By Aiyeku Timothy
The US Food and Drug Administration (FDA) said it will revise a fact sheet for recipients of the Pfizer-BioNTech Covid-19 vaccine after two people had allergic reactions.
The decision was made after two people, both health workers, were vaccinated in Alaska and one of them had a serious or “anaphylactic” reaction resulting in hospitalization.
Deputy director of the FDA’s division of vaccines, Doran Fink, on Thursday said: “All of these individuals were treated with appropriate medical intervention and thankfully, all are recovered or recovering. We anticipate that there may be additional reports, which we will rapidly investigate.”
He added that US authorities, including the Centers for Disease Control and Prevention, were investigating the two cases and working with Britain as they recorded two similar cases earlier.
“While the totality of data at this time continues to support vaccinations under the Pfizer EUA (emergency use authorization), without new restrictions, these cases underscore the need to remain vigilant during the early phase of the vaccination campaign,” Fink said.
To this end, he said, “FDA is working with Pfizer to further revise the fact sheets and prescribing information for their vaccines to draw attention to CDC guidelines for post-vaccination monitoring and management of immediate allergic reactions.”
