RFK, Jr. Warned FDA Three Months Ago About Ingredient in Pfizer COVID Vaccine That Likely Caused Life-Threatening Reaction in Two UK Healthcare Workers

An investigation this week identified polyethylene glycol (PEG) as the likely reason two people in the UK suffered anaphylaxis after receiving Pfizer’s COVID vaccine. In September, CHD Chairman RFK, Jr. warned the FDA that PEG in COVID vaccines could lead to severe allergic reactions.

By Lyn Redwood, RN, MSN2

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On Dec. 2, Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) became the first in the world to approve a COVID-19 vaccine developed by Germany’s BioNTech and Pfizer.

A mass vaccination campaign that targeted frontline workers to receive the vaccine began on Dec. 8. Within 24 hours of launching the campaign, MHRA acknowledged two reports of anaphylaxis and one report of a possible allergic reaction.

Reuters reported late yesterday afternoon that an investigation into the anaphylactic reactions by MHRA has identified polyethylene glycol, or PEG, as the likely culprit.

Imperial College London’s Paul Turner, an expert in allergy and immunology who has been advising the MHRA on its revised guidance, told Reuters: “The ingredients like PEG which we think might be responsible for the reactions are not related to things which can cause food allergy. Likewise, people with a known allergy to just one medicine should not be at risk.”

It was also reported that PEG, which helps to stabilize the shot, is not in other types of vaccines.

The statements by Turner that “PEG is not in other types of vaccines” and that people with allergies to “just one medicine should not be at risk” are a failed attempt to provide false assurances and are patently untrue.

Moderna, Pfizer/BioNTech and Arcturus Therapeutics COVID vaccines all utilize a never-before-approved messenger RNA (mRNA) technology, an experimental approach designed to turn the body’s cells into viral protein-making factories. This technology involves the use of lipid nanoparticles (LNPs) that encapsulate the mRNA to protect them from degradation and promote cellular uptake.

The LNP formulations in the three COVID-19 mRNA vaccines are “PEGylated,” meaning that the vaccine nanoparticles are coated with a synthetic, non-degradable and increasingly controversial PEG.

COVID mRNA vaccines are not the only vehicle for PEG involvement in COVID-19 vaccine production. Researchers at Germany’s Max Planck Institute report developing a process for COVID-19 vaccine production to purify virus particles at “high yield.” The process involves adding PEG to a virus-containing liquid and passing the liquid through membranes.

On Sept. 25, Robert F. Kennedy, Jr., chairman and chief legal counsel for Children’s Health Defense (CHD), notified the Steven Hahn, director of the U.S. Food and Drug Administration (FDA), Dr. Peter Marks director of FDA’s Center for Biologics Evaluation and Research and Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, of the serious and possibly life-threatening anaphylactic potential of PEG.

CHD received the following response from the FDA, on Dec. 2, but has not yet received a response from Fauci.

In earlier communications with Moderna scientists regarding the controversial use of PEG in the company’s COVID-19 vaccine due to the potential for life-threatening anaphylaxis and need for pre-screening for PEG antibodies prior to vaccine administration, they insisted that the existence of PEG antibodies was purely hypothetical and underserving of concern:

“Pre-screening populations based on hypothesized biomarkers, such as anti-PEG antibodies, is not a strategy currently employed in our clinical trials.”

Given the recent evidence of PEG anaphylaxis in Pfizer mRNA vaccine recipients, I wonder if FDA and vaccine manufacturers will now reconsider their position.

An extensive review of PEG therapeutics, published in 2013, documented adverse effects of PEGylation and questioned the wisdom behind the continued use of PEG in drug development. The authors concluded that “the accumulating evidence documenting the detrimental effects of PEG on drug delivery make it imperative that scientists in this field break their dependence on PEGylation.”

The statement by Turner that “people with a known allergy to just one medicine should not be at risk,” is also not true.

2018 study, “Immediate Hypersensitivity to Polyethylene Glycols and Polysorbates: More Common Than We Have Recognized” reports there are more than 1,000 products, including prescription drugs, that contain PEG. (See chart below for detailed descriptions of PEG containing drugs.)

The decision to allow people with other medication allergies to receive vaccines that utilize PEG in the manufacturing or delivery of the vaccine is a very risky proposition — especially given that Pfizer has said people with a history of severe adverse allergic reactions to vaccines or the candidate’s ingredients were excluded from their late stage trials.

We have no idea what the incidence of allergy or anaphylactic reactions will be once Pfizer begins global distribution of the vaccine, without such exclusions.

