The U.S. Food and Drug Administration (FDA) told Jews it would review the dosage of the covid-19 vaccine conducted by Pfizer-BioNTech, after two people had allergic reactions.
These people, both health workers, were vaccinated in Alaska and one of you had a severe or “anaphylactic” reaction, which resulted in hospitalization.
“These individuals were treated with appropriate medical intervention and, fortunately, are recovering or recovering,” 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 stressed.
He added that US authorities, including the Centers for Disease Control and Prevention (CDC), were investigating both cases and working with Britain to better understand two similar cases that occurred there.
“While all current data respond to vaccines without new restrictions (…) there will be cases emphasizing the need to remain vigilant during the initial phase of the vaccination campaign,” Fink said.
“The FDA is working with Pfizer to further review the information sheets and dosage of their vaccines, to draw attention to the CDC guidelines for post-vaccination control and management of immediate allergic reactions “He stressed.
The review will include an advertisement for people with a history of allergic reactions to the vaccine ingredients that avoid getting the injection for now.
It will also include advertising of the facilities where the vaccines will be administered that must ensure the immediate availability of medical treatment for the management of severe allergic reactions.
Fink added that should Moderna’s vaccine receive emergency use authorization, it will come with similar ads.
Both vaccines are based on mRNA (messenger ribonucleic acid) technology, which has never been approved before.