FDA Says Pfizer Vaccine Vial Keeps Additional Doses, Increases Supply

The federal government has not publicly announced the guidance; Pfizer inquired about the change this afternoon.

Pfizer vials are believed to contain five doses, but pharmacists have found that they have enough for the sixth or seventh dose. Putting those in use could significantly increase Schott’s initial supply to the United States, reducing the possibility of a “vaccine cliff” this spring because it is a supply of demand.

Manufacturers usually overfill vaccine vials to protect against spills and other wastes, said Erin Fox, a pharmacy specialist at the University of Utah who monitors drug shortages. “Completely extra dose or more although this is very unusual – but it seems so!” He said in an email.

But many pharmacists, confused without federal clarity, threw out hundreds of additional doses since vaccination began on Monday. In Utah, Fox said, pharmacists are advised to stick to FDA emergency use guidelines, which state that there are five doses.

Pharmacists nationwide paid attention to excess supplies, which helped Pfizer exit.

Pfizer spokesman Sharon Castillo told POLITICO, “The amount of vaccine left in a multidose vial may vary after removal of 5 doses, depending on the type of needle and syringe used.” “At this time, we cannot recommend the use of a vaccine balance from each vial. Vaccinees need to consult their institution’s policies for the use of multidose vials.”

Both Pfizer and the FDA stated that vaccines left over from many vials should not be mixed, as there is a risk of contamination.

Former Obama administration acting CMS chief Andy Slavitt tweeted on Tuesday about possible vaccine wastage and emphasized that Pfizer is now submitting paperwork so that pharmacists can use additional supplements when available.

“I think it’s more clever pharmacists than what Pfizer had missed,” he told POLITICO.

Castillo said Pfizer continues “to closely coordinate with the FDA on this matter.”

For the company to provide additional shots early next year, the possibility of a higher dose in the current Pfizer supply comes due to pressure from the US government, after passing on options to buy more this fall. HHS Secretary Alex Azar said Wednesday that the administration is negotiating with Pfizer for more than the $ 100 million that was originally promised, but Pfizer CEO Albert Borla has said the company will take those shots by this summer Can not provide.

Rachel Rubin contributed.

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