2016 study reported detectable and sometimes high levels of anti-PEG antibodies in approximately 72% of contemporary human samples and about 56% of historical specimens from the 1970s through the 1990s. The population’s increased exposure to PEG-containing products since the 1990’s makes it natural to assume that anti-PEG antibodies will continue to be widespread.

As approval of PEGylated mRNA vaccines for COVID-19 occurs, the uptick in exposure to injected PEG products will be unprecedented and potentially disastrous.

While four out of five doctors regularly prescribe PEGylated drugs, only one out of five are aware of the potential for anti-PEG antibody responses. And only a third even know that PEG is in the drugs that they are prescribing.

A Vanderbilt University researcher agrees that there is a widespread lack of recognition that PEG hypersensitivity is possible, much less that it manifests on a regular basis. While it has been recommended to screen patients for anti-PEG antibody levels “prior to administration of therapeutics containing PEG” such testing is currently only available in research settings.

In a declaration effective Feb. 4, the Secretary of Health and Human Services invoked the Public Readiness and Emergency Preparedness Act (PREP Act) and declared Coronavirus Disease 2019 (COVID-19) to be a public health emergency warranting liability protections for covered countermeasures, including vaccines.

The fact that the FDA has abdicated its responsibility for assuring the safety of COVID vaccines to vaccine  manufacturers means we are on our own to study the science, and weigh the benefits and risks of all drugs and vaccines.

CHD will continue to monitor this important safety issue in an effort to keep you well informed on the science and public policies surrounding COVID-19 vaccine development.

Descriptions of PEG containing drugs:

The views and opinions expressed in this article are those of the authors and do not necessarily reflect the views of Children’s Health Defense.SUGGEST A CORRECTION

Dog Treat Recall!

Dear Fellow Dog Lover,

Because you signed up on our website and asked to be notified, I’m sending you this special recall alert.
On December 31, 2014, the U.S. Food and Drug Administration announced that Jump Your Bones, Inc. of Boca Raton, Florida is recalling its Jump Your Bones Roo Bites pet treats due to possible contamination with Salmonella bacteria.

To learn which products are affected, please visit the following link:

Jump Your Bones Pet Treats Recall

Please be sure to share the news of this alert with other pet owners.

Mike Sagman, Editor
The Dog Food Advisor

P.S. Not already on our dog food recall notification list yet? Sign up to get critical dog food recall alerts sent to you by email. There’s no cost for this service.

From ENews: Warning on Volcano Destroying Japan At Any Moment

Warning on Volcano Destroying Japan At Any Moment

Experts warn of volcano destroying Japan at any moment, causing nation’s extinction — Millions buried by lava in minutes, ‘hopeless’ for 120,000,000 people — Reactors would be devastated and spread nuclear waste worldwide — Gov’t: Volcano near nuke plant is shaking, tremor 7 minutes long… ‘Stay away’ — Increased eruption risk due to 3/11 quake
Published: October 24th, 2014 at 3:08 pm ET
By ENENews
http://enenews.com/experts-warn-volcano-destroying-japan-time-making-country-extinct-millions-buried-lava-hours-risk-eruptions-increased-311-quake-nuclear-plants-be-devastated-continue-spread-radioactive-materi?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+ENENews+%28Energy+News%29

Wall St Journal, Oct. 23, 2014 (emphasis added): One major volcanic eruption could make Japan “extinct,” a study by experts at Kobe University warns… “We should be aware… It wouldn’t be a surprise if such gigantic eruption were to take place at any moment.”
ontake volcano eruption 2 84205 600x450

Japan Times, Oct. 24, 2014: Colossal volcanic eruption could destroy Japan at any time: study — Japan could be nearly destroyed by a volcanic eruption over the next century that would put nearly all of its population of 127 million people at risk… “It is not an overstatement to say that a colossal volcanic eruption would leave Japan extinct as a country,” Kobe University earth sciences professor Yoshiyuki Tatsumi and associate professor Keiko Suzuki said… A disaster on Kyushu… would see an area with 7 million people buried by flows of lava and molten rock in just two hours [and] making nearly the entire country “unlivable”… It would be “hopeless” trying to save about 120 million…

Japan Times, Oct. 24, 2014: Volcano near Sendai nuclear plant is shaking and may erupt… Authorities warned on Friday that a volcano a few dozen kilometers from the Sendai nuclear plant… may erupt. It warned people to stay away… Ioyama [shows] signs of rising volcanic activity recently, including a tremor lasting as long as seven minutes… the Meteorological Agency’s volcano division said… [T]he area around the crater is dangerous, he added… On Friday, the warning level for the Sakurajima volcano was at 3, which means people should not approach the peak… Experts warn [the] earthquake in March 2011 may have increased the risk of volcanic activity throughout the nation…

