But federal health officials managing government contracts for syringes told the FDA that more than 70 percent of the sites were using more efficient syringes and more easily purchased or manufactured according to another person knowledgeable about the condition Could go
Nevertheless, Pfizer’s efforts to pressure the FDA destabilized some health officials, especially because the company itself originally calculated that the vials contained five doses. If an additional dose can be taken out, it means that the vaccine supply can be increased, protecting more Americans from the virus. On the other hand, some of the special syringes would mean that the government could pay for wasted supplements.
In early January, a spokesman for the FDA said the debate was resolved after a “standard and general legal review process”. On January 6, in an amendment to the Emergency Authority, the FDA formally changed the vaccine’s fact sheet to specify six doses.
“Low dead-volume syringes and / or needles can be used to extract six doses from a single vial,” the new US Fact Sheet read. It also warned, “If standard syringes and needles are used, there may not be enough volume to extract a sixth dose from a vial.”
In a statement, an FDA spokesperson said the agency agreed to Pfizer’s request, considering several factors, including the availability of special syringes, from the fact that other health officials had taken a similar decision and that The change would vaccinate Americans more quickly.
Pfizer and the federal government have agreed to track which sites are receiving syringes and other equipment to remove the excess dose, and the company will not charge the United States for six doses per vial on sites whose There are no tools, according to a person familiar with the talks who was not authorized to speak because the talks are confidential.
According to a federal official not authorized to discuss the matter, early next week, the number of Pfizer allocated to each state by the federal government could be estimated. The CDC and the Department of Health and Human Services were discussing as recently as Friday afternoon when they can make changes.