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COVID-19 vaccine only 19-29% effective??
COVID-19 vaccine only 19-29% effective?? OVID-19 vaccine has been questioned, and the true effective rate is only 19-29%! Suspected cases are 20 times as many as confirmed cases?
The British Medical Journal (BMJ) is one of the world’s four major comprehensive medical journals. Peter Doshi, the associate editor of BMJ, questioned the falsification of experimental data on the COVID-19 vaccine of Pfizer and Moderna. His article was published on the BMJ website. .
Evidence shows that the protection rate of Pfizer and Moderna vaccine against the new coronavirus is far from the 95% announced by the Trump administration and the company, but it is likely to be 29%, which is much lower than the 50% set by the U.S. Food and Drug Administration. % Minimum standard.
This conclusion is based on some of the data that Pfizer has released; at the same time, Pfizer has released few details and raw data, which also strengthens its skepticism.
Considering that Pfizer vaccine was developed in a short period of time lower than the general scientific law, the strong support of the US government is also one of the key factors.
Coupled with the current vaccine research and development activities of other major countries in the world, we have reason to ask: human The anti-epidemic that saves one’s own life is on the path of global “political leadership” and “how fast and better?”
Questions about Pfizer’s statistical methods
This question was raised by Peter Dorsey, the associate editor of the British Medical Journal.
His conclusion is actually that: Pfizer vaccine’s research and development personnel used statistical methods that clearly violated scientific principles, that is, did not base on original data, to create a reassuringly high protection rate of 95% of Pfizer vaccine.
Or in other words: the credibility of Pfizer vaccine against the new coronavirus with a high protection rate of 95% is a conclusion drawn through statistical methods that violate scientific principles.
Peter Dorsey wrote an article in the British Medical Journal on January 4, and gave the following introduction to the above issues:
All eyes around the world are focused on the excellent protection rate of Pfizer’s COVID-19 vaccine: volunteers participating in clinical trials have reported a total of 170 Covid-19 cases confirmed by laboratory PCR tests, 8 cases in the vaccine group and 8 in the placebo group. And 162 cases.
However, the suspected Covid-19 cases in the case definition are those patients who have symptoms of Covid-19 infection but have not been confirmed by laboratory PCR. The proportion is too high, which makes the so-called “high protection rate” somewhat discounted. . According to the U.S. Food and Drug Administration (FDA) report on Pfizer’s vaccine, “Among all the volunteers in the study, there were a total of 3,410 suspected Covid-19 cases without diagnosis, 1594 cases in the vaccine group and 1816 cases in the placebo group. “
The article believes: “Suspected cases are 20 times the number of confirmed cases. It is unbelievable that patients such as suspected cases cannot simply be tested negative by laboratory PCR and not counted as patients. A simple estimate of the vaccine protection rate is: regardless of PCR detection Whether or not, anyone with symptoms should be counted as patients.
In this case, the protection rate is 19%, which is far lower than the 50% threshold set by the US Food and Drug Administration. It is further broken down and removed. For cases that occurred within 7 days after vaccination (409 people in Pfizer’s vaccination group and 287 people in the placebo group, these people have not been effective due to the vaccine and the side effects of vaccination can cause similar side effects), the vaccine protection rate is only 29%.”
According to Peter Dorsey, there is another fact that can also explain the problem: 371 volunteers of Pfizer Vaccine were excluded from the protection rate analysis for no reason in the statistics.
The article pointed out that another reason we need more raw data is that a detail in the U.S. FDA’s review of Pfizer’s vaccine review form is unexplainable. That is, 371 volunteers had been Significant deviations in the clinical research program” were excluded from the calculation of the protection rate. “What is more worrying is that the number of excluded volunteers is unevenly distributed and not randomized.
That is, there are 311 people in the vaccine group and 60 people in the placebo group.” In contrast, in Moderna’s trial, only Thirty-six volunteers were excluded from the analysis of the protection rate due to “deviations from the main clinical protocol”-namely 12 in the vaccine group and 24 in the placebo group.
Peter Dorsey asked: In Pfizer’s research, what do these “deviations from clinical research protocols” specifically refer to? Why are 5 times more participants in the vaccine group than in the placebo group excluded from the statistical analysis? According to reports, the US FDA report did not explain this, and these excluded volunteers were not disclosed in Pfizer’s report and later published literature.
