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In September, before either vaccine had been approved, CHD asked the FDA to inform Moderna trial participants that the vaccine contained PEG, and to inform them of the "well-documented evidence of adverse PEG-related immune reactions, including life-threatening anaphylactic immune reactions."
In a letter to Marks and FDA Commissioner Stephan Hahn, Kennedy also said Moderna should ask trial participants if they'd ever had an allergic reaction to any other drug containing PEG, and the company should prescreen trial participants for PEG allergies, as many people who have anti-PEG antibodies don't know they have them.
The FDA responded by suggesting that CHD take its concerns directly to Moderna. On Saturday, after the reports of allergic reactions in Alaska and Illinois, Hahn told the Hill:
"One of the things that the FDA does very well and uniquely is really getting to the bottom of events like allergic reactions so we can completely understand the circumstances and better inform the public and also our regulatory decisions."
Following last week's reports of allergic reactions, including anaphylaxis, the FDA said it is "working closely" with the Centers for Disease Control (which has officially acknowledged six allergic reactions) and "colleagues" in the UK, where the first allergic reactions to the Pfizer vaccine were reported.
An initial investigation into the allergic reactions experienced by the UK healthcare workers suggested PEG may have been the culprit, according to Reuters.
UK health officials have since advised that anyone who has a history of any severe allergic reactions should not get the vaccine. The country is reportedly rolling out "resuscitation centers" equipped to respond quickly to anyone who experiences anaphylactic shock after receiving the vaccine.
In the U.S., however, the CDC says anyone who has a history of severe allergic reactions not related to vaccines or injectable medications - such as allergies to food, pet, venom, environmental or latex - may still get vaccinated but should be monitored for 30 minutes instead of the usual 15 minutes after the vaccine is administered. New CDC guidelines issued after the allergic reactions in the U.S. state:
"If you have ever had a severe allergic reaction to any ingredient in a COVID-19 vaccine, CDC recommends that you should not get that specific vaccine. If you have had a severe allergic reaction to other vaccines or injectable therapies, you should ask your doctor if you should get a COVID-19 vaccine. Your doctor will help you decide if it is safe for you to get vaccinated."
These guidelines are inadequate, Redwood said. "Many people who have never previously experienced any type of allergic reaction may be at risk of a severe reaction to the Pfizer and Moderna vaccines," Redwood said. "That's because millions of people may have developed anti-PEG antibodies as a result of having unknowingly been exposed to PEG in the past."
According to research published in 2018, there are more than 1,000 products on the market - including pharmaceuticals, processed foods, cosmetics and disinfectants - that contain PEG. PEG is also the main ingredient in antifreeze.
"Anyone who's had a colonoscopy, depending on what was used for preparation for the procedure, may have anti-PEG antibodies," Redwood said, because many of those products contain PEG.
"It's a simple blood test," Redwood said. "Everyone considering getting the Pfizer or Moderna COVID vaccine should ask their doctor for a blood test to rule out anti-PEG antibodies before getting the vaccine."
Some of the healthcare workers who suffered severe allergic reactions to the Pfizer vaccine, including the woman hospitalized in Alaska, had no prior history of allergic reactions to anything, including other vaccines or pharmaceuticals.
Studies estimate that approximately 72% of the U.S. population has acquired anti-PEG antibodies. The referenced study used blood samples taken from 1990-1999 and earlier, showing a steady increase over time in the percentage of those with antibodies to PEG, making it conservative to estimate, after two decades, that the incidence is closer to 80% today.
According to a 2018 physicians survey, only 22% of respondents were aware of anti-PEG antibodies, and only 35% were aware of having been prescribed medications containing PEG.
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