribution as well.

Getting vaccines from the manufacturer and into the hands of vaccine providers in Alaska requires a coordinated, collaborative effort among partners in both the public and private sectors. Alaska’s COVID-19 response effort is spearheaded by the Department of Military and Veterans Affairs, the Department of Public Safety, and the Department of Health & Social Services (DHSS), along with the COVID-19 Vaccine Task Force, says Military and Veterans Affairs Incident Commander Bryan Fisher.

This collaboration and coordination are important given that the details of rolling out a COVID-19 vaccine are being developed simultaneously with the vaccine itself. Because it is currently unknown exactly when a vaccine will be available or how much will be distributed to each state, Alaska must prepare for several different distribution scenarios.

“Initially, states were told to have plans in place for October 2020, and then further information was provided that suggested that limited COVID-19 vaccine doses may be available early in November of 2020 and that the vaccine supply will increase substantially in early 2021,” said Sondra LeClair, emergency program manager with the Division of Public Health Rural and Community Health Systems Bureau, during a September COVID-19 Vaccine ECHO (a videoconference connecting Alaska’s COVID-19 experts with specific audiences about specific topics). “That is the limitation of the information that’s been given about timeline.”

“What we know right now—and that could change—but what everybody nationwide is preparing for is that the COVID vaccine will be distributed through the state vaccine program… There will likely be tweaks in the process, but we anticipate it will come to the state’s handling site and then come to us in a similar process.”

—Dr. Laura Brunner, Medical Director, Fairbanks Memorial Hospital Pediatrics & NICU

Alaska’s COVID-19 plan is being created with guidance from the CDC’s COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations, says Clinton Bennett, communications director for the Alaska DHSS. Since the plan was still under development DHSS did “not want to release information that has not been finalized and could end up changing, thus potentially confusing the process,” he adds.

But the information provided at a series of COVID-19 ECHO informational sessions, along with details about how Alaska’s vaccine program works in general, help paint a picture of what Alaskans might expect when the COVID-19 vaccine finally arrives.

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Prioritizing Vaccine Recipients

Alaska communities have been practicing social distancing since early 2020, and communities have transitioned in and out of varying levels of shutdowns, causing disruptions across the board. One thing is known for certain: a vaccine will not be available for every person immediately, so with every person affected—which populations will be the first to get it?

“When it comes to vaccine allocation, I will say there are a lot of unknowns,” said LeClair at the ECHO in September.

Vaccine allocation has two distinct components. One is prioritizing which populations will receive it, which is important when it comes to the COVID-19 vaccine as the federal government anticipates releasing it in phases. The second consideration is how the available vaccine will be allocated to the states. Those decisions fall to the CDC’s Advisory Committee on Immunization Practices (ACIP), which forwards its recommendations to the CDC director for approval.

“[The federal government] has stated that likely prioritized groups will include healthcare and critical workforce who maintain essential functions of society and potentially staff and residents of long-term care and assisted living facilities,” LeClair said.

The federal government has indicated that critical workers who maintain essential functions of society are likely to be prioritized in receiving a COVID-19 vaccine.

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According to the CDC’s vaccination playbook, decisions regarding initial priority groups had not yet been finalized but were anticipated to include healthcare workers likely to be exposed to, or treating patients with, COVID-19; individuals at increased risk of developing severe illness from COVID-19, including those with underlying medical conditions and those age sixty-five and older; and other workers essential to maintaining critical infrastructures, such as law enforcement and other first responders and educators.

The CDC has indicated that the vaccine is likely to be distributed in three phases. The first phase would include a limited supply and be made available to identified critical populations. Phase 2 would see a larger supply of available vaccines administered to populations outlined in Phase 1 and the general population. In Phase 3, a sufficient supply of the vaccine would be available and administered equitably to all residents.

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“We anticipate that the first phase will be a small quantity released to targeted populations,” LeClair said. “We have no idea how much will actually come to the state.”

Decisions about how the vaccine will be allocated to states are also determined by ACIP recommendations.

“The allocation of the COVID-19 vaccine to states and jurisdictions will be based on multiple factors,” LeClair said. “Some of the elements [the federal government] will consider, according to some of their guidance, are populations that are recommended by ACIP. So whoever has some of those larger populations for that priority for the vaccine. They may look at the current local spread and prevalence of COVID-19. And of course, depending on the production and availability levels, those are some of the elements they have discussed.”

From Manufacturer to Provider

How vaccines get from the manufacturer to medical providers depends on whether they’re provided by the state or paid for through insurance.

For state-provided vaccines, distribution is coordinated through the Alaska State Immunization Program and the VacTrAK system.

“Medical providers enrolled to receive vaccine through the Alaska Immunization Program submit a vaccine order through VacTrAK, the State Immunization Information System,” Bennett says. “Alaska Immunization Program staff review and approve the order and forward it to the national distributor warehouse, McKesson, which is in Colorado.”

Vaccine manufacturers then ship the vaccine to McKesson, which packs and ships the order directly to providers, he adds. Providers can track their shipments and manage vaccine inventory through VacTrAK.

“I keep track of how many vaccines we have in the facility at all times and I have to report that to the state every two weeks, whether it’s the flu vaccine or childhood vaccines or even vaccines for adults,” says Dayna Cook, vaccine coordinator for the Tanana Valley Clinic in Fairbanks. “Then I can order more from the state and replenish our supplies, and within a few days those come our way.”

“We are working through the logistics right now. There are multiple vaccines in development currently. Some of the new mRNA-based vaccines can be manufactured rapidly but are fragile and require very, very cold storage. The other vaccines will likely be refrigerated and utilize our current process.”

