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Interviews with logistics experts, vaccination professionals, and drug delivery experts, along with the recent American Centers for Disease Control and Prevention planning documents, give a clear picture of how coronovirus vaccines will be in the hands of millions of Americans.
The fast and so far positive effort to create vaccines to fight COVID-19 has been notable, but it is only half the work, Tinglong Dai, a professor of operations management who studies health care analytics at Johns Hopkins University.
“this is incredible. I think the vaccine supply chain is one of the most mind-bogglingly complex supply chains, ”he said.
The process will be carried out by the CDC, which oversees vaccine delivery in the United States for decades and attempted the last national vaccination during the 2009 H1N1 influenza pandemic.
“We are happy to see the front and center of the CDC,” Drs. Kelly Moore called Associate Director of Immunization Education with the Vaccination Education Movement. “They are the right organization to be this pioneer.”
All vaccines supplied in the initial stages will be purchased by the US government and no fees will be charged for the actual dose. In early September, it was unclear if clinics would be allowed to charge an administration fee to receive their shots. If an allegation was made, it is unclear whether insurance could be reimbursed for it if the vaccine was issued under the Emergency Use Authority, CDC documents say.
The vaccine is expected to be in short supply, at least initially, although CDC planning documents state that by January 2021, much more will be available.
The CDC is still finalizing who will be eligible for the first vaccination, but from its advisory committee meetings on vaccination practices, it will provide frontline medicalists, first-responders and those at high risk for critical illness to get first TB.
Dozens of experimental COVID-19 vaccines are being developed in and outside the United States, seven of which have been funded by at least the US government. All will require two doses except 21 or 28 days. Those getting vaccinated will receive a COVID-19 vaccination record card that tells them which vaccine they have received, when they have received it and when they should receive their next shot, CDC plan documents show.
Currently, two out of seven vaccine candidates are seen as front-runners because they are in Phase 3 clinical trials, make-or-break in humans, large-scale trials that determine whether a vaccine Works or not.
They are being produced by Pfizer and Modern. The two vaccines must be stored at different temperatures and will therefore be distributed slightly differently. A third, from AstraZeneca in the United Kingdom, is also in Phase 3 trials, but does not appear to be part of the CDC’s initial planning scenarios.
An initial vaccination plan
Here’s how it will work: Medical offices, clinics, hospitals, pharmacies, and other groups that want to vaccinate people for COVID-19 must first enroll in the US COVID-19 vaccination program Necessarily, they will sign an agreement with the CDC and prove that they have the space, the necessary equipment and the properly trained staff to conduct the shots.
Because the CDC documents state that the requirements to store, handle and administer shots are so challenging, the government will prioritize vaccinations in places that can reach a large number of priority people and by vaccinating many people Can.
When a vaccine becomes available, a vaccination site will request a dose through the state agency, usually its public health department. This was typically done during the 2009 nH1N1 influenza epidemic, said Julie Swan, a professor of industrial and systems engineering at North Carolina State University, who was then a science advisor at the CDC.
The Department of Health will confirm that the site was fine for distributing the vaccine. At that point, if the supply of the vaccine is limited, the state can determine how much vaccine to allocate to that specific site, perhaps less than it was requested.
Next, the order will be transmitted electronically to the CDC. Moore said that the CDC could also decide what dose to allocate to a given site if the supply of the vaccine was limited, Moore said.
The CDC would then dispatch the order to its contracted partner McKesson, the largest drug delivery and technology company in the United States. It already has distribution centers located across the country and is building more for COVID-19.
The CDC’s planning documents state that vaccine orders will be dispatched within 24 hours, depending on supply.
National pharmaceutical chains such as Walgreens and CVS may partner directly with CDC. Military allocation will be through the Department of Defense.
Along with the vaccine, a separate supply kit is to be sent which includes surgical masks and face shields including needles, syringes, alcohol prep pads and a small supply of personal protective equipment for the vaccine staff.
Devil (freezer) is in the details
Here’s where things differ a bit. Modern candidate vaccines must be stored at minus 4 Fahrenheit, but Pfizer is required to be stored at minus 94. If any of those first vaccines are available, a 90 degree difference means that they must be delivered regularly.
The modern vaccine will be stored at either the manufacturing plant or the McKesson distribution center. Moore said that when an order arrives, McKesson will send it directly to the medical facility.
The modern-vaccine comes as a frozen liquid in a 10-dose vial and contains no preservatives. If this dry ice, CDC documents show, can be stored in the freezer or in its shipping container. 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 should be used within six hours.
After puncturing the vial to remove the first dose, it is good for six hours and then it should be thrown away. Because the vaccine will be in short supply, particularly earlier, clinical sites will need to schedule patients so that none is wasted.
In order to be effective, Modern requires two doses of the vaccine in addition to 28 days. It should be the same vaccine at both times.
The Pfizer vaccine is more granular due to its ultra-low temperature storage requirements, although this may change when more tests are conducted. Due to current requirements, the CDC will send orders directly to Pfizer, which will ship to vaccination sites, Moore said.
Pfizer’s vaccine will be sent in a special transport container filled with dry ice that keeps it cool enough. The box can be topped with dry ice every five days to keep it at the proper temperature. The vaccine comes in five-dose vials without preservatives, according to a presentation the company gave to the CDC last week.
Individual vaccine vials can be refrigerated for up to 48 hours, but can only be held at room temperature for six hours.
Swann said, “States are currently surveying their systems to find out where their sub-80 (Celsius) freezers are?” I would expect such cold storage to be available in large hospitals, scientific research facilities, and some large pharmacies. ”
Each of Pfizer’s specially designed transport containers, which are about the size of a thick pizza box, contains 195 vials equivalent to 975 doses. A container can hold those five boxes, or 4,875 in dosage form. Moore said that because it is only being shipped in larger versions, the Pfizer vaccine will be distributed to large medical centers or public health departments with the ability to vaccinate a large number of people, and also to have proper storage facilities on site. is.
Before use, Pfizer’s vaccine needs to be mixed with a special liquid to dilute it, perhaps something like sterile water. That liquid will be sent separately. Once it is mixed, it should be used within six hours or left as per immunological action alliance. It requires two doses in addition to 21 days.
In other vaccines closest to applying for authorization with the FDA, some require refrigeration and can be stored at room temperature at least once. If more than one vaccine is ultimately authorized, distribution will depend on how well each individual works for different populations, Prashant Yadav, medical supply chain specialist and senior partner at the Center for Global Development, Washington, Said in DC
Moore said that due to the complexity of FDA approval, storage, distribution and tracking of multiple vaccines with different requirements, today Mure said.
“Planning now allows us to identify longer glitches in our process,” she said. “We can’t wait until a vaccine is approved.”
This article was originally published on USA Today: ‘Mind-Boglingly Complex’: Here we know how the COVID vaccine will be distributed when it is approved.
Video: Findings from initial vaccine testing suggest that has been promised, researchers say (WBIR-TV Knoxville)
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