Some syringes distributed by the federal government are not efficient enough to extract the sixth dose, leading hospitals to throw away a valuable vaccine. Earlier this month, officials from Operation Warp Speed, the Trump administration’s vaccine accelerator, acknowledged the problem and said the federal government was “rapidly evaluating options” to reconfigure vaccination kits sent to providers.
Pfizer says the change to its label was made to “clarify matters for healthcare providers, minimize vaccine wastage and allow the most efficient use of the vaccine.”
The FDA told POLITICO that before changing the label at Pfizer’s request, it reviewed the availability of low dead volume syringes – the type needed to extract the extra dose – and the changes already made by the Organization. World Health and the European Medicines Agency using the additional liquid.
“By far the most important, [FDA considered] the need to ensure that the maximum number of individuals were vaccinated in the United States as quickly as possible, as using 6 doses from the vials would vaccinate 16.6% of Americans over 5 doses, ”said said a spokesperson.
But without enough specialized syringes, Pfizer’s decision likely means the United States will have fewer usable doses than it expected.
The FDA etiquette change is the latest twist in a troubled deployment that has seen vaccinations lag behind targets set by the Trump administration.
President Joe Biden signed executive orders this week invoking the Defense Production Act in an attempt to quickly speed up the availability of certain supplies. Agencies identify supply shortages, such as the shortage of effective syringes, according to a White House official. However, it is not known when production would increase.
The Centers for Disease Control alarmed some state officials on Thursday when the agency said it would start counting vials of Pfizer’s vaccine as containing six doses, according to an agency email obtained by POLITICO. The CDC has said it will increase the number of syringes it ships with the vaccine, but that it may not be the “low dead volume” variety that can extract the extra doses.