A network composed of experts from inside and outside the U.S. government repeatedly recommended that people who suffered adverse events following COVID-19 vaccination receive additional shots, even when the experts could not rule out the vaccines as the cause of the events, documents obtained by The Epoch Times show.
The network, the Clinical Immunization Safety Assessment (CISA) Project, is run by a doctor who has received extensive funding from pharmaceutical giants, including the top two COVID-19 vaccine manufacturers, according to other records.
In one example, CISA was presented with records showing a 63-year-old woman experienced chronic kidney disease, with symptoms including kidney swelling, after receiving a second dose of Pfizer’s COVID-19 vaccine.
CISA subject matter experts (SMEs) said that the diagnosis could not be definitively confirmed without a kidney biopsy but that they still felt comfortable using a causality algorithm for the presumed diagnosis developed in part by Dr. Kathryn Edwards, CISA’s principal investigator.
Applying the algorithm to the case resulted in an “indeterminate” designation, or an inability to rule out the vaccine causing the problem, in part because there was no evidence of other causes. But that inability did not stop the program from recommending additional shots.
“Weighing the potential risks of COVID-19 vaccination and the benefits of preventing COVID-19, the SMEs provided their opinion that the patient should receive future COVID-19 vaccinations,” the Feb. 24, 2023, letter to the patient’s doctor stated.
At the time, the effectiveness of the vaccines against symptomatic infection had been shown to start low and wane quickly, while protection against severe disease began higher but also rapidly dropped.
After the woman received her next shot, the CISA experts said, the doctor should check in on her to see if she experienced recurrent hematuria, or blood in her urine.
“Although the CDC’s subject matter experts claim to have no idea if inflammation of the kidneys in a 63-year-old woman was caused by the mRNA COVID-19 biological, they tell the attending physician to go ahead and give the woman another COVID shot. That amounts to a challenge/re-challenge experiment on a sick woman without informed consent,” Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, told The Epoch Times in an email.
“Government officials admitting ignorance about a biological product’s potential side effects but directing a doctor to risk a patient’s life by continuing to inject the product into a patient, who already has suffered an injury following use of that product, is immoral,” she added. “We expect and deserve government health officials to adhere to a higher professional and ethical standard of care.”
Some people who experience a problem after a dose of a COVID-19 vaccine have experienced a recurrence of the problem following another dose, according to case studies and surveillance data.
Dr. Edwards, until recently of Vanderbilt University Medical Center, and the CDC did not respond to requests for comment.
CISA features experts with the CDC and other institutions, including Vanderbilt University, Boston Medical Center, and Johns Hopkins University collaborating to respond to doctors who ask the program to review patient cases and provide recommendations.
“CISA provides consultations for U.S. healthcare providers with complex vaccine safety questions about their patients and conducts vaccine safety clinical research,” the CDC states on its website.
The first COVID-19 vaccines were authorized and recommended in December 2020. From Dec. 1, 2020, through June 1, 2023, CISA provided 48 recommendations to doctors dealing with COVID-19 vaccines, the records show.
In 39.5 percent of the cases, CISA recommended another vaccination. In 23 percent of the cases, CISA recommended against another vaccination. In 14.5 percent of the cases, CISA said there were no reasons patients could not receive more doses. In the remaining cases, CISA advised reassessing the matter down the road or advising a patient who had not yet received a vaccine to receive a vaccine.
The recommendations for future doses came even in cases where CISA was unable to say the vaccine did not cause the adverse event.
In a letter dated May 4, 2021, CISA experts said there was “no evidence” to support non-vaccine causes for the patient’s condition but that there was “no definitive known association” between the condition and Pfizer’s vaccine, leading to an indeterminate designation in the causality algorithm.
While one of the experts said that in a person “with the right immunologic makeup,” the vaccine “could be an initial inciting injury” causing the condition, many of the experts advised the patient to receive another dose.
