The US Food and Drug Administration on Monday issued an updated authorization letter and healthcare provider fact sheet on appropriate dosing of the Pfizer/BioNTech coronavirus vaccine.
The agency said the updates are “consistent with previous FDA advice that it would be acceptable to use every full dose obtainable (the sixth, or possibly even a seventh) from each vial” until scientists can resolve the issue.
“However, since the vaccine does not contain preservative, it is critical to note that any further remaining product that does not constitute a full dose should not be pooled from multiple vials to create one,” the FDA said in a statement.
Almost two weeks ago, when the first Pfizer vaccines rolled out, some providers realized there was an extra dose or two in the vaccine vials that were supposed to contain only five shots. The FDA said at the time it was fine to squeeze an extra shot or two out of the vials.
What's in the fact sheet? The fact sheet for healthcare providers is a summary of the instructions for administering a Covid-19 vaccine on how to store, thaw, prepare and administer the vaccine.
The fact sheet includes a reminder to providers enrolled in the federal Covid-19 Vaccination Program to report all administration errors, serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and cases of coronavirus that result in hospitalizations or death following a Pfizer/BioNTech shot.
The instructions contain a warning against giving the Pfizer vaccine to people with a history of severe allergic reactions. The agency said treatment used to manage severe allergic reactions must be immediately available onsite in case of an anaphylactic reaction.
The agency also warned against mixing the Pfizer and Moderna vaccines, specifying that an initial Pfizer shot should be followed up with another Pfizer shot three weeks later, and the same for the Moderna vaccine.