FDA says Pfizer vaccine vials contain additional doses, expanding the range

Pharmacists have found a way to squeeze extra doses from vials of Pfizer’s vaccine, potentially expanding the country’s scarce supply by as much as 40 percent.

The Food and Drug Administration said late on Wednesday that those extra doses could be used, removing the confusion that had led some pharmacists to throw out the leftover vaccine for fear of violating the rules the agency set last week.

“Given the public health emergency, the FDA recommends that it is acceptable to use any full dose available,” an agency spokesperson told POLITICO, echoing the language a federal health official sent to the national Wednesday morning. vaccine suppliers.

The federal government has not publicly announced the guidelines; Pfizer heard about the change this afternoon.

The Pfizer bottles are supposed to contain five doses, but pharmacists have found that they are enough for a sixth or even a seventh dose. Putting these into use could significantly increase the scarce early supply of the shot in the United States, reducing the likelihood of a “vaccine cliff” this spring as demand outstrips supply.

Manufacturers usually overfill vaccine vials to protect against spills and other waste, said Erin Fox, a pharmacy expert at the University of Utah who monitors drug shortages. “It’s quite uncommon to get a full or more extra dose, but it seems to be there!” she said in an email.

But many pharmacists, left in confusion with no federal clarity, have been throwing out hundreds of extra doses since the vaccinations began Monday. In Utah, Fox said, pharmacists are advised to adhere to FDA emergency guidelines, which dictate that there are five doses.

Pharmacists across the country quickly noticed the additional offering, reaching Pfizer itself.

“The amount of vaccine remaining in the multi-dose vial after 5-dose disposal can vary depending on the type of needles and syringes used,” Pfizer spokesperson Sharon Castillo told POLITICO. “At this time, we cannot recommend the use of the amount of vaccine remaining from each vial. Vaccinators should consult their facility’s policies for the use of multiple dose vials.”

Both Pfizer and the FDA said leftover vaccine from multiple vials should not be mixed due to the risk of contamination.

Andy Slavitt, acting CMS chief of the former Obama administration, tweeted Tuesday about the potential waste of vaccines and insisted that Pfizer is now filing paperwork to allow pharmacists to use the extra doses if available.

“I think these are smarter pharmacists than anything Pfizer has overlooked,” he told POLITICO.

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

The possibility of more doses in Pfizer’s existing offering is coming under pressure from the US government, after passing on options to buy more this fall so that the company can give additional shots early next year. HHS Secretary Alex Azar said Wednesday that the government is negotiating with Pfizer for more than the 100 million doses it originally promised, but Pfizer CEO Albert Bourla has said the company will not be able to give these shots until this summer.

Rachel Roubein contributed.