Registered Nurses Swab Patients During COVID-19 Testing in Philadelphia | Photo credit: AP
Washington: The U.S. Food and Drug Administration (FDA) said Thursday it was working with Pfizer to review a fact sheet for recipients of the Pfizer-BioNTech Covid-19 vaccine after two people experienced allergic reactions.
The two people, both health workers, were vaccinated in Alaska and one of them had a severe or “anaphylactic” reaction resulting in hospitalization.
Doran Fink, deputy director of the FDA vaccines division said, “All of these individuals have been treated with appropriate medical intervention and, fortunately, all have recovered or are recovering.
“We anticipate there may be further reports, which we will investigate quickly.”
He added that US authorities, including the Centers for Disease Control and Prevention, were investigating the two cases and working with Britain to better understand two similar cases that occurred there.
“While the totality of the 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 initial phase of the vaccination campaign,” he said Fink.
To that end, he said, “the FDA is working with Pfizer to further review fact sheets and prescribing information for their vaccines to draw attention to CDC guidelines for post vaccination monitoring and management of immediate allergic reactions. “.
The review will include the current warning for people who have a history of allergic reactions to the vaccine ingredients to avoid getting the injection for now.
It will also include the caveat that facilities where vaccines are administered must ensure the immediate availability of medical care for the management of severe allergic reactions.
Fink added that should Moderna receive an emergency use permit, it will come with similar alerts.
Both of these vaccines are based on mRNA (messenger ribonucleic acid) technology, which has never been approved before.