Some Vials of Covid-19 Vaccine Contain Extra Doses, Expanding Supply, FDA Says

npr.org

4 points·rolph··3 comments

>>The Food and Drug Administration says that some of the vials of Pfizer-BioNTech COVID-19 vaccine being distributed throughout the U.S. contain extra doses and the agency is encouraging hospitals and clinics to use the additional shots to speed up the nationwide immunization campaign.

The agency issued the guidance Wednesday after health care workers reported throwing out the excess vaccine, fearing it would be against the rules to use it.<<

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Questions arise in this case, such as Why the extra volume in some vials, where did it come from.

what is the effect on concentration of active components, and the final dilution to an individual dosage.

do these "extra" doses contain elevated amounts of settled components?

by extension approximately 2 doses of 7 out of a vial labled as 5 doses are off lable usage, in the strictest interpretation of the product lable.

It reduces logistical volume of the shipped product I think was the rationale. Not sure about the other questions.

this is not a uniform phenomenon, some vials of ~stock~ concentration have more volume than listed.

a 5 dose vial with 7 doses volume means an error of 40% .

the final bottling process is not obvious, so

H1: the stock concentration could _possibly_ be diluted by up to 40% in some vials.

H0: the vials are filled in one aliquot of appropriate concentration at higher volume.

bare minimum this is sloppy manufacture, due to deviation in portion control.

worst case 7 people are receiving off lable dosages.

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