A last-minute snafu this fall threatened to disrupt the smooth rollout of the first Covid-19 vaccine approved in the United States, according to industry officials.
At issue was how to monitor the temperature of the ultra-cold storage containers being used to distribute vials of the vaccine developed by Pfizer and its partner BioNTech. Pfizer, the officials told STAT, planned to disconnect temperature-monitoring sensors on the containers once they were delivered to health care providers — though many of the providers needed to use the boxes to store the vials for up to 30 days. Without the monitoring systems, providers would have no way of knowing if the vials had thawed prematurely, rendering the vaccine unusable.
In the end, the U.S. government’s Operation Warp Speed scrambled to address the problem, signing a $25 million deal in mid-November with Controlant Global, an Icelandic company that created the proprietary temperature-monitoring platform for all Pfizer’s shipping containers. Under this agreement, Pfizer will discontinue its temperature monitoring once the boxes arrive at their destination, and the federal government will simultaneously turn the system back on.
Still, the episode highlights how, in the frenzy to get a vaccine to the public, details crucial to its distribution were overlooked until late in the game. And it reflects how, despite efforts to protect vaccine makers from liability, legal concerns are shaping their actions. Experts said concerns over legal action, as well as bad publicity if vaccine doses were lost to thawing after delivery, likely drove Pfizer’s thinking.
Pfizer is shipping its vaccines in special containers packed in dry ice to keep them at the required minus-70 degrees Celsius. As few freezers get that cold, many health systems are using these containers to store the vaccines after they arrive. Premier, a group purchaser for U.S. hospitals, said that it asked Pfizer in November to reconsider its decision to disconnect the sensors, and that for weeks, health care providers sought to clarify whether they would need to purchase their own temperature sensors.
“These vaccines need to be maintained at a specific temperature to ensure they stay viable. When holding vaccines in a cooler and refreshing with dry ice, it’s hard to know if you’re maintaining the temperature,” said Jessica Daley, vice president of strategic supplier engagement at Premier.
It’s fairly unusual for temperature-monitoring devices to go to ultra-low temperatures, and Daley said there weren’t enough alternatives available to replace those that Pfizer turned off. It was only in early December that Premier and providers learned that Operation Warp Speed (OWS) had resolved the problem, said Premier’s director of advocacy, Soumi Saha.
Neither Pfizer, Controlant, nor the Trump administration would explain exactly how the monitoring handoff works. “Pfizer will de-activate the temperature monitor on their shipping container once they are delivered. Operation Warp Speed contracted with the manufacturer of the device to immediately re-activate it with no loss of temperature monitoring and no loss of data,” Natalie Baldassarre, a spokeswoman for the Department of Health and Human Services, said in a statement.
The contract makes clear that OWS had little choice but to pick up responsibility. “As Pfizer will only monitor the temperature through transportation and up to Government acceptance, the Government requires the ability to monitor the vaccine … until the vaccine has been utilized and the shipping containers returned to Pfizer,” reads the contract.
Operation Warp Speed only started market research into temperature-monitoring for the boxes on Nov. 9, according to the Controlant agreement, though the government signed a $1.95 billion contract with Pfizer to provide 100 million doses of the vaccine in July.
The late-stage contract with Controlant suggests that this issue wasn’t fully thought through when the U.S. government signed the contract with Pfizer, said Ameet Sarpatwari, assistant professor of medicine at Harvard Medical School.
“Somewhere the ball got dropped,” he said. “Instead of turning off [the monitoring system], turning back on, it could have just been a continuous process. From a safety standpoint, that seems to be a better way to go.”
He said the original contract with Pfizer could have left room for discussions over who would have oversight of maintaining the ultra-cold temperatures. “A bit more of a systematic process that included transparency could have secured input from others that would have shown some details were insufficient with this contract,” said Sarpatwari. “Rather than being forced upon us, it could have been a decision of how we want to allocate that burden.”
Pfizer did not respond to requests to explain why it decided to disconnect the remote temperature monitoring devices. The company “is working very closely with Operation Warp Speed (OWS) on ensuring a temperature monitoring solution for points of uses if our thermal shipper is the chosen method for frozen storage,” spokesperson Amy Rose wrote in an email.
The problem is unique to Pfizer’s vaccine. The Moderna vaccine expected to receive emergency authorization later this week can be stored in most standard freezers, and is stable for 30 days at refrigerated temperatures. Only Pfizer’s shot requires such ultra-cold storage that doses will be kept in the containers they’re shipped in.
Neither the U.K. nor Canada has faced the issue yet. In both countries, the first Pfizer vaccines are being sent to sites equipped with ulta-cold freezers, so the shipping containers will not be used for storage after delivery.
In the U.S., once Pfizer had a signed supply contract with OWS, there was no reason for the company to go beyond what the terms require, said bioethicist Arthur Caplan, of New York University. “There’s way too much risk there, which they don’t need,” said Caplan. “If I’m Pfizer, I’ve sold my vaccine, I’ve made it, I’ve shipped it to where you told me, I’m not in the rest of these businesses, and I don’t care.”
Vaccine manufacturers and distributors are protected from liability claims under the Public Readiness and Emergency Preparedness (PREP) Act. But several experts say that, despite these protections, Pfizer may well have acted from a fear of repercussions.
“How much can Pfizer do? They don’t have their staff there,” said Mark Capofari, who was director of global logistics at Merck from 1995 to 2007 and currently lectures on supply chain management at Penn State University. “I don’t know if any company would want to be liable from that point forward.”
Given the lack of control Pfizer has once a vaccine reaches its destination, continuing to monitor temperature would bring unnecessary added risks. “It’s the job of the lawyers to anticipate potential claims,” said Dorit Reiss, law professor at the University of California, Hastings College of the Law, whose research focuses on vaccines.
Efforts to avoid liability tend to create inefficiencies and slow down the process, which the PREP act was intended to mitigate. The plan to change ownership of the temperature monitoring system “is only going to lead to disruptions and problems,” said Lawrence Gostin, a professor of global health law at Georgetown University. “It’s not efficient and reliable. And it’s unnecessary.”
Concerns over its public image could also have pushed Pfizer to disentangle itself from temperature monitoring at the final stage of vaccine storage. The company has garnered tremendous positive publicity through its quick development of a Covid-19 vaccine, and has an interest in protecting this reputation. “There could be publicity issues,” said Robert Field, professor of law and health management and policy at Drexel University. “If they’re concerned problems could occur at the end point, the pharmacy or wherever injections occur, they wouldn’t want to be associated. They may feel it’s not in their comfort zone, that’s not their expertise.”
Companies are naturally risk-averse and, having created a vaccine, there’s little benefit to Pfizer in continuing to keep track of vaccine storage standards beyond the delivery date. “It’s wiping your hands of accountability. You don’t want to be blamed legally or publicly, you don’t want to be held accountable and so push it over to some other entity, in this case the government,” said Gostin. “History teaches us that companies will try to protect themselves and the bottom line at any cost. Any time they can push off responsibility, whether it’s to a government or a hospital or private hospital or to a doctor’s office or pharmacy, they will.”