Pfizer is relying on the extra coronavirus vaccine it uses to complete each of its vials to fulfill its commitment to provide 200 million injections to respond to the United States pandemic – although there are not enough syringes to squeeze out the extra fluid.
The Trump Food and Drug Administration approved on January 6 a request by Pfizer to update its vaccine label to clarify that six doses, instead of five, can be withdrawn from each vial. The new label came several weeks after the agency said pharmacists could manage any surplus they could extract from the bottles.
This means that Pfizer is delivering fewer vials of vaccine as new, more contagious variants of the coronavirus have specialists clamoring to increase the rate of vaccinations and some states complain that vaccines have run out. The New York Times reported the change for the first time.
“We will deliver on our supply commitments under our existing agreements – which are based on the delivery of doses, not bottles,” Amy Rose, a spokeswoman for Pfizer, wrote in an email Friday night.
While drug makers typically fill the vials with extra vaccine to protect against spillage and waste, the pharmacists who administer Covid’s first injections found that there was enough in each vial for an extra full injection – if they used the right syringes.
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.