But federal health officials who manage government syringe contracts told the FDA that more than 70 percent of locations were using more efficient syringes and that more could be easily purchased or manufactured, according to someone else familiar with the situation.
Still, Pfizer’s attempts to put pressure on the FDA unsettled some health workers, especially since the company itself originally calculated that the bottles contained five doses. If an extra dose could be extracted, it would mean that the vaccine supply could be expanded, protecting more Americans from the virus. On the other hand, the lack of special syringes would mean that the government could end up paying for missed doses.
In early January, the debate was resolved after a “standard and usual legal review process,” said an FDA spokeswoman. On January 6, in an amendment to the emergency authorization, the FDA formally amended the vaccine’s information leaflet to specify six doses.
“Low-volume syringes and / or needles can be used to extract six doses from a single bottle,” says the new US newsletter. He also warned: “If standard syringes and needles are used, there may not be enough volume to extract the sixth dose from a single bottle”.
In a statement, an FDA spokesman said the agency considered several factors when agreeing to Pfizer’s request, including the availability of special syringes, the fact that other health officials made a similar decision and that the change would vaccinate. Americans more quickly.
Pfizer and the federal government have agreed to track which locations are receiving the syringes and other equipment needed to extract the additional dose, and that the company will not charge the United States for six doses per bottle in locations that do not have this equipment, according to a person familiar with the negotiations who was not allowed to speak because the conversations are confidential.
As of next week, the number of Pfizer vaccines that the federal government distributes to each state may be based on the assumption that each bottle contains six doses, according to an unauthorized federal authority to discuss the matter. The CDC and the Department of Health and Human Services were discussing recently, on Friday afternoon, when they could make the move.