Team Ensures Vaccines Keep Their Cool, Arrive on Time

The agency's Distribution Operations Center professionals are experts in cold chain management, said Maj. Patrick Garman, agency pharmacy consultant and deputy director for distribution operations of the Military Vaccine Office. The center, he said, is a core group of highly skilled specialists recognized within DoD for packing and storing of medical materiel that requires refrigeration or has other special handling requirements.

"USAMMA has been a pioneer in the process of controlling a product's temperature during shipping," he said. "We have a good reputation within DoD, and we also send our representatives to train civilian companies in cold chain management."

Since February 1998, the group has dedicated its energies toward developing protocols for packing vaccines properly and finding cutting-edge temperature monitoring devices. They also ensure vaccine refrigerators used in shipping are running properly and make sure customers understand the importance of keeping vaccines at the proper temperature.

"We make sure no vaccine is compromised because of temperature variations, so it is safe for the soldiers receiving the immunization," said Ruben Gueits, system support analysis. "We also save the government money by limiting the amount of vaccine that has to be wasted due to being exposed to temperature extremes.

For the past 10 months, the group has been hustling. After a two-year hiatus from shipping the anthrax vaccine, the staff awoke that dormant program. By fall 2002, the center started its annual distribution of the Army's supply of flu vaccine. During the winter it also geared up to ship the smallpox vaccine to Southwest Asia along with other specialized biologicals.

Even with the increased workload, not one dose of the 2002 flu vaccine was lost. "Most years, the military services order extra because they know they'll lose some to temperature fluctuations," Garman, a pharmacist, said. "Next year, we know we'll need to order only as much as we need."

The team goes to extreme lengths to make sure its cargo stays at the appropriate temperature so it's safe for vaccine recipients and no doses are lost to temperature fluctuations. To do so, it uses insulated shipping containers and portable refrigerators that can keep vaccines at their optimal temperature of 36 to 46 degrees Fahrenheit on land, sea or air.

In fact, several team members flew on cargo planes this winter, escorting shipments of anthrax and smallpox vaccine as well as investigational new drugs that may have been needed if soldiers in Operation Iraqi Freedom encountered biological warfare.

Of the thousands of vials of unique products the team escorted, it considered each one "priceless." "In some cases, we shipped all there was of the product, so we weren't going to take a chance on losing any of it," Garman said. He added that shipments of those products were split to make sure at least some would survived in case the unthinkable happened.

Why all the fuss about temperature? A good analogy for the sensitivity of vaccines to temperature extremes is the "spaghetti noodle" example, Garman said. "Many -- but not all -- vaccines are made up of proteins that resemble long spaghetti noodles floating in a suspension. They have unique topographies, like valleys, crevices and jagged edges that alert your body's immune system to the fact that they are a foreign material and a threat. Thus your immune system reacts to this specifically shaped 'noodle' to form antibodies that are ideally shaped to interact and neutralize the foreign particle.

"Now imagine taking that protein and exposing it to high temperatures, say above 77 Fahrenheit," he continued. "It reacts like a spaghetti noodle left to boil in a pot. It starts to get soft and jelly-like, its shape changes and, even when it is cooled, its topography remains changed permanently.

"If you take that same cooked pliable spaghetti noodle and freeze it," Garman note, "now it is susceptible to breakage, not to mention nicks and gouges received by floating in a suspension full of millions of tiny shards of ice crystals before freezing solid."

If the noodle is warmed, its shape remains forever changed, and the change in the protein's topography, either from heat or cold, fundamentally alters the body's reaction to it and can reduce the immune benefits from vaccination. The group acts much like a dispatcher when it comes to anthrax or smallpox vaccine shipments. The Distribution Operations Center staff takes the order, passes the request to Bioport -- the anthrax vaccine manufacturer -- or the Centers for Disease Control and Prevention, which fills requests for smallpox vaccine, then tracks the vaccine until it reaches the customer.

Because of the need to control the vaccine's temperature from manufacturer to shipper to customer, communication is a paramount concern, and the staff is tenacious about tracking shipments, Gueits said.

"Communication with the commercial carrier ensures that all three parties -- the Distribution Operations Center, the carrier and the receiver -- know that a temperature-sensitive shipment is making its way through the shipping agents' delivery process," he said.

Garman added that his staff has also found that "the simple act of calling the receiving point of contact to alert them when a shipment is going out and when it can be expected to be delivered dramatically decreases the likelihood of mishaps compromising the product."

This attention to detail is why the Distribution Operations Center maintains an exceptionally high success rate of safely delivering temperature-sensitive products. Team members do whatever it takes to ensure their customer's needs are met, Garman said.

When medical staffs in Iraq needed drugs and supplies for Iraqi burn patients, a team member went to Brooke Army Medical Center in San Antonio to pack and coordinate the shipment of temperature-sensitive medicine. The team also developed a training CD-ROM so their customers know about the tools and procedures for moving pharmaceuticals within narrow temperature ranges.

"We don't want our shipping containers sitting on a pier in the hot sun," Garman said. "The better informed our carriers and our customers are, the less likely it is that will happen."

The major said his staff is also looking at technology that will prevent the pier scenario from happening. They are exploring the idea of including a global-positioning satellite device with the current temperature monitors. Then, if a carrier loses track of a shipping container, the GPS technology will let the center's staff say exactly where it is and what the temperature of the contents are.

"We don't want to make things so high tech that people can't easily use our methods and equipment," Garman said. "Still, because we're on the leading edge of vaccine shipment for the Army, we hope to export our practices to all of DoD."

Center officials say to get more information on shipping vaccines or a copy of the training CD-ROM, call 301-619-7235 or 301-619-4198.

(Karen Fleming Michael is a staff writer for the Standard, the, Ft. Detrick, Md., newspaper.)