The Food and Drug Administration (FDA) may probe the allergic reactions to Pfizer’s vaccine, according to medical experts.
The two allergic reactions were experienced by U.K. health-care workers who took Pfizer's vaccine against Covid-19.
The U.K’s Medicines and Healthcare Products Regulatory Agency posted new guidance on Wednesday for people who had experienced “significant” allergic reactions. They are advised to forgo the vaccine made by Pfizer and BioNTech. The updated guidance came after two National Health Service members had allergic reactions to Pfizer’s vaccine, though both are in recovery, according to the national medical director for the NHS.
“We know from the extensive clinical trials that this was not a feature, but if we need to strengthen our advice now that we have had this experience in vulnerable populations, the groups selected as a priority, we get that advice to the field immediately,” Dr. June Raine, head of the MHRA, told a U.K. government select committee on Wednesday.
Moncef Slaoui, the chief science advisor for the White House’s Operation Warp Speed, explained that FDA will likely assess the events. However, it is normal for people who develop severe allergic reactions to vaccines to not be a part of the clinical trials.
The FDA will hold a meeting of its Vaccines and Related Biological Products Advisory Committee, or VRBPAC, to assess Pfizer’s coronavirus vaccine for emergency use authorization in the U.S.
“My expectation is that this is new news, and I would assume — but of course the FDA will make those decisions — that tomorrow this will be part of the consideration,” Slaoui said. The FDA refused to say whether the committee would address the allergic reactions to Pfizer's vaccine, but a spokeswoman mentioned that the agenda touches on vaccine safety.
Dr. William Schaffner, a professor of infectious diseases at Vanderbilt University Medical Center, pointed out that vaccine trials do not usually include people with chronic underlying health conditions or those who may have severe allergic reactions.
The allergic reactions should not hinder the vaccine’s authorization, he stressed. Such issue is one of those that the committee “deals with routinely because lots of vaccines are associated with allergic reactions in some small percentage of the population,” he said.
“They may indeed try to exclude certain people for a period of time, or make the recommendation that every vaccination site have equipment in place so that they can deal efficiently with allergic reactions,” he said. “They may make the recommendation that people should be observed for a short period of time after their vaccination.”
He believes that it shows that “the system is working and working very efficiently because we would do exactly the same thing here in the U.S.”
Dr. Syra Madad, senior director of the systemwide special pathogens program at New York City Health + Hospitals, explained that the allergic reactions are “certainly nothing to be extremely surprised about” but require further investigation.
Madad stressed that the U.K. should have probed the cases further before they released “a blanket statement” urging people with severe allergies to not get vaccinated.
“A lot of these things are going to happen as these massive campaigns roll out,” Madad told MSNBC. “I think this is something to be expected.”
