U.S. Distribution Plans Still Murky for Pfizer COVID-19 Vaccine

Distribution plans for the Pfizer-BioNTech COVID-19 vaccine in the U.S. remain an enormous question mark as an initial roll-out of mass vaccination gets under way in the UK.

The White House has pledged that deployment of the vaccine to the states for distribution will begin within 24 hours of an Emergency Use Authorization from the FDA, which could come as early as this weekend.

“The Pfizer vaccine presents a tremendous challenge in that it needs to be stored at minus 70 degrees Celsius, but it’ll be using its existing supply-chain capabilities to deliver the vaccine to state health authorities, who will then coordinate the final distribution and vaccination plan,” Neel Jones Shah, global head of air carrier relationships at Flexport, a freight forwarder, told FDAnews. “Pfizer’s roll-out is predicated on its existing, robust cold-chain infrastructure.”

“Over the past six months, collaboration has proven key to improving global cold-chain capabilities,” added Jones Shah, who is part of the International Air Cargo Association’s COVID-19 task force. “For example, dry ice was once thought to be a massive blocker in vaccine distribution, but airline manufacturers and carriers coordinated to find the revised limit of dry ice transportation, increasing the limit by about six times and enabling a much larger quantity of vaccine to be transported.”

Flexport is not directly involved in moving COVID-19 vaccines but will likely provide support in moving the ancillary equipment, such as vials, syringes and personal protective equipment (PPE). Jones Shah led Flexport’s air freight strategy in moving more than 400 million units of PPE earlier this year to combat COVID-19’s spread.

Hundreds of millions or even billions of doses of any approved COVID-19 vaccines will have to be shipped at a time when passenger air travel, which vaccine manufacturers often piggyback on, is in an unprecedented depression because of the pandemic, Jones Shah told FDAnews in September (DID, Sept. 11).

In a recent statement on the matter, Pfizer said Nov. 16 that it had begun a pilot program with Rhode Island, Texas, New Mexico, and Tennessee, “to help refine the plan for the delivery and deployment of the company’s COVID-19 vaccine candidate that is being co-developed with BioNTech… [and] better support the states’ planning, deployment, and administration of the COVID-19 vaccine candidate (DID, Nov. 18).”

And on Tuesday, Pfizer told FDAnews “we seek to work with governments to support distribution to their defined priority groups.”

BioNTech and the Department of Health and Human Services, which is responsible for Operation Warp Speed, did not reply to requests for comment. — Martin Berman-Gorvine