Some syringes distributed by the federal government are not efficient enough to extract the sixth dose, causing hospitals to throw away the precious vaccine. Earlier this month, officials from Operation Warp Speed, the Trump administration’s vaccine accelerator, acknowledged the problem and said the federal government was “quickly evaluating options” to reconfigure the vaccination kits sent to suppliers.
Pfizer says the change in its label was made to “provide clarity to healthcare professionals, minimize vaccine waste and allow more efficient use of the vaccine”.
The FDA told POLITICO that before making the label change at the request of Pfizer, it considered the availability of low dead volume syringes – the type needed to extract the extra dose – and the changes already made by the World Health Organization and European Agency Medicines to allow using the extra fluid.
“By far, the most important, [FDA considered] the need to ensure that the maximum number of individuals is vaccinated in the United States as quickly as possible, since the use of 6 doses of the vials will vaccinate 16.6% more Americans than 5 doses, ”said a spokesman.
But without enough specialized syringes, Pfizer’s decision likely means that the U.S. will have fewer usable doses than it expected.
The change in the FDA label is the latest twist in a troubled launch that has seen vaccinations lag far behind the goals set by the Trump administration.
President Joe Biden signed executive orders this week invoking the Defense Production Act in an effort to try to speed up the availability of certain supplies quickly. Agencies are identifying shortfalls in supply, such as a shortage of efficient syringes, according to a White House official. However, it is not clear when production would increase.
The Centers for Disease Control alarmed some state officials on Thursday when the agency indicated it would begin counting Pfizer’s vaccine bottles as containing six doses, according to an agency email obtained by POLITICO. The CDC said it would increase the number of syringes shipped with the vaccine, but that they may not be the “low dead volume” type capable of extracting extra doses.