It takes a lot of people to develop a COVID-19 vaccine. Volunteers may be one of the most important.
We don’t know when a COVID-19 vaccine will arrive, but we’re starting to know how it will be distributed.
Interviews with logistics experts, immunization professionals and pharmaceutical distribution specialists, together with recent U.S. Centers for Disease Control and Prevention planning documents, give a clearer picture of how coronavirus vaccines will get from manufacturers into the arms of millions of Americans.
The swift and so far positive effort to create vaccines to fight COVID-19 has been remarkable but it’s only half of the work, said Tinglong Dai, a professor of operations management who studies health care analytics at the Johns Hopkins University.
“It’s just incredible. I think the vaccine supply chain is one of the most mind-bogglingly complex supply chains ever built,” he said.
The process will be run by the CDC, which for decades has overseen vaccine distribution in the United States and ran the last national vaccination effort during the 2009 H1N1 influenza pandemic.
“We’re happy to see CDC front and center,” said Dr. Kelly Moore, associate director of immunization education with the Immunization Action Coalition. “They’re the right organization to be leading this.”
All the vaccine supplied in the initial phases will be purchased by the U.S. government and no one will be charged for the actual dose. As of early September, it wasn’t clear if clinics would be allowed to charge an administration fee to those getting their shots. If one was charged, it’s not clear whether insurance could be reimbursed for it if the vaccine is issued under an Emergency Use Authorization, CDC documents say.
At least at the beginning, vaccine is expected to be in short supply, though CDC planning documents say significantly more will be available by January 2021.
CDC is still finalizing who will be eligible to be vaccinated first, but from meetings of its Advisory Committee on Immunization Practices, it appears front-line medical workers, first-responders and people at high risk for severe disease will get first dibs.
There are dozens of experimental COVID-19 vaccines being developed in the United States and beyond, seven of which have been funded at least in part by the U.S. government. All but one will require two doses, given 21 or 28 days apart. People getting vaccinated will get a COVID-19 vaccination record card that will tell them which vaccine they got, when they got it and when they should get their next shot, CDC planning documents show.
Currently, two of the seven vaccine candidates are seen as the front-runners because they are in Phase 3 clinical trials, the make-or-break, large-scale tests in humans that determine if a vaccine works or not.
They are being manufactured by Pfizer and Moderna. The two vaccines must be stored at different temperatures and so will be distributed slightly differently. A third, from AstraZeneca in the United Kingdom, also is in Phase 3 trials but doesn’t appear to be part of CDC’s initial planning scenarios.
An initial vaccination plan
Here’s how it would work: Medical offices, clinics, hospitals, pharmacies and other groups that want to vaccinate people for COVID-19 need to first enroll in the U.S. COVID-19 vaccination program They’ll sign an agreement with CDC and prove they have the space, the necessary equipment and properly trained staff to administer the shots.
Because the requirements for storing, handling and administering the shots are so challenging, the government will prioritize getting vaccine to sites that can reach large numbers of priority populations and vaccinate lots of people quickly, CDC documents say.
When a vaccine becomes available, a vaccination site will request doses through a state agency, usually its department of public health. That’s how it was generally done during the 2009 nH1N1 influenza pandemic, said Julie Swann, a professor of industrial and systems engineering at North Carolina State University who was a science advisor to the CDC at the time.
The department of health would confirm the site was OK’d to distribute the vaccine. At that point, if vaccine supplies are limited, the state could determine how much vaccine to allocate to that specific site, perhaps less than was requested.
Next, the order will be electronically transmitted to the CDC. The CDC also could make decisions about how many doses to allocated to a given site, if vaccine supplies are limited, said Moore.
CDC will then transmit the order to itscontracted partner McKesson, the largest pharmaceutical distribution and technology company in the United States. It already has distribution centers located across the country and is building more for COVID-19.
Vaccine orders will be shipped within 24 hours of approval depending on supply, CDC’s planning documents say.
National pharmaceutical chains such as Walgreens and CVS could partner directly with CDC. Military allocations would go through the Department of Defense.
Along with the vaccine, a separate supply kit is to be sent that includes needles, syringes, alcohol prep pads and a small supply of personal protective equipment, including surgical masks and face shields for the staff giving the vaccine.
The devil is in the (freezer) details
Here’s where things diverge a bit. Moderna’s candidate vaccine has to be stored at minus 4 Fahrenheit but Pfizer’s requires it be stored at minus 94. If either of them are among the first vaccines available, that 90-degree difference means they must be distributed differently.
The Moderna vaccine will be stored either at the manufacturing plant or at a McKesson distribution center. When an order comes in, McKesson will ship it directly to the medical facility that ordered it, said Moore.
The Moderna vaccine comes as a frozen liquid in a 10-dose vial and contains no preservatives. It can be stored in a freezer or in its shipping container if it’s replenished with dry ice, CDC documents show. It can be stored for up to two weeks at normal refrigerator temperatures (36 to 46 degrees) according to data provided by the Immunization Action Coalition. Once at room temperature it must be used within six hours.
After the vial has been punctured to take out the first dose, it is good for six hours and then must be thrown away. Because vaccine will be in short supply, especially at first, clinical sites will need to schedule patients so none is wasted.
To be effective, the Moderna requires two doses of vaccine given 28 days apart. It must be the same vaccine both times.
The Pfizer vaccine is more finicky because of its ultra-low temperature storage requirements, though that may change as more tests are conducted. Because of the current requirements, the CDC will send orders straight to Pfizer, which will ship to the vaccination sites, said Moore.
The Pfizer vaccine will be shipped in a special transportation container filled with dry ice that keeps it cold enough. The box can be topped off with dry ice every five daysto keep it at the appropriate temperature. The vaccine comes in five-dose vials without preservatives, according to a presentation the company gave to the CDC last week.
The individual vaccine vials can be refrigerated for up to 48 hours but can only be held at room temperature for six hours.
“States are currently surveying their systems to know where their sub-80 (Celsius) freezers are,” said Swann. “I would expect that kind of cold storage to be available at large hospitals, scientific research facilities and some large pharmacies.”
Each of Pfizer’s specially-designed transportation containers, which are about the size of a thick pizza box, contains 195 vials, equal to 975 doses. One container can hold five of those boxes, or as many as 4,875 doses. Because it’s only being shipped in large volumes, the Pfizer vaccine likely would be distributed at larger medical centers or public health departments that have the capacity to vaccinate large numbers of people, and also have the proper storage facilities on site, Moore said.
Before use, Pfizer’s vaccine will have to be mixed with a special liquid to dilute it, probably something like sterile water. That liquid would be shipped separately. Once it’s mixed it must be used within six hours or discarded, according to the Immunization Action Coalition. It requires two doses given 21 days apart.
Among the other vaccines closest to applying for authorization with FDA, some require refrigeration and at least once can be stored at room temperature. If more than one vaccine is eventually authorized, distribution will depend on how well each works for different populations, said Prashant Yadav, a medical supply chain expert and senior fellow at the Center for Global Development, a think tank in Washington, D.C.
Whatever the eventual timing of an FDA vaccine approval, the complexity of storage, delivery and tracking multiple vaccines with different requirements means states have to be setting up systems today, said Moore.
“Planning now allows us to identify the glitches in our process now,” she said. “We can’t wait until a vaccine is approved.”
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