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Pfizer is counting the additional coronavirus vaccine it uses to supplement each of its vials as part of its commitment to deliver 200 million vaccines for the U.S. pandemic response – even if there aren’t enough syringes capable of extracting additional liquid.
On January 6, the Trump administration’s Food and Drug Administration approved a request by Pfizer to update its vaccine label to clarify that six doses, instead of five, can be taken from each vial. The new label came weeks after the agency said pharmacists could administer any excess they could successfully extract from the vials.
This means Pfizer is delivering fewer vials of vaccine as newer, more contagious coronavirus variants are asking experts to step up the pace of vaccinations and some states are complaining that they are running out of vaccines. The New York Times first reported the change.
“We will meet our supply commitments in accordance with our existing agreements – which are based on delivery of doses, not vials,” Amy Rose, a spokesperson for Pfizer, wrote in an email Friday night.
While drugmakers typically fill vials with additional vaccine to protect against spills and waste, pharmacists administering the first injections of Covid have found there is enough in each vial for an entire additional injection – if they were using the right syringes.
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 things for healthcare professionals, minimize vaccine wastage and allow the most efficient use of the vaccine.”
The FDA told POLITICO that before proceeding with the label change 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 ‘World Health Organization and the European Medicines Agency to allow 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 are identifying 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.
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