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Drastic drop in Covid vaccine effectiveness – study
5 Nov, 2021 15:44
Three different coronavirus shots – those mainly available in the US and Europe – have shown a dramatic decline in efficacy over time, a study of nearly 800,000 Americans reveals.
Covid-19 vaccine effectiveness against both infection and death was studied in three US approved jabs – the Pfizer-BioNTech and Moderna mRNA shots, and the Janssen viral vector vaccine.
Having analyzed data from 780,225 US veterans of different ages and sexes between February and October, researchers came to a disturbing conclusion. Vaccine protection against Covid-19 infection dropped from 89.2% at its highest to a low of 13.1%, according to a joint study by the Public Health Institute, the Veterans Affairs Medical Center, and the University of Texas Health Science Center, published in the Science journal on Thursday.
While effectiveness against infection in March was 89.2% for Moderna, 86.9% for Pfizer, and 86.4% for Janssen, by September there were massive declines to 58%, 43%, and 13% respectively.
The emergence and dominance of the Delta strain of the virus during the time of the study may have played a role, researchers said, adding that vaccine protection waned across all studied age groups.
More than 26,000 positive PCR tests occurred in some 498,000 fully vaccinated veterans.
The authors said the pattern of breakthrough infections shows a “worrisome temporal trend.” While the analysis covers 2.7 percent of the US population, other domestic and international studies have shown significantly waning efficacy.
On a brighter note, vaccine effectiveness against hospitalization and death remained high.
For how long?
As breakthrough infections, hospitalizations, and deaths continue to emerge in fully vaccinated people, there is “an urgent need to reinstate multiple layers of protection, such as masking and physical distancing – even among vaccinated persons,” the scientists warn.
Big Pharma ought to refund most of the money spent on purchasing these vaccines.
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Ivermectin-COVID-19 study retracted; authors blame file mixup
Retraction Watch
The authors of a study purportedly showing that ivermectin could treat patients with SARS-CoV-2 have retracted their paper after acknowledging that their data were garbled.
The paper, “Effects of a Single Dose of Ivermectin on Viral and Clinical Outcomes in Asymptomatic SARS-CoV-2 Infected Subjects: A Pilot Clinical Trial in Lebanon,” appeared in the journal Viruses in May. According to the abstract:
A randomized controlled trial was conducted in 100 asymptomatic Lebanese subjects that have tested positive for SARS-CoV2. Fifty patients received standard preventive treatment, mainly supplements, and the experimental group received a single dose (according to body weight) of ivermectin, in addition to the same supplements the control group received. …
Results results results … and:
Ivermectin appears to be efficacious in providing clinical benefits in a randomized treatment of asymptomatic SARS-CoV-2-positive subjects, effectively resulting in fewer symptoms, lower viral load and reduced hospital admissions. However, larger-scale trials are warranted for this conclusion to be further cemented.
However, in early October, the BBC reported — in larger piece about the concerns about ivermectin-Covid-19 research — that the study:
was found to have blocks of details of 11 patients that had been copied and pasted repeatedly – suggesting many of the trial’s apparent patients didn’t really exist.
The study’s authors told the BBC that the ‘original set of data was rigged, sabotaged or mistakenly entered in the final file’ and that they have submitted a retraction to the scientific journal which published it.
That’s not quite what the retraction notice states:
The journal retracts the article, Effects of a Single Dose of Ivermectin on Viral and Clinical Outcomes in Asymptomatic SARS-CoV-2 Infected Subjects: A Pilot Clinical Trial in Lebanon [1], cited above.
Following publication, the authors contacted the editorial office regarding an error between files used for the statistical analysis.
Adhering to our complaints procedure, an investigation was conducted that confirmed the error reported by the authors.
This retraction was approved by the Editor in Chief of the journal.
The authors agreed to this retraction.
Re-analysing the original data,
the conclusions of the paper remained valid.
Ali Samaha, of Lebanese University in Beirut, and the lead author of the study, told us:
It was brought to our attention that we have used wrong file for our paper. We informed immediately the journal and we have run investigations. After revising the raw data we realised that a file that was used to train a research assistant was sent by mistake for analysis. Re-analysing the original data, the conclusions of the paper remained valid. For our transparency we asked for retraction.
About that BBC report? Samaha said:
The BBC article was generated before the report of independent reviewers who confirmed an innocent mistake by using wrong file.
Samaha added that he and his colleagues are now considering whether to resubmit the paper.
The article has been cited four times, according to Clarivate Analytics’ Web of Science — including in this meta-analysis published in June in the American Journal of Therapeutics, which concluded that:
Moderate-certainty evidence finds that large reductions in COVID-19 deaths are possible using ivermectin. Using ivermectin early in the clinical course may reduce numbers progressing to severe disease. The apparent safety and low cost suggest that ivermectin is likely to have a significant impact on the SARS-CoV-2 pandemic globally.