The patient might want to receive Johnson & Johnson’s vaccine, which uses different technology than the Pfizer and Moderna messenger RNA shots, CISA said in the letter. “Support for this guidance included that it would avoid the lipid envelope and the mRNA presentation of the antigen to this patient,” they wrote.
In another letter, dated Jan. 18, 2022, CISA experts also found no evidence for non-vaccine causes for the patient’s condition, which appeared after Pfizer vaccination. But they repeated the claim that there was no definitive association between the vaccine and the condition, leading to an indeterminate designation.
CISA experts “strongly felt that the risk of COVID-19 infection was higher than the potential risk from another dose of vaccine,” according to the letter, and recommended a second Pfizer dose.
In a third letter, dated May 23, 2022, CISA experts said the causality algorithm resulted in an indeterminate designation “due to lack of strong evidence against a causal association.” They described a “very perplexing case” and acknowledged the patient’s condition was “not understood.”
But CISA experts still advised the patient, who suffered an event after a Pfizer dose and had also recovered from COVID-19, to receive another shot.
“This would be especially important in light of the current surge in circulating Omicron variants,” they wrote.
Small Number of Causal Determinations
A small number of cases led to the determination that the vaccination caused an adverse event.
In six instances, CISA experts determined that the event was “consistent with causal association,” or caused by the vaccination, because the condition suffered by each patient was “a known possible adverse event following immunization.”
In all six cases, experts recommended against additional doses while advising the doctors caring for the patients to follow up with the patients to figure out which non-COVID vaccines the patients could safely receive.
CISA experts also advised against additional COVID-19 vaccine doses in five other cases. The designations in those cases were also indeterminate, making the differences between them and those that resulted in recommendations for future doses unclear apart from several involving people who had expressed opposition to receiving more shots.
In seven other cases, CISA experts said there were no contraindications, or no reasons for not receiving at least one additional dose. The CDC has maintained a short list that currently includes just two contraindications for the COVID-19 vaccines—a history of severe allergic shock or a history of a known diagnosed allergy to a component of one of the shots.
Patients with other conditions, such as heart inflammation after COVID-19 vaccination, are generally advised to avoid additional doses, the CDC says in the list. But that is only a “precaution,” not a contraindication.
CISA also advised doctors of nine of the patients to reassess future COVID-19 vaccination down the road and, in two of the cases, told doctors that patients who had not yet received a COVID vaccine could receive one.
Hidden Information
The case of the patient with kidney disease was the only one in the CISA records obtained by The Epoch Times that the specific adverse event or events following COVID-19 vaccination was disclosed.
The CDC claimed that the diagnosis information was protected under federal law, which provides exemptions that enable government officials to withhold some information. The CDC redacted the diagnosis information and some other portions of the letters, such as the names of the CISA experts who penned them.
The agency has not explained why one diagnosis was provided while the others were not. The Epoch Times has filed an appeal with the U.S. Department of Health and Human Services, the CDC’s parent agency. The appeal is pending.
Dr. Edwards’ Funding
Dr. Edwards was a professor of pediatrics at Vanderbilt University School of Medicine along with her CISA work. She retired from the university in January. Dr. Edwards has repeatedly backed COVID-19 vaccination for many Americans, including children.
“I agree with the current recommendations that all children between 5-11 years old should be vaccinated. The risk of disease is greater than the risk of myocarditis,” Dr. Edwards told The Epoch Times in an email in 2022. She did not provide any citations.
Dr. Edwards has received funding from numerous companies, including Pfizer and Moderna. Pfizer has paid Dr. Edwards $83,491 since 2016, according to a U.S. government website listing payments to doctors. Pfizer paid Dr. Edwards at least $11,900 each year from 2020 to 2022.
Moderna and Johnson & Johnson subsidiary Janssen have also paid Dr. Edwards, including during her time as principal investigator of CISA.
Dr. Edwards disclosed her conflicts of interest in some papers but not at other times, such as at least sometimes when speaking to reporters or in public presentations. Dr. Edwards was also part of the board that oversaw Pfizer’s trial.
