When boxes of Pfizer vaccines began arriving across the country this week, hospital pharmacists made a surprising discovery: some of the glass vials that are said to hold five doses contained enough for a sixth or even a seventh person.
The news sparked a violent exchange on Twitter and on pharmacy message boards this week as hospital workers considered the tempting possibility that the limited supply of much-needed vaccines could be expanded to reach more people.
But it also sparked a wave of confusion and debate about whether the extra doses should be used or thrown away. For example, at Northwell Health in New York, an executive estimated that the hospital network may have released enough extra vaccine to absorb 15 to 20 doses while waiting for guidance from the state health department.
The pharmacists received an answer on Wednesday. In a statement, the Food and Drug Administration said that “in light of the public health emergency,” it was acceptable to use any full dose remaining in each vial. The agency consulted with Pfizer to determine “the best way forward” and advised health officials not to bundle the doses from multiple vials.
“We never want to waste – waste drugs, waste vaccines,” said Anna Legreid Dopp, senior director of clinical guidelines and quality improvement for the American Society of Health System Pharmacists. “So that would be exciting if this were an opportunity.”
The vaccine developed by Pfizer and the German company BioNTech is extremely scarce. Pfizer said it made enough vaccine to deliver at least 25 million doses to the United States before the end of the year – enough for 12.5 million people since it takes two shots – but federal officials carefully allocated it and only distributed 2.9 million Doses begin this week after the FDA approved the emergency application last Friday.
Because the vaccine is so rare, it will be given to the front lines of health care first, as well as to residents and nursing home workers, and experts have said a vaccine will not be available to every American who has a vaccine well into next year would like to have.
In a statement, Pfizer said there is a consistent amount of vaccine in each vial, but the amount left after removing five doses may vary depending on the type of syringes and needles and the amount of diluent used. The company consulted with the FDA about the issue and was unable to “make a recommendation on how to use the remaining amount of vaccine from each vial.” It recommended that the staff performing the vaccinations contact local institutions.
Erin Fox, the senior pharmacy director for drug information and support services at the University of Utah, said she received a call from pharmacists Tuesday shortly after they started diluting the vaccine with saline and drawing it into syringes.
A little “overfilling” in multi-dose vials is normal, she said, but that was different. “They initially thought they got it wrong because there was so much left in the vial after they pulled up the five cans,” said Dr. Fox. “You sent us a picture and thought we could use the extra?”
Dr. Fox said her employees reached out to Pfizer and the Utah Health Department and told them not to use the extra doses as it was not according to the company’s instructions. She said the cans were discarded but that the staff would now start making additional cans.
Dr. Northwell Health’s chief quality officer, Mark Jarrett, said Wednesday that doctors who gave the Pfizer vaccine to health care workers this week noticed that some vials had enough for a sixth dose. The health system has asked the New York State Department of Health for guidance on whether it could be used.
Dr. Jarrett said that “some people used the sixth dose because they didn’t realize the question about it.” Northwell only dispenses five doses from each vial, however, and discards the extra medication – around 15 to 20 doses as of Tuesday.
He said he hadn’t seen the FDA’s guidance yet. “We have to document it somewhere so we can feel better,” he said.
New York state health officials reached out to the FDA Wednesday morning for advice after learning of the problem that morning, according to a health department spokesman. During a call on Wednesday with nearly 200 healthcare providers, State Health Commissioner Dr. Howard A. Zucker identified the problem and said additional doses could be used.
Dr. Michael J. Consuelos, a health advisor, said hospital pharmacists made a similar discovery during the H1N1 influenza pandemic in 2009 at the Lehigh Valley Health Network in Pennsylvania, where he then monitored the response to the pandemic. This vaccine was also scarce, and officials decided to use the extra doses.
“We want to provide people with as many doses as possible as safely and efficiently as possible,” said Dr. Consuelos, who participated in the Pfizer vaccine study as a volunteer. If hospital professionals can do this safely, “we should take advantage of these opportunities.”
The news that hospitals may be able to vaccinate more people than expected also creates new complications. Federal officials carefully managed vaccine supplies, keeping enough doses in reserve for any person who received the first dose three weeks later to receive a booster shot.
Dr. Dopp said hospitals that squeeze out extra doses need to make sure the person doesn’t get the second shot. “This is where we need really nimble tracking systems and real-time information systems so that we can make these decisions in quick succession,” she said.
But Dr. Dopp admitted that it’s a good problem too. “These are some of the lessons that we cannot learn until the vaccine is in hand,” she said.
Roni Caryn Rabin contributed to the coverage.
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