“Very ridiculous”: what we know about how the COVID vaccine will be distributed when approved-News-Athens Banner Herald

I don’t know when the COVID-19 vaccine will arrive, but I’m starting to know how it will be distributed.

Interviews with logistics specialists, vaccination specialists, drug distribution specialists, and recent U.S. Centers for Disease Control and Prevention planning documents put coronavirus vaccines from manufacturers into the arms of millions of Americans The way it arrives will be clearer.

Tinglong Dai, a professor of operations management who studies healthcare analysis at Johns Hopkins University, is notable for his rapid and proactive efforts to create a vaccine to fight COVID-19. But only half of that.

“It’s incredible. I think the vaccine supply chain is one of the most dauntingly complex supply chains ever built,” he said.

This process was carried out by the CDC, which over the decades has overseen the distribution of vaccines in the United States and performed the last national vaccination campaign during the 2009 H1N1 influenza pandemic. ..

“I’m happy to see the front and center of the CDC,” said Dr. Kelly Moore, associate director of vaccination education at the Coalition of Vaccinations. “They are the right organization to lead this.”

All vaccines provided in the early stages are purchased by the US Government and no one is charged for the actual dose. As of early September, it was not clear whether the clinic would be allowed to charge the person who took the shot for an administrative fee. According to the CDC document, it is unclear whether insurance will be reimbursed if one person is indicted and the vaccine is issued under an emergency license.

At least initially, vaccines are expected to be scarce, but the CDC Plan document states that by January 2021 quite a lot will be available.

The CDC is still deciding who is eligible to be vaccinated first, but from a meeting of the Advisory Committee on Vaccination Practices, first-line healthcare workers, first responders, and People at high risk seem to get the first dives.

Dozens of COVID-19 vaccines have been developed in the United States and beyond, seven of which are at least partially funded by the US government. When given 21 or 28 days apart, all but one requires two doses. Those who are vaccinated will get a COVID-19 vaccination record card. This card will tell you which vaccine you received, when you received it, and when you should receive the next vaccination.

Currently, two of the seven vaccine candidates are seen as front runners because they are Phase 3 clinical trials, a large human trial to determine if the vaccine works.

They are manufactured by Pfizer and Moderna. The distributions are slightly different because the two vaccines need to be stored at different temperatures. One-third of AstraZeneca in the UK is also in Phase 3 trials, but does not appear to be part of the CDC’s initial planning scenario.

First vaccination plan

The mechanism is as follows. Clinics, clinics, hospitals, pharmacies and other groups wishing to be vaccinated against COVID-19 must first enroll in the US COVID-19 vaccination program. They signed a contract with the CDC and had staff properly trained to manage the space, necessary equipment and shots.

The requirements for storing, handling, and managing shots are so strict that the government prioritizes vaccination of sites that can reach large numbers of priority populations quickly and vaccinate large numbers of people quickly, the CDC document says. States.

As vaccines become available, vaccination sites request doses through state agencies, usually the Public Health Service. That’s a common practice during the 2009 outbreak of the nH1N1 flu, says Julie Swan, a professor of industrial engineering and systems engineering at North Carolina State University, then science counsel at CDC.

The Department of Health confirmed that the site had no problems distributing the vaccine. At that point, if the vaccine supply is limited, the state can determine the amount of vaccine to allocate to that particular site.

The order is then submitted electronically to CDC. Moore said the CDC could also determine the dose assigned to a particular site if the vaccine supply was limited.

CDC then sends the order to its contract partner, McKesson, the largest US drug distribution and technology company. Already there are distribution centers across the country and more are under construction for COVID-19.

According to the CDC planning document, vaccine orders will be shipped within 24 hours upon approval.

National drug chains such as Walgreens and CVS can partner directly with CDC. Military distribution passes through the Department of Defense.

Along with the vaccine, you will receive a separate supply kit that includes a small supply of personal protective equipment, including needles, syringes, alcohol preparation pads, and surgical masks and face shields for vaccine-administering staff.

The devil is in the (freezer) details

This is a little different place. Moderna’s candidate vaccine should be stored at minus 4 degrees Fahrenheit, while Pfizer should be stored at minus 94 degrees Fahrenheit. If either is one of the first vaccines available, a 90 degree difference means they must be distributed differently.

Moderna vaccines are stored either at the manufacturing plant or at the McKesson distribution center. When the order arrives, McKesson will ship it directly to the medical facility that ordered it, Moore said.

Moderna vaccine is provided as a frozen liquid in 10 dose vials and contains no preservatives. If the dry ice is replenished, it can be stored in the freezer or shipping container, as indicated in the CDC documentation. According to the Immunization Action Coalition data, it can be stored at normal refrigerator temperature (36-46 degrees) for up to 2 weeks. Once it reaches room temperature, it should be used within 6 hours.

After piercing the vial and removing the first dose, it is valid for 6 hours and should be discarded. Nothing is wasted, especially at the beginning because of a lack of vaccines, which requires clinical patient scheduling.

For Moderna to be effective, the vaccine must be given twice every 28 days. Both must have the same vaccine.

Pfizer vaccine is more cumbersome because it needs to be stored at ultra-low temperatures, but things can change from test to test. Due to the current requirements, CDC will send orders directly to Pfizer and ship to the vaccination site, Moore said.

Pfizer vaccines are shipped in special shipping containers filled with dry ice and kept cool enough. You can refill the box every 5 days with dry ice to keep it at the proper temperature. According to a presentation the company submitted to the CDC last week, the vaccine is in a preservative-free, five-dose vial.

Individual vaccine vials can be refrigerated for up to 48 hours, but can only be kept at room temperature for 6 hours.

“The state is currently investigating the system to figure out the location of the Sub-80 (Celsius) freezer,” Swann said. “We expect such refrigeration to be available in large hospitals, scientific research facilities, and some large pharmacies.”

Each of Pfizer’s specially designed shipping containers is about the same size as a thick pizza box and contains 195 vials equal to 975 doses. One container can hold five of these boxes, or 4,875 doses. According to Moore, Pfizer vaccine will only be shipped in large quantities, so it will be distributed to large medical centers and public health departments, capable of vaccinating a large number of people, and there is also an appropriate storage facility. is.

Prior to use, Pfizer’s vaccine should probably be mixed with some special liquid such as sterile water to dilute it. The liquid will be shipped separately. According to Immunization Action Coalition, it should be used within 6 hours after mixing or discarded. It should be given twice every 21 days.

Some of the other vaccines closest to FDA approval require refrigeration and can be stored at least once at room temperature. Ultimately, when multiple vaccines are licensed, depending on how well the distribution works in each population, Prashant Yadav, a senior researcher and medical researcher at the Center for Global Development Washington DC think tank He said.

Whatever the ultimate timing of FDA’s vaccine approval, Moore said, the complexity of storing, delivering, and tracking multiple vaccines with different requirements means states must set up systems today. ..

“Planning has helped us pinpoint process issues,” she said. “We can’t wait until the vaccine is approved.”