Japan Times, Oct 18, 2014: Sendai reactors vulnerable to eruptions [and] could cause a nationwide disaster, said Toshitsugu Fujii, University of Tokyo professor emeritus who heads a government-commissioned panel… [R]egulators ruled out a major eruption… [Fujii] said at best an eruption can be predicted only a matter of hours or days. Studies have shown that pyroclastic flow… at one of the volcanos near the Sendai plant… reached as far as 145 kilometers away, Fujii said. He said a pyroclastic flow from Mount Sakurajima… could easily hit the nuclear plant, which is only 40 kilometers away. Heavy ash falling from an eruption would make it impossible to reach the plant… he said. Many nuclear power plants could be affected…

Asahi Shimbun, May 12, 2014: Now is the time to rethink the risk of operating nuclear power plants… it is the first time that Japan has seriously evaluated… the danger posed by volcanoes… Nuclear power plants… would suffer devastating damage from catastrophic eruptions… radioactive materials will continue to be scattered throughout the world…

University of Tokyo professor Toshitsugu Fujii, head of government panel on eruption prediction: “Scientifically, they’re not safe… If [reactors] still need to be restarted… it’s for political reasons, not because they’re safe, and you should be honest about that.”

See also: Expert: Island off Tokyo 15X larger after huge eruption…pay close attention (VIDEO)

IN FROM JAPAN: “Warning ‘crisis could get worse’ as 180 km/hr storm heading to area”

Well typhoon Phanfone passed causing enough trouble to choke a horse…NEXT up is the killer typhoon Vongfong! Read it, and pray for the Japanese, and the rest of the world!

FromL http://enenews.com/japan-times-records-shattered-fukushima-surging-radiation-levels-after-typhoon-tepco-doesnt-happening-warning-crisis-could-worse-180-kmhr-storm-heading-area?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+ENENews+%28Energy+News%29:

Japan Times: ‘Records shattered’ at Fukushima — Radiation levels surge after typhoon — Tepco “doesn’t know why” this is happening — Warning “crisis could get worse” as 180 km/hr storm heading to area
Published: October 12th, 2014 at 12:16 pm ET
By ENENews

Original Japan Times headline: Tritium surges tenfold in groundwater at Fukushima nuclear plant; typhoon effect suspected

Altered Japan Times headline: Tritium up tenfold in Fukushima groundwater after Typhoon Phanfone Tritium up tenfold in Fukushima groundwater after Typhoon Phanfone

Japan Times (Jiji Press), Oct. 12, 2014 (emphasis added): The radioactive water woes at [Fukushima] got worse over the weekend after the tritium concentration in a groundwater sample surged more than tenfold… [Tepco] said Saturday that heavy rain caused by Typhoon Phanfone probably affected the groundwater… [The] 150,000 becquerels… is a record for the well… [Beta ray emitters at the well] also shattered records with a reading of 1.2 million becquerels… close to the plant’s port in the Pacific… [Another well had] a record 2.1 million becquerels of a beta ray-emitting substance, nearly double the level from a week earlier… The cesium activity in the sample was 70 percent higher at 68,000 becquerels… Readings hit record highs at three points after the heavy rain caused by the typhoon, but the utility said it does not know why.

Perhaps it has something to do with this report just after the typhoon hit last weekend: Officials: Typhoon triggers alarm at Fukushima plant — Warning of leakage at Reactor No. 1 turbine building — Leak then detected at Reactor No. 3 — Camera captures images of water pouring in after “very heavy rain” — Powerful storm still packing gusts of up to 180 km/hr off Fukushima coast

Japan Times (Jiji Press), Oct. 12, 2014: The water crisis could get worse… Typhoon Vongfong… was still packing winds of up to 180 kph… The Meteorological Agency said it [would be] gradually losing strength as it races north toward Tohoku [which includes Fukushima.]

