The Food and Drug Administration (FDA) is investigating allergic reactions to the Pfizer coronavirus vaccine that were reported in several states after it was started this week.
Peter Marks, director of the FDA’s Biological Assessment and Research Center, told reporters Friday that the reactions had been reported in more than one state other than Alaska and that the FDA is investigating five reactions.
“We are working hand in hand with the Centers for Disease Control and Prevention (CDC) and in fact we have been working closely with our colleagues in the UK, who of course reported the allergic reaction. I think that we will look at all the data we can from each of these reactions to resolve exactly what happened and we will also try to understand what component of the vaccine could help produce them, ”he says.
“I think right now we have the right strategy … of mitigation with the availability of treatment for a severe allergic reaction ready, and we will continue to monitor it very closely,” he added.
Marks said the FDA wasn’t sure what caused the reactions, but indicated a chemical called polyethylene glycol, which is found in vaccines produced by Pfizer and BioNTech, as well as by Moderna, “could be the culprit.” He added that the reaction some people have experienced could be more frequent than previously thought.
“Obviously, we will be watching very closely what is happening. We are working very closely with the CDC on this, and this week there have been meetings almost every day between CDC and the FDA, making sure we are aware of what is happening, ”he said.
Reports of allergic reactions in Alaska follow two similar cases reported last week in Britain, the first nation to approve the Pfizer vaccine.
Current FDA guidelines say 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 Friday that people with a history of severe allergic reactions to any component of Moderna’s shot should avoid the vaccine.
“The FDA takes the safety of the medical products we authorize and approve very seriously and, no doubt, in a vaccine setting, is one of the reasons why Dr. Marks and his team, in collaboration with the CDC, have created a very robust surveillance system to assess safety. One of the things the FDA does very well and uniquely is get to the bottom of events like allergic reactions, so that we can fully understand the circumstances and better inform the public and also our regulatory decisions, ”he said. say the FDA commissioner. Stephen Hahn
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