Pfizer’s decision on vaccine temperature sensors forced to mix up

A last-minute snafu this fall threatened to disrupt the smooth rollout of the first Covid-19 vaccine approved in the United States, industry officials said.

The question was how to control the temperature of the ultra-cold storage containers used to distribute vials of the vaccine developed by Pfizer and its partner BioNTech. Pfizer, officials told STAT, planned to disconnect temperature monitoring sensors on the containers once they were delivered to healthcare providers – although many of the healthcare providers had to use the boxes to store the bottles for up to 30 days. Without the monitoring systems, healthcare providers would not be able to know if the vials had thawed prematurely, rendering the vaccine useless.

Ultimately, the US government’s Operation Warp Speed ​​attempted to address the problem, signing a $ 25 million deal in mid-November with Controlant Global, an Icelandic company that has created Pfizer’s proprietary temperature monitoring platform for all of Pfizer’s shipping containers. Under this agreement, Pfizer will stop its temperature monitoring once the boxes arrive at their destination, and the federal government will simultaneously re-enable the system.


Still, the episode shows how, in the frenzy of getting a vaccine to the public, details crucial to its distribution were overlooked until late in the game. And it shows how, despite efforts to protect vaccine makers from liability, legal concerns are shaping their actions. Experts said concerns about legal action, as well as bad publicity if the vaccine doses were lost due to postpartum thawing, likely drove Pfizer’s thinking.

Pfizer ships its vaccines in special containers packed in dry ice to keep them at the minus-70 degrees Celsius requirement. Since few freezers get that cold, many health systems use these containers to store the vaccines after they arrive. Prime Minister, a group purchaser for US hospitals, said it asked Pfizer in November to reconsider its decision to disconnect the sensors, and that health care providers spent weeks trying to clarify whether to purchase their own temperature sensors.


“These vaccines have to be kept at a certain temperature to make sure they remain viable. Keeping vaccines in a cooler and refreshing with dry ice makes it difficult to know if you’re maintaining the temperature, ”said Jessica Daley, Prime Minister’s vice president of strategic supplier engagement.

It’s fairly uncommon for temperature monitoring equipment to go to ultra-low temperatures, and Daley said there weren’t enough alternatives available to replace the ones Pfizer shut down. It wasn’t until early December that Premier and providers found out that Operation Warp Speed ​​(OWS) had solved the problem, said Soumi Saha, Premier’s director of advocacy.

Neither Pfizer, Controlant, nor the Trump administration would explain exactly how the transfer of monitoring works. “Pfizer will turn off the temperature monitor on their shipping container once they are delivered. Operation Warp Speed ​​has contracted with the device manufacturer to reactivate it immediately without loss of temperature monitoring and data loss, ”said Natalie Baldassarre, a spokeswoman for the Department of Health and Human Services, in a statement. .

The contract makes it clear that OWS had little choice but to assume responsibility. “Since Pfizer only monitors the temperature through transportation and until the government accepts it, the government requires the ability to monitor the vaccine… until the vaccine has been used and the shipping containers are returned to Pfizer,” the contract reads.

Operation Warp Speed ​​didn’t begin market research into temperature monitoring for the boxes until Nov. 9, according to Controlant’s agreement, even though the government signed a $ 1.95 billion contract with Pfizer to provide 100 million doses of the vaccine in July.

The late contract with Controlant suggests that this issue was not fully thought out when the U.S. government signed the contract with Pfizer, said Ameet Sarpatwari, assistant professor of medicine at Harvard Medical School.

“The ball fell somewhere,” he said. ‘Instead of switching off [the monitoring system], it could have just been a continuous process. From a security point of view, that seems a better way to go. “

He said the original contract with Pfizer could have allowed for discussions about who would oversee maintaining the ultra-cold temperatures. “A slightly more systematic process involving transparency could have received input from others who would have shown that some details were insufficient with this contract,” Sarpatwari said. “Rather than imposing on us, it could have been a decision about how we want to share that burden.”

Pfizer did not respond to requests to explain why it decided to disconnect the remote temperature monitoring equipment. The company “is working very closely with Operation Warp Speed ​​(OWS) to provide a point-of-use temperature monitoring solution if our thermal sender is the method of choice for frozen storage,” wrote spokesman Amy Rose in an email.

The problem is unique to Pfizer’s vaccine. The Moderna vaccine, which is expected to receive an emergency permit 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 are kept in the containers they ship in.

Neither the UK nor Canada have dealt with the issue so far. In both countries, the first Pfizer vaccines will be shipped to sites equipped with ultra-cold freezers, so the shipping containers will not be used for storage after delivery.

Once Pfizer signed a supply contract with OWS, there was no reason in the US for the company to go beyond what the terms require, said New York University bioethicist Arthur Caplan. “There is far too much risk out there, which they don’t need,” said Caplan. “If I’m Pfizer, I sold my vaccine, I made it, I shipped it where you told me, I’m not in the rest of these companies, 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 this protections, Pfizer may have acted out of fear of repercussions.

How much can Pfizer do? They don’t have staff there, ”said Mark Capofari, who served as director of global logistics at Merck from 1995 to 2007 and currently teaches supply chain management at Penn State University. “I don’t know if a company would want to be liable from then on.”

Given the lack of control Pfizer has once a vaccine reaches its destination, continuing to monitor temperatures would create unnecessary additional risks. “It is the job of the lawyers to anticipate potential claims,” ​​said Dorit Reiss, a law professor at the University of California, Hastings College of the Law, whose research focuses on vaccines.

Attempts to avoid liability tend to create inefficiencies and slow the process, which the PREP law sought to mitigate. The plan to change ownership of the temperature control system “will only lead to disruptions and problems,” said Lawrence Gostin, a professor of global health law at Georgetown University. “It is neither efficient nor reliable. And it is not necessary. “

Concerns about its public image could also have prompted Pfizer to break away from temperature monitoring in the final stages of vaccine storage. The company has received tremendous positive publicity through the rapid development of a Covid-19 vaccine, and has an interest in protecting this reputation. “There may be publicity issues,” said Robert Field, a professor of law and health management and policy at Drexel University. “If they are concerned that problems could arise at the endpoint, the pharmacy, or wherever injections take place, they don’t want to be involved. They may feel like it’s not in their comfort zone, that’s not their expertise. “

Companies are risk-averse by nature and, once they develop a vaccine, Pfizer has little benefit from continuing to adhere to vaccine storage standards beyond the date of delivery. It wipes your hands from accountability. You don’t want to be blamed legally or publicly, you don’t want to be held accountable and so hand it over to another entity, in this case the government, ”said Gostin. “History tells us that companies will try at all costs to protect themselves and the bottom line. Any time they can turn away their responsibility, be it a government, a hospital or a private hospital, or a doctor’s office or pharmacy, they will. “