Baltimore Sun

Wasted doses of fragile vaccine

Amount squandered in Maryland highlights difficulti­es in handling

- By Alex Mann and Hallie Miller

Vials have shattered. Vans transporti­ng the vaccine in Oregon have gotten stuck in snow. Doses have been thawed from a deep freeze before their time. In one case, a Maryland hospital’s freezer malfunctio­ned and more than 1,500 immunizati­ons were spoiled.

The national rollout of the coronaviru­s vaccines has not been without obstacles — or waste. As of Friday, at least 1,748 COVID19 vaccines have gone unused in Maryland since doses first arrived in December, according to the state health department.

Though that’s just a sliver — less than 1% — of the roughly 1.26 million doses Maryland has obtained from the federal government, the number depicts the challenges of handling the delicate vaccine, for which there is a stubbornly short supply and overwhelmi­ng demand. It also underscore­s the need for more vaccine candidates to be approved, public health experts say.

The two vaccines authorized for use in the United States, made by Moderna and Pfizer/BioNTech, are difficult to transport and to store. They go bad if they’re kept at the wrong temperatur­e, or if they’re not used quickly after thawing, according to the U.S. Centers for Disease Control and Prevention.

That means vaccinator­s have to be versed in dry ice and technologi­es used to track the temperatur­e of the trays. They also must be vigilant of doses once they’ve been thawed. Every last detail, from the condition of the syringe to the time of injection, is important.

Both the CDC and the Maryland health department urge providers to avoid wasting what limited doses are available. They say it’s better that someone gets inoculated, regardless of their eligibilit­y under state or federal guidelines, than to have a dose spoil.

That means luck has some role to play in deciding who gets vaccinated and when. Shoppers have been approached at retail pharmacies when excess doses surface, and others have sought to put their names on waitlists at clinics for end-of-day excess.

One Maryland researcher, who has published findings about the state’s vaccinatio­n rate compared with that of West Virginia, had a local health department staffer tap on his car window with a miraculous extra dose after initially being turned away from a vaccinatio­n appointmen­t. And on the Facebook group Maryland Vaccine Hunters, frustrated Marylander­s have traded tips about whether any providers were likely to have excess shots available

due to a recent winter storm.

To become a vaccinator, providers have to sign an agreement with the CDC, which directs them to report vaccine waste according to their jurisdicti­on’s mandates.

The Maryland health department requires providers to report all COVID-19 vaccine wastage and reserves the right to reduce the allocation to any provider or facility that commits or allows spoilage.

Charles Gischlar, a health department spokesman, said no provider has been sanctioned for wasting vaccines.

It’s unclear how other states have fared with wastage. The CDC has been collecting informatio­n about national waste, spokeswoma­n Kristen Nordlund said, and would make it public “when the data is more complete.”

To avoid waste, providers should maintain active lists of people they can call on short notice when extra vials surface, said Dr. Eric Toner, a senior scholar at the Johns Hopkins Center for Health Security. Vaccinatin­g people outside the prioritiza­tion schedule is an acceptable strategy to ensure no dose goes unused, he said.

Under Maryland guidelines, it’s up to local health department­s to devise a plan to minimize waste for all providers in their jurisdicti­ons.

Even then, disaster can occur. That’s what happened on Maryland’s Eastern Shore early in the state’s vaccine rollout.

On Dec. 31, an ultra-low-temperatur­e freezer at TidalHealt­h

Peninsula Regional hospital in Wicomico County malfunctio­ned. The resulting temperatur­e shift rendered 1,580 doses unusable, Gischlar said.

The hospital quickly replaced the special freezer and worked with the health department to improve the cold-storage logistics by reinforcin­g the temperatur­e monitoring system for the freezer, said Roger Follebout, a TidalHealt­h spokesman.

Follebout called the loss of vaccines “devastatin­g,” but said TidalHealt­h pushed forward, administer­ing 17,000 doses of the vaccine as of Thursday afternoon.

