FDA Urges Pharmacists To Use Extra Doses In Each Vial Of COVID Vaccine To Expand Supply

STRATFORD, ENGLAND - DECEMBER 15: Vials of the Pfizer/BioNTech Covid-19 vaccine are seen during a vaccination clinic at the Sir Ludwig Guttmann Health and Wellbeing Centre on December 15, 2020 in Stratford, England. ... STRATFORD, ENGLAND - DECEMBER 15: Vials of the Pfizer/BioNTech Covid-19 vaccine are seen during a vaccination clinic at the Sir Ludwig Guttmann Health and Wellbeing Centre on December 15, 2020 in Stratford, England. After rolling out the vaccine to dozens of "hub" hospitals last week, the NHS is now enlisting several hundred primary care practices in its covid-19 vaccination campaign. (Photo by Leon Neal/Getty Images) MORE LESS
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The Food and Drug Administration said Wednesday that pharmacists can draw additional doses from vials of the Pfizer coronavirus vaccine, an effort that would expand the country’s supply of the first vaccine to win its authorization by millions of doses.

“At this time, given the public health emergency, FDA is advising that it is acceptable to use every full dose obtainable — the sixth, or possibly even a seventh — from each vial, pending resolution of the issue,” an agency spokesman said in a statement, urging pharmacists to draw beyond each vial’s expected five doses as it handles the matter with Pfizer.

Politico, the first to report the development, pointed out that if the additional supply in each vial is consistent, the amount of remaining vaccine could be up to 40 percent greater.

But according to Sharon Castillo, a Pfizer spokeswoman, the amount of vaccine remaining in each vial “can vary,” and depends on the type of needles and syringes used. 

“At this time, we cannot provide a recommendation on the use of the remaining amount of vaccine from each vial,” Castillo said in a statement to Politico. “Vaccinators need to consult their institution’s policies for the use of multidose vials.”

The FDA and Pfizer further warned that any leftover vaccine from different vials that is smaller than a full dose should not be mixed together at risk of cross-contamination.

The push to use every drop in each coveted vaccine vial, comes as the Trump administration scrambles to negotiate with Pfizer to sell the government tens of millions of additional doses so that it can increase vaccine rollout this spring after the drug company said the United States would likely have to wait until summer.

The New York Times reported last week that the Trump administration had dropped the ball by passing on an offer from Pfizer to purchase millions more doses of its vaccine earlier this year. 

Months after rejecting that offer, which was reissued as recently as October according to the Washington Post, the nation has secured only enough doses of two coronavirus vaccines to vaccinate 150 million people against COVID-19 by the end of June.

That includes a vaccine from Moderna which is expected to receive authorization from FDA in the coming days.

Federal officials on Wednesday continue to insist that they have secured enough doses to meet their targets, in spite of criticism.

Operation Warp Speed’s chief science adviser Moncef Slaoui defended the administration’s decision to turn down Pfizer’s earlier offer to ensure coverage for more Americans, saying, “you wouldn’t buy something before you knew it works if you had six opportunities to have one provider provide you with what you needed.” 

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  1. Avatar for nycabj nycabj says:

    Anyone else find it more than a little disturbing that Pfizer can’t measure the amount it puts in a vial?

  2. A little issue of quality control, if the vials weren’t filled properly. Generally (having done a few Quality Management implementations in the life sciences sector, including AZ), those filling devices operate on a weight of the vial when filled. If it doesn’t meet the criterion, the vial is pushed out for quality control.

    I didn’t do the Pfizer implementation, but I don’t see how this would’ve been missed in the design of the system or the filling machine.

  3. This is pretty normal in the industry. Every process has an error range and filling is typically set such that the lower end is the desired quantity, so that no vial is underfilled.

  4. Avatar for nycabj nycabj says:

    Understood. But this sounds as though it was at least one extra dose and possibly two. That seems rather generous.

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