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After the surprise discovery of an extra dose in every vial, Pfizer executives successfully lobbied the F.D.A. to change the vaccine’s formal authorization language. The company charges by the dose. Pfizer, after discovering it could squeeze an extra vaccine dose out of vials that were supposed to contain only five, plans to count the surprise sixth dose toward its previous commitment of 200 million doses of Covid vaccine by the end of July. That means it will be providing fewer vials than once expected for the United States And yet, pharmacists at some vaccination sites say they are still struggling to reliably extract the extra doses, which require the use of a specialty syringe. For weeks, Pfizer executives pushed officials at the Food and Drug Administration to change the wording of the vaccine’s so-called emergency use authorization so that it formally acknowledged that the vials contained six doses, not five The distinction was critical: Pfizer’s contract with the federal government requires that it be paid by the dose. At one point, Pfizer executives lashed out at the top federal vaccine regulator over the government’s reluctance to budge on the request, according to people familiar with the discussions who were not authorized to discuss them.
On Jan. 6, Pfizer got what it wanted. The F.D.A. changed the language in its fact sheet for doctors to confirm that the vials contain a sixth dose. The change mirrors similar labeling updates by the World Health Organization and the F.D.A.’s counterpart in the European Union. Company officials, including the chief executive, Dr. Albert Bourla, have said that the sixth dose allows Pfizer to stretch its supply of scarce vaccine even further — it was one factor, for example, in the company’s new estimates that it will be able to manufacture two billion doses for the world this year, instead of the 1.3 billion it had originally planned. The U.S. negotiations come at a particularly harrowing time, as the Biden administration is said to be discussing the purchase of a third round of 100 million doses of Pfizer’s vaccine later in the year. The country is racing to vaccinate as many people as possible before more contagious virus variants become widespread, potentially spurring a wave of new hospitalizations and deaths.