The above position has been recognized by people who have been engaged in public health work for many years, the pharmaceutical industry and the World Health Organization. They told the author: There are serious problems with the statistical methods of the US Food and Drug Administration and Pfizer.
They believe that people who have the disease of the COVID-19 virus but are difficult to detect infection should be listed as patients. Such statistics are accurate; and there are too many people like Pfizer here, and suspected patients are 20 times the number of confirmed patients. It is impossible to accurately judge the reliable protection rate of the vaccine.
BMJ Deputy Editor-in-Chief Peter Doshi stated: I have been pursuing the public release of vaccine trials and have signed an open letter, calling for independence and transparency in decision-making related to the covid-19 vaccine.
The author elaborated the following points:
Five weeks ago, when I questioned the results of Pfizer and Moderna’s covid-19 vaccine trial, the only information available was the publicly released research protocol and some press releases.
Today, before the agency urgently authorized the approval of the mRNA vaccines of these commercial companies, they submitted two journal publications and approximately 400 pages of abstract data to the FDA in the form of multiple reports.
Although some details are reassuring, some are not. Here, I list the issues related to the reliability of vaccine efficacy results in the report.
“The effectiveness of the covid-19 COVID-19vaccine is questionable”
Everyone was very impressed with the vaccine efficacy claimed by the merchants: Pfizer reported 170 confirmed cases of covid-19 by PCR, and the number of confirmed patients in the vaccine group and placebo group were 8 and 162 respectively.
However, the number of patients with covid-19 confirmed by PCR is too far apart from the number of patients with “suspected covid-19”. According to the FDA’s report on Pfizer’s vaccine, “There were 3,410 suspected but unconfirmed cases of covid-19 in the entire study population, including 1,594 in the vaccine group and 1,816 in the placebo group.”
There are 20 times more suspicious cases than confirmed cases. Just because there is no positive PCR test result, this type of suspected COVID-19 population cannot be ignored. In fact, how to understand and interpret this set of data is particularly important.
A rough estimate of the vaccine’s effective prevention of covid-19 symptoms, regardless of whether there is a positive PCR test result, can reduce the relative risk by 19% (see footnote), far below the 50% effective threshold set by the regulatory agency.
Even if the cases that occurred within 7 days after vaccination are eliminated (409 on Pfizer vaccine and 287 on placebo) (which should include most symptoms due to short-term vaccine reactogenicity), the efficacy of the vaccine is still very low: 29% (see footnote).
If many or most of these suspected cases are PCR false negatives, this will greatly reduce the effectiveness of the vaccine. But considering that influenza-like diseases are always caused by multiple reasons, such as rhinovirus, influenza virus, other coronaviruses, adenovirus, respiratory syncytial virus and so on. Some suspected cases of covid-19 may be caused by different pathogens.
But why is etiology important? If these “suspected covid-19” patients and the confirmed covid-19 patients participate in the same clinical course, the clinical endpoint statement as “suspected covid-19 patients” may be more accurate than the statement as a confirmed covid-19 patient .
However, if the clinical symptoms of a confirmed covid-19 patient are more severe than those of a suspected covid-19 patient, we still have to record the specific time when the trial is terminated, not just the incidence of disease severity.
The number of suspected covid-19 patients is 20 times more than the number of confirmed covid-19 patients, and the purpose of the trial is not to assess whether the vaccine can interrupt the spread of the virus, so regardless of the cause, the hospitalization rate of patients participating in this experiment should be measured , ICU cases and deaths are analyzed, which is the only way to assess whether the vaccine is really effective in preventing a pandemic.
Obviously data is needed to answer these questions, but Pfizer’s 92-page report did not mention 3,410 “suspected covid-19” cases. The journal articles published in the New England Journal of Medicine did not mention this.
371 patients excluded from the Pfizer vaccine efficacy analysis
Another reason we need more data is to analyze the unexplainable details found in the FDA’s review of Pfizer vaccines: 371 patients were excluded from efficacy due to “dose 2 or 7 days after or prior to the important protocol deviation” Beyond analysis. Interestingly, the number of these excluded individuals is unbalanced between randomization: 311 in the vaccine group and 60 in the placebo group. (In contrast, in Moderna’s trial, only 36 subjects were excluded from the “significant protocol deviation” efficacy analysis, namely 12 vaccine groups and 24 placebo groups.)
