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The fact sheet and prescribing information provided with Pfizer’s Covid-19 vaccine will warn that people with a history of severe allergic reactions to any the vaccine’s components should not get it, an official at the US Food and Drug Administration said on Thursday.
“Over the last couple of weeks, we have been working with Pfizer on generating fact sheets and prescribing information,” Dr. Marion Gruber, director of the Office of Vaccines Research and Review in the FDA Center for Biologics Evaluation and Research, said during Thursday’s FDA Vaccines and Related Biological Products Advisory Committee meeting.
The advisory committee is discussing a possible emergency use authorization for Pfizer’s Covid-19 vaccine candidate.
“The fact sheet and the prescribing information will state that this vaccine should not be administered to individuals with known history of severe allergic reactions to any components of Pfizer’s Covid-19 vaccine and the warning statement will say appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Pfizer Covid-19 vaccine,” Gruber said.
“So that has made it already in the fact sheets and prescribing information weeks ago,” Gruber said. “We, however, will consider any additional information that we’re going to be receiving over the next couple of days and factoring this into our decision-making.”
On Wednesday: Reports emerged out of the United Kingdom about two health care workers with a significant history of allergic reactions having reactions following Covid-19 vaccination. The health workers have since recovered.
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