When boxes of Pfizer vaccines arrived across the country this week, hospital pharmacists made a startling discovery: Some glass vials that should hold five doses hold enough for a sixth – or even a seventh – person.
The news sparked a wave of excited exchanges on Twitter and pharmacy message boards this week, as hospital workers contemplated the tempting possibility that the limited supply of much-needed vaccines could be stretched to reach more people.
But it also caused a wave of confusion and discussion about whether or not to use the extra doses or throw them away. At Northwell Health in New York, for example, a director estimated that the hospital network may have thrown out enough extra vaccine to deliver 15 to 20 doses while it waited for guidance from the state health service.
The pharmacists received an answer on Wednesday. In a statement, the Food and Drug Administration said that “given the public health emergency,” it was acceptable to use any full dose left in every bottle. The agency said it consulted Pfizer to determine “the best way forward,” and advised health officials not to collect doses from multiple vials.
“We never want to waste medication, throw away vaccines,” said Anna Legreid Dopp, senior director of clinical guidelines and quality improvement at the American Society of Health-System Pharmacists. “So that would be exciting if that’s an opportunity.”
The vaccine, developed by Pfizer and the German company BioNTech, is very scarce. Pfizer has said it will have produced enough vaccine by the end of the year to deliver at least 25 million doses – enough for 12.5 million people since it takes two injections – to the United States, but federal officials have carefully assigned it , with just 2.9 million doses starting this week after the FDA cleared emergency use last Friday.
Because the vaccine is so scarce, it’s first given to primary care health workers and residents and staff in nursing homes, and experts have said a vaccine won’t be available until well into next year for any American who wants one.
In a statement, Pfizer said the company was consulting with the FDA about the additional vaccine in some vials and “could not recommend the use of the amount of vaccine remaining from each vial.” It advised employees doing the vaccinations to consult with local institutions.
Erin Fox, the senior pharmacy director of drug information and support services at the University of Utah, said she received a call from pharmacists on her staff Tuesday shortly after they began diluting the vaccine with saline and sucking it into syringes.
A little “overfilling” in multiple dose vials is normal, she said, but this was different. “They initially thought they were doing it wrong because there was so much in the vial after they took the five doses,” Ms. Fox said. “They sent us a picture and said, can we use the extra?”
Ms. Fox said her staff contacted Pfizer and the Utah health department, which she said should not use the extra doses because it was not in accordance with the company’s instructions. She said the doses were thrown away, but the staff would now start taking additional doses.
Dr. Mark Jarrett, chief quality officer for Northwell Health, said on Wednesday that clinicians administering the Pfizer vaccine to health professionals this week have noted that some vials contain enough for a sixth dose. The health system has asked the New York State Department of Health for advice on whether it could be used.
Dr. Jarrett said that “some people took the sixth dose because they didn’t recognize the question about it.” But Northwell only gives five doses from each vial and throws out the extra medication – which works out to about 15 to 20 doses on Tuesday.
He said he had not yet seen the FDA guidelines. “We need to see it documented somewhere, it would make us feel better,” he said.
According to a health department spokesman, New York State health officials reached out to the FDA on Wednesday morning for advice after learning of the problem that morning. During a phone call Wednesday with nearly 200 health care providers, public health commissioner Dr. Howard A. Zucker, raised the issue and said additional doses could be used.
Dr. Michael J. Consuelos, a health adviser, said hospital pharmacists made a similar discovery during the 2009 H1N1 flu pandemic at the Lehigh Valley Health Network in Pennsylvania, where he then monitored the response to the pandemic. That vaccine was also scarce and officials decided to use the extra doses.
“What we want to do is give people as many doses as possible as safely and efficiently as possible,” said Dr. Consuelos, who said he volunteered in the Pfizer vaccine trial. If hospital professionals can do it safely, “then we need to seize those opportunities.”
The news that hospitals may be able to vaccinate more people than expected is also creating new complications. Federal officials carefully managed the supply of vaccines, keeping enough doses in reserve for each person who received the first dose to receive a booster shot three weeks later.
Ms Dopp said hospitals that squeeze extra doses should make sure the person is waiting for the second shot. “Here we need really flexible tracking systems and real-time information systems so that we can make these decisions quickly,” she said.
But Ms. Dopp acknowledged that it is also a good problem to have. “These are some of the lessons we cannot learn until the vaccine is available,” she said.
Roni Caryn Rabin contributed to the reporting.