THE industry officials said the autumn last-minute snafu threatened to disrupt the first Covid-19 vaccine to be approved in the United States.
The question was how to control the temperature of the ultra-cold containers used to dispense vaccine vials developed by Pfizer and its partner, BioNTech. Officials, Pfizer told STAT, planned to separate the temperature control sensors from the containers after they were shipped to healthcare providers – although many providers had to use the boxes to store the vials for up to 30 days. Without monitoring systems, providers would not be able to find out if the vials had melted prematurely, making the vaccine unusable.
Eventually, the U.S. government’s Warp Speed operation tackled the problem, signing a $ 25 million contract with Controlant Global in Iceland in mid-November to set up its own temperature control platform for all of Pfizer’s transport tanks. Under this agreement, Pfizer will stop monitoring temperatures as soon as the boxes arrive at their destination, and the federal government will re-enable the system at the same time.
Nevertheless, the episode highlights that the madness of bringing the vaccine to the public neglected the details that were crucial for distribution until the game was late. And it reflects how, despite efforts to protect vaccine producers from liability, legal concerns shape their actions. Experts say Pfizer’s mindset was probably due to concerns about legal action, as well as poor disclosure if vaccine doses were lost after shipment due to thawing.
Pfizer supplies the vaccines in special dry ice containers to keep them at the required minus -70 degrees Celsius. Because few freezers get so cold, many health systems use these containers to store vaccines after they arrive. Premier, a group buyer of U.S. hospitals, said it had asked Pfizer in November to reconsider its decision to disconnect the sensors and that healthcare providers had been trying for weeks to find out if they would need their own temperature sensors.
“These vaccines need to be kept at a certain temperature to stay viable. If you keep fire extinguishers in a cooler place and refresh with dry ice, it’s hard to know if you’ll maintain the temperature, ”said Jessica Daley, vice president of Premier’s strategic supplier commitment.
It’s quite unusual for temperature monitors to go to extremely low temperatures, and Daley says there aren’t enough alternatives to replace those turned off by Pfizer. It wasn’t until early December that Premier and service providers learned that Operation Warp Speed (OWS) had solved the problem, said Soumi Saha, Premier’s director of advocacy.
Neither Pfizer, nor Controlant, nor the Trump administration explain exactly how the attention transfer works. “After delivery, Pfizer will turn off the shipping container temperature gauge. Operation Warp Speed has contracted with the device manufacturer to reactivate it immediately without temperature control and data loss, ”said Natalie Baldassarre, a spokeswoman for the Department of Health and Human Services.
The contract makes it clear that OWS had no choice but to take responsibility. “Since Pfizer will only control the temperature by shipping and until accepted by the government, the government requires the ability to control the vaccine … as long as the vaccine is used and the shipping containers are returned to Pfizer,” the contract said.
Operation Warp Speed did not begin market research for temperature control of cans until November 9, according to the Controlant agreement, although the government signed a $ 1.95 billion contract with Pfizer to provide 100 million doses of vaccine in July.
Controlant’s contract at a late stage suggests that this issue was not fully reconsidered when the U.S. government signed the contract with Pfizer, said Ameet Sarpatwari, an assistant professor of medicine at Harvard Medical School.
“The ball fell somewhere,” he said. – Instead of turning it off [the monitoring system], reconnected, it could only be an ongoing process. From a security standpoint, this seems like a better way to go. “
He said the original contract with Pfizer could have given way to discussions about who could oversee maintaining the ultra-cold temperature. “A slightly more systematic process that included transparency could have secured the input of others, which would have shown that some details were not enough with this contract,” Sarpatwari said. “Instead of being forced on us, he could have decided how we wanted to distribute that burden.”
Pfizer did not respond to a request to explain why it decided to turn off remote temperature monitoring devices. The company “works very closely with Operation Warp Speed (OWS) to provide a temperature control solution at the point of use if our carrier is the chosen method of frozen storage,” a spokeswoman Amy Rose wrote in an email.
The problem is unique to vaccinating Pfizer. The Moderna vaccine, which is expected to receive emergency approval at the end of the week, can be stored in most standard freezers and is stable for 30 days at refrigerated temperatures. Only a shot from Pfizer requires an extremely cold storage to keep the batches in the transported containers.
Neither the UK nor Canada has yet faced the issue. In both countries, the first Pfizer vaccinations are sent to sites equipped with ulta-cold freezers, so shipping containers are not used for storage after shipping.
In the U.S., after Pfizer signed a supply contract with OWS, there was no reason for the company to go beyond what the terms require, said bioethicist Arthur Caplan of the University of New York. “There’s too much risk they don’t need,” Caplan said. “If I’m Pfizer, I sold my vaccine, made it, shipped it to where you said I wasn’t in the other businesses, and I didn’t care.”
Vaccine manufacturers and distributors are protected from liability claims under the Public Preparedness and Emergency Preparedness Act (PREP). However, according to several experts, despite the defense, Pfizer probably acted out of fear of the consequences.
“How much can Pfizer do? They don’t have employees there, ”said Mark Capofari, who was Merck’s global director of logistics from 1995 to 2007 and currently lectures on supply chain management at Penn State University. “I don’t know if any of the companies want to take responsibility from that point on.”
Due to the lack of control, Pfizer has delivered a vaccine to its destination, monitoring temperature with unnecessary added risks. “Lawyers have a responsibility to anticipate potential claims,” said Dorit Reiss, a law professor at the University of California, Hastings College of Law, whose research focuses on vaccinations.
Efforts to avoid liability usually result in ineffectiveness and slow down the process that the PREP Act sought to alleviate. The plan to change ownership of the temperature control system “will only lead to interruptions and problems,” said Lawrence Gostin, a global health law professor at Georgetown University. “It’s not efficient and reliable. And unnecessary.
Concerns about its public image may also have prompted Pfizer to move away from temperature control in the final stages of vaccine storage. The company has gained tremendous positive publicity through the rapid development of the Covid-19 vaccine and has an interest in protecting that reputation. “There may be publicity issues,” said Robert Field, professor of law and health management and policy at Drexel University. “If they’re worried they may have problems at the endpoint, at the pharmacy, or wherever an injection is made, they don’t want to be associated with them. They may feel that they are not in their comfort zone, that is not their skill. “
Of course, companies are not prone to risk, and once a vaccine is created, Pfizer will not benefit much from continuing to monitor vaccine storage requirements beyond the delivery deadline. – He wipes the hand of accountability. He doesn’t want to be blamed legally or publicly, he doesn’t want to be held accountable and thus handed over to some other organization, in this case the government, ”Gostin said. “History teaches us that companies try to protect themselves and the outcome at all costs. They can shirk responsibility at any time, be it the government, a hospital, a private hospital, a doctor’s office or a pharmacy. “