Two days after the first COVID-19 vaccine was administered in the U.S. — to a healthcare worker in Long Island, New York — two healthcare workers in Alaska who received Pfizer’s COVID vaccine experienced allergic reactions. One of those, a woman with no prior history of allergies, suffered an anaphylactic reaction and spent at least two nights in the hospital.
The reactions, similar to those experienced on Dec. 8, shortly after rollout of the same Pfizer vaccine in the UK, raise renewed concerns about the potential for life-threatening reactions to the vaccine.
Those concerns include the vaccine maker’s exclusion of people with severe allergies from the clinical trials, and the failure to pre-screen patients for polyethylene glycol (PEG), the compound suspected of triggering the reactions, before administering the vaccine.
An initial investigation into the allergic reactions experienced by the two UK healthcare workers identified PEG as the likely trigger for those anaphylactic reactions.
In September, Children’s Health Defense’s chairman and chief legal counsel, Robert F. Kennedy, Jr., warned the FDA about the potential for vaccines containing PEG — an ingredient used in the Pfizer and Moderna vaccines — to cause severe allergic reactions.
On learning Wednesday of the hospitalization of the woman in Alaska, Kennedy said:
“When we warned FDA Director Peter Marks that the nanoparticles in this vaccine pose deadly risks from anaphylaxis, he suggested we take our concerns directly to the vaccine makers. We clearly have a systematic problem when government health regulators have utterly abdicated their responsibility to safeguard public health and refer safety concerns about shoddily tested, zero-liability vaccines to pharmaceutical companies.”
Vaccine makers have zero legal or financial incentive to make their products safe, Kennedy added. “Let’s remember that Pfizer will make billions so long as it keeps its vaccine in play, no matter how many people experience life-threatening reactions,” he said.
A spokeswoman for Pfizer told the Washington Post the company is “actively working with local health authorities to assess” what happened in Alaska. She also told the Post that prospective participants in Pfizer’s late-stage clinical trial were excluded if they had a history of severe allergic reactions associated with a vaccine or to any component of this vaccine.
“Clearly, this fact has fallen on deaf ears,” Children’s Health Defense’s President Lyn Redwood said in reference to Alaska’s Chief Medical Officer Dr. Anne Zink’s comment to PBS: “There were over 40,000 people in the trials and we did not see any reactions like this.”
“Of course we didn’t see any reactions,” Redwood explained. “People who had previous reactions to vaccines were excluded from the trials.”
Zink also relayed a comment made by someone who treated the Alaskan woman’s adverse reaction: “Lightning’s going to strike somewhere.” But Redwood wasn’t reassured. “Lightning strikes in the U.S. 20 million times a year,” she said.
CDC guidance on potential PEG allergies falls short
CDC guidance says people with a history of severe reactions to other vaccines or injectable therapy “may still receive vaccination, but they should be counseled about the unknown risks of developing a severe allergic reaction,” the Washington Post reported. “People who have mild allergies to food, pets, environment or latex can still get the Pfizer-BioNTech vaccine.”
According to Redwood, PEG allergies often go unrecognized which means individuals who have no history of allergies, like the healthcare worker in Alaska, could have severe life-threatening reactions to PEG.
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.
“The decision to allow people with other drug allergies to receive the Pfizer vaccine is a very risky proposition,” Redwood said. She explained that it’s common that patients and doctors have no idea what compound in a drug caused their adverse reaction. “If that compound was PEG, it would be very dangerous to administer a vaccine containing PEG, as that next reaction could be more severe,” Redwood said.
With plans to vaccinate “tens of millions” of people in the U.S. alone, Redwood is very concerned. She wonders how many people with no prior history of allergies are potentially at risk of a severe reaction to COVID vaccines that contain PEG.
Pfizer claims anaphylactic reactions to vaccines in general are rare, estimated at just over one per million doses. But Redwood said the more likely answer to how many people are at risk is “we don’t know.”
Anti-PEG antibodies have been detected not only in patients treated with PEGylated therapeutics, but also in individuals who have no knowledge of PEG exposures.
According to researchers, how PEG antibodies are generated in individuals who have never received any formal treatment with PEGylated therapeutics remains largely unknown. It is natural to assume that frequent exposure to PEG could lead to the inevitable formation of anti-PEG antibodies.
At the very least, Redwood said, patients should be screened for anti-PEG prior to being administered the Pfizer vaccine to prevent potentially life-threatening reactions. She cited a 2012 study in which the authors concluded, “patients should be pre-screened and monitored for anti-PEG prior to and throughout a course of treatment with a PEGylated compound.”
But the CDC makes no such recommendation in its guidelines for the Pfizer and Moderna vaccines, both of which use similar mRNA technology (never before used in vaccines), and both of which contain PEG.
Instead, the CDC recommends the vaccine be administered in settings that have supplies, including oxygen and epinephrine, to manage anaphylactic reactions.
Beyond PEG — other concerns about Pfizer and Moderna vaccines
Allergic reactions that have occurred in the UK and Alaska are not the only concerns that have been raised by medical professionals and other experts about the Pfizer and Moderna COVID vaccines.
“To imagine that Moderna’s unlicensed COVID vaccine, tested for under a year, will be safe is wishful thinking,” Mary Holland, general counsel for Children’s Health Defense said. “There’s a reason vaccine producers insist on blanket indemnification from injuries and deaths.”
Holland is referring to the fact that vaccine makers, already immune from liability for vaccine injuries under the National Childhood Vaccine Injury Act of 1986, were granted additional protection via the Declaration Under the Public Readiness and Emergency Preparedness (PREP) Act for Medical Countermeasures Against COVID-19 in March.
Children’s Health Defense has also reported on concerns about pathogenic priming, especially in older adults. Pathogenic priming is a condition that occurs in some people when a vaccine triggers autoimmunity, causing severe illness and or death.
Children’s Health Defense is calling for further studies on how the vaccine might impact Blacks, who were not adequately represented in the clinical trials.