Pharmacists have found that they can squeeze an additional dose from some of the glass vials that were supposed to contain five doses of the Pfizer vaccine.
Some vials of the Covid-19 vaccine distributed this week have been found to contain enough for a sixth, or even seventh, dose.Credit…Benjamin Rasmussen for The New York Times
- Dec. 16, 2020
As boxes of Pfizer vaccines began arriving around the country this week, hospital pharmacists made a surprising discovery: Some of the glass vials that are supposed to hold five doses contained enough for a sixth — or even a seventh — person.
The news prompted a flurry of excited exchanges on Twitter and pharmacy message boards this week as hospital workers considered the tantalizing possibility that the limited supply of desperately needed vaccine might be stretched to reach more people.
But it also set off a wave of confusion and debate over whether to use the extra doses, or to throw them out. At Northwell Health in New York, for example, an executive estimated that the hospital network might have thrown out enough extra vaccine to account for 15 to 20 doses while it waited for guidance from the state health department.
On Wednesday, the pharmacists got an answer. In a statement, the Food and Drug Administration said that, “given the public health emergency,” it was acceptable to use every full dose left over in each vial. The agency said it was consulting with Pfizer to determine “the best path forward” and advised health officials not to pool doses from multiple vials.
“We never want to waste — waste medication, waste vaccine,” 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 is an opportunity.”
The vaccine, which was developed by Pfizer and the German company BioNTech, is in extremely short supply. Pfizer has said it has manufactured enough vaccine to supply at least 25 million doses — enough for 12.5 million people since it requires two shots — to the United States before the end of the year, but federal officials have allocated it carefully, doling out only 2.9 million doses beginning this week after the F.D.A. authorized its emergency use last Friday.
Because the vaccine is so scarce, it is being given first to frontline health care workers and residents and staff in nursing homes, and experts have said a vaccine won’t be available for every American who wants one until well into next year.
In a statement, Pfizer said there is a uniform amount of vaccine in every vial, but that the amount left over after five doses are removed could vary based on the type of syringes and needles as well as the amount of diluting solution used. The company said it was consulting with the F.D.A. about the issue and could not “provide a recommendation on the use of the remaining amount of vaccine from each vial.” It advised staff members 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 got a call from pharmacists on her staff Tuesday, shortly after they began diluting the vaccine with saline and drawing it into syringes.
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Answers to Your Vaccine Questions
With distribution of a coronavirus vaccine beginning in the U.S., here are answers to some questions you may be wondering about:
- If I live in the U.S., when can I get the vaccine? While the exact order of vaccine recipients may vary by state, most will likely put medical workers and residents of long-term care facilities first. If you want to understand how this decision is getting made, this article will help.
- When can I return to normal life after being vaccinated? Life will return to normal only when society as a whole gains enough protection against the coronavirus. Once countries authorize a vaccine, they’ll only be able to vaccinate a few percent of their citizens at most in the first couple months. The unvaccinated majority will still remain vulnerable to getting infected. A growing number of coronavirus vaccines are showing robust protection against becoming sick. But it’s also possible for people to spread the virus without even knowing they’re infected because they experience only mild symptoms or none at all. Scientists don’t yet know if the vaccines also block the transmission of the coronavirus. So for the time being, even vaccinated people will need to wear masks, avoid indoor crowds, and so on. Once enough people get vaccinated, it will become very difficult for the coronavirus to find vulnerable people to infect. Depending on how quickly we as a society achieve that goal, life might start approaching something like normal by the fall 2021.
- If I’ve been vaccinated, do I still need to wear a mask? Yes, but not forever. Here’s why. The coronavirus vaccines are injected deep into the muscles and stimulate the immune system to produce antibodies. This appears to be enough protection to keep the vaccinated person from getting ill. But what’s not clear is whether it’s possible for the virus to bloom in the nose — and be sneezed or breathed out to infect others — even as antibodies elsewhere in the body have mobilized to prevent the vaccinated person from getting sick. The vaccine clinical trials were designed to determine whether vaccinated people are protected from illness — not to find out whether they could still spread the coronavirus. Based on studies of flu vaccine and even patients infected with Covid-19, researchers have reason to be hopeful that vaccinated people won’t spread the virus, but more research is needed. In the meantime, everyone — even vaccinated people — will need to think of themselves as possible silent spreaders and keep wearing a mask. Read more here.
