As the death toll from the coronavirus pandemic mounts in the U.S., the country finally has some reason for hope: Nurses, doctors, the elderly and other vulnerable people across America are getting the first Covid vaccine shots.
An army of pilots, delivery drivers and pharmacists last month started to ship, distribute and administer millions of vaccine doses. The small vials are traveling on airplanes and trucks, and some times inside of specially made hand-held coolers.
So far, two vaccines have been cleared by the Food and Drug Administration for emergency use in the U.S.: those by Pfizer-BioNtech and Moderna. Several other drugmakers also have agreements to provide their vaccines to the federal government once they are approved. AstraZeneca’s vaccine, developed with Oxford University, was just approved for emergency use in the U.K. but is still in clinical trials in the U.S.
The much-awaited vaccines — and whether they’re distributed quickly, smoothly and widely — will help determine whether the U.S. can gain control of a virus that’s killed more than 355,000 people across the country, overwhelmed hospitals and thrust the nation’s economy into a recession.
Health-care workers and nursing home residents were among the first to receive them in mid-December, followed by older Americans or those considered more at risk based on their job, age or medical conditions, depending on the state. The U.S. has distributed just over 17 million doses, and 4.8 million people have been given their first shot as of Tuesday — far short of the country’s original goal of immunizing at least 20 million people by the end of 2020.
Eventually, the shots will be available to the general public at neighborhood pharmacies and grocery stores.
Here’s how that journey looks for the vaccines:
Loading planes & trucks
Within hours of the FDA’s approval of the Pfizer and Moderna vaccines last month, FedEx and United Parcel Service started shipping vials of doses. The logistics rivals teamed up and split deliveries by state, UPS Healthcare President Wes Wheeler told a Senate panel at a hearing last month.
Delivering coronavirus vaccines, however, isn’t first time the companies have handled sensitive medical products. UPS provided logistical support throughout Pfizer’s clinical trials. FedEx delivers flu vaccines every year and shipped over 80 million H1N1 vaccine doses in 2009, said Richard Smith, FedEx Express executive vice president.
“This is what we were built for, and we plan for things like this regularly,” Smith told lawmakers. “Maybe not on this scale with all of the ins and outs, but we are well-versed in this type of planning.”
Pfizer’s vaccine is being transported in custom thermal shippers designed to keep the doses at minus 94 degrees Fahrenheit. Each suitcase-sized box can hold 4,875 doses, according to the Centers for Disease Control and Prevention. The shippers also have a GPS-enabled thermal sensor.
Ensuring the vials are kept at the right temperature is a tricky process that’s had to be adjusted along the way. U.S. officials quarantined several thousand doses of Pfizer’s vaccine in California and Alabama in mid-December after an “anomaly” in the transportation process caused the storage temperature to get too cold.
After leaving Pfizer’s storage sites in Michigan and Wisconsin, Covid vaccine shipments receive priority treatment, UPS and FedEx said.
Vaccine packages that UPS delivers are given a gold priority label embedded with four trackers so the company can see the package as soon as it arrives at every destination. Each of its trucks also has a device that monitors its location, light exposure and temperature. Those vaccines are transferred to UPS’ Worldport facilities in Louisville, Kentucky, where they are immediately expedited.
“We will see the package; it will get priority,” Wheeler said. “It goes on the plane first. It comes off the plane first.”
UPS created a 24/7 command center just for vaccine shipments where employees monitor the shipments and intercept a package if something goes wrong, Wheeler said. Similar to UPS, FedEx’s “priority alert” team actively tracks the shipments using its own technology.
Passenger airlines also play a role. Even before Pfizer’s vaccine was cleared by the FDA, United Airlines started shipping doses on Boeing 777s from Brussels, near the pharmaceutical giant’s Belgium plant to the carrier’s hub at Chicago O’Hare. They were taken by truck from the airport to Pfizer’s plant in Kalamazoo, Michigan to position them for distribution.
American Airlines ran trial flights in November between Miami and South America to stress test thermal packaging and handling before it started shipping the vaccines.
Last month, United and Delta Air Lines started shipping smaller loads of the vaccine in the bellies of passenger planes within the U.S.
Airplanes carrying the vaccine get takeoff and landing priority from the Federal Aviation Administration. The FAA also gave United special approval to carry more dry ice than typically allowed to transport doses from Brussels to Chicago.
The airlines and logistics companies had mobilized extra manpower last month as a snowstorm swept through the Northeast and threatened to shut down runways. The FAA urged airports to have people ready to clear snow.
Freezers, dry ice and portable coolers
Shipments from FedEx and UPS head to different hubs for distribution. In some cases, they arrive at hospitals or health-care systems where they are stored and later administered to staff. In other cases, they head to retail pharmacies.
UT Health Austin received notice on Dec. 12 that it would receive its first shipment of 2,925 doses of vaccine the next day, said Dr. Amy Young, chief clinical office. It had already received supplies needed for administering the shot, like syringes and alcohol swabs, about a week before, said Young, who also is vice dean of professional practice at Dell Medical School at the University of Texas at Austin.
When the shipment arrived via FedEx truck, hospital staff checked the temperature of the doses at the facility’s loading dock to make sure they remained at the necessary temperature, Young said. They then transported the boxes to their ultra-cold freezer for the night. Hospital staff started immunizing people the next day.
Riverside Health System in Virginia, which received its first shipment of just under 3,000 doses on Dec. 15, followed a similar process, said Cindy Williams, vice president and chief pharmacy officer. Riverside was able to track the FedEx shipment as it arrived at a nearby airport.
“We did, in fact, get notification that it was on the ground and within about an hour or so it was pulling into our loading dock,” Williams said.
