FDAnews
www.fdanews.com/articles/200243-faa-works-with-drugmakers-carriers-as-first-large-scale-air-shipment-of-a-vaccine-goes-out

FAA Works With Drugmakers, Carriers as First Large-Scale Air Shipment of a Vaccine Goes Out

December 1, 2020

The Federal Aviation Administration (FAA) confirmed that the first mass air shipment of Pfizer’s COVID-19 vaccine was carried out on Friday.

The vaccine shipment was delivered from Belgium to the U.S., HHS confirmed, but did not give specifics, citing the need to minimize “potential risk to delivery and distribution.” It was widely reported, however, that the cargo was a supply of Pfizer’s COVID-19 vaccine shipped from Brussels to Chicago’s O’Hare International Airport. Pfizer did not respond to a request for comment on the shipment.

The FAA said it is prioritizing cargo flights and helping drugmakers, air carriers and airport authorities to safely transport large quantities of dry ice needed to ship the Pfizer vaccine, among others.

“In addition to mitigating safety risks related to the safe transport of vaccines, the FAA is ensuring around-the-clock air traffic services to keep air cargo moving and prioritizing flights carrying cargo, such as vaccines, and personnel critical to the nation’s response to and recovery from COVID-19,” the FAA told FDAnews in a statement.

The agency noted that it assembled a vaccine air transport team in October to help with the safe and rapid shipping of coronavirus vaccines, some of which have special considerations because they must be stored at very low temperatures.

Pfizer’s vaccine must be shipped at the extremely cold temperature of -94 Fahrenheit (-70 Celsius), which poses logistical problems the government and the drugmaker have sought to address before full-scale distribution begins, assuming the candidate receives Emergency Use Authorization.

AstraZeneca’s vaccine candidate is facing a possible delay over uncertain efficacy results because of a dosing error may be further evaluated in a new trial (DID, Nov. 30), also requires super-cold temperatures.

Moderna’s candidate, by contrast, requires temperatures of just -4 Fahrenheit (20 Celsius) and can be stored in a refrigerator for 30 days, meaning its distribution will be significantly easier than what is required for Pfizer’s and AstraZeneca’s vaccines.

An Operation Warp Speed official said last week that the government is ready to distribute Pfizer’s vaccine despite the potential difficulties posed by its temperature requirements, and the company has been vigorously testing its distribution strategy to ensure a smooth rollout (DID, Nov. 25). The drugmaker expects to make up to 50 million vaccines by the end of the year — enough to vaccinate 25 million — and up to 1.3 billion shots in 2021. — James Miessler