The U.S. government is putting together the infrastructure for widespread distribution of a COVID-19 vaccine, if and when one is granted emergency use authorization (EUA) or full approval.
The U.S. government is putting together the infrastructure for widespread distribution of a COVID-19 vaccine, if and when one is granted emergency use authorization (EUA) or full approval. But as they put these pieces in place, it is becoming clearer just how complicated it is.
On August 17, Operation Warp Speed chose McKesson Corp. to help distribute the vaccines. McKesson had already had a vaccine distribution contract with the U.S. government beginning in 2017, and had similar contracts before that, including for the H1N1 vaccine during the 2009-2010 pandemic.
Although it was greeted with some skepticism by critics, on September 3 the U.S. Centers for Disease Control and Prevention (CDC) notified the public health departments in all 50 states and five large cities to prepare for the possibility of distribution of a vaccine by November 1. As part of the implementation, the CDC indicated the states may have to waive some of the typical licensing and permit requirements that might slow the process down.
“The normal time required to obtain these permits presents a significant barrier to the success of this urgent public health program,” the CDC wrote in a letter to state governors. “CDC urgently requests your assistance in expediting applications for these distribution facilities and, if necessary, asks that you consider waiving requirements that would prevent these facilities from becoming fully operational by November 1, 2020.”
Tinglong Dai, a professor of operations management whose professional focus is health analytics at the Johns Hopkins University, told USA Today, “It’s just incredible. I think the vaccine supply chain is one of the most mind-bogglingly complex supply chains ever built.”
The CDC, which has decades of experience overseeing vaccine distribution in the U.S., is again handling the COVID-19 vaccine distribution. Initially the vaccine supplies will be acquired by the U.S. government and no one will be charged for the actual dosage. There are some indications that there will be an administration fees charged by clinics giving the actual shots, and it’s not yet clear if insurance will reimburse for it under an EUA.
The CDC documents suggest, should a vaccine be granted EUA before the end of the year, the supplies will be limited, although they expect wider, although not broad, distribution available by January 2021. All of that planning is contingent on the safety and efficacy data coming out of several ongoing Phase III clinical trials of vaccine candidates. The leading U.S.-European efforts are by Moderna, Pfizer and BioNTech, and AstraZeneca and the University of Oxford.
In keeping with that short supply, the CDC is finalizing dosing priorities. So far, based on meetings of the CDC’s Advisory Committee on Immunization Practices, the top priorities will be front-line medical workers, first responders, and individuals at high risk for severe disease.
According to USA Today, under the initial vaccination plan, medical offices, clinics, hospitals and pharmacies that intend to vaccinate people will be required to enroll in the U.S. COVID-19 vaccination program. This will require signing an agreement with the CDC and proving they have the space, required equipment and appropriately trained staff to administer the vaccines.
Complicating matters is that the vaccine candidates have differing storage requirements, some of them extremely difficult to deal with. Moderna’s vaccine candidate, for example, must be stored at -4 degrees F. Pfizer and BioNTech’s, on the other hand, needs to be stored at -94 degrees F. Obviously, these require two very different distribution and storage pathways.
The Moderna vaccine can be stored at the manufacturing facility or at a McKesson distribution center. Once ordered, McKesson will transport it directly to the clinic or medical facility that ordered it. This vaccine comes as a frozen liquid in a 10-dose vial. There are no preservatives. Storage can be in a freezer or if there is replenished dry ice, in its shopping container. It can be stored for up to two weeks at normal refrigerator temperatures, 36 to 46 degrees F. But once at room temperature it has to be used within six hours. After the vial has been punctured, it has to be used in six hours and then thrown away. Because of the limited supply, patients will likely be put on a schedule. The Moderna dose requires two doses 28 days apart.
Most of the vaccines require two doses and they are not interchangeable. If you receive the first dose of the Moderna vaccine, the second vaccine cannot be one of the other vaccines, for example.
The Pfizer vaccine, with its ultra-low temperature storage requirements, will be receive orders directly, which will then ship the vaccine to the vaccination sites. It will be transported in a special container filled with dry ice and will have to be refilled with dry ice every five days. The vaccine comes in five-dose vials with no preservatives. It is possible that further tests will show the ultra-low temperatures are not required, but so far that is not the case. The individual vaccine vials can be refrigerated up to 48 hours but only at room temperature for six hours.
Julie Swann, a professor of industrial and systems engineering at North Carolina State University who formerly advised the CDC, told USA Today, “States are currently surveying their systems to know where their sub-80 (Celsius) freezers are. I would expect that kind of cold storage to be available at large hospitals, scientific research facilities and some large pharmacies.”
Pfizer’s uniquely designed transportation containers are about the size of a pizza box and contain 195 vials, or about 975 doses. One of its containers can hold five of the boxes, or about 4,875 doses. Because of the need to ship larger volumes, the Pfizer vaccine will probably be distributed to bigger medical centers or public health departments. The Pfizer vaccines has to be mixed with a sterile liquid, probably sterile water, which will be shipped separately. Once mixed, it has to be used within six hours, then discarded. It requires two doses 21 days apart.
Patients receiving the vaccines will likely be issued identification cards indicating what date they received each dose and the specific vaccine they received.
