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.
The Epoch Times obtained, through the Freedom of Information Act, letters sent by CISA to physicians.
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.