Vaccine advisers to the US Food and Drug Administration say they are worried about how the US public will react to reports about severe allergic reactions in Britain to Pfizer’s coronavirus vaccine.
“I'm worried about these severe anaphylactic reactions,” Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said during discussion ahead of the committee’s vote.
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.
“We don't know the details of those two cases. We don’t know specifically what it was they were allergic to, or what their history with severe allergies was,” Offit said during the meeting of the Vaccines and Related Biological Products Advisory Committee.
Offit, a voting member of the committee, said he was concerned Americans with allergies might be afraid to get vaccinated. Public Health officials in Britain are now telling people with a history of severe allergies not to get the vaccine, Offit said.
“There are tens of millions of people in this country who carry EpiPens with them — because they have peanut allergies, because they have egg allergies — who are going to believe now that they can't get this vaccine,” Offit said. “That's a lot of people.”
Pfizer earlier reported it saw no serious allergic reactions to the vaccine in its Phase 3 trial involving 44,000 volunteers, but people with a history of allergic reactions to vaccines were excluded from the trial.
Dr. William Gruber, senior vice president of vaccine clinical research and development at Pfizer said, “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’d gotten the first dose, and they had a significant type one hypersensitivity response, then that would preclude giving a second dose.”
Gruber said during the trial, Pfizer’s investigators did not encounter anyone who had to be excluded from getting the second dose of vaccine.