The US Food and Drug Administration (FDA) said on Thursday it would review the dose of Pfizer-BioNTech COVID-19 vaccine after two people had allergic reactions.
These people, both health workers, were vaccinated in Alaska and one of them had a severe or “anaphylactic” reaction, leading to hospitalization.
“These individuals have been treated with proper medical intervention and are fortunately recovering or undergoing repair,” said Doran Fink, deputy director of the FDA’s vaccine division.
“We anticipate that there may be additional reports, which we will investigate quickly,” he said.
He added that US authorities, including the Centers for Disease Control and Prevention (CDC), are investigating the two cases and are working with the UK to better understand two similar cases that have taken place there.
“While all current data continues to support vaccines without new restrictions … these cases underscore the need to be vigilant in the initial phase of the vaccination campaign,” Fink said.
“The FDA is working with Pfizer to further review its vaccine fact sheets and dosage, to draw attention to the CDC’s guidelines for post-vaccination monitoring and management of immediate allergic reactions,” he said. .
The review will include a warning for people with a history of allergic reactions to the vaccine’s ingredients to avoid self-injection.
It will also include a warning that vaccine facilities must ensure the immediate availability of medical treatment for the management of severe allergic reactions.
Fink added that if the Moderna vaccine receives an emergency use authorization, it will come with similar warnings.
Both vaccines are based on mRNA (messenger ribonucleic acid) technology, which has never been approved before.