By now you have no doubt heard that the Pfizer and BioNTech COVID mRNA vaccine must be stored at -70 degrees Celsius. That is -94 degrees Fahrenheit. This is not arbitrary. Proper COVID vaccine storage is absolutely critical if the immunization is going to work as hoped. If the vaccine is shipped or stored above that temperature, it could degrade and not work as expected.
How Cold is -94 Degrees F?
Most people have no idea how cold COVID vaccine storage needs to be. A really cold day in North Dakota in February might hit -40 degrees F. The coldest temperature ever recorded on Mount Everest was -43.6 degrees F. In 1933 observers at the Oymyakon weather station in Siberia noted a temperature of -89 degrees F. That has been considered the coldest temperature ever recorded in the Northern Hemisphere.
Your home freezer should hover around 0 degrees F. The new Pfizer vaccine will have to be kept at -94 F which is clearly much, much colder than any normal freezer. Hospitals and health centers have been searching for ultra-cold freezers for COVID vaccine storage.
Even the Moderna vaccine, which has less stringent requirements than the Pfizer vaccine, still needs to be stored at -20 degrees C (-4 degrees F). It will remain stable for up to six months at that temperature. Moderna maintains that its COVID vaccine storage is much less critical than Pfizer’s. The vials remain viable for 30 days at refrigerator temperature (36 degrees to 46 degrees F). In theory, they will be injected as fast as they arrive in hospitals or clinics, so long storage time should not be an issue.
Why Is Temperature So Important for COVID Vaccine Storage?
Both the Pfizer/BioNTech and Moderna vaccines contain messenger RNA (mRNA). This is new technology. The fear is that if temperatures go above the allowable limits, the vaccines could lose effectiveness.
The COVID vaccines leave little room for error. Viable vaccine could be the difference between life and death for some people.
Moving the vaccines from the place of manufacture to an airplane; from the airplane to a distribution center; from a distribution center to hospitals or clinics will require very careful chain of command oversight. Temperature will need to be monitored at every step of the process.
What About Your Medicine?
Is there a lesson to be learned from the COVID vaccine storage challenge? Clearly, most medicines do not need ultra cold storage. They don’t even need freezer temperatures. But there are lessons to be learned from the challenges that have been faced by the COVID vaccine manufacturers.
How do you get your medications? Have you been accustomed to picking them up at your local pharmacy? Has the pharmacy been delivering them to your front door or have you been using mail-order pharmacy services?
In the time of COVID-19, many people who once would have gone to their local drugstore have switched to delivery services. This requires a little advance planning. Prescriptions need to be ordered far enough ahead so you don’t run out. But have you ever wondered about the weather or how long your medicines sit in the mailbox?
All the news about COVID vaccine storage has made people aware of how complicated the drug supply chain can be. Most ordinary medicines are much less delicate than mRNA, but they still need to be kept within a fairly narrow temperature range. The FDA provides guidance for virtually all drugs it approves. Here are some examples.
FDA Drug Storage and Shipping Guidance:
The thyroid medicine levothyroxine (Synthroid) has the following instructions:
“Store at 25 degrees C (77 degrees F); excursions permitted to 15 degrees to 30 degrees C (59 degrees to 86 degrees F).”
The cholesterol-lowering drug atorvastatin (Lipitor):
“Is supposed to be kept between 68 degrees and 77 degrees F (20-25 degrees C).”
Palbociclib (Ibrance) is a breast cancer medication. The official prescribing information states:
“Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted between 15 °C to 30 °C (59 °F to 86 °F).”
The trouble with these very clear FDA recommendations is that they are often ignored.
Readers Speak Out:
A woman with stage 4 metastatic breast cancer received her Ibrance from a UPS delivery truck. She lives in Florida. On the day her medication arrived, the temperature outside was 97 degrees (F). The temperature in the truck likely exceeded that for several hours before the delivery was made. By the way, a bottle of Ibrance can cost over $11,000 for a month’s supply.
One reader wrote:
“I have been taking Lipitor since it was introduced. A while ago, my insurance company induced me to buy a 90-day supply from their mail-order outlet instead of getting it each month at my pharmacy.
“For several years there were odd variations in my cholesterol readings. I lived in an area with very hot summers and very cold winters. One summer day, I noticed that my black mailbox was too hot to touch. I then read about the acceptable range of temperatures for this drug. My mailbox could take the package way out of this range.
“Since that time, I have gotten my medications at the local pharmacy and have had very stable cholesterol readings. More insurance companies and retailers are providing mail-order pharmacy services. Is receiving medication packages in a mailbox during extreme temperatures as much of a problem as I noticed?”
Who’s in Charge?
There is a huge vulnerability in our national drug supply system. The challenges of COVID vaccine storage have demonstrated how difficult it can be to ship drugs within a narrow temperature range.
Although the FDA sets standards for storage, no one enforces compliance. A chemical may be made in China and shipped to India to be turned into a finished drug product. How does it get from the chemical plant to the drug company and who is monitoring?
Once the finished pills are put into a container, how do they get from the Indian drug manufacturer to a ship or airport? Are the trucks temperature- and humidity-controlled? The FDA has not been able to answer our questions about this phase of the journey.
But wait, there’s more. Are those pills shipped under strict temperature and humidity-controlled conditions from India to the United States? What happens to them when they reach an airport or port of entry? How long do they wait for customs officials to check them out?
Who Monitors Medicines in the US?
Now your pills have to be shipped from their port of entry to some distribution point. The board of pharmacy in California is responsible for the pills from their arrival in LA to the border of Arizona, Nevada or Oregon. But then the board of pharmacy for each of those states takes over. And when the pills reach the next state, say New Mexico, Utah or Idaho, each state’s board of pharmacy is responsible until the pills move on to another state.
Who is monitoring the shipping vehicles for temperature and humidity? The FDA doesn’t seem to care. Neither does anyone else, as far as we can tell. And when they reach their destination at some warehouse in Wisconsin, Ohio or Massachusetts, who monitors them there?
While mail-order medicines may be exposed to extreme temperatures in delivery trucks or mailboxes, wholesale shipments to pharmacies may also stray beyond temperature-controlled conditions. And if a pharmacy is delivering to your doorstep, how long will those pills sit if you are not home to receive them?
Learning from the COVID Vaccine Storage:
Perhaps we should learn from the extraordinary efforts going into COVID vaccine storage and shipping. Although vaccines are especially fragile, other medications should also be held at the proper temperature and humidity.
If we want our drugs to work as expected, manufacturers, shippers, pharmacies and consumers should treat them properly. Following the FDA’s stringent guidelines seems like a necessary first step.