Some say government officials could have provided more support to local health department­s, hospitals, pharmacies and other immunizers, who have adapted to great personal and profession­al challenges in an extraordin­arily condensed timeline to get shots into arms.

Brian Castrucci, president and CEO of the public health advocacy group the de Beaumont Foundation, said vaccinator­s should not be singularly blamed for what wastage has occurred.

“We knew while the Pfizer and Moderna vaccines were being developed that they’d need to be at extremely low temperatur­es. And we knew we didn’t have the capability to do that,” Castrucci, an epidemiolo­gist, said. “The fridge infrastruc­ture isn’t there, and we knew this. What were we doing while these vaccines were going through these trials?”

The Eastern Shore hospital’s story, while rare, also stresses the need for more vaccine candidates to come online, especially singledose products and those that don’t require ultra-cold storage, Toner said.

He said both approved products are made using fragile messenger RNA that must be kept frozen at specific temperatur­es, giving providers just a few hours to deliver it into an arm from after doses are pulled from the freezer. And while the two products use similar ingredient­s, they must be stored at different temperatur­es.

The Moderna vaccine requires storage between 5 and minus 13 degrees. It can also be kept in a refrigerat­or for 30 days without spoiling. Meanwhile, the vaccine made by Pfizer/BioNTech must be kept between minus 112 and minus 76 degrees, requiring an ultracold freezer or thermal shipping container, according to the CDC. It can be stored in a refrigerat­or, but only for five days. A new Israeli study suggests it might work just as well with standard freezer temperatur­es within two weeks.

For now, “there’s real restrictio­ns on which facilities can handle the Pfizer,” Toner said. “Not only the cold handling, but also the way it’s packaged.”

Boxes of the Moderna vaccine contain 10 multidose vials, each of which has enough vaccine for 10 shots, according to the CDC, though the company has proposed adding more doses per vial. But the thermal shipping containers of the Pfizer product contain up to five trays. Each tray has 195 vials, good for 975 doses.

“Once you open the box, you’ve got to use it,” Toner said. “You can’t use that in a setting where you don’t have a thousand people.”

The head of the Federal Aviation Administra­tion said Sunday that he was requiring “immediate or stepped-up inspection­s” of Boeing 777 planes equipped with a particular Pratt & Whitney engine model one day after the jet suffered a dramatic engine failure over Colorado.

That episode, involving a United Airlines flight Saturday, saw the plane shed debris across three neighborho­ods before landing in Denver.

The Boeing 777-200 was headed to Honolulu with 231 passengers and 10 crew aboard. Flames erupted under a wing as the plane began to lose altitude. There were no injuries.

Sunday’s announceme­nt came after the aviation authority in Japan ordered airlines there to stop flying the plane. Both the Japanese and American orders apply to Boeing 777s equipped with Pratt & Whitney PW4000 engines.

“We reviewed all available safety data following yesterday’s incident,” the FAA administra­tor, Steve Dickson, said in a statement. “Based on the initial informatio­n, we concluded that the inspection interval should

be stepped up for the hollow fan blades that are unique to this model of engine, used solely on Boeing 777 airplanes.”

Dickson said the FAA was working with its counterpar­ts around the world and said that its safety experts were meeting “into the evening” with Pratt & Whitney and Boeing to complete details of the required inspection­s. United Airlines is the only American carrier using planes affected by the FAA order, according to the agency. Only airlines in the United States, Japan and South Korea operate Boeing 777s with the affected Pratt & Whitney PW4000 engine model, according to the agency.

 ?? MICHAEL CIAGLO/GETTY ?? Pieces of an airplane engine from United Airlines Flight 328 fell Saturday in Broomfield, Colorado.
MICHAEL CIAGLO/GETTY Pieces of an airplane engine from United Airlines Flight 328 fell Saturday in Broomfield, Colorado.

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