A. last-minute snafu threatened to disrupt the smooth rollout of the first Covid-19 vaccine approved in the United States, according to industry officials.
The question was how to monitor the temperature of the ultra-cold storage vessels used to disperse filters of the vaccine by Pfizer and its partner BioNTech. Pfizer, officials told STAT, planned to disconnect temperature monitoring sensors on the vessels once they were delivered to health care providers – although many of the suppliers would have to use boxes to store the filters for up to 30 days. Without the monitoring systems, providers would have no way of knowing if the filters had melted too quickly, making the vaccine unusable.
Eventually, Operation Warp Speed scraped the U.S. government to address the problem, signing a $ 25 million contract in mid-November with Controlant Global, an Icelandic company that created the temperature monitoring platform property for all Pfizer shipping devices. Under this agreement, Pfizer will suspend its temperature monitoring once the boxes reach their destination, and the federal government will turn the system back on at the same time.
However, the program clarifies how, in the real growth to get vaccinated to the public, details that were essential for its release were viewed late in the game. And it appears that despite efforts to protect vaccine manufacturers from liability, legal concerns are shaping what they do. Experts said concerns about a lawsuit, as well as poor transparency if vaccine doses were missed by melting after delivery, may have eroded Pfizer ‘s thinking.
Pfizer delivers its vaccines in special containers packed in dry ice to keep them at the required minus-70 degrees Celsius degrees. Because many freezers do not get that cold, many health systems use these freezers to store the vaccines once they arrive. Premier, a group buyer for U.S. hospitals, said he asked Pfizer in November to reconsider its decision to disconnect the sensors, and for weeks, health care providers were trying to clarify whether they would have to purchase their own temperature sensors.
“These vaccines need to be kept at a certain temperature to ensure they last. When you keep vaccines cooler and refreshed with dry ice, it ‘s hard to tell if you’re keeping up the temperature, ”said Jessica Daley, vice president of strategic provider communications at Premier.
It is very unusual for temperature monitoring devices to go to very low temperatures, and Daley said there were not enough alternatives to replace the ones that Pfizer turned off. It was only in early December that Premier and suppliers learned that Operation Warp Speed (OWS) had solved the problem, Premier’s application director Soumi Saha said.
Neither Pfizer, Controlant, nor the Trump administration would explain exactly how the scrutiny arm works. “Pfizer will remove the temperature monitor from their carrier once they have been delivered. Operation Warp Speed contracted with the manufacturer of the device to implement it immediately without loss of temperature monitoring and without loss of data, ”Natalie Baldassarre, spokeswoman for the Department of Health and Human Services, said in a statement.
The contract makes clear that OWS had little choice but to take responsibility. “As Pfizer only monitors the temperature through transport and up to Government approval, the Government needs to be able to monitor the vaccine… until the vaccine is used and the transport vessels are used. return to Pfizer, ”read the contract.
Operation Warp Speed only began market research on temperature checks for the boxes on November 9, according to a Controlant agreement, although the government signed a $ 1.95 billion contract with Pfizer to deliver 100 million doses of the vaccine in July .
The late contract with Controlant suggests that this issue was not fully considered when the U.S. government signed the contract with Pfizer, said Ameet Sarpatwari, an associate professor of medicine at Harvard Medical School.
“Somewhere the ball went down,” he said. “Instead of turning it off [the monitoring system], turning back, it may have been an ongoing process. From a safety standpoint, that seems like a better way to go. ”
He said the original contract with Pfizer could have left room for negotiations over who would be in charge of maintaining the extreme cold temperatures. “A little more of a systematic process that involved transparency could have been supported by others who would have shown that some detail was not sufficient with this contract,” Sarpatwari said. “Rather than being forced upon us, it could be a decision about how we want to alleviate that burden.”
Pfizer did not respond to requests to explain why it decided to disconnect the remote temperature monitoring devices. The company “is working closely with Operation Warp Speed (OWS) to ensure a temperature monitoring solution for points of use if our thermal skimmer is the preferred method for frozen storage,” spokeswoman Amy wrote Rose in an email.
The problem is unique to the Pfizer vaccine. The Moderna vaccine, which is expected to receive emergency approval later in the week, can be stored in most conventional freezers, and is stable for 30 days at cooling temperatures. Only Pfizer bullets require such cold storage that doses are kept in the containers in which they are delivered.
The UK and Canada have not yet addressed the issue. In both countries, the first Pfizer vaccines are shipped to sites with ulta-cold freezers, so the shipping containers will not be used for storage after delivery.
In the U.S., once Pfizer had a named supply contract with OWS, there was no reason for the company to go beyond what the conditions require, said biologist Arthur Caplan, from New York University. “There’s too much danger in there, they don’t need it,” Caplan said. “If I’m Pfizer, I’ve sold my vaccine, I’ve done it, I’ve been sent to the place where you told me, I’m not in the rest of the those businesses, and I’m not worried. ”
Vaccine manufacturers and distributors are protected from liability claims under the Public Preparedness and Emergency Preparedness Act (PREP). But several experts say that, despite these protections, Pfizer may have acted out of fear of reactions.
“What can Pfizer do? Their staff are not there, ”said Mark Capofari, Merck’s director of global logistics 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 then on.”
With Pfizer ‘s lack of control once the vaccine has reached its destination, there would be additional risks without the need to monitor the temperature. “The job of lawyers is to anticipate potential claims,” said Dorit Reiss, a professor of law at the University of California, Hastings College of Law, whose research focuses on vaccines.
Attempts to avoid responsibility tend to create inefficiencies and slow down the process, which the PREP act was intended to alleviate. The plan to change ownership of the temperature monitoring system is “just going to cause upheavals and problems,” said Lawrence Gostin, a professor of global health law at Georgetown University. “It is not efficient and reliable. And no need. ”
Concerns about its public image could have pushed Pfizer to separate itself from temperature monitoring at the final stage of vaccine storage. The company has gained good publicity through the rapid development of the Covid-19 vaccine, and is interested in defending this reputation. “There could be transparency issues,” said Robert Field, professor of law and health regulation and policy at Drexel University. “If they are concerned that problems may eventually occur, at the pharmacy or wherever the injection is, they would not want to be involved. They may feel it’s not in their comfort zone, that’s not their experience. ”
Companies are naturally against risk and, once they create a vaccine, there is little benefit for Pfizer in monitoring vaccine storage levels beyond the delivery date. “It simply comes to our notice then. You don’t want to be blamed legally or publicly, you don’t want to be held accountable and so push it over to another entity, in this case the government, ”said Gostin. “History teaches us that at any cost, companies will try to defend themselves and the bottom line. Whenever they can relieve responsibility, whether to a government or a hospital or a private hospital or to a doctor’s office or pharmacy, they will do so. “