Though Riverside predicted the first week of vaccinations would have a slow start, the process was much more efficient, Williams said.
“We are ramping things up pretty rapidly, and we’re also finding that team members are very willing to step up and sign up for the clinics,” Williams said.
The special containers for the Pfizer-BioNTech vaccines also act as mobile freezers for clinics that don’t have specialty equipment. They can be stored for up to 30 days if they’re refilled with dry ice every five days.
The vaccine developed by Moderna must be kept frozen — but not at the ultra-low temperatures required for Pfizer’s shots. Moderna’s needs to be stored at between negative 13 and 5 degrees Fahrenheit and protected from light, according to CDC guidelines.
Moderna’s vaccine, however, can be stored in the refrigerator at between 36 and 46 degrees Fahrenheit for up to 30 days.
UPS is producing its own dry ice — over 24,000 pounds a day — for anyone who needs it for the vaccines.
Walgreens and CVS Health have turned some of their drugstores into designated hubs with special freezers, dry ice and staff trained about how to handle the vaccines. The federal government tapped the companies to inoculate residents and staff at nursing homes and assisted living facilities across the country.
“Once we get them into those hubs, that’s where the planning really works locally with the states, with the long-term care facilities and with our field teams,” said Rick Gates, Walgreens’ senior vice president of pharmacy and health care.
About 10% of CVS pharmacies are serving as “hubs” or “depots,” said Chris Cox, a senior vice president at CVS and a liaison to Operation Warp Speed, the federal effort to help develop, make and distribute Covid vaccines.
“There’s nothing special about these pharmacies other than their geographic proximity to the most number of nursing homes, so that we can really optimize our routes,” he said.
Pharmacists and technicians at long-term care facilities wait until the morning of the vaccinations to move the Pfizer-BioNTech inoculations from ultra-cold storage and into a refrigerator, where it thaws, Cox said. The doses can be stored in a regular refrigerator at 35 to 46 degrees Fahrenheit for up to five days, according to Pfizer’s Covid-19 vaccine fact sheet.
They are then loaded into a specially made small, hand-held cooler designed to maintain that temperature for up to 24 hours.
The Moderna vaccine must remain frozen for transport. It’s then carried in the same cooler — but with cooling inserts and is thawed on-site at the facility before it is administered, Cox said.
Each cooler can hold 500 Pfizer doses or 1,000 Moderna doses since the Pfizer shots come in smaller bottles, according to CVS. Before giving the shot, health-care staff must add a saline solution to Pfizer’s dose before it’s injected, while Moderna’s vaccine doesn’t need to be diluted.
Both vaccines need to be thawed before injecting and cannot be refrozen, putting unused doses at risk of going bad. Pfizer’s vaccine takes 30 minutes and Moderna’s vaccine takes an hour to thaw at room temperature, a CVS spokesman said.
Both vaccines also need to be used relatively quickly after thawing. Undiluted vials of Pfizer’s vaccine cannot be stored at room temperature for more than two hours. Once diluted, they need to be used within six hours.
Moderna’s vaccine is stable at room temperature for up to 12 hours if the vials haven’t been punctured and six hours once they’ve been punctured.
Reports of unused and discarded doses have started to trickle in across the country as local health departments struggle to meet the tricky dosing requirements.
Authorities in Wisconsin said they arrested a pharmacist last week after he admitted to removing 57 vials containing 500 doses of Moderna’s vaccine from a pharmacy refrigerator and intentionally allowing them to spoil.
A jab in the arm
The vaccine’s final stop is the same: jabbed into millions of American arms.
Teams of pharmacists from CVS and Walgreens are administering the vaccines at more than 70,000 long-term care facilities, including nursing homes, according to CVS Chief Medical Officer Dr. Troyen Brennan. The size of the teams will vary based on the number of staff and residents.
At nursing homes, pharmacists in protective gear go room by room to vaccinate residents who have agreed to be inoculated, Cox said. At facilities where residents are more mobile, they’ll have a central on-site clinic. They’ll also vaccinate staff.
Those vaccinations began Dec. 18 in Ohio, Connecticut and Florida. They are now available in nursing homes in almost every state and the District of Columbia.
CVS and Walgreens, are nudging people to return for their second shot with phone calls, emails and text messages as well as reminder cards. Doses must be spaced out properly — 21 days for the Pfizer vaccine and 28 days for the Moderna vaccine.
U.K. health officials have decided to implement a 12-week delay between the first and second doses of the Pfizer-BioNTech and Oxford-AstraZeneca vaccines in order to cover as much of the population as possible.
U.S. health officials, who haven’t approved AstraZeneca’s vaccine yet, have advised against any changes in the dosing schedules, although Trump administration vaccine czar Moncef Slaoui said they are considering cutting Moderna’s dose in half for younger people to increase its availability.
The distribution has been slow going, hampered by the holidays, manufacturing delays and funding shortfalls and glitches in state programs designed to administer the shots to people. Roughly 4.8 million doses have been distributed to long-term care facilities, but just 429,066 shots have been given as of Tuesday morning, according to the CDC.
CVS and Walgreens executives still think the shots could be available to all Americans at their nearby grocery store or drugstore as early as March, much like they are for the seasonal flu. More than a dozen retail chains and pharmacies, including Kroger, Walmart and Costco, have signed on as partners with the federal government to give the shots. Some of them, such as Walmart, say they’re already getting staff and freezers ready — even as they wait for doses to arrive.
CNBC’s Leslie Josephs, Kevin Stankiewicz, Will Feuer and MacKenzie Sigalos contributed to this story.
Source: Business - cnbc.com
