In a few weeks, if all goes well with FDA reviews and approvals, Pfizer’s Covid-19 vaccine will begin to be administered to healthcare workers in the US, followed by Moderna’s. We will immediately begin hearing about, on the one hand, well-connected people of any background getting the vaccine, and on the other hand, people saying there’s no way they’ll allow a rapidly developed vaccine approved by a suspect process of the current administration to enter their veins. Fast forward a year or so, and a variety of vaccines will be available at multiple outlets (hospitals, pharmacies, doctors’ offices), and the campaigns to encourage more vaccinations will begin to get boring.
Between now and then, vaccine makers, governments and contract logistics providers will be making multiple choices over how to move the vaccines from their manufacturing sites to the point of dispensing, across the US and around the world. Already, some outlines of this process are beginning to emerge, based on various press sources.
On Nov. 27, the Wall Street Journal reported that United Air Cargo is beginning to ship Pfizer’s vaccine from sites in Kalamazoo, MI, and Puurs, Belgium. Pfizer has opted to perform its own distribution, sidestepping both the US military’s management of distribution (under Operation Warp Speed) as well as the contract let to McKesson Corporation, the US’ leading wholesaler-distributor, by the Centers for Disease Control and Prevention (CDC). Pfizer, according to multiple press reports, is also avoiding the use of active (powered) air freight containers that can ship pallets worth of drugs under temperature control. Rather, it has opted for case-level passive packaging, loaded with dry ice—perhaps to take advantage of the simplified next step in distribution, to move these cases from, say, an airport warehouse to multiple dispensing points. (Delivery of a pallet would necessitate breaking down the pallet to individual cases, along with potentially requiring repackaging.)
Pfizer’s vaccine requires storage at -70 °C (-94 °F); Moderna’s at -20°C (-4 °F); both are well below the conventional 2-8 °C (35.6-46.4 °F) setpoint for refrigerated pharmaceuticals.
United Air Cargo, according to the WSJ, has requested an exemption from an FAA requirement to limit the amount of dry ice on an aircraft; this limit exists because the carbon dioxide gas emitted from warming dry ice is a hazard to breathing. Wide-body aircrafts have a limit of 1,088 kg (2,399 lb) of dry ice typically, according to a DHL analysis, “Delivering Pandemic Resilience”; FAA will allow United to carry 6,804 kg (15,000 lb).
More to come
Depending on who’s counting, and the global location, there are well over 100 Covid-19 vaccines in development; and about a half-dozen in clinical trials expected to be reviewed by FDA for the US market. These include others based on mRNA; viral-vector vaccines; protein fragments (of the coronavirus); and deactivated coronavirus itself. Leading candidates include a viral vector type from AstraZeneca and Oxford University, and a similar one from Johnson & Johnson.
J&J received a $1 billion-contract from the US government for its 100 million doses of its vaccine, now in a Phase III trial. There are two potential advantages to the J&J route: a single dose (rather than the two required by Pfizer and Moderna); and 2-8 °C (35.6-46.4 °F) storage and shipping.
Luis Roman, global VP of delivery at J&J’s Janssen subsidiary, says the company is already well along in establishing manufacturing locations, warehousing and shipping for its vaccine. The vaccine is fill-finished at a Catalent facility in Wiley, IN, and Leiden, Netherlands; other “nodes,” as he puts it, are in the works. “We are leveraging the clinical capabilities of our logistics partners as we prepare for the commercial distribution,” he noted. The company has committed to 600 million dosages by the end of next year, with half of that committed to the US market. The current Phase III trial has 60,000 participants.
The 2-8 °C (35.6-46.4 °F) temperature requirement of the vaccine will allow the company to utilize standard containers and storage measures for refrigerated pharmaceuticals. In addition, the company is planning to track distribution with “real time location tags” on final packages (this implies use of RFID technology, although Roman would not confirm that).