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‘Sixth Dose’ of Pfizer-BioNTech COVID-19 Vaccine Creates Complications

Amid all of the pressure to vaccinate as many Americans as possible against COVID-19, pharmacists providing the Pfizer-BioNTech product might also find themselves in a mad search for more low dead-volume syringes. The reason is that the special equipment is necessary to access the “sixth dose” of vaccine in each vial. Here is more information.

WASHINGTON, DC – The news that each vial of Pfizer-BioNTech COVID-19 contained an unexpected sixth dose initially was met with great excitement. Did that mean more vaccine was available than originally thought?

The elation soon faded when Pfizer said the sixth dose would be considered in meeting its commitment to the United States of 200 million Covid-19 vaccine doses, which now would be met by the end of May, two months sooner than previously expected. Making matters worse is the difficulty in producing enough of the special syringes required to access the sixth doses.

Complications ensued when the Food and Drug Administration approved an updated label that reads, "Low dead-volume syringes and/or needles can be used to extract six doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial."

The FDA also changed the following: “After dilution, one vial contains 6 doses of 0.3 mL. Vial labels and cartons may state that after dilution, a vial contains 5 doses of 0.3 mL. The information in this Fact Sheet regarding the number of doses per vial after dilution supersedes the number of doses stated on vial labels and cartons.”

Regulators further state that each dose must contain 0.3 mL of vaccine, explaining that, if the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, the vial and content should be discarded, and excess vaccine should not be pooled from multiple vials.

Although federal officials say that some low dead-volume syringes will be shipped with Pfizer-BioNTech vaccine allotments, many vaccinators – including pharmacists – might find they need extra. That is likely to be a problem, at least in the short-term.

Manufacturers have said that producing more of the special needles was not a priority for the Trump Administration, so they directed their efforts to other products. Now, to fill supply shortfalls, President Joe Biden has said he will invoke the Defense Production Act (DPA). A White House press release said Biden issued an executive order which “directs agencies to fill supply shortfalls using all available legal authorities, including the DPA, and the United States has identified twelve immediate supply shortfalls that will be critical to the pandemic response, including shortages in the dead-space needle syringes available to administer the vaccine.”

https://www.whitehouse.gov/wp-content/uploads/2021/01/National-Strategy-for-the-COVID-19-Response-and-Pandemic-Preparedness.pdf

Other areas that might have production increases through the DPA include N95 masks, isolation gowns, nitrile gloves, polymerase chain reaction (PCR) sample collection swabs, test reagents, pipette tips, laboratory analysis machines for PCR tests, high-absorbency foam swabs, nitrocellulose material for rapid antigen tests and rapid test kits.