Tuesday, October 11, 2022
Independent task-force releases new report into origins of COVID-19
A new report by a team of independent global scientists has found it “highly likely” the origins of Covid-19 was bats who passed the virus to animal hosts and then to people working in the wildlife trade at a seafood market in China.
The report, published Tuesday by the Independent Task Force on Covid-19 in the Proceedings of the National Academy of Sciences (PNAS) concluded that based on the available evidence it was highly unlikely the virus was created in or released from a laboratory.
The team of 12 internationally renowned experts from a diverse range of disciplines included Dr Danielle Anderson from Victoria.
The team found the evidence strongly indicated that Covid-19 originated via a pathway similar to SARS-CoV, involving a spillover from bats to animals to people leading to the first known cluster of Covid-19 at the Huanan Seafood Market in Wuhan in China in December 2019.
Dr Anderson, from the Royal Melbourne Hospital and a research scientist at the Victorian Infectious Diseases Reference Laboratory (VIDRL) at the Doherty Institute, said the team looked at hundreds of research papers and preprints – papers yet to be peer-reviewed and published – and interviewed those who had an opinion on the pandemic.
Dr Anderson, an expert on bat-borne viruses who also worked at the Wuhan Institute of Virology prior to the outbreak, said based on the evidence the team reviewed, there were no big surprises.
“We did this to understand some of the information people were referencing,” she said.
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Are COVID Jabs Causing Leukemia? A Preliminary Analysis of Adverse Event Cases
On November 23, 2021, former South Korean President Chun Doo-hwan died at the age of 90. According to South Korea’s JTBC TV, a former Cheong Wa Dae (South Korean presidential palace) secretary revealed that Chun had not eaten properly for 10 consecutive days since he received the Pfizer COVID-19 vaccine. His health deteriorated rapidly and he lost 20 pounds. And he was diagnosed with leukemia and was hospitalized for 12 days. One of his former aides suspected that his leukemia was related to the side effects of the vaccine.
Moreover, an open letter from a group of Mainland Chinese leukemia patients was circulating on Chinese social media platforms in early May 2022, but it was quickly taken down. In the letter, the patients, aged 3 to 70 years old and from more than 30 provinces and central government directly controlled municipalities across China, stated that they had developed leukemia after receiving COVID-19 vaccines and suspected that their disease was a severe vaccination adverse event. And they hoped that the government would investigate the matter.
So, is it possible that vaccination can cause leukemia? What are the possible causes of the disease, and how can we prevent it?
Principles of Pharmacovigilance
Dr. Yuhong Dong, virologist and infectious disease doctor, has also worked in pharmacovigilance department for cancer drugs at a major international pharmaceutical company.
According to the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E2A (Page 4): “An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.” (pdf)
In the pharmacovigilance industry, there is a generally accepted principle: “It is better to make 3,000 misjudgments rather than to miss one case.”
Regardless of the source of the adverse event report and whether the report was made by a professional or not, every piece of information regarding a potential adverse experience of a new drug or vaccine must be properly taken as an AE. And it has to be included in the vaccine adverse event report database for medical analysis. The purpose is to collect as much information as possible to find patterns in these cases and monitor any potential serious adverse events proactively.
According to international good practice principles in the pharmaceutical industry in monitoring vaccine adverse events, an adverse drug or vaccine event is considered eligible to be reported if the piece of information meets the following four conditions:
There is an identifiable patient;
There is an identifiable reporter;
There is exposure to a drug or vaccine;
There is an adverse experience (symptoms or signs or lab test, etc), regardless of whether a causality relationship with the drug or vaccine has been established or not
The key rationale is that after the new vaccine or drug is applied in a large population, the top priority would be safety rather than efficacy. There are many examples of pharmaceuticals or vaccines that have been recalled or even withdrawn from the market due to safety issues. So if there is a safety concern, it must be addressed immediately and proper actions shall be taken in order to protect humanity’s safety.
Case Study: Almost 1,000 People Suspected of Developing Leukemia after Vaccination
A veteran journalist has provided Dr. Dong with two large excel sheets of adverse leukemia events made collectively by mainland Chinese-manufactured vaccine recipients. These data sheets contain adverse events reported by nearly 1,000 patients as of June 4, 2022, at 10 p.m. EST. The adverse events are mentioned in great detail, and the reports’ contents are alarming.
Due to time constraints, we have so far conducted a preliminary analysis of 235 valid cases, accounting for approximately 20 percent of the total.
What we presented here in this paper is the preliminary data analysis, but a more complete analysis will be performed during the coming weeks.
In terms of gender, the victims in 56 percent of these 235 cases were male; 2 percent were female; and 42 percent of the cases didn’t specify gender information. There is currently a lot of missing information, and the gender ratio is predicted to be around 1:1 in the complete data, with the number of men possibly slightly larger.
Their age range was 3 to 79 years old, with an average age of 30 years old.
Vaccines are mainly from Sinovac Life Sciences Co., Ltd, but some are produced by Beijing Institute of Biological Products Co., Ltd., Wuhan Institute of Biological Products Co., Ltd., and several others.
