- The rollout of Pfizer and BioNTech's coronavirus vaccine in the U.S. has had several hiccups this week, with several thousand doses diverted after getting too cold and growing confusion between the federal government, states and Pfizer over how many doses are being delivered, and when.
- Earlier in the week, the temperature of four trays of vaccine doses, shipped to California and Alabama, dropped about 10 degrees Celsius lower than the specified range before delivery, leading to those doses being returned and replaced, Gen. Gustave Perna, who heads operations for the U.S.' Operation Warp Speed initiative, said Wednesday.
- By Thursday, several states indicated they were being told by Operation Warp Speed to expect fewer doses than they had originally anticipated in the next round of shipments. In a statement Thursday, Pfizer denied having any production issues, and said "millions more doses" were sitting in its warehouses without instructions on where they should be sent.
The Food and Drug Administration's authorization of Pfizer and BioNTech's vaccine last Friday launched a nationwide push to ship millions of doses rolling off the drugmakers' production lines to all 50 U.S. states and territories.
The effort is complicated by the many players involved — with Pfizer relying on carriers like UPS to send doses to sites chosen by state and federal officials — and by the extremely cold temperature at which doses need to be kept.
Encased by dry ice, doses are shipped and stored at temperatures between minus 60 and minus 80 degrees Celsius. The Food and Drug Administration and the Centers for Disease Control and Prevention are working with Pfizer to determine if the vaccines are safe after reaching colder temperatures, as happened to the four trays sent to California and Alabama.
"As you can imagine, the risk of a dry ice shipment ... going too low due to outside factors is effectively impossible," Volker Kirchner, director of Temperature Control Solutions at World Courier, said in an email.
Shipments becoming too cold is more common for those kept between 2 degrees Celsius to 8 degrees Celsius, Kirchner said, noting this range is "where temperature control really turns into an art and a science."
Perna, who leads Operation Warp Speed along with Moncef Slaoui, disclosed the shipment issues Wednesday after successful distribution and vaccination had taken place across the country. Perna said he expected vaccine doses would be delivered to 886 more locations on Thursday.
"It's a constant flow of vaccine always expanding the distribution network in every state that we're really going for," he said.
But some states are now saying they're being told to expect less than they anticipated. Florida Gov. Ron DeSantis, for example, said a "production issue" could result in the state getting fewer than the 452,000 doses it expected.
"Pfizer is not having any production issues with our COVID-19 vaccine, and no shipments containing the vaccine are on hold or delayed," Pfizer said in a statement.
"This week, we successfully shipped all 2.9 million doses that we were asked to ship by the U.S. Government to the locations specified by them. We have millions more doses sitting in our warehouse but, as of now, we have not received any shipment instructions for additional doses," the company added.
Health and Human Services Secretary Alex Azar has suggested otherwise, telling reporters on Wednesday "the core issue ... is Pfizer's ability to manufacture by a date certain."
Azar also noted Operation Warp Speed has less visibility into Pfizer's production process than other vaccine manufacturers, as Pfizer declined to accept federal funding for its vaccine development and manufacturing.
Operation Warp Speed determines the allocations of vaccine doses to states, information which it then communicates to Pfizer. The drugmaker ships to sites specified by state health officials.
Operation Warp Speed's ability to track the temperature of vaccine doses and intervene is through a technology platform called Tiberius designed specifically for the rollout process. The platform incorporates data from manufacturers, logistics partners, states, Census, and supply information on kitting and syringes.
UPS President of Global Healthcare Wes Wheeler said last week that UPS would send data from its trucks to Operation Warp Speed for shipment tracking. Information is gathered from a label on the shipment with radio beacons transmitting the location, a GPS tracker in the trucks that provides temperature and light exposure data, and data from Pfizer's package.
"All that data streams into our command center, and we transmit that data to Operation Warp Speed," Wheeler said. "So, we were all watching the packages all day long."
A Pfizer spokesperson noted the company has strict quality control measures in place for the vaccine. By monitoring real-time location and tracking temperature at all times, Pfizer can step in when it sees a shipment has fallen outside of the desired temperature range.