The United States has experienced its first obstacles in delivering COVID-19 vaccines–the recent distribution effort to deliver nearly 4,000 vaccinations to two states saw a concerning holdup. Additionally, Pfizer Inc. had to announce that it would be distributing a million fewer doses than were intended to ship that particular week.
In mid-December, Alabama and California had four Pfizer-BioNTech SE vaccine delivery trays removed from delivery. These doses were returned back to Pfizer, as they had arrived at a colder temperature than was necessary, explained Operation Warp Speed’s chief operations officer, Gustave Perna.
Pfizer indicated that its vaccines must be stored at exactly 70 degrees below zero Celsius, or 94 degrees below zero Fahrenheit. These four trays were much colder than this required temperature, Perna explained, which ended up becoming quite a loss. Each of these trays would have held enough doses to vaccinate 975 people.
“We were taking no chances,” said Perna, noting that there is still research being done by federal health agencies alongside Pfizer to understand whether or not a dose can still be safely and effectively used after reaching lower-than-intended temperatures.
In addition to this unexpected loss of vaccines, Pfizer was only able to allocate around 2 million doses throughout the United States, down from the nearly 3 million that were allocated the week prior during the initial shipments of the vaccinations.
These are not the first distribution or production difficulties seen by Pfizer in regards to COVID-19 vaccine doses, explained Department of Health and Human Services secretary, Alex Azar.
“As you know, they ended up coming [up] short by half of what they thought they’d be able to produce and what they’d announced they’d be able to produce,” during 2020, he said. “They’re, right now, producing at their maximum capacity to deliver on the 100 million that is in the first tranche of the contract with us, and we’re providing manufacturing support.”
Recently, Ron DeSantis, Governor of Florida, noted that his state hadn’t yet received the hundreds of thousands of vaccines that had been promised because of a “production issue with Pfizer.”
However, in response to DeSantis’ statement, a Pfizer company spokeswoman said that Pfizer “has not had any production issues with our COVID-19 vaccine, and no shipments containing the vaccine are on hold or delayed. We are continuing to dispatch our orders to the locations specified by the U.S. government.”
Interestingly, Pfizer refused any development or research money from Operation Warp Speed when developing the vaccine, although other vaccine developers did. Therefore, U.S. government officials have not had nearly as much oversight or knowledge in regards to Pfizer’s vaccine production as they may have preferred.
“The relationship that Pfizer wanted with Operation Warp Speed was the guaranteed purchase of a vaccine if approved by the FDA,” said Azar. “To date, we have had less visibility into their manufacturing processes, their manufacturing capacities, their locations, supplies, raw material issues, supply chain management, than we do with [other companies],” such as AstraZeneca, Johnson & Johnson, and Moderna Inc.
However, Azar assures that the Department of Health and Human Services has made it a priority to boost its insight and involvement with Pfizer’s efforts, as well as with the obstacles Pfizer may encounter during both the production and distribution processes.
“Part of our ongoing discussions is to remediate that and get better visibility into what they’re doing [and] what challenges they’re facing, because they’ve made significant commitments to us and others in their manufacturing,” Azar explained.
Pfizer was the first vaccine manufacturer to gain emergency approval from the U.S. Food and Drug Administration, allowing for immunizations to begin taking place in early December.
Operation Warp Speed gained 100 million doses of Pfizer’s vaccination in December–each dose consists of two separate shots for each patient. Operation Warp Speed has also noted that it planned to acquire enough vaccines to provide to 20 million Americans in December and many more in January from the doses it contracted between both Pfizer and Moderna Inc.
For more information regarding Operation Warp Speed and the availability of COVID-19 vaccinations, click here.