Authored by Zachary Stieber via The Epoch Times (emphasis ours),
A community composed of specialists from inside and out of doors the U.S. authorities repeatedly really useful that individuals who suffered hostile occasions following COVID-19 vaccination obtain further pictures, even when the specialists couldn’t rule out the vaccines as the reason for the occasions, paperwork obtained by The Epoch Times present.
The community, the Clinical Immunization Safety Assessment (CISA) Project, is run by a physician who has acquired intensive funding from pharmaceutical giants, together with the highest two COVID-19 vaccine producers, in keeping with different data.
In one instance, CISA was introduced with data exhibiting a 63-year-old girl skilled continual kidney illness, with signs together with kidney swelling, after receiving a second dose of Pfizer’s COVID-19 vaccine.
CISA subject material specialists (SMEs) mentioned that the analysis couldn’t be definitively confirmed with out a kidney biopsy however that they nonetheless felt comfy utilizing a causality algorithm for the presumed analysis developed partly by Dr. Kathryn Edwards, CISA’s principal investigator.
Applying the algorithm to the case resulted in an “indeterminate” designation, or an incapacity to rule out the vaccine inflicting the issue, partly as a result of there was no proof of different causes. But that incapacity didn’t cease this system from recommending further pictures.
“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 affected person’s physician said.
At the time, the effectiveness of the vaccines towards symptomatic an infection had been proven to start low and wane rapidly, whereas safety towards extreme illness started greater but in addition rapidly dropped.
After the girl acquired her subsequent shot, the CISA specialists mentioned, the physician ought to examine in on her to see if she skilled 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, advised The Epoch Times in an e mail.
“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.“
Dr. Edwards, till just lately of Vanderbilt University Medical Center, and the CDC didn’t reply to requests for remark.
The Epoch Times obtained, by means of the Freedom of Information Act, letters despatched by CISA to physicians.
CISA options specialists with the CDC and different establishments, together with Vanderbilt University, Boston Medical Center, and Johns Hopkins University collaborating to answer medical doctors who ask this system to evaluate affected person instances and supply suggestions.
“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 had been licensed and really useful in December 2020. From Dec. 1, 2020, by means of June 1, 2023, CISA offered 48 suggestions to medical doctors coping with COVID-19 vaccines, the data present.
In 39.5 p.c of the instances, CISA really useful one other vaccination. In 23 p.c of the instances, CISA really useful towards one other vaccination. In 14.5 p.c of the instances, CISA mentioned there have been no causes sufferers couldn’t obtain extra doses. In the remaining instances, CISA suggested reassessing the matter down the highway or advising a affected person who had not but acquired a vaccine to obtain a vaccine.
The suggestions for future doses got here even in instances the place CISA was unable to say the vaccine didn’t trigger the hostile occasion.
In a letter dated May 4, 2021, CISA specialists mentioned there was “no evidence” to assist non-vaccine causes for the affected person’s situation however that there was “no definitive known association” between the situation and Pfizer’s vaccine, resulting in an indeterminate designation within the causality algorithm.
While one of many specialists mentioned that in an individual “with the right immunologic makeup,” the vaccine “could be an initial inciting injury” inflicting the situation, lots of the specialists suggested the affected person to obtain one other dose.
The affected person may wish to obtain Johnson & Johnson’s vaccine, which makes use of completely different know-how than the Pfizer and Moderna messenger RNA pictures, CISA mentioned within 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 one other letter, dated Jan. 18, 2022, CISA specialists additionally discovered no proof for non-vaccine causes for the affected person’s situation, which appeared after Pfizer vaccination. But they repeated the declare that there was no definitive affiliation between the vaccine and the situation, resulting in an indeterminate designation.
CISA specialists “strongly felt that the risk of COVID-19 infection was higher than the potential risk from another dose of vaccine,” in keeping with the letter, and really useful a second Pfizer dose.
In a 3rd letter, dated May 23, 2022, CISA specialists mentioned 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 affected person’s situation was “not understood.”
But CISA specialists nonetheless suggested the affected person, who suffered an occasion after a Pfizer dose and had additionally recovered from COVID-19, to obtain one other 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 variety of instances led to the dedication that the vaccination brought about an hostile occasion.
In six cases, CISA specialists decided that the occasion was “consistent with causal association,” or attributable to the vaccination, as a result of the situation suffered by every affected person was “a known possible adverse event following immunization.”
In all six instances, specialists really useful towards further doses whereas advising the medical doctors caring for the sufferers to comply with up with the sufferers to determine which non-COVID vaccines the sufferers might safely obtain.
CISA specialists additionally suggested towards further COVID-19 vaccine doses in 5 different instances. The designations in these instances had been additionally indeterminate, making the variations between them and those who resulted in suggestions for future doses unclear other than a number of involving individuals who had expressed opposition to receiving extra pictures.
In seven different instances, CISA specialists mentioned there have been no contraindications, or no causes for not receiving at the least one further dose. The CDC has maintained a short list that at present contains simply two contraindications for the COVID-19 vaccines—a historical past of extreme allergic shock or a historical past of a identified identified allergy to a element of one of many pictures.
Patients with different situations, comparable to coronary heart irritation after COVID-19 vaccination, are usually suggested to keep away from further doses, the CDC says within the listing. But that’s solely a “precaution,” not a contraindication.
CISA additionally suggested medical doctors of 9 of the sufferers to reassess future COVID-19 vaccination down the highway and, in two of the instances, advised medical doctors that sufferers who had not but acquired a COVID vaccine might obtain one.
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