Storage requirements may determine which COVID-19 vaccines go to different Texas areas

Coronavirus

AUSTIN (KXAN) — With an announcement from AstraZeneca Monday, there are now three major companies with late-stage trial results, suggesting they have vaccines that will be effective against COVID-19.

While these vaccines will still need approval from entities like the U.S. Food and Drug Administration before they can go out to consumers, state and regional governments are making preparations for the likelihood that one or more of these vaccines will soon be available.

State and Austin-area health agencies don’t know yet which of these vaccines will be approved and in what time frame.

The Texas Department of State Health Services made it clear to KXAN in an email Monday that it is “actively working to ensure that every community across the state” will be able to access COVID-19 vaccines once they are available.

The department said it has been preparing to distribute multiple COVID-19 vaccines that are all in Phase 3 of clinical trials: Pfizer’s, Moderna’s, AstraZeneca’s and Johnson & Johnson’s.

However, the department noted, “which vaccine becomes widely available in certain areas may depend on the storage requirements of the vaccine.”

Storage requirements for different vaccines

For example, a spokesperson for the department wrote in an email, that it’s the department’s understanding the Pfizer vaccine requires ultra-cold frozen storage, Moderna requires frozen conditions if kept longer than 30 days and the AstraZeneca vaccine doesn’t need to be kept as cold as the other two, but it still needs to be refrigerated.

The Pfizer COVID-19 vaccine is reported to require the coldest storage among all the current vaccine candidates, with a required temperature of -94 degrees Fahrenheit. Two weeks ago, a spokesperson for DSHS explained to KXAN the Pfizer vaccine is going to be shipped directly from the manufacturer to the people who will be using it, which will initially be hospitals and healthcare workers.

The spokesperson added Pfizer will ship the vaccines in thermal coolers, which can be stocked with up to 5,000 doses of the vaccine and topped off with a layer of dry ice. Orders for these thermal cooler shipments will need to include a minimum of around 1,000 doses of the vaccine.

FILE – This May 4, 2020, file photo provided by the University of Maryland School of Medicine, shows the first patient enrolled in Pfizer’s COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore. (Courtesy of University of Maryland School of Medicine via AP, File)

At first, the DSHS spokesperson said, these shipments of the Pfizer vaccine will go to places that have ultra-cold freezers that can store the vaccines. But for places without those special freezers, the thermal coolers can be restocked with dry ice to last longer.

Austin Public Health tells KXAN that they’ve been informed by DSHS the Moderna vaccine will be shipped in temperature-controlled trucks.

DSHS says it is continuing to recruit additional locations across Texas to make sure there are enough access points to COVID-19 vaccines. Facilities can also request dry ice from the state to help store vaccines, a spokesperson for the department wrote in an email Monday.

DSHS said it also plans to be strategic in using the Pfizer and Moderna vaccines.

“For locations that can vaccinate 1,000 people in five days, they would not need to keep the vaccine in a deep freezer,” the DSHS spokesperson wrote. “With Moderna’s vaccine being stable under refrigerated conditions for 30 days, it allows the state to allocate the vaccines more easily to rural areas that may not have the ultra-cold storage.”

FILE – In this Monday, July 27, 2020 file photo, a nurse prepares a shot as a study of a possible COVID-19 vaccine, developed by the National Institutes of Health and Moderna Inc., gets underway in Binghamton, N.Y. (AP Photo/Hans Pennink)

Additionally, the department said it is encouraging partnerships at the local level for those providing vaccines who have the ultra-cold storage capacity to coordinate with communities to help provide vaccines.

DSHS also plans to have a specialized vaccine team which will go directly to areas that might not have access to vaccines. Communities can request specific help from the DSHS vaccine team here.

Implications in the Austin area

In the Austin area, Austin Public Health said it is part of a local vaccine coalition with members from Williamson, Hays, Travis and Bastrop Counties, as well as state organizations.

“With those relationships we’ve built, for example with Bastrop County, we are planning very closely with them, because they are a smaller county [and] they right next to us, it’s going to be important for us to continue those conversations,” said APH Director Stephanie Hayden noted at a media briefing Wednesday.

Austin Public Health hosted a flu vaccine event on Nov. 7 at the Travis County Expo Center, as “practice” for distributing a future Covid-19 vaccine. (Photo: Austin Public Health and the City of Austin)

Hayden added it is still unclear what amount of the vaccines cities and counties will receive.

“We can never anticipate exactly how much we are going to receive, but we will be ready to provide the vaccine to our community with our partners,” Hayden said.

APH told KXAN its expectation is that COVID-19 vaccines will be rapidly distributed to “priority populations.”

“Providers are expected to have cold storage facilities on site if longer-term storage is needed,” APH said.

APH noted there are 133 COVID-19 vaccine providers in Austin-Travis County enrolled with DSHS. Some of those providers have shown they have ultra-cold storage and most have demonstrated they have cold storage capacity, APH said.

Cold storage conundrum

Pharmacy Professor Dr. Robert Williams III at the University of Texas at Austin has been working on a technology to turn frozen drugs into a powder that can be inhaled. The technology he is working on is called thin film freezing, and company TFF Pharmaceuticals Inc. has acquired the patents regarding thin-film freezing and inhalation. Together Williams and TFF have been able to publish several papers on vaccine antigens and more recently they have moved towards what he calls “solving the cold-chain requirement” for mRNA vaccines.

When the COVID-19 pandemic hit, Williams said he was able to pivot his lab’s research on thin film freezing and apply what they had been studying to coronavirus response, including looking at applications for niclosamide and remdesivir. Williams’ lab also applied this technology to COVID-19 vaccines.

Williams explained for the Pfizer and Moderna vaccines, which are mRNA vaccines, the mRNA protein is not stable at room temperature conditions. So when those vaccines are in liquid form, he said, they need to be kept frozen and have a relatively short shelf life of use.

“The problem for these types of vaccines is the active ingredients—they’re very unstable protein materials,” Williams told KXAN, explaining instability is also why the vaccines must be kept so cold. “And so we thought there would be a stability issue, and hence, we started applying our technology to try and anticipate that.”

Thin film freezing to turn those vaccines into a powder form would eliminate those cold temperature requirements, Williams said. But that powder technology isn’t ready to be applied to COVID-19 vaccines just yet, Williams views it as something that could be used during the second generation of COVID vaccines that come out in the following years.

Vaccines like the ones from Pfizer, Moderna and AstraZeneca need to be used as soon as possible, Williams emphasized.

Urban areas of Texas, Williams believes, can probably handle distributing vaccines with cold storage requirements “without too much trouble.”

“It’s costly but we can do it,” he said. “But you start getting out to small rural areas where, you know, the case of the vaccine comes in and its in a dry ice storage kit that has a shelf life of just a few days, then the distribution has to be such that patients are lined up basically ready to be vaccinated as that cold vaccine is thawed to room temperature.”

State leaders, Williams said, will have to plan accordingly once they learn which vaccines are approved by the FDA and adjust for the requirements of those specific vaccines.

He noted these varying storage requirements will make things, “confusing, not only for the initial vaccination, the Day 0, but also either day 21 or day 28 for the second required dose for each person.”

“From a logistical standpoint, that is the challenge, but I have complete confidence in our state leaders that we can do it, we have an infrastructure to be able to do it,” he said.

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