COVID-19 Vaccine Distribution Challenges Loom Large

As the race for COVID-19 vaccines intensifies, the unprecedented problems of distributing them once they get regulatory approval are coming into focus — including the need for refrigeration throughout the supply chain.

Hundreds of millions or even billions of doses will have to be shipped at ultra-cold temperatures at a time when passenger air travel, which vaccine manufacturers often piggyback on, is in an unprecedented slump.

The logistical challenges are an immediate concern for the governors of all 50 states who received a recent letter from Centers for Disease Control and Prevention Director Robert Redfield urging them to be prepared to distribute a COVID-19 vaccine by Nov. 1. (DID, Sept. 3).

Since  mid-August, the CDC has been holding weekly calls with state health officials about vaccine distribution and has completed pilot programs in California, Florida, North Dakota, Minnesota and the city of Philadelphia that will be used as models in other states.

Some infrastructure matters need addressing urgently, including airline capacity, temperature-controlled shipping containers, airport cold-chain capacity, refrigerated trucks, proper ground- handling processes and employee training, Neel Shah Jones, global head of air carrier relationships at the freight forwarded, Flexport, told FDAnews.

Nearly half of global air freight flies in passenger jet bellies. But with global passenger travel down 85 percent in June 2020 year-over-year and a full recovery not expected until 2024, “we anticipate severe capacity issues for the next 18 to 24 months at a minimum,” Jones said.

“There are limits on the amount of dry ice allowed on aircraft, so it’s important to plan the necessary flight capacities,” Larry St. Onge, president, global sector-life sciences and healthcare at international shipping company DHL, said.

Certain critical points in the pipeline will pose the hardest challenges for the temperature requirements of several of the COVID-19 vaccines. “The most vulnerable time for high-value shipments like vaccines is when they’re between the plane and airport cold-storage facilities,” Jones said. “Any variance in temperature or handling instructions could ruin the entire shipment. In the U.S. alone, we’ve got well over half a billion vaccines that will need to be handled with such care. This means that airlines and freighter companies must be in close communication with airports and ground handling operations leaders to ensure a swift, safe shipment.”

The cold storage and shipment problems are particularly challenging since some of the vaccines will require temperatures as low as minus 80 Celsius (minus 112 Fahrenheit) to remain effective.

A UPS spokesperson told FDAnews the international shipping company is prepared for such challenges. “We have extensive warehousing, distribution and cold-chain logistics services,” he said.

“The lesson for us was to start preparing for a vaccine and its potential distribution right away and we started working on this within 30 days of the global pandemic lockdown,” DHL’s St. Onge said.

He pointed to the need for “a highly coordinated approach” when shipping temperature-controlled vaccines. Some of the requirements, he said, are “intimate knowledge of the minute details, such as packaging, storing, air and land routing, timing, carrier selection and specific handling requirements.

Flexport’s Jones agreed. “I can’t emphasize the importance of cross-industry collaboration enough,” he said.

The UPS clinical subsidiary, Marken, is already working working with several pharmaceutical companies and their partners while their vaccines and treatments are in clinical trials. “Our involvement in the clinical phase provides us with close-hand knowledge of how to manage the logistics for these complex products,” the UPS spokesperson said. — Martin Berman-Gorvine