The Food and Drug Administration (FDA) is investigating allergic reactions to the Pfizer coronavirus vaccine that were reported in multiple states after it began being administered this week.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told reporters late Friday that the responses had been reported in more than one state except Alaska and that the FDA is investigating five responses.
“We work closely with the Centers for Disease Control and Prevention (CDC), and we even worked closely with our British colleagues, who of course reported the allergic reaction. I think we will look at all possible data from each of these reactions to find out what exactly happened, and we will also try to understand what component of the vaccine could help produce them, ”Marks said.
“I think we have the right … mitigation strategy at this point with the availability of treatment for a serious allergic reaction in the attack, and we will continue to monitor it very closely,” he added.
Marks said the FDA was not sure what triggered the reactions, but indicated that a chemical called polyethylene glycol, which is present in the vaccines produced by Pfizer and BioNTech and by Moderna, “could be the culprit.” He added that the reaction some people have experienced is more common than previously thought.
‘We will of course keep a close eye on what is going on. We are working closely with the CDC on this and there have been meetings between the CDC and the FDA almost every day this week to make sure we keep a very close eye on what is going on, ”he said.
The reports of allergic reactions in Alaska follow two similar cases reported last week in Britain, the first country to approve Pfizer’s vaccine.
Current FDA guidelines say that most Americans with allergies should be allowed to take the vaccine, but people who have had severe reactions to other vaccines should not be vaccinated. It also said Friday that people with a history of serious allergic reactions to any of the components of the Moderna injection should avoid that vaccine.
“The FDA takes the safety of the medical products we approve and approve very seriously, and especially in a vaccination setting, this is one of the reasons Dr. Marks and his team, in conjunction with the CDC, have established a very robust monitoring system for assessing safety. One of the things that the FDA does very well and uniquely is really getting 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 ”, said FDA commissioner Stephen Hahn
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