Hospital pharmacists throughout the United States have discovered that some vials of Pfizer's and BioNTech's coronavirus vaccine contain more than the expected doses. Amid initial confusion and a lack of clear guidance, providers discarded many of the extra doses.
Pharmacists discover extra doses of Pfizer's coronavirus vaccine—and some get thrown away
According to Politico, Pfizer has said that each vial of its coronavirus vaccine should contain five doses. However, as pharmacists and providers began administering the first authorized doses of the vaccine early this week, they noticed that some of the vials contained enough remaining material for a sixth and sometimes seventh dose. According to Politico, those extra doses potentially could expand the country's scarce supply of the vaccine by up to 40%.
Erin Fox, senior pharmacy director of drug information and support services at the University of Utah, told Politico that drugmakers usually overfill vaccine vials to protect against losing any full doses due to spills and other types of waste. However, she wrote in an email to Politico that "[i]t's pretty unusual to have a full extra dose or more," but in this case, "it does seem to be there!"
Fox said pharmacists on her staff told her about the extra doses of vaccine on Tuesday, shortly after they had started to dilute and draw the vaccine into syringes. "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," Fox said. "They sent us a picture and were like, can we use the extra?"
On Twitter and message boards, pharmacists and others welcomed the discovery, also hoping the extra doses could mean America's limited supply of Pfizer's and BioNTech's coronavirus vaccine could be stretched to vaccinate more Americans. But there was one problem: Initially, pharmacists and providers lacked guidance on whether they could use the extra doses, and without that guidance, some providers discarded the excess.
Fox said her staff contacted Pfizer and the Utah Department of Health for guidance on what to do with the extra doses. The state's health department told her staff to not use the extra doses, in order to keep with Pfizer's instructions on how to use the vaccine. As such, her staff discarded those extra doses.
Similarly, Mark Jarrett, Northwell Health's chief quality officer, said Northwell clinicians administering the vaccine noticed some vials contained enough for a sixth dose of the vaccine. "[S]ome people used the sixth dose, because they didn't recognize the question about it," Jarrett said.
However, Jarrett said, without clear guidance from the New York State Department of Health or FDA on what to do with the extra doses, the health system generally had been dispensing five doses of the vaccine from each vial and discarding the remaining doses, which amounts to up to 20 discarded vaccine doses.
Jarrett said the health system contacted the New York State Department of Health for guidance on whether clinicians could use the extra vaccine doses to vaccinate health care workers. After state health officials learned about the issue Wednesday morning, they asked FDA for guidance, a spokesperson for the state's health department said. Later in the day, Howard Zucker, New York's health commissioner, held a call with nearly 200 health care providers and told them to use the extra doses, the New York Times reports.
Paul Biddinger, Mass General Brigham's medical director for emergency preparedness, said he had first heard of the extra vaccine doses from the United Kingdom's vaccine rollout earlier this month. Although his team had been prepared for the extra doses, they still had to throw them away because of the lack of guidance regarding what they should do with the excess, he said.
What should providers do with the extra doses?
Pfizer has said every vial of its coronavirus vaccine contains a uniform amount of material that should allow for about five doses. However, the drugmaker said there could be a varying amount of material left over after five doses have been administered, depending on the amount of dilution solution and types of syringes and needles that providers use to vaccinate people.
Pfizer spokesperson Sharon Castillo told STAT News that each dose of the vaccine must contain 0.3ml. In statements to both Politico and STAT News, Castillo said, "The amount of vaccine remaining in the multidose vial after removal of five doses can vary, depending on the type of needles and syringes used." She added, "At this time, we cannot provide a recommendation on the use of the remaining amount of vaccine from each vial. Vaccinators need to consult their institution's policies for the use of multidose vials."
According to the Times, Pfizer also said it was consulting with FDA on the issue and would provider further guidance.
Late Wednesday, FDA in a statement said pharmacists and providers should use any extra, full doses contained in the vials. "Given the public health emergency, FDA is advising that it is acceptable to use every full dose obtainable," the agency said.
Both FDA and Pfizer said providers should not pool together any remaining material from separate vials to make full doses, however, because to the risk of contamination, Politico reports. FDA added that it was consulting with Pfizer to determine "the best path forward," and they agency hasn't yet issued any formal guidance on what clinicians should do with extra doses of the vaccine, according to Politico.
Jarrett said he would prefer for FDA to release formal guidance on how clinicians should handle the additional vaccine doses. "We need to see it documented somewhere, it would make us feel better," Jarrett said.
According to Inside Health Policy, the American Hospital Association on Wednesday issued a "Special Bulletin" recommending that providers consult with their state health departments on questions regarding statewide policies on how they should handle the extra doses. If providers determine they can use the extra material, they should ensure that they are able to provide a full dose from the excess, AHA said. In addition, AHA echoed FDA's warning about pooling material from several vials, Inside Health Policy reports.
US reports record numbers of new coronavirus cases, hospitalizations, and deaths
Amid the rollout of Pfizer's and BioNTech's coronavirus vaccine, U.S. officials on Wednesday reported a new, single-day high of about 245,033 new cases of the novel coronavirus, according to data compiled by the Times. As of Thursday morning, U.S. officials had reported a total of about 17 million cases of the virus since America's epidemic began—up from about 16.7 million cases reported as of Wednesday morning.
According to the Times, the United States' average daily number of newly reported coronavirus cases over the past week was 211,008—which is up by 29% when compared with the average from two weeks ago.
As of Thursday morning, data from the Times showed that the rates of newly reported coronavirus cases were "staying high" in Puerto Rico; the U.S. Virgin Islands; Washington, D.C.; and 40 states that have had a daily average of at least 15 newly reported cases per 100,000 people over the past week. Those states are Alabama, Alaska, Arizona, Arkansas, California, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Mississippi, Missouri, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, and Wisconsin.
Meanwhile, the Times' data showed that, as of Thursday morning, the daily average number of newly reported cases over the past seven days was "going down" in nine states that had been seeing comparatively higher rates of coronavirus transmission. Those states are Colorado, Iowa, Michigan, Minnesota, Montana, Nebraska, North Dakota, South Dakota, and Wyoming.
Hawaii has had comparatively low case rates, but it was seeing those rates "going up" as of Thursday morning, according to the Times. In Guam, meanwhile, rates of newly reported coronavirus cases were "staying low" as of Thursday morning, the Times' data showed.
U.S. hospitalizations for Covid-19, the disease caused by the novel coronavirus, grew to a new high for the 19th consecutive day on Wednesday, according to data from The Atlantic's COVID Tracking Project. The data showed that 113,090 Americans with Covid-19 were hospitalized for treatment on Wednesday, including 21,936 who were receiving care in an ICU and 7,778 who were on a ventilator.
U.S. officials on Wednesday also reported about 3,611 new deaths linked to the virus, which is the highest number of new deaths tied to the coronavirus that the country has reported in a single day since its epidemic started. As of Thursday morning, U.S. officials had reported a total of about 307,642 U.S. deaths linked to the virus since the country's epidemic began, up from about 303,963 deaths reported as of Wednesday morning.
(Thomas, New York Times, 12/16; Owermohle, Politico, 12/16; Wang, Inside Health Policy, 12/16 [subscription required]; Goldhill, STAT News, 12/16; FDA tweet, 12/16; Diaz, NPR, 12/17; New York Times, 12/17; "The COVID Tracking Project," The Atlantic, accessed 12/17).