The practice is clear
I state that in clinical trials of tens of thousands of subjects, adverse events even of a certain severity can occur and the practice is clear and tested: suspend, investigate by independent experts and decide whether or not the event is related to the vaccine, and if it is not, start the experimentation again immediately, especially in a situation like the present one in which it is expected that the vaccine can control if not eradicate a pandemic. I have participated in studies of this kind and I know the complexity and difficulty of this subject. I add that the confidentiality and confidentiality of the clinical data and characteristics of the subjects under trial deserve the right respect and help to proceed correctly and without external interference, very deleterious with such a spasmodic and politically-charged of a vaccine like now.
The opposite side of the coin
However, there is also the opposite side of the coin and it is the certainty that citizens, who are also very tried and sensitive to the matter as in this terrible circumstance, must be offered the absolute safety of a vaccine that is expected to be administered to millions. of people. It would therefore be good, advantageous for those responsible for this vaccination trial and especially for people who are anxiously waiting to be vaccinated, that the Company give some more information on the two cases of neurological diseases, in particular the last one that led to the suspension. of the trial. There has been talk of a spinal pathology in a rather convoluted and generic way. A transverse myelitis, some have said, a serious and very rare pathology of the spinal cord but it is not really known what disease it is, who was actually affected, what was the real extent of the symptoms and if it was reversible.
Clarity is essential
The fact that the trial was not suspended, as in the first event, or was quickly resumed, as in the second event, would indicate that the adverse effect occurred in subjects of the control group, i.e. the non-vaccinated, who generally they receive a placebo or a vaccine not related to Covid-19, or even in subjects, if belonging to the vaccinated group, who already suffered from this previous disease in a silent way or who contracted it with a viral infection, for example example from herpes viruses, therefore independently of the vaccine. Whatever the case, why don’t you say it clearly? Dr. Di Lorenzo, director of Irbm, invokes the confidentiality and privacy of the subjects, but goodbye it can be said, without mentioning name and surname and date of birth, if the subject with the adverse event was a vaccinated or a control not vaccinated? I don’t think this is known yet, in which case it would be serious to have restarted the vaccine after only three days. Maintain a profile like this “ascetico“on the information of the case, perhaps due to the fear of generating unjustified fears and suspicions, it may seem reasonable, but if one exceeds in silence, the exact opposite effect is obtained and this can become dangerous for this vaccine and the acceptance of vaccines in general.
Meanwhile, the FDA seems to be taking its time to decide when and how to restart the vaccine trial in the US and a leading researcher from the Department of Neurology of the National Health Institute of Bethesda, Dr. Avindra Nath, says he is worried and invokes what I said above: a minimum of clarity, please.
* Membro dell’American Academy of Microbiology
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