In fact, officials at the Japan Meteorological Agency forecast Vongfong’s wind speed to lose just 5-6 mph from it’s current level by the time it reaches Fukushima prefecture. See: Typhoon winds up to 110 mph to hit Fukushima Daiichi, storm surge advisory issued — Nearly all gov’t forecasts show eye passing right over plant — Nuclear Expert: Expect radioactive material washing into Pacific Ocean (MAPS)

Although not mentioned in the Japan Times’ report, a spike in Cobalt-60 was also seen after Typhoon Phanfone. The Co-60 concentration more than doubled the record high for any well since Tepco began publishing results. See: Officials: Typhoon caused significant increase in radioactive releases from Fukushima — Record levels of ‘highly toxic’ nuclear material found in ground outside reactor — Among the most poisonous substances at plant

Published: October 12th, 2014 at 12:16 pm ET
By ENENews

Gov’t issues ‘inundation warning’ for Fukushima Daiichi as year’s strongest storm to hit within hours — Tepco bracing for overflows — Officials warn of landslides and torrential rains… ‘ground-loosening’ south of plant — Danger from tornadoes, storm surge, violent waves along coast October 13, 2014
Officials: Typhoon triggers alarm at Fukushima plant — Warning of leakage at Reactor No. 1 turbine building — Leak then detected at Reactor No. 3 — Camera captures images of water pouring in after “very heavy rain” — Powerful storm still packing gusts of up to 180 km/hr off Fukushima coast October 6, 2014
Typhoon winds up to 110 mph to hit Fukushima Daiichi, storm surge advisory issued — Nearly all gov’t forecasts show eye passing right over plant — Nuclear Expert: Expect radioactive material washing into Pacific Ocean (MAPS) October 12, 2014
Forecast shows Fukushima to get eye wall of Typhoon Wipha — Weather Channel: Things may be getting worse at plant; Storm surge to combine with inland flooding at site (VIDEO) October 15, 2013
NHK: Severe storm is heading to Fukushima plant — Workers now scrambling to protect facility — Worried over impact of strong winds — Warning for tornadoes, landslides, high waves (VIDEO) September 16, 2013
October 12th, 2014 | Category: Fukushima Daiichi, Japan (Fukushima)

CDC HEALTH ADVISORY

From CDC :

Evaluating Patients for Possible Ebola Virus Disease: Recommendations for Healthcare Personnel and Health Officials

Health Alert Network logo.

This is an official

CDC HEALTH ADVISORY

Distributed via the CDC Health Alert Network
October 2, 2014, 20:00 ET (8:00 PM ET)
CDCHAN-00371

http://emergency.cdc.gov/han/han00371.asp

Summary

The first case of Ebola Virus Disease (Ebola) diagnosed in the United States was reported to CDC by Dallas County Health and Human Services on September 28, 2014, and laboratory-confirmed by CDC and the Texas Laboratory Response Network (LRN) laboratory on September 30. The patient departed Monrovia, Liberia, on September 19, and arrived in Dallas, Texas, on September 20. The patient was asymptomatic during travel and upon his arrival in the United States; he fell ill on September 24 and sought medical care at Texas Health Presbyterian Hospital of Dallas on September 26. He was treated and released. On September 28, he returned to the same hospital, and was admitted for treatment.

The purpose of this HAN Advisory is to remind healthcare personnel and health officials to:

(1) increase their vigilance in inquiring about a history of travel to West Africa in the 21 days before illness onset for any patient presenting with fever or other symptoms consistent with Ebola;

(2) isolate patients who report a travel history to an Ebola-affected country (currently Liberia, Sierra Leone, and Guinea) and who are exhibiting Ebola symptoms in a private room with a private bathroom and implement standard, contact, and droplet precautions (gowns, facemask, eye protection, and gloves); and

(3) immediately notify the local/state health department.

Please disseminate this information to infectious disease specialists, intensive care physicians, primary care physicians, and infection control specialists, as well as to emergency departments, urgent care centers, and microbiology laboratories.

Background

The first known case of Ebola with illness onset and laboratory confirmation in the United States occurred in Dallas, Texas, on September 2014, in a traveler from Liberia. The West African countries of Liberia, Sierra Leone, and Guinea are experiencing the largest Ebola epidemic in history. From March 24, 2014, through September 23, 2014, there have been 6,574 total cases (3,626 were laboratory-confirmed) and 3,091 total deaths reported in Africa. Ebola is a rare and deadly disease caused by infection with one of four viruses (Ebolavirus genus) that cause disease in humans. Ebola infection is associated with fever of greater than 38.6°C or 101.5°F, and additional symptoms such as severe headache, muscle pain, vomiting, diarrhea, abdominal pain, or unexplained hemorrhage. Ebola is spread through direct contact (through broken skin or mucous membranes) with blood or body fluids (including but not limited to urine, saliva, feces, vomit, sweat, breast milk, and semen) of a person who is sick with Ebola or contact with objects (such as needles and syringes) that have been contaminated with these fluids. Ebola is not spread through the air or water. The main source for spread is human-to-human transmission. Avoiding contact with infected persons (as well as potentially infected corpses) and their blood and body fluids is of paramount importance. Persons are not contagious before they are symptomatic. The incubation period (the time from exposure until onset of symptoms) is typically 8-10 days, but can range from 2-21 days. Additional information is available at http://www.cdc.gov/vhf/ebola/index.html.

