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Scientists from around the world have signed an open letter expressing fear at allegations that Russia has produced a vaccine that confers some immunity against the coronavirus.
In August, the Russians were the first to approve a coup after less than two months of human testing. Vladimir Putin announced that the vaccine had “sustainable immunity” against the virus and that one of his daughters had been vaccinated.
Experts were primarily cynical, yet hopes were slightly higher on September 4 when two “small but encouraging” studies found the vaccine was, and produced an immune response.
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While many have pointed out that this was a “so far very good” case, a letter from Dr. Enrico Bucci of Temple University in Philadelphia has called some of the findings “highly. Fantastic. “
The signatories, who numbered 26 on Wednesday night, expressed “excessive public interest and expectations of an effective vaccine,” but added that this “motivates the clinical network to pay even more attention to the evidence. “
In the prestigious medical journal The Lancet, a team of Russian scientists concluded that there were no serious protection considerations in 36 volunteers until 42 days after handling the vaccine.
It was also found to cause an immune reaction in 40 volunteers in 21 days. However, many experts rushed to point out that the jab’s ability to save him infections or serious illnesses “has not yet been demonstrated. “
Some added that the effects were encouraging enough for the vaccine to be studied in larger studies.
However, everyone is convinced.
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An open letter published about the Italian Cattivi Scienziati – who promises to “fight evil and pseudoscience” – is addressed to Russian scientists and Richard Horton, editor of The Lancet.
The signatories, from the University of Milan to the University Hospitals of Leeds, accused the scientists of offering “digital knowledge for all experiments”.
This “would be of great help in comparing the study provided, allowing all analyses and effects to be replicated directly, rather than seeking to do so from the knowledge extracted or inferred from the numbers,” they wrote.
Based on the “research described in the article”, the signatories highlighted “several other issues of concern”.
Russian scientists analyzed a frozen and lyophilized vaccine.
Both formulations are based on adapted strains of the adenovirus. This makes the not unusual bloodless has been modified to account for the coronavirus spike protein, which it uses to power cells.
For vaccine protection in a phase 1 trial, 4 teams of nine healthy volunteers won the frozen or lyophilized vaccine.
One organization won a frozen edition of an adenovirus strain called type 26, while the organization got type five. The remaining two teams won the type 26 or type five lyophilized formulas.
To assess the effectiveness of the formulations in trial 2, 40 volunteers earned a frozen or lyophilized Type 26 jab, followed by a Type 26 booster 3 weeks later.
A table in The Lancet combined the antibody responses of the volunteers after vaccination with the other formulations. Antibodies are proteins produced through the immune formula to fight infection.
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The signatories were skeptical that “various knowledge models will appear repeatedly. “
Of the volunteers who received a frozen edition of type 26, the nine gave the impression of having “antibody titles equal to days 21 and 28,” they wrote.
This is also true for seven of the nine volunteers who won the freeze-dried edition of type 5, the signatories added.
In other parts of the studies, the volunteers’ antibody grades “differed across a consisting of two absolutely independent experiments,” while the grades were “absolutely preserved between [one] two other teams of absolutely independent volunteers. “
“It turns out to us that, based on undeniable probabilistic assessments, it is highly unlikely to observe so many knowledge problems among other experiments,” the signatories write.
They added knowledge of antibodies for each volunteer during the other days, which would be “very useful for reporting (and therefore) interpreting the results”.
Apart from antibodies, the effects also that other facets of the immune reaction were “continuous in nature” among the other formulations of the vaccine, a “coincidence” that the signatories called “even less likely”.
“Note that in the absence of original numerical knowledge, no definitive conclusions can be drawn on the reliability of the knowledge presented, with respect to the obvious duplications detected,” they wrote.
Instead of having a placebo organization, the popular gold of medical studies, Russian scientists know its effects on the immune reaction of other people who naturally fought coronavirus, and concluded that it “appears to be superior in other vaccinated people. “
The signatories described this as an “additional concern”.
“The authors specified sufficient characteristics of the convalescent [recovering] patients used as control,” they wrote.
“How did you pair with the other teams of registered volunteers?It is also to know when the plasma was extracted: for each patient, how many days have passed since the symptoms and seronegativization [negative coronavirus check] occurred?
“During the ongoing pandemic, the public’s excessive interest and expectations for an effective vaccine are perfectly understandable.
“However, the same reasons motivate the clinical network to pay even more attention to clinical evidence and the underlying data, so it is of paramount importance that they are fully available for further examination. “
At the time of publication of the studies, the complaint was that the trials were too small to assess safety, as well as the uncertainty as to whether an antibody reaction “results in coverage in the body. ” floor”.