Pfizer had already made it quite clear that it doesn’t need the U.S. government to help distribute its COVID-19 vaccine, should it be authorized by the FDA. Now it’s putting an exclamation point on that declaration.
The company will not use the government’s chosen distribution partner, McKesson, but rather its own system to deliver the COVID vaccine directly to healthcare providers, said Tanya Alcorn, Pfizer's vice president for biopharma global supply chain, during a recent webinar from the U.S. Chamber of Commerce. A Pfizer spokesperson confirmed that plan in an email to FiercePharma.
Late last month, Pfizer outlined an ambitious vaccine distribution effort centered on sites in Michigan and Belgium. Because the mRNA vaccine has be stored at minus 94 degrees Fahrenheit, the plan includes shipping containers that can keep doses at that temperature for 10 days. And the company has lined up additional locations in Wisconsin and Germany for storage.
"Our distribution model as agreed with the U.S. government is built on a flexible just-in-time system which will ship the frozen vials directly from our plants to the point of vaccination," the Pfizer spokesperson said. Thus "our distribution will be direct from Kalamazoo to point-of-use (POU), or our distribution center at Pleasant Prairie, WI to the points of vaccination or equivalent location."
The need to keep the vaccine at an ultra-cold temperature means Pfizer must monitor its shipments closely, Alcorn said during the webinar. The company developed real-time GPS capability that will report any temperature deviations, for example. And its distribution system further reduces the chance of the vaccine losing potency before it’s given to patients.
Pfizer is under pressure from all sides to make its COVID-19 vaccine rollout a success. With interim data from a phase 3 trial yet to come, the company already has a $1.95 billion deal with the U.S. government to supply up to 100 million doses of its candidate vaccine, BNT162b2. Pfizer has vowed to distribute 40 million of those doses before the end of the year.
During an earnings call late last month, Pfizer CEO Albert Bourla predicted an interim analysis of trial data would take five to seven days after the data become available, which could have made a report possible this week. But the data still has not yet arrived, casting doubt on the company’s earlier projection that it could file for emergency use authorization in the third week of this month.
The U.S. government assigned McKesson to work with the Centers for Disease Control and Prevention on a COVID-19 vaccine distribution plan back in August. McKesson has some experience handling pandemic responses: The Obama administration tapped it back in 2009 to distribute vaccines to combat the H1N1 flu outbreak.
Still, the cold-storage requirement would be a challenge for any distributor. And it’s not just Pfizer facing that hurdle; Moderna’s mRNA vaccine will need to be stored at negative 4 degrees. Moderna CEO StéphaneBancel predicted during an October event that his company wouldn't seek emergency use authorization from the FDA before November 25. The company is aiming to be ready for widespread distribution of the COVID vaccine next spring.