But federal health officials managing government contracts for injection have told the Food and Drug Administration that more than 70 percent of sites were using the most efficient syringes and that more could be easily purchased or manufactured, according to another person familiar with the situation.
However, Pfizer’s attempts to lobby the FDA upset some health officials, especially since the company itself originally calculated that the vials contained five doses. If an extra dose could be drawn, that means the vaccine supply could stretch, protecting more Americans from the virus. On the other hand, the small number of specialized syringes could mean that the government may ultimately pay for the missed doses.
A spokeswoman for the Food and Drug Administration said that by early January, the debate had been resolved after “a normal and normal legal review process.” On January 6, in Shuffled To the emergency clearance, the Food and Drug Administration officially changed the vaccine fact sheet to set six doses.
Low dead volume syringes and / or needles may be used to extract six doses from one vial. The New American Fact Sheet Read. He also warned that “if standard needles and syringes are used, there may not be sufficient volume to extract a sixth dose from one vial.”
A spokeswoman for the Food and Drug Administration said, in a statement, that the agency took into account several factors when approving Pfizer’s request, including the availability of special syringes, and the fact that other health authorities made a similar decision and that the change would feed Americans faster.
Pfizer and the federal government have agreed to track the sites that receive the syringes and other equipment needed to extract the extra dose, and that the company will not charge the United States for six doses per vial at sites without that equipment, according to a person familiar with the negotiations who was not authorized to speak. Because the conversations are confidential.
Starting next week, the number of Pfizer vaccines the federal government allocates to each state could be based on the assumption that each vial contains six doses, according to a federal official not authorized to discuss the matter. The CDC and the Department of Health and Human Services were recently discussing Friday afternoon when they could make the change.