Among the vaccine related adverse events concerning leukemia, the most common is acute myeloid leukemia (49 percent of the cases). It is followed by acute lymphoblastic leukemia (34 percent), aplastic anemia (9 percent), and several other hematological malignancies such as lymphoma.
In 44 percent of the cases, symptoms or diagnoses of these adverse events were reported to occur on average 84 days after the second dose.
In 16 percent of the cases, these leukemia-like events were reported to occur on average 52 days after the third dose. This is a reasonable time frame, as leukemia involves genetic mutations, and there would be a pathological process, which is a chronic adverse reaction. It does not occur in a short period of one or two weeks like the acute side effects of myocarditis or blood clots.
In 16 percent of the patients, the symptoms appeared on average 40 days after the first dose of the vaccine. During this time period, many people might have already received a second dose. So it is likely that they are still classified as having received a second dose, as the patients’ reporting habits vary.
Most of these patients are currently undergoing treatment, with some requiring organ transplantation and/or chemotherapy, and there hasn’t been any case of recovery so far.
https://www.theepochtimes.com/health/leukemia-preliminary_4530742.html ?
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‘Not having a big impact’: COVID drug fails to beat placebo in major trial
A COVID-19 medication that was thought to strongly reduce the risk of the illness becoming life-threatening and was bought in bulk by the federal government works no better than a placebo, preliminary findings from a major new study suggest.
Molnupiravir, sold in Australia under the brand name Lagevrio, disrupts the coronavirus’ ability to copy itself and was the first COVID-19 antiviral to win government subsidy here.
The medication is intended for people at high risk of serious illness – those aged over 50 who have risk factors, and the immunocompromised – after they test positive to COVID-19 but before they are sick enough to need a hospital. Australia was one of the most aggressive movers in securing access to molnupiravir, buying 300,000 courses in late 2021, before it was approved by medical regulator the Therapeutic Goods Administration (TGA).
But some scientists have long been suspicious of strange results in the drug’s early trials. Data from the new trial has hardened their scepticism.
The University of Oxford’s PANORAMIC trial enrolled 25,783 people with COVID-19, half of whom got molnupiravir. After 28 days, 103 people given molnupiravir had died, compared with 96 in the second group.
“Clearly, it isn’t having a big impact,” said Professor Peter Wark, an expert on antivirals at the University of Newcastle. “I think we’d have to look very critically as to the cost-effectiveness of continuing in this sort of way.”
Governments keen to end COVID restrictions had leant on antivirals as a way out of the pandemic, Wark said. “A slower relaxation of restrictions probably would have had a bigger impact than relying heavily on these antivirals.”
Dr Kyle Sheldrick – a University of NSW researcher who co-authored a paper earlier this year on molnupiravir’s problems – is critical of the TGA’s approach. “I did not think it should have been approved before PANORAMIC,” he said “I certainly don’t think it should be now.”
The Health Department did not answer questions on how much it had spent on the drug, but the US paid about $US700 ($1099) a dose at the same time.
Australia’s National COVID-19 Clinical Evidence Taskforce said it was reviewing the study and would probably soon update its recommendations, which endorse molnupiravir.
A spokesman for the drug’s sponsor Merck said PANORAMIC had focused on a low-risk group, and pointed to other studies showing the treatment was effective.
In April Merck predicted it would make $US5 billion to $US5.5 billion selling the drug this financial year.
In an effort to get more people using the drug, the Australian government widened eligibility in July and Merck launched an advertising campaign.
Due to uncertainties about the clinical trial evidence, molnupiravir remains unapproved by the European Union; France cancelled its order in December.
Merck’s spokesman argued the patients in PANORAMIC were relatively healthy, whereas in Australia, the drug is reserved for people with major risk factors. “Other recent real-world studies, including the Clalit study from Israel, have indicated that [molnupiravir] was associated with a significant reduction in hospitalisations and mortality due to COVID-19 in patients 65 years and above,” he said.
Initial uncertainties about molnupiravir stemmed from strange results in the original Merck trial that got the drug approved.
Merck’s trial recruited about 1500 patients and gave half the drug. Early results from the first half of patients tested were so positive – a halving of the chance of death – that the trial was stopped early so everyone could get the apparently life-saving treatment.
But when data from the remaining half of patients in the trial was published a month later, it told a different story. The second group had done far worse than the first. In fact, the data suggested molnupiravir did not improve their outcomes. Combined, the full trial suggested molnupiravir may not cut the risk of death.
“We think this is unprecedented. None of us had ever seen anything like this before,” said Sheldrick.
The strange results may have been caused by a new coronavirus variant emerging mid-trial, he said. Merck disputes that, and claims the early results were the key ones.
Wark said it was possible the drug was of less use in a highly vaccinated population faced with a milder variant such as Omicron.
Sheldrick said the PANORAMIC results suggested governments need to think differently about rushing to approve drugs with limited evidence – even in the middle of a pandemic.
A spokeswoman for the TGA said the drug remained provisionally approved for use. “It is noted that while, in the PANORAMIC trial, hospitalisation and death was not reduced by molnupiravir for adults under 65 years, the time to first self-reported recovery was six days shorter.”
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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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