There are now two vaccines for COVID-19. They both must be stored and shipped frozen. The Pfizer/BioNTech vaccine has to be maintained at -94 degrees Fahrenheit during storage and transit. The Moderna vaccine must be kept at -4 degrees F while being shipped or stored. One reader wants to know how he can be sure the COVID vaccine is good when it comes time for him to get his shot.
Q. I am wondering how an individual who is being vaccinated might determine if the vaccine they are receiving has been properly stored at the extreme cold temperature necessary.
Maybe it will be impossible to know if the vaccines in some batches have been heat-damaged in transit or storage. I want to get vaccinated, but I do wonder about the possibility of getting a “dud” vaccine.
CDC Requires Strict Monitoring to Ensure the COVID Vaccine Is Good!
A. The CDC has issued stringent guidelines for shipment and storage of COVID-19 vaccines. Hospitals and clinics that plan to administer these vaccines will be required to sign the COVID-19 Vaccination Program Provider Agreement certifying that they have the necessary equipment and well-trained staff to comply with the guidelines.
For the Pfizer and BioNTech vaccine, that will include a “pharmaceutical grade” ultra-cold freezer and a continuous temperature monitoring device called a digital data logger (DDL).
The Pfizer Monitoring Glitch:
You know that the Pfizer/BioNTech vaccine requires ultra-cold transport and storage. Pfizer promises to maintain that level from manufacturing plant to destination. But here’s the catch.
According to Stat News (Dec. 17, 2020), the company was planning 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.”
Monitors to Make Sure the COVID Vaccine Is Good:
Ultra-cold monitors are not readily available. The Pfizer monitors actually come from Controlant Global in Iceland. Most hospitals would not have access to such ultra-sophisticated technology.
If Pfizer turns off the switch, health care facilities will be out of luck. It would be hard to verify that all vials are kept at the appropriate temperature.
There was a creative solution, however. A $25 million check from U.S. taxpayers allows the government to turn the temperature monitoring system back on as soon as Pfizer turns it off.
Bad Planning!
If this plan sounds a bit bizarre, we won’t disagree. But at least it is supposed to maintain the integrity of the ultra-cold chain of custody.
The STAT article suggests that this temperature monitoring snafu wasn’t uncovered until fairly late in the process:
“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.’”
We just hope that there are qualified representatives capable of turning the monitors back on once they reach their destinations.
Moderna Is Easier:
The Moderna vaccine does not require an ultra-cold freezer. It can be stored in a standard freezer. Your home freezer is normally kept around 0 degrees F. Hospital and pharmacy freezers should be able to get to -4 degrees F without too much trouble.
How to Make Sure the COVID Vaccine Is Good:
When the time comes for your vaccine, ask the health care facility to assure you that they have signed and are following the CDC’s COVID-19 agreement. The good news is that the Moderna vaccine can be stored at refrigerator temperature for 30 days. It remains viable at room temperature for 12 hours.
We doubt that many COVID vaccines will be allowed to sit for very long. The demand is such that they will likely be administered within days of arrival at distribution sites.
