Feds on COVID-19 mRNA vaccine distribution: Pfizer's dry runs predict a 'very doable process'

What will it take to distribute the first 6.4 million doses of Pfizer’s COVID-19 mRNA vaccine, if all goes according to plan and they ship in mid-December?

Alex Azar, secretary of health and human services, acknowledged during a press conference Tuesday that the logistics—which include the need for ultra-cold storage—will be far from easy. But Azar and two other top officials running the government’s Operation Warp Speed effort to speed COVID-19 vaccine distribution did their best to boost the public’s confidence.

The FDA has scheduled a meeting to review Pfizer’s vaccine on December 10, and if it’s authorized as expected, it could start shipping within 24 hours, Azar said. In addition to speeding the vaccine to healthcare workers, “CVS Health has said they expect to be vaccinating residents of nursing homes, one of the top priority groups, within 48 hours of FDA authorization,” he said.

To pull off the ambitious plan, Warp Speed has enlisted Pfizer, which has been running “dry rehearsals” at more than 50 vaccine distribution sites across the country, said Gen. Gustave Perna, who is leading the effort, during the press conference. The company is running the sites through the process of receiving the vaccines, opening them, and administering them, even going so far as to create YouTube videos for staffers to consult along the way.

“As Pfizer has walked the administration sites through the execution, we see growing confidence in everybody,” Perna said. “I personally have gone through the process, and it is a very, very doable process.”

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It’s no wonder Pfizer is going out of its way to get vaccine distributors comfortable with its product. The vaccine has created a logistical challenge in that it must be stored and transported at sub-freezing temperatures.

Moderna’s COVID-19 vaccine, which could come soon after Pfizer’s, also requires cold storage, but at temperatures equivalent to that of a “freezer that is most commonly found in most pharmacies,” Perna said. The easier logistics associated with that product “will enable us to get to many places throughout the country…from inner city out to rural America.”

After COVID-19 vaccines are distributed to priority populations, the government will allocate what’s left according to a “population-based formula” that hinges on the number of adults in each jurisdiction, Azar said, adding, “We thought it best to keep it simple.”

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Whether large portions of the population will accept COVID-19 vaccines is clearly a matter of concern, both for Azar and Operation Warp Speed co-leader Moncef Slaoui. “Hopefully the majority of the U.S. will stay with an open mind in terms of accepting” vaccination, Slaoui said during the press conference. “Listen to all the data that will be shared transparently through the FDA reviews,” he urged.

Slaoui’s remarks came just days after trial data from a third vaccine candidate from AstraZeneca raised questions about efficacy. The company said that one of the dosing regimens was only 62% effective—a result that paled in comparison to the 95% efficacy bar set by Pfizer and Moderna.

Slaoui said AstraZeneca’s U.S. trial could generate more in-depth data soon, given the fact that the pandemic is raging again and “progressing so fast that it is very likely that not long from now…we may have enough evidence to assess the efficacy of the vaccine,” he said.

AstraZeneca has been touting the advantages of its vaccine over the mRNA contenders. It can be stored at normal refrigerated temperatures, easing the distribution logistics, for example. And AstraZeneca has promised to manufacture 3 billion doses of its mRNA vaccine in 2021—more than double what Pfizer and its partner BioNTech have said they could produce.