“I’ve been an adviser to Pfizer and I’ve been working very, very closely with Pfizer, particularly their COVID vaccines and going over lots of reactions and adverse [events],” Dr. Edwards said in a 2022 deposition.
When pressed on whether financial incentives can affect people’s judgement, Dr. Edwards said it does not affect her decisions.
“What you’re presuming is that because I have been an adviser makes me on their dole or makes me going to say what they want me to say that … is not and has never been a part of my being. I say what I believe based on my expertise,” she said.
Emails
Another set of documents obtained by The Epoch Times shows doctors contacting the CDC for CISA consultations.
“Hello, needing safety advice for a patient of mine on COVID-19 vaccination with mRNA vaccine,” one doctor wrote. The doctor said that one of their new patients had a reaction to Tdap (tetanus, diphtheria, pertussis) vaccine and wondered whether it would be safe for them to receive Pfizer’s COVID-19 vaccine.
In another email, a doctor said that a patient experienced a problem two hours after receiving a dose of Moderna’s vaccine but that the condition had “mostly resolved” later. The doctor asked whether it was safe to receive a second Moderna dose or whether it would be better for the patient to receive Johnson & Johnson’s shot.
A third email showed a doctor describing a “somewhat atypical case” where a patient presented with symptoms 25 days after a Pfizer shot. “I haven’t heard of [redacted] before this case,” the doctor said, before requesting advice on whether the patient should receive another dose.
In other cases, doctors asked the CDC whether patients should receive waivers for COVID-19 vaccination. The CDC informed the doctors that the agency does not issue exemptions from COVID-19 vaccination requirements.
Full Numbers
Here are the full number of inquiries and completed consults for CISA through Nov. 4, 2022:
Total inquiries: 1,394 Inquiries for COVID-19 or COVID-19 vaccines: 1,334 Number of CISA consults completed: 79
Number of COVID-19 inquiries in December 2020: 41 Number of COVID-19 inquiries in 2021: 1,077 Number of COVID-19 inquiries in 2022: 216
Article cross-posted from our premium news partners at The Epoch Times.
Bypass Big Tech Censors
Two Storms, One Harvest
Every food crisis in living memory has been a one-shock event. The 2008 price spike was a commodity bubble. The 2020 shortages were a logistics failure. The 2022 grain scare was a war on one exporter’s ports. Each time, the system bent, adjusted, and recovered, and each time the experts assured us afterward that global markets are simply too big and too diversified to fail.
What nobody in Washington seems eager to discuss is that 2026 is shaping up to be something the modern food system has never actually faced. Two independent shocks, one climatic and one geopolitical, are converging on the same harvest cycle at the same time. Not sequentially. Simultaneously.
Start with the weather. The Pacific Ocean is currently building toward what forecasters now openly call a record event. NOAA’s Climate Prediction Center puts the odds of at least a strong El Niño near 88 percent, with roughly two in three odds it reaches “very strong” status, the tier reserved for perhaps three or four events in the entire satellite era. Every major global model now projects a median peak in Super El Niño territory, and most of them project it exceeding the 2015-16 event, which until now held the modern record. Sea surface anomalies were already brushing the super threshold in mid-July, months before these events normally peak. The atmosphere has already shifted into El Niño mode, and the event is forecast to crest in late fall and early winter.
This is not about “climate change.” It’s about the standard cycles of weather, and the cycle we’re currently in is one that has likely devastated societies in the past. We’re better prepared as a society today, but not all Americans are equally prepared.
Serious households have started doing the quiet math on their own. Grocery bills tell part of the story, and the forecast maps tell the rest, which is why long-term food storage has moved from fringe hobby to mainstream line item in the family budget, with established suppliers like Heaven’s Harvest seeing demand from people who five years ago would have rolled their eyes at the idea. That instinct is not paranoia. It is pattern recognition, and the pattern is worth walking through carefully.
Editor’s Note: Heaven’s Harvest IS a sponsor, but the warnings of this article are real and would be written even if we didn’t have a survival food sponsor. With that said, those who take advantage of what they offer can use promo code “Patriot” for 15% off.