—Christopher Sperry, Clinical Coordinator of Pharmacy Services, Bartlett Regional Hospital

Vaccines acquired through the state Immunization Program are given to patients free of charge, although medical providers can charge administration fees, says Dr. Laura Brunner, medical director of the Fairbanks Memorial Hospital Pediatrics and NICU units.

“There is a fee that gets billed by our facility for the actual administration of the vaccine, but the vaccine itself is free to people who qualify,” she says. “The state does give a cap on how much we can even charge for the administration.”

Vaccines administered to people—typically adults—who don’t qualify for state-provided vaccines are acquired through a separate purchase program.

“That’s our buyer, and she orders our vaccines and they come in direct from the company rather than through the state portal, and I distribute them to the [providers] who need them,” Cook says.

It is anticipated that the ordering process for the COVID-19 vaccine will go through the state system.

“What we know right now—and that could change—but what everybody nationwide is preparing for is that the COVID vaccine will be distributed through the state vaccine program,” Brunner says. “There will likely be tweaks in the process, but we anticipate it will come to the state’s handling site and then come to us in a similar process.”

LeClair said guidance from the federal government indicates that the vaccine will be shipped like other state-provided vaccines.

“Shipments will be routed in ways that they hope mirrors the usual vaccine distribution process as much as possible, meaning that this is not going to be routed through a strategic national stockpile and into a single warehouse in the state for further distribution,” LeClair said during the ECHO. “That’s not the intended distribution of this; it’s intended to be routed through that vaccine immunization program process.”

“[The federal government] has stated that likely prioritized groups will include healthcare and critical workforce who maintain essential functions of society and potentially staff and residents of long-term care and assisted living facilities.”

—Sondra LeClair, Emergency Program Manager, Division of Public Health Rural and Community Health Systems Bureau

Ancillary supplies needed to administer the vaccine are also part of the distribution process.

“When they speak about ancillary supply kits, they are talking about needles, syringes, alcohol prep pads, vaccination record cards, and what they call a minimum supply of personal protective equipment, [which] is likely to include surgical masks and face shields for vaccinators,” LeClair said. “The federal government has indicated that the supply kits will ship separately but are meant to be timed in conjunction with vaccine shipments.”

Vaccine Storage and Record-keeping

Vaccines have specific guidelines for storage, from both a medical and administrative standpoint. Because this vaccine is still under development and it is unknown which vaccine or vaccines will ultimately be distributed, the CDC has advised states and medical providers to prepare for multiple storage scenarios.

“We are working through the logistics right now,” says Christopher Sperry, clinical coordinator of pharmacy services at Bartlett Regional Hospital in Juneau. “There are multiple vaccines in development currently. Some of the new mRNA-based vaccines can be manufactured rapidly but are fragile and require very, very cold storage. The other vaccines will likely be refrigerated and utilize our current process.”

Cold-chain storage and handling requirements for COVID-19 vaccines currently in development will vary, LeClair said in September.

“There are generally three different temperature ranges that have been shared with us as potential temperature ranges of the vaccine,” she said. “One would be refrigerated, so that’s 2°C to 8°C; frozen, -20°C; or ultra-cold, -60°C to -80°C. We do not know which one will be distributed, but they are providing those three potential temperature ranges.”

The temperature requirements associated with different vaccines dictate the shipping method.

“McKesson packs the vaccine, ships it, usually via FedEx, in a temperature-controlled container. The shipments have a certain number of days to reach their destination and still be within the appropriate temperature range inside the container,” Bennett says. “There is a different process and shipping container to maintain freezer temperatures while the vaccine is in transit. The frozen vaccine orders are forwarded directly to the vaccine manufacturer, instead of McKesson, and the vaccine manufacturer ships the frozen vaccine directly to the provider via UPS.”

In addition to ensuring vaccines are stored at the proper temperature, vaccines ordered through the state Immunization Program must either be stored separately from those purchased directly from the manufacturer or be clearly identified.

“Purchased vaccines are unpacked and stored separately, or, if they are going to be anywhere near each other, they need to be labeled,” Cook says. “That’s a requirement by the state.”

Vaccine providers must also adhere to federal and state administrative requirements.

Several COVID-19 vaccines are still under development and it is unknown which vaccine or vaccines will ultimately be distributed, so the CDC has advised states and medical providers to prepare for multiple storage scenarios.

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“A provider must meet all rules and requirements set by the CDC and the Alaska Immunization Program and are required to complete annual training and education,” Bennett says. “If the provider continues to not adhere to all rules and requirements, the Alaska Immunization Program can un-enroll the provider and remove their state-supplied vaccine.”

While the state anticipates it will be able to use its existing distribution and ordering process once the COVID-19 vaccine is available, the Alaska Immunization Program manager is updating the VacTrAK system.

“We’ll be enhancing VacTrAK to do a little bit more in terms of its function in terms of scheduled appointments,” Alaska Immunization Program Manager Matt Bobo said during the September ECHO.

The enhancements are necessary due to the anticipated vaccine dosage requirements. The federal government expects the COVID-19 vaccine to require two doses, spaced twenty-one to twenty-eight days apart, LeClair said. Part of the update to VacTrAK is to help providers to remind patients to come in for their second dose at the proper time.

Despite the required enhancements and the uncertainties surrounding the vaccine distribution date and the ultimate prioritization of vaccine recipients, the systems already in place should ease the transition.

“I think there are still a lot of unknowns that we’re working through,” said Kelsey Pistotnik, deputy program manager with the Alaska Immunization Program during the September ECHO. “I think it’s really exciting that we are able to leverage all the systems that the immunization program already has in place, so I think that we are in a really great position to roll this out throughout our state.”

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