- Will it hurt? What are the side effects? The Pfizer and BioNTech vaccine is delivered as a shot in the arm, like other typical vaccines. The injection into your arm won’t feel different than any other vaccine, but the rate of short-lived side effects does appear higher than a flu shot. Tens of thousands of people have already received the vaccines, and none of them have reported any serious health problems. The side effects, which can resemble the symptoms of Covid-19, last about a day and appear more likely after the second dose. Early reports from vaccine trials suggest some people might need to take a day off from work because they feel lousy after receiving the second dose. In the Pfizer study, about half developed fatigue. Other side effects occurred in at least 25 to 33 percent of patients, sometimes more, including headaches, chills and muscle pain. While these experiences aren’t pleasant, they are a good sign that your own immune system is mounting a potent response to the vaccine that will provide long-lasting immunity.
- Will mRNA vaccines change my genes? No. The vaccines from Moderna and Pfizer use a genetic molecule to prime the immune system. That molecule, known as mRNA, is eventually destroyed by the body. The mRNA is packaged in an oily bubble that can fuse to a cell, allowing the molecule to slip in. The cell uses the mRNA to make proteins from the coronavirus, which can stimulate the immune system. At any moment, each of our cells may contain hundreds of thousands of mRNA molecules, which they produce in order to make proteins of their own. Once those proteins are made, our cells then shred the mRNA with special enzymes. The mRNA molecules our cells make can only survive a matter of minutes. The mRNA in vaccines is engineered to withstand the cell’s enzymes a bit longer, so that the cells can make extra virus proteins and prompt a stronger immune response. But the mRNA can only last for a few days at most before they are destroyed.
A little bit of “over fill” in vials that contain multiple doses is normal, she said, but this was different. “They initially thought that they had incorrectly done it because there was so much left in the vial after they pulled up the five doses,” Dr. Fox said. “They sent us a picture and were like, can we use the extra?”
Image Overfill, left over in a vial of the Pfizer vaccine at the University of Utah Health.Credit…Tom Sanders, PharmD
Dr. Fox said her staff reached out to Pfizer as well as Utah’s health department, which she said told them not to use the extra doses because it was not in keeping with the company’s instructions. She said the doses were discarded, but that the staff would now begin drawing up extra doses.
Dr. Mark Jarrett, chief quality officer for Northwell Health, said Wednesday that clinicians administering the Pfizer vaccine to health care workers this week noticed that some vials contained 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 recognize the question about it.” But Northwell is only dispensing five doses from each vial, and is discarding the extra medication — amounting to about 15 to 20 doses on Tuesday.
He said he had not yet seen the guidance from the F.D.A. “We need to see it documented somewhere, it would make us feel better,” he said.
New York state health officials contacted the F.D.A. for guidance on Wednesday morning after learning of the issue that morning, according to a health department spokesman. On a call Wednesday with nearly 200 health care providers, the state health commissioner, Dr. Howard A. Zucker, discussed the issue and said extra doses could be used.
Dr. Michael J. Consuelos, a health care consultant, said that during the H1N1 influenza pandemic in 2009, hospital pharmacists made a similar discovery at the Lehigh Valley Health Network in Pennsylvania, where he then worked overseeing the response to the pandemic. That vaccine was also scarce, and officials decided to use the extra doses.
“What we want to do is provide as many doses to people as safely and as efficiently as possible,” said Dr. Consuelos, who said he participated as a volunteer in the Pfizer vaccine trial. If hospital professionals can do it safely, “then we should take those opportunities.”
The news that hospitals may be able to vaccinate more people than expected also creates new complications. Federal officials have carefully managed the supply of vaccine, holding in reserve enough doses for each person who got the first dose to receive a booster shot three weeks later.
Dr. Dopp said hospitals that squeeze extra doses will have to make sure that the person will have the second shot waiting for them. “This is where we really need nimble tracking systems and real-time information systems so that we can make these decisions in quick order,” she said.
But Dr. Dopp acknowledged that it’s also a good problem to have. “These are some of the lessons that we can’t learn until vaccine is in hand,” she said.
Roni Caryn Rabin contributed reporting.