That article was a social media darling, receiving more than 45,000 tweets and pickups in 90 news outlets, according to Altmetrics, which ranks it No. 7 among all papers published at that time.
The retraction marks the 189th for papers on Covid-19, by our count.
Pfizer stays mum about price of its new ‘game-changer’
anti-Covid-19 pill set to compete with Merck’s drug
5 Nov, 2021 12:59
Drugmaker Pfizer is ramping up production of its yet-to-be-approved antiviral pill, after a small-scale study showed great promise in preventing serious cases of Covid-19. The company has not announced the price of its product.
The clinical trial, reported by Pfizer on Friday, involved several hundred adult patients at high risk of hospitalization who were given the drug, branded Paxlovid. Of the 389 receiving it within three days of developing symptoms, only three were hospitalized and none died. In the control group, which received a placebo, 27 patients of 385 required hospitalization, with seven subsequent deaths. That translates into an 89% reduction in hospitalizations.
A similar positive effect was recorded in a parallel trial, in which treatment was started within five days, in order to test how big the window of opportunity is for starting treatment. There were six hospitalizations and no deaths among the 607 patients who received Paxlovid, compared to 41 hospitalizations and 10 subsequent deaths among the 612-strong control group.
“Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic,” Pfizer CEO Albert Bourla said.
It shouldn't be a game-changer if Big Pharma hadn't spent small fortunes destroying the truth about Ivermectin. Pfizer's drug produces similar results to Ivermectin but at many times the cost. What's in the drug, is it Ivermectin by another name?
Pfizer will “cease further enrollment into the study due to the overwhelming efficacy demonstrated in these results,” the company said, citing a recommendation by a US Food and Drug Administration (FDA) monitoring committee. It will now seek an emergency use authorization for the pill, it added.
A dose of Paxlovid contains a new chemical, currently designated ‘PF-07321332’, and a ritonavir, an anti-HIV medication which helps the main component to remain active for a longer time, according to Pfizer.
The pharma giant is racing against competitor Merck, which likewise seeks authorization for its oral anti-Covid-19 treatment, based on the compound molnupiravir. The UK has already given it the green light, while the FDA is set to evaluate it after Thanksgiving. Merck called its product “game-changing,” too.
Pfizer appears to be quite confident in finding a large market for its medicine, planning to manufacture over 180,000 packs by the end of the year and ramp up production to at least 21 million packs in the first half of 2022. Merck aims to produce 10 million treatment courses this year.
The price tag for Paxlovid was not disclosed, with Pfizer stating only that “high and upper-middle income countries will pay more than lower income countries,” and promising to “invest up to approximately $1 billion to support [its] manufacturing and distribution” in less-fortunate nations.
The two competing pills have different mechanisms for quashing the virus. Paxlovid inhibits an enzyme that it needs during its copying process, similar to how certain drugs suppressing HIV and hepatitis C work. Molnupiravir attacks the virus by inducing errors during its replication that are missed by its regular genome ‘proofreading’ mechanisms. Some scientists are concerned that Merck’s product may negatively affect human genes.
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BioNTech shares nosedive on news of whistleblower report & Covid pills
6 Nov, 2021 00:30
Shares of the German biotechnology company BioNTech that co-developed a Covid-19 vaccine with America’s Pfizer took a dramatic 20-percent plunge on Friday, in wake of a damning whistleblower report.
The price of BioNTech shares traded on the US NASDAQ exchange briefly fell by some $60 and stood at around $216 at the time of writing.
Some analysts have immediately tied the dramatic fall – which amounted to more than 20% – to the publication of an explosive report on the trial of the Pfizer-BioNTech Covid jab. Published in the British Medical Journal (BMJ) on Tuesday, the report cites a former contractor and claims to expose a staggering level of incompetence in management, handling of data and patient safety during the testing process.
The whistleblower, identified as Brook Jackson, claimed that the company hired poorly-trained vaccinators, that it was “slow” to investigate the jab’s adverse effects and even “falsified data” on the trials. She also provided the BMJ with dozens of internal documents to substantiate her claims.
Another possible reason for the surprise stock plunge is said to be Pfizer announcing successful results of its anti-Covid drug. On Friday, the US pharmaceutical giant cited the trial data as showing that its “game-changer” pill Paxlovid reduces Covid-19 hospitalizations by 89%.
Pfizer's news came on the heels of Merck & Co, another US pharma company, announcing that clinical trials had shown that its own drug reduces the risk of hospitalization and death in patients with mild to moderate Covid-19 by 50%. Merck’s drug has since been approved for treatment of Covid-19 patients in the UK.
Media speculation then assumed that the emergence of Covid-19 drugs might have made investors believe that demand for vaccines, including that of Pfizer and BioNTech, would fall. Notably, another vaccine developer – Moderna – also took a $55 loss on Friday and briefly stood at $229 before slightly recovering. Novavax shares plunged as well.
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