Recommendations

Early recognition is critical to controlling the spread of Ebola virus. Consequently, healthcare personnel should elicit the patient’s travel history and consider the possibility of Ebola in patients who present with fever, myalgia, severe headache, abdominal pain, vomiting, diarrhea, or unexplained bleeding or bruising. Should the patient report a history of recent travel to one of the affected West African countries (Liberia, Sierra Leone, and Guinea) and exhibit such symptoms, immediate action should be taken. The Ebola algorithm for the evaluation of a returned traveler and the checklist for evaluation of a patient being evaluated for Ebola are available at http://www.cdc.gov/vhf/ebola/pdf/ebola-algorithm.pdf andhttp://www.cdc.gov/vhf/ebola/pdf/checklist-patients-evaluated-us-evd.pdf.

Patients in whom a diagnosis of Ebola is being considered should be isolated in a single room (with a private bathroom), and healthcare personnel should follow standard, contact, and droplet precautions, including the use of appropriate personal protective equipment (PPE). Infection control personnel and the local health department should be immediately contacted for consultation.

The following guidance documents provide additional information about clinical presentation and clinical course of Ebola virus disease, infection control, and patient management:

The case definitions for persons under investigation (PUI) for Ebola, probable cases, and confirmed cases as well as classification of exposure risk levels are at http://www.cdc.gov/vhf/ebola/hcp/case-definition.html.

Persons at highest risk of developing infection are:

  • those who have had direct contact with the blood and body fluids of an individual diagnosed with Ebola – this includes any person who provided care for an Ebola patient, such as a healthcare provider or family member not adhering to recommended infection control precautions (i.e., not wearing recommended PPE
  • those who have had close physical contact with an individual diagnosed with Ebola
  • those who lived with or visited the Ebola-diagnosed patient while he or she was ill.

Persons who have been exposed, but who are asymptomatic, should be instructed to monitor their health for the development of fever or symptoms for 21 days after the last exposure. Guidelines for monitoring and movement of persons who have been exposed to Ebola are available athttp://www.cdc.gov/vhf/ebola/hcp/monitoring-and-movement-of-persons-with-exposure.html.

Diagnostic tests are available for detection of Ebola at LRN laboratories as well as CDC. Consultation with CDC is required before shipping specimens to CDC. Information about diagnostic testing for Ebola can be found at http://www.cdc.gov/vhf/ebola/hcp/interim-guidance-specimen-collection-submission-patients-suspected-infection-ebola.html.

Healthcare personnel in the United States should immediately contact their state or local health department regarding any person being evaluated for Ebola if the medical evaluation suggests that diagnostic testing may be indicated. If there is a high index of suspicion, U.S. health departments should immediately report any probable cases or persons under investigation (PUI) (http://www.cdc.gov/vhf/ebola/hcp/case-definition.html) to CDC’s Emergency Operations Center at 770-488-7100.

The Centers for Disease Control and Prevention (CDC) protects people’s health and safety by preventing and controlling diseases and injuries; enhances health decisions by providing credible information on critical health issues; and promotes healthy living through strong partnerships with local, national and international organizations.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

HAN Message Types

  • Health Alert: Conveys the highest level of importance; warrants immediate action or attention. Example: HAN00001
  • Health Advisory: Provides important information for a specific incident or situation; may not require immediate action. Example: HAN00346
  • Health Update: Provides updated information regarding an incident or situation; unlikely to require immediate action. Example: HAN00342
  • Info Service: Provides general information that is not necessarily considered to be of an emergent nature. Example: HAN00345

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This message was distributed to state and local health officers, state and local epidemiologists, state and local laboratory directors, public information officers, HAN coordinators, and clinician organizations.
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PEDIGREE DOG FOOD RECALL!!!

Important Dog Food Recall Alert

Dear Fellow Dog Lover,

Because you signed up on my website and asked to be notified, I’m sending you this special recall alert. On August 26, 2014, Mars Petcare US announced it is recalling specific lots of its Pedigree Dry Dog Food due to the possible presence of small metal fragments.

To learn which products are affected, please visit the following link:

Pedigree Dog Food Recall

Please be sure to share the news of this alert with other pet owners.

Mike Sagman, Editor
The Dog Food Advisor

P.S. Our Editor’s Choice members get instant access to the complete recall history of our most recommended brandsClick here to learn more.