The World Health Organization does not approve that vaccination against Covid-19 is mandatory in any country, although he defends the importance of immunization. A spokesperson for the agency said this (as stated in a launch by the breaking latest news news agency on August 13) in response to the fact that several countries are considering making it mandatory.
WHO spokesperson Fadela Chaib at the press conference then added that these vaccines are just “one of several tools we have in our hands” to fight the Covid-19 pandemic.
And, as beraking latest news reports , mandatory vaccination “should not be the first choice”.
Meanwhile, the article entitled “Transparency of trials on the Covid-19 vaccine: decisions without data has been published in the British Medical Journal ”.
Yet “the transparency of the data is an essential requirement for the conclusions to be verifiable,” explains the Assis association , Studies and Health Information.
Therefore, as stated in the BMJ, the lack of transparency of COVID-19 vaccine trials produced decisions without data.
And on this important issue, Assis adds:
«Data transparency is one established standard in biomedical research and is particularly important for widely used public health interventions such as COVID-19 vaccines;
COVID-19 vaccine trials received lavish public funding and taxpayers should have the right to access the results;
There is a inadequate availability of documents e data on testing COVID-19 vaccines; some information will not be available for months, or years, for most vaccines;
The adoption of public interventions without full transparency of the data raises concerns on the rational use of COVID-19 vaccines;
Transparency must be immediate and continuous. THE protocols of study should be made public before the results are published, and should be accompanied by documents and data before decisions are taken on the use of the product being tested. ‘
With regard to the studies that would lead to recommend the third dose of Covid vaccines, the analysis proposed by Andrea Capocci in the newspaper Il Manifesto is interesting. .
Capocchi recalls the data published by Pfizer-BioNTech researchers in March 2021 on the effectiveness of the vaccine of the same name, which showed a decline in protection in the first 4-6 months of administration, according to data from a study started in July 2020 that was initially expected to last until 2023.
“According to the scientific community, only these” randomized and controlled “studies make it possible to establish whether a drug or vaccine is really effective and represent the compass on which to plan any recall vaccination campaigns and the relative timing” reads the article.
But, “as the companies themselves write, the “randomized and controlled” study will end prematurely and these will be the last reliable data on the duration of immunity. Of the 44,000 participants, the majority chose to know their vaccination status, and possibly vaccinate themselves according to the rules established locally by the countries where the study took place. The data relating to coverage six months after vaccination concern only 7% of the initial participants, and by now the percentage of volunteers still enrolled in the double-blind study is close to zero “writes Il Manifesto again.
“Pfizer and BioNTech justify the early termination of the study with” the ethical and practical need to immunize placebo recipients based on the emergency use authorization and recommendations from public health authorities. ” In other words: it would be unethical to deny an available vaccine putting the lives of thousands of volunteers at risk for research reasons alone – the article continues – In December 2020, during the emergency authorization process, the Food and Drug Administration (l ‘US regulatory agency) had asked the company to extend the randomized study while safeguarding the protection of the participants with the adoption of the cross-over strategy: authorization was obtained, those who were initially in the placebo group would be vaccinated, and those who received the vaccine would be given the placebo, without disclosing the status of the two groups. In this way, everyone would have been vaccinated, the scientific rigor would have been preserved but by examining the difference in protection in the two groups it would have been possible to measure the duration of immunity ”.
But “the company had refused to comply with the regulatory agency’s request. And Moderna too had communicated the same unavailability, considered “too burdensome” from an organizational point of view. However, the companies had pledged to encourage volunteers not to abandon the study. 18 experts, including one from the FDA, had written an appeal in which the hypothesis of stopping the trial after only six months was considered “disastrous”. According to another article on New England Journal of Medicine signed by the WHO vaccination task force “the opportunity to obtain reliable evidence on long-term effects would be canceled by immediate vaccination of participants and disclosure of their vaccinated status or not”. As the volunteers later revealed in numerous testimonies, despite public promises, the companies had already proposed to the volunteers to abandon the placebo group to receive the vaccine, sabotaging their own research ».
Capocci writes again: «Pfizer now promises to continue to monitor the participants even in this phase. “Observing participants for two years within the study, together with efficacy data from the vaccination campaign, will establish the benefit of a booster over a longer period.” But these are spurious data, collected in a less rigorous way, without double blind and therefore more exposed to distortions. Knowing that you have been vaccinated recently or for several months, for a vaccine that is known to have decreased protection, can lead to different behaviors and to influence risk exposure between one group and another, for example. In order to obtain solid evidence from the data of the vaccination campaigns, it will take longer, losing the advantage acquired by clinical studies that started a year ago. Political decisions on the third dose, however, must be made in these months, and they will not be able to wait that long. Without rigorously collected data, the need for a recall will be entrusted to choices more influenced by emotional factors and collective suggestions. Of this uncertainty about the actual efficacy of the vaccine companies will take advantage of that their investors have already spoken of the third dose as a “significant opportunity” to raise the price of the product. The effects are already visible. In Israel, the administration of the third dose has already begun. The European Union has booked 900 million doses for 2022 boosters (plus an option of equal value). At a price of 19.5 euros per dose, known only thanks to rumors given that the contracts are secret, it would be almost 20 billion euros: a gigantic collection, which alone is worth more than half of the company’s entire revenue in the 2020 (35 billion euros) “.
“In theory, regulatory agencies would have the means to oppose these strategies that have more to do with marketing than science. The FDA guidelines provide verbatim that “the FDA does not believe that the availability of an anti-Covid vaccine on the basis of an emergency authorization is a sufficient reason to stop the double-blind continuation of an ongoing clinical trial”. Therefore the agency could, at least on paper, revoke the authorization for the violation of the rules by the companies ».
As stated in the article, “In times of emergency, companies have the knife on the side of the handle and know how to take advantage of it. The pharmaceutical company Gilead, for example, obtained an authorization for the experimental antiviral remdesivir after a trial on a few patients carried out during the first wave of Covid in the US and interrupted prematurely when the preliminary results were positive. A larger study carried out by the WHO also showed that remdesivir is substantially ineffective . But now the orders for remdesivir have skyrocketed. The drug brought in more than $ 2 billion in revenues in 2020, pushing the company’s revenues to over $ 24 billion by 2020. According to analysts, the 2021 budget is also expected to lead to similar results. This is what happens when pharmaceutical development is entirely subcontracted to private companies, which from research to patents have gained the power to impose on governments the most advantageous rules for themselves ».
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