Discarding Precious Vaccine Can Be an Unintended Side Effect of Regulation

Jeffrey A. SingerSeveral doses of Pfizer ’s new mRNA COVID vaccine were wasted when pharmacists noted that many of the vials of vaccine, intended to contain five doses, had enough left over vaccine for one or two additional doses. Because the product description on page 3 of the Food and Drug Administration ’sEmergency Use Authorization for the vaccine stated that each vial, upon dilution, contains five doses of vaccine, many pharmacists were uncertain if the regulatory agency permitted them to use any residual vaccine in the vial. It is not unusual for manufacturers to add a little extra to the vials in case of spillage by staff administering the vaccine.Politico reports that at least some academic pharmacists were recommending the excess be discarded, because the EUA made no mention of what to do with any excess vaccine, and described the authorized product as containing five doses per vial.Upon consulting with the FDA, a spokesperson for the agency told Politico, “Given the public health emergency, FDA is advising that it is acceptable to use every full dose obtainable.” Well, of course.So now the extra vaccine can be put to good use, immunizing more people. Unfortunately, the already discarded doses cannot be recovered. While the pharmacists ’ fear of thwarting federal regulations is certainly understandable, their hesitancy and the resulting loss of valuable vaccine is one side effect of a complex and overbearin...
Source: Cato-at-liberty - Category: American Health Authors: Source Type: blogs