The US Food and Drug Administration (FDA) said Thursday it is working with Pfizer to revise a fact sheet for recipients of the Pfizer-BioNTech COVID-19 vaccine after two people had allergic reactions to it, AFP reports.
The two people, both health workers, were vaccinated in Alaska and one of them had a serious or "anaphylactic" reaction resulting in hospitalization.
Doran Fink, deputy director of the FDA's division of vaccines said, according to AFP, "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.
US authorities, including the Centers for Disease Control and Prevention, are investigating the two cases and working with Britain to better understand two similar cases that occurred there, said Fink.
"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 added, "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."
Last week, it was reported that two British healthcare workers had suffered anaphylactic reactions after receiving the Pfizer vaccine.
The FDA just last week approved the Pfizer and BioNTech vaccine for emergency use, following a recommendation from its own vaccine advisers.