Pfizer Will Count COVID-19 Vaccine Vial Overfills Toward US Quota of Doses

Kevin Kunzmann

Kevin Kunzmann is the managing editor for Contagion, as well as its sister publication HCPLive. Prior to joining parent company MJH Life Sciences in 2017, he worked as a health care and government reporter for The Pocono Record, and as a freelance writer for NJ Advance Media, The Express-Times, The Daily Journal, and more. He graduated from Rowan University with a degree in journalism in 2015. In his spare time, he enjoys reading, cooking, running his dog, and complaining about the Mets. Follow him on Twitter @NotADoctorKevin or email him at [email protected]

In a move being ill-received by clinicians, the COVID-19 vaccine producer is lessening the count of vials being supplied to the government through July.

Following discovery of a potential sixth dose in distributed five-dose vials of Pfizer-BioNTech coronavirus 2019 (COVID-19) vaccine BNT162b2 due to overfill, Pfizer intends to count the supplemental doses toward its commitment of 200 million doses distributed to the US by the end of July 2021.

The decision, initially reported by The New York Times, comes at a time when vaccine administration has been slower than the rate of distribution itself—and with administering pharmacists are stating the uncovered overflow “sixth doses” are not consistent with each vial.

According to the report, Pfizer executives have been challenging wording of the vaccine’s Emergency Use Authorization (EUA) to acknowledge distributed vials contain 6 doses, not 5. The difference, acknowledged by the FDA on January 6, influences the pharmaceutical company’s contract with the US government.

Rather than the company being able to provide up to 20% more doses of the agreed-upon 100 million vaccine doses in the US—as hoped for upon discovery of the vial overfills—they will be able to renegotiate with the government at the end of their distribution deal.

A Pfizer spokesperson told the Times that the company’s supply commitment pertains to a delivery of doses, not vials. They added the intent of the FDA label change was to “provide clarity to health care providers, minimize vaccine wastage, and enable the most efficient use of the vaccine.”

As clinicians noted, this decision adds the pressure of properly procuring a full sixth vaccine dose in every vial during a still-rampant pandemic.

“This is gross, money-extracting behavior in the midst of the greatest health emergency our world has seen,” Megan Ranney, MD, MPH, of Brown University, wrote on Twitter.

Dr. Maurizio Cecconi, president of the European Society of Intensive Care Medicine (ESICM), echoed that the decision is perceivably bad given the “advantage of the sixth (sic) dose for the vaccination campaign.”

“Pfizer will make a lot of money from these vaccines, and the US government assumed a lot of the upfront risk in this case, so I’m not sure why Pfizer didn’t just continue to fill their supply as planned, even if it meant oversupplying a little,” Aaron S. Kesselheim, MD, JD, MPH, a professor of medicine at the Brigham and Women’s Hospital and Harvard Medical School, said in the report.