What are the deviations of these plans in Pfizer’s research? Why did the number of excluded participants in the vaccine group increase fivefold? The FDA report does not say that these exceptions are even hard to find in Pfizer’s reports and journal publications.
Blind use of fever and pain medications, and primary incident adjudication committee
Last month, I expressed concern about the potential confounding effects of painkillers and fever medicines in treating symptoms. I think such drugs may mask the symptoms, leading to undetected cases of covid-19, and there may be more people vaccinated to prevent or treat adverse events.
However, it seems that their influence on the results of the experiment is quite limited: although the results indicate that these drugs are taken in vaccines approximately 3–4 times more frequently than placebo recipients (at least for Pfizer’s vaccine-Moderna, it is not reported clearly ), the use of drugs is probably concentrated in the first week after the vaccine is used to alleviate local and systemic adverse events after injection. But the cumulative incidence curve shows that the incidence of confirmed covid-19 cases is fairly stable over time, and the date of onset of symptoms is much longer than one week after administration.
In other words, the higher rate of drug use in vaccine experiments provides a further reason for blind use of drugs. Considering the reactogenicity of the vaccine, it is hard to imagine that participants and researchers cannot make educated guesses about their population.
The primary endpoint of the trial was relatively subjective, so it did not cause people’s attention. However, neither the FDA nor the two companies appear to have formally discussed the reliability of the blinding process and its impact on the results of the report.
We also know very little about the procedures of the Junior Incident Adjudication Committee in handling covid-19 cases. Do they learn about antibody data and patient symptoms in the first week after vaccination?
What are the criteria they adopted, and is it necessary for the committee to determine this in a major event consisting of patient-reported results (covid-19 symptoms) and PCR test results?
It is also important to know who the members of these committees are. Although Moderna appointed a four-member adjudication committee, all doctors from university hospitals, Pfizer’s experimental operation manual indicated that all three Pfizer employees were doing this work. Yes, employees of Pfizer.
How effective is the vaccine against patients already infected with the new coronavirus?
People with a history of SARS-CoV-2 infection or a previous diagnosis of Covid-19 were excluded from the Moderna and Pfizer trials. However, at baseline, 1125 (3.0%) and 675 (2.2%) participants participated in the SARS-CoV-2 positive tests of Pfizer and Moderna, respectively.
The vaccine safety and effectiveness of these subjects have not received much attention, but since more and more people in the population of many countries may be “Covid infected”, these data seem to be important, especially in The US Centers for Disease Control and Prevention recommends that “previously symptomatic or asymptomatic SARS-CoV-2 infection history should not be considered.”
This recommendation is based on the conclusions of Pfizer Vaccine, and it is against previous SARS-CoV-2 infections People with ≥92% efficacy, and “no special safety hazards”.
According to my calculations, Pfizer apparently reported 8 confirmed symptomatic Covid-19 cases that were positive for SARS-CoV-2 at baseline (using the difference between Table 9 and Table 10, 1 case in the vaccine group and 7 cases in the placebo group) and Moderna, 1 case (placebo group; Table 12).
There are only about 4 to 31 cases of reinfection worldwide. However, in this trial involving tens of thousands of subjects and a median follow-up time of two months, SARS-CoV- 2 How can there be 9 confirmed cases of covid-19 among infected patients? Does this represent a meaningful vaccine efficacy that the CDC seems to have recognized? Can the symptoms of covid-19 be prevented through vaccines or medications that suppress symptoms, regardless of reinfection?
We need raw data
To solve many of the open questions about these trials, access to the original trial data is required. But currently, no company seems to share data with any third parties.
Pfizer said it is “providing data on request and under review.” This is still a long way from the publicly available data, but at least it opens the door. It is not yet clear how open it is, because the research plan states that Pfizer will only start providing data 24 months after the study is completed.
Moderna’s data sharing statement promises that the data “will be available upon request once the trial is completed.” This means that a 2-year follow-up is planned for mid to late 2022.
The same goes for Oxford/AstraZeneca’s vaccine data. They also claim to disclose the data “when the trial is complete.” The ClinicalTrials.gov entry for Russia’s Sputnik V vaccine says that there is no plan to share individual participant data.
However, the European Medicines Agency and Health Canada may share data on any authorized vaccines earlier. EMA and Health Canada have pledged to publish the data submitted by Pfizer on their website “in due course.”
(source:internet, reference only)