This entire article is a great read, but I came across something below I had not heard before.
Pfizer executives found a partial fix to their supply problem in the vaccine vials themselves. They just needed authorization to change the labels to say the vials contained six doses instead of five. It’s standard practice in the pharmaceutical industry to overfill vials slightly to avoid running the risk of undershooting and violating FDA labeling laws. Pfizer was overfilling each vial by just enough for an extra dose if vaccinators used what are called low dead-volume syringes.
But not all vaccination sites had the syringes. Moreover, the company’s application to the FDA and other regulators specified five-dose vials. Pfizer needed to generate data showing the extra shot could be reliably extracted.
The company did that and then began pressing FDA officials to change the authorization to recognize the sixth dose. OWS officials were against the change, anticipating nightmare logistical implications right when they were starting the biggest mass vaccination campaign in U.S. history, the former senior administration officials say. Pfizer’s vaccine needed to be kept at subarctic temperatures—it was already difficult enough to distribute without last-minute rejiggering. (Recently the FDA announced that it can be kept at normal freezer temperatures for up to two weeks.)
The company’s lobbying efforts succeeded. On Jan. 6 the FDA revised its fact sheet, allowing the sixth dose and effectively boosting Pfizer’s production by 20%. Regulators in Europe, the U.K., and elsewhere followed suit. The U.S. and the U.K. had managed to source the syringes, but other countries were left scrambling. Sweden and Japan complained they didn’t have enough special syringes to extract the sixth dose and warned it would likely mean millions of doses would be thrown away.
Looked at a different way, doses weren’t being ‘thrown away’ but instead the vials didn’t quite contain that sixth dose.
Bourla defended the policy change by saying the company had validated 36 syringe-needle combinations that could get the extra dose out. “It would be criminal if we can use six doses, and we are throwing away one vaccine that can save lives right now,” he told Bloomberg in late January.
The rationale for calling it a sixth dose isn’t bad, either! Two perspectives on the same situation, with the result being someone can say “we’re throwing away vaccine doses” and be both technically correct while also being rather wrong.