FDA Panel Votes to Authorize Emergency Use of Pfizer Vaccine: Minute by Minute



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FDA Vaccine Advisors Raise Concern Over Allergic Reactions To Pfizer Vaccine In UK

Vaccine advisers to the U.S. Food and Drug Administration (FDA) say they are concerned about how the U.S. public will react to reports of severe allergic reactions to Pfizer’s coronavirus vaccine in the United States. UK.

“I am concerned about these severe anaphylactic reactions,” said Dr. Paul Offit, director of the Center for Vaccine Education at Children’s Hospital of Philadelphia, during the debate prior to the committee vote.

On Wednesday, reports emerged from the UK of two healthcare workers with a significant history of allergies who had reactions after getting vaccinated against COVID-19. They have since recovered.

‘We don’t know the details of those two things. We don’t know specifically what they were allergic to or what their history of severe allergies was, “Offit said during the Vaccines and Related Biologics Advisory Committee meeting.

Offit, a voting member of the committee, said he was concerned that Americans with allergies feared getting vaccinated. Britain’s Public Health officials are now telling people with a history of severe allergies not to get vaccinated, Offit said.

“There are tens of millions of people in this country who carry EpiPens with them, because they have a peanut allergy, because they have an egg allergy, that they are now going to believe that they cannot receive this vaccine,” Offit said. “That’s a lot of people.”

Pfizer said earlier that it had not recorded serious allergic reactions to the vaccine in the phase 3 trial that involved 44,000 volunteers. However, people with a history of allergic reactions to vaccines were excluded from the trial.

Dr. William Gruber, senior vice president for vaccine research and clinical development at Pfizer said that ‘the nature of what was actually excluded from the trial was really restricted to those individuals who had had a severe allergic reaction to a vaccine, any vaccine, previously, or obviously during the course of the trial if they had received the first dose, and had a significant type one hypersensitivity response, then that precluded the administration of a second dose.

Gruber said that during the trial, the Pfizer researchers did not find anyone who had to be excluded from receiving the second dose of the vaccine.

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