Pfizer Can Count Bonus Doses Toward Fulfilling Contracts With Feds

 

Pfizer, the pharmaceutical company to develop the nation’s first authorized COVID-19 vaccine, will begin counting the bonus dose of vaccine that pharmacists discovered in vials late last year toward fulfilling its contractual obligations with the U.S. government.

According to The New York Times, the move was made possible after the Food and Drug Administration changed the wording in the authorization — which grants the public access to the COVID-19 vaccine — to note that six doses can be extracted from vialsWhile each vial was intended to only hold five doses of the COVID-19 vaccine, pharmacists distributing the vaccine discovered early on that vials could be stretched to produce a full extra dose due to the manufacturing process, which includes more volume than needed to ensure every dose can be given. As Pfizer is paid by the dose, not by the vial, formalizing the change has allowed Pfizer to fulfill its contractual obligations with the government more quickly.

In order to extract the extra dose from the vial, pharmacists will need to use low dead space syringes, which maximizes the amount of vaccine that can be used per vial. However, as Politico notes, these syringes aren’t always accessible to pharmacists.

The Washington Post, citing an anonymous official close the negotiations, reports that the sixth dose will only be counted when shipped along with low dead space syringes. The New York Times has since reported the same thing.

From The Washington Post:

The Biden administration and Pfizer finalized a deal Friday that will allow the government to track which shipments are accompanied by low dead space syringes and which are not, according to an individual close to the negotiations who spoke on the condition of anonymity to discuss the details.

Vials accompanied by regular syringes will be counted as five doses against Pfizer’s contract for 200 million shots, and those accompanied by special syringes will count as six shots toward contract fulfillment.

The New York Times, which first reported the change of language in the emergency use authorization, reports that specialty syringes that can extract the extra dose may be available at more than 70% of vaccination sites.

From The New York Times:

In late December, federal health officials sought to figure out whether there were enough of the specialized syringes to justify the shift. Officials at the Centers for Disease Control and Prevention said they were uncertain whether the supply was sufficient, according to a person familiar with the conversations.

But federal health officials who manage the government’s contracts for syringes told the F.D.A. that more than 70 percent of the sites were using the more efficient syringes and that more could be easily bought or manufactured, according to another person knowledgeable about the situation.

In a statement to Politico on Friday, Pfizer spokesperson Amy Rose said: “We will fulfill our supply commitments in line with our existing agreements — which are based on delivery of doses, not vials.” According to The Washington Post, the Biden administration plans to increase the availability of syringes needed to extract the sixth dose. It’s unclear how long that will take..