The Fertilizer Clock Is Already Running
While the Pacific warms, the second shock has been unfolding in the Strait of Hormuz. The conflict with Iran turned the world’s most important energy chokepoint into a contested waterway, and the consequences reach far beyond the gas pump. Roughly a third of global fertilizer trade moves through Hormuz, and the disruption sent urea prices up 86 percent year over year by March, with a 53 percent jump in a single month.
The World Bank projects energy prices rising about 24 percent in 2026 and fertilizer about 31 percent. By its own accounting, fertilizer prices ran 35 percent higher in the first five months of this year than the same period last year.
Here is the mechanism the nightly news will not explain. Fertilizer is not a grocery item. It is a time-delayed input. The nitrogen a farmer in Iowa or Punjab could not afford to apply this spring does not show up as a problem this spring. It shows up as a thinner harvest six to twelve months later.
The World Bank’s own food security brief concedes that the effects of reduced applications earlier this season “are likely to become visible only later in harvest outcomes.” Translate that from institutional language into plain English and it means this. The damage is already done, it is already in the ground, and we are simply waiting for it to arrive on the shelf.
Now check the calendar. Six to twelve months from the spring planting season lands us squarely in late 2026 and early 2027. Which is precisely when the strongest El Niño in the instrumental record is forecast to peak, bringing its signature droughts to Southeast Asia, Australia, southern Africa, northern Brazil, and South Asia, the very regions that grow the world’s rice, sugar, and oilseeds.
The World Bank warns openly that a strong El Niño “could disrupt multiple crop belts simultaneously” on top of the conflict-driven input costs. Their baseline projection assumes the Middle East disruptions ease by autumn. What in the last two years of Middle East history suggests that assumption is safe?
The System Has No Slack Left
The comfortable answer is that global markets always adjust. But adjustment requires slack, and the slack is gone. Global cereal production is expected to decline from last year’s records even before El Niño does its work. The UN World Food Programme, hardly a den of right-wing preppers, is calling this the most significant disruption to its supply chains since Covid and the invasion of Ukraine, and its supply chain director put the stakes bluntly.
Today’s supply chain challenges are tomorrow’s hunger crisis.
There is also a political dimension that markets cannot price. When food gets scarce, governments do not behave like economists. They behave like politicians. Export bans, hoarding mandates, and panic buying at the national level turned the modest rice shortfall of 2008 into a global crisis, and analysts are already warning that import-dependent nations are the first dominoes.
The 2015-16 Super El Niño, a far weaker event than what is now forecast, threw tens of millions into food stress across Africa and Asia. This one is projected to be stronger, and it arrives with fertilizer already rationed by price and shipping lanes already contested by missiles.
What Joseph Knew
Scripture does not treat preparation for lean years as faithlessness. It treats it as wisdom delivered in advance to those willing to act on it.
Behold, there come seven years of great plenty throughout all the land of Egypt: And there shall arise after them seven years of famine; and all the plenty shall be forgotten in the land of Egypt.
Joseph did not respond to that warning with a hashtag or a committee. He stored grain during the years of abundance, and when the famine came, Egypt stood while its neighbors begged. The lesson is not that famine is certain. It is that the time to prepare is precisely when preparation still looks optional.
Nobody who filled a pantry in a year of plenty has ever regretted it, and nobody standing in an empty aisle has ever been glad he waited for certainty.
None of this calls for panic, and panic is the enemy of sound judgment anyway. It calls for the same unglamorous prudence our grandparents considered ordinary. Keep some cash margin, know your local growers, and put real food in deep storage while it is cheap and available, because the entire arc of this story is that cheap and available is a closing window.
Families looking for a straightforward place to start can visit Heaven’s Harvest and use promo code Patriot for 15 percent off long-term storable food. The forecasts may yet soften, the strait may yet reopen, and we should pray they do. But hope is a fine thing to hold and a foolish thing to eat.