Vaccine distribution poses many challenges

Ample ultra-cold storage just one issue facing distribution of 20M doses

Some are bigger than the fridge in your kitchen. Others are as small as the cooler you lug to the beach.

They’re way colder than the Arctic, in extremely high demand and absolutely essential for getting the first wave of some coronavirus vaccines — “the proverbial light at the end of this very long, dark tunnel,” as Gov. Gavin Newsom said — from the manufacturer into the bodies of those who need protection.

Most of these specialized freezers cost $7,000 to $15,000 each, with the most imposing models topping out at $26,000 — and California governments and health care providers are snapping them up as they lay the complex groundwork for a massive COVID-19 vaccination campaign that, they hope, marks the beginning of the pandemic’s end.

“We’re seeing a very significant surge in orders — a 50 percent increase over January — with very significant backlogs that we’re trying to address,” said Dusty Tenney, CEO of Stirling Ultracold in Ohio, which makes freezers that can keep Pfizer’s vaccine at minus-80 degrees Celsius, an unusually cold temperature for a vaccine, and Moderna’s at a more common minus-20 degrees Celsius.

“Every day is a fast-and-furious kind of day,” said Tenney. “It’s dynamic, it’s energizing and it has a purpose: making sure the vaccines get to where they need to go so they remain viable and have the efficacy the manufacturers are out there touting.”

California and its counties have been quietly working on the daunting logistics of vaccinating some 40 million people since April, lining up vaccine providers, prepping data systems for tracking who gets which shots and when, and designing public information campaigns to ease concern in diverse communities.

They’re wrestling over exactly who, in priority populations, should have priority. They’ve as

sembled a team of scientists to double- check the FDA’S work when vaccine approvals finally come. And, as of late, they’re grappling with potentially problematic “cold-chain storage” issues, necessitated by the innovative messenger RNA technology used by both Pfizer and Moderna to fuel the fastest vaccine rollout in history.

The two companies say they can produce 70 million doses by the end of the year, with Pfizer responsible for the bulk of that. That should allow states to begin to vaccinate those at highest risk — California, like most states, will start with health workers — but most of us probably won’t get our shots until the middle of next year.

“On paper, California’s plan is very robust,” said Josh Michaud, associate director for global health policy with the nonprofit Kaiser Family Foundation, which

examined 47 state vaccine rollout plans. “There’s a structure in place that is quite comprehensive, with multiple task forces of experts looking at multiple areas of vaccine distribution that have been meeting for months already. But California is in the same boat as every other state. It’s not 100% able to make decisions about how this will actually play out because specific vaccines haven’t been approved yet.”

The task looms larger because California is a massive state with a massive and diverse population. It must launch a communications plan that addresses people’s hesitancy about the vaccines — and prepare for those cold- chain issues. “If the Pfizer vaccine is the only game in town for a while, those freezer capabilities will really loom large,” Michaud said.

Other vaccines, still at an earlier stage of development and employing a different technology, will not need cold storage when they become available likely in mid2021.

Richard Carpiano, a public health scientist and medical sociologist at UC Riverside, was duly impressed with the state’s planning. “It’s heartening to see that they’re really thinking about the details of dissemination and planning and coordination, but no battle plan ever survives the first shot,” he said. “Your boxing strategy changes as soon as you get punched in the nose. That’s the reality of policy.”

Cold chain

The day after a vaccine is approved by the FDA, it will be shipped far and wide, and within a day after that, “we’ll be seeing those vaccines injected into Americans, with a particular focus on those most vulnerable and those that are providing health care to the American people,” Vice President Mike Pence said at a Thursday briefing. Those first doses are expected in California, and everywhere else, in mid- to late December.

“It’s relatively simple,” said U. S. Army General Gustave F. Perna, who’s

overseeing distribution. “We take the Pfizer vaccine. They are capable of distributing on their own; they will utilize Fedex and UPS in order to execute distribution. Simultaneously, we will ship ancillary kits — needles, syringes, alcohol wipes, and the diluent required for the vaccine — to meet the vaccine at the end-state facilities.”

For the Moderna vaccine, the federal government will “meet up” vaccine with ancillary kits at a distribution warehouse, put them together, then distribute via Fedex and UPS to local administration sites. That’s expected to include state and county health departments, as well as local health care providers. And that’s where cold- chain issues hit home.

“We are currently working on improving our preparedness for cold- chain management, as this area has proved problematic in the past,” California told the U.S. Centers for Disease Control in its vaccine rollout plan.

While local health de

partments have experience handling refrigerated vaccines, they have little experience with frozen vaccines and no experience with ultra-low temperature vaccines, the state said. Few have capabilities for frozen storage or transport of vaccines from a central storage facility to actual injection sites, and about half have plans to purchase or lease additional cold- chain storage equipment.

“If the vaccine requires frozen or ultra- cold- chain storage and transport, and if enrolled providers cannot meet this requirement, (the California Department of Public Health) will need to assist local health departments with cold chain,” the state told the CDC.

The state is conducting training webinars for local health authorities on coldchain management, providing weekly informational briefs on storage and handling, and purchasing ultralow temperature freezers of its own to create backup storage capability for emergency use, the department said.

Ramping up

Counties are where the nitty-gritty of the vaccination effort will unfold, and they’re formalizing plans and placing orders.

“Alameda County is planning vaccine distribution with an equity lens to ensure that high-risk and highly impacted populations are prioritized,” said Neetu Balram, spokeswoman for the Alameda County Public Health Department. “We will work closely with health care providers across the county, and seek input from community providers and representatives of priority populations and neighborhoods. The goals of our stakeholder engagement are to build trust with communities, provide accurate and timely information, ensure equitable distribution, and increase uptake of vaccine.”

Community flu clinics are practice models for figuring out what’s needed for mass COVID-19 vaccination, Balram said, and it will leverage that experience for COVID-19 vaccine storage and handling and distribution.