Physicians Face Potential Peril With Leftover Vaccine Doses

Marcia Frellick

February 01, 2021

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A Texas judge last week dismissed a theft charge against an emergency medicine physician recently fired from his public health job after he gave leftover COVID-19 vaccine doses to people he knew ― highlighting the difficult position many clinicians find themselves in when there are unused doses but no one is on hand to administer them to and the clock is ticking.

The charges against Hasan Gokal, MD, quickly drew international attention. Although Harris County judge Franklin Bynum has dismissed the charges, the Harris County District Attorney's Office has said the evidence will go to a grand jury.

Harris County District Attorney Kim Ogg said in a January 21 statement that the charges were brought because "he abused his position to place his friends and family in line in front of people who had gone through the lawful process to be there."

Gokal's defense team said he tried to get takers from healthcare workers and law enforcement at the county vaccination site but, finding no takers, he called people he knew so the 10 leftover doses he had at the end of the day in the punctured bottle of Moderna vaccine would not be wasted (Moderna's vials contain 10 doses, Pfizer's vials contain six doses). The vaccine in the vial was going to expire 6 hours after being opened.

"Dr Gokal is a dedicated public servant who ensured that COVID-19 vaccine dosages that would have otherwise expired went into the arms of people who met the criteria for receiving it," Gokal's attorney, Paul Doyle, told Medscape Medical News. "Harris County would have preferred Dr Gokal let the vaccines go to waste."

Doyle said in a recent press conference, "If these doctors are going to get criminally prosecuted for trying to use leftover vaccines, there's going to be more and more waste than there already is."

Fears May Lead to More Waste

John Swartzberg, MD, clinical professor emeritus in the Division of Infectious Diseases and Vaccinology at the University of California Berkeley–UC San Francisco Joint Medical Program, agrees such legal actions will have a chilling effect and could lead to more waste at a time of dire need.

The Centers for Disease Control and Prevention (CDC) reported that as of Sunday, 25.2 million people had received at least one dose of a COVID-19 vaccine and that 5.6 million people had been fully vaccinated. The federal government said it has delivered about 49.9 million doses.

Swartzberg said the objective should be to "use every drop of the available vaccine." After that, the priority should be get it to people who "would benefit the most from it in an equitable way."

But, "given the fickleness of these vaccines in terms of administration, it's hard to end the day in your clinic exactly right," Swartzberg said. "Some people may not show up. You're going to have some doses left over."

If the groups who need it the most are not available in the specified viability window, he said, "you give it to anybody you can find. That's much better than throwing it out."

The argument against that thinking, he acknowledged, is that bending the rules is a slippery slope.

Although acknowledging that isolated abuses of the system can happen, he said, "I think that's a small price to pay."

Institutions that set up the distribution systems need better protocols and clearer instructions on how the leftover doses should be used, Swartzberg said.

"That takes the legal as well as the psychological burden off the physician administering it," he said.

Ways to use leftover vaccine are anything but consistent.

Last week in Josephine County, Oregon, county health officials gave extra doses to drivers who were stuck on the side of the road during a snowstorm to avoid wasting them, according to news site KTVL.

The New York Post reported that a 31-year-old man happened to get a vaccine after shopping in a grocery store in Washington, DC. A woman from the in-store pharmacy came up to him and said, "I got two doses of the Moderna vaccine. The pharmacy is closing in 10 minutes. Do you want them?"

Potential for Vaccine Waste

The potential for waste is great even with unpunctured vials, owing to the complex storage guidelines.

Moderna vials can be stored frozen between -13° F and 5° F and can be refrigerated for up to a month before use. Unpunctured vials can be kept at room temperature for up to 12 hours.

The Pfizer-BioNTech vaccine has to be kept frozen at between -112° F and -76° F. If thawed in a refrigerator, the doses keep for up to 5 days, but if thawed at room temperature, they are ineffective after half an hour, according to the US Food and Drug Administration.

Neither vaccine can be refrozen, and both must be given within 6 hours after the vial is punctured.

A sixth dose can be squeezed out of the Pfizer vials but only with a special syringe, and those are in short supply, the Washington Post reports. Thus, the sixth dose is often discarded.

Swartzberg said the problem will likely be alleviated with future vaccines that promise longer shelf life in the refrigerator and fewer temperature requirements and that only require a single dose.

Johnson & Johnson announced Friday that its single-dose vaccine is 85% effective against severe COVID-19 illness.

"It's wonderful we have these vaccines, but it's too bad they're so fickle in how we can administer them," he said.

Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune and Nurse.com and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick.

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