Yesterday I reported the potential of increasing the number of Pfizer doses available by 20% using vaccine syringes that had little dead space. This allowed the possibility of getting six doses of Pfizer coronavirus vaccine from a vial that was labeled as having only five.
Unfortunately, Pfizer realized about a month ago that there was a potential for an additional dose in each vial of vaccine and successfully petitioned the F.D.A. to change their formal authorization language.
This story, first reported by the New York Times, outlines that the F.D.A.’s change allows Pfizer to deliver 20% fewer vaccine vials, but to charge for the same number of doses, since they get reimbursed by the dose not by the vial.
“Now there’s more pressure to make sure that you try to get that sixth dose out,” said Michael Ganio, the senior director for pharmacy practice and quality at the American Society of Health-System Pharmacists, who was quoted by the NYT.
Evidently, Pfizer executives have pushed officials at the Food and Drug Administration to change the wording of the vaccine’s F.D.A. approval, called “emergency use authorization” so that it formally acknowledged that the vials contained six doses, not five.
At one point according to the Times, Pfizer executives lashed out at Dr. Peter Marks, the top federal vaccine regulator, over the government’s hesitation to approve the request, according to people familiar with the discussions who were not authorized to discuss them.
Still, Pfizer’s attempts to pressure the F.D.A. unsettled some health officials, especially since the company itself originally calculated that the vials contained five doses. If an extra dose could be extracted, that would mean the vaccine supply could be stretched, protecting more Americans from the virus. On the other hand, too few of the specialty syringes would mean the government could end up paying for wasted doses.
Evidently, the change was approved by early January, since on January 6th, in an amendment to the emergency authorization, the F.D.A. formally changed the vaccine’s fact sheet to specify six doses.
Pfizer’s insisting on an extra dose per vial has also raised concerns in Europe, where several countries, including Belgium, say they have had to cancel vaccination appointments after discovering that Pfizer is sending them fewer vials. “It’s linked to the sixth dose,” Sabine Stordeur, an official overseeing vaccination efforts in Belgium, told the newspaper Le Soir. “It’s still a private company, so one shouldn’t be surprised.”
Unfortunately, the U.S. is still totally unprepared for the change. McKesson, the company with the federal contract to deliver vaccination supplies, is still providing kits that contain only enough supplies for five doses per vial. According to a McKesson spokesman, the company began sending out kits that account for the sixth dose this week.
Jen Psaki, the White House press secretary, said on Thursday that the Biden administration might use the Defense Production Act to accelerate production of the specialized syringes in order to increase supply, suggesting that the federal government is uncertain about the supply of low dead space syringes in the future.
My apologies for raising expectations. While this vaccine is still a great achievement for BioNTech and Pfizer, I would hope the change in authorization does not lead to wasting of the vaccine and a decrease in overall vaccinations.