The Food and Drug Administration (FDA) is investigating allergic reactions to the Pfizer coronavirus vaccine that have been reported in several states since it began being administered this week.
Peter Marks, director of the FDA’s Center for Biological Evaluation and Research, told reporters late Friday that reactions have been reported in several states except Alaska and that the FDA is examining five reactions.
“We work hand in hand with the Centers for Disease Control and Prevention (CDC) and have worked closely with our colleagues in the UK, who, of course, have reported the allergic reaction. I think we will analyze all the data we can from each of these reactions to solve exactly what happened and we will also seek to understand what component of the vaccine could help produce them. ” said.
“I think we have the right mitigation strategy at the moment … with the availability of treatment for a severe allergic reaction that is ready and we will continue to monitor it very closely,” he added.
Marks said the FDA is not sure why it caused the reactions, but indicated a chemical called polyethylene glycol, which is present in vaccines produced by Pfizer and BioNTech, as well as Moderna, “could be to blame.” He added that the reaction that some people have experienced may be more common than previously thought.
“Obviously, we will monitor very carefully what is happening. We work very closely with the CDC on these and there have been meetings between the CDC and the FDA every day of each week, making sure we keep a very close record of what is happening, ”he said.
Reports of allergic reactions in Alaska follow two similar cases reported last week in the UK, the first nation to approve the Pfizer vaccine.
The current FDA guide says that most Americans with allergies should be allowed to get the vaccine, but that people who have had severe reactions to other vaccines should not be vaccinated. He also said on Friday that people with a history of severe allergic reactions to any of the components of the Moderna shot should avoid taking this vaccine.
“The FDA takes the safety of the medical products we authorize and approve very seriously, and certainly in a vaccine setting, that’s one of the reasons Dr. Marks and his team, in collaboration with the CDC, created a system very robust surveillance device for safety assessment. One of the things that the FDA does very well and uniquely is to get to the bottom of events, such as allergic reactions, so that we can fully understand the circumstances and better inform the public, as well as our regulatory decisions. ” declared the FDA commissioner Stephen Hahn
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