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Ema and Aifa, European and Italian pharmaceutical agencies, have strict and well-defined approval standards. Without sufficient evidence of safety and efficacy, nobody passes: this is why it is important that vaccines are tested before they are marketed and administered.
The media debate on Vaccines for COVID-19 sometimes it seems to have become a question zone for the expert, of the kind “But would she get the vaccine or not?”. A trick question that in fact always lends itself to controversy, both with him Yep that with him No. With on the one hand the need to grant science and authorities the correct time for all necessary evaluations – time that, moreover, has already been compressed as much as possible – and on the other the issue of not being accused of affinity with the mondo NoVax or conspiracy tendencies.
Of course, if the answer to the question can be articulated in more than one monosyllable, the matter is quite clear. We certainly cannot be satisfied and claim victory just on the basis of media ads conducted by pharmaceutical companies in recent weeks. And on the other hand we must recognize the public authorities in charge its function, that is, in fact trust your work. Otherwise, yes the conspiracy would have prevailed.
So there is only one possible recipe: Wait that the authorities obtain from the companies i Scientific data related to phase 3 clinical trials, which do their analyzes and evaluations and come up with their own reply. If the answer is yes, you can rest assured. If not, too bad, and let’s move on to the next one. About the fact that then these data and these evaluations must somehow be extended to community there is no doubt, although at the same time it cannot be thought that the citizens of half the world will transform themselves from coaches on Sunday into forecasters of the epidemic peak on Wednesday and into vaccine advisers on Friday.
But who are these authorities?
To put it in a sentence, the relevant authorities for us are theItalian drug agency (Aifa) and theEuropean Medicines Agency (Ema), respectively with jurisdiction in the Italian territory and in that of the European Union. To be more precise, in the case of biotech vaccines the centralized response of the EMA is indispensable, while in other cases the procedure of a national authority may also be sufficient.
Within the Ema, then, there is the Committee for Medicinal Products for Human Use (Chmp) to address the analysis of available scientific data, while the Pharmacovigilance Risk Assessment Committee (To wash) performs the task that its own name makes explicit. To these, which are the standard organisms, is added the Working group for the Covid-19 pandemic Ema (ETF), which by its constitution focuses only on drugs to counter the ongoing pandemic. And at the Italian level, cascading with respect to the European opinion, AIFA must also be authorized to market it.
How safe is a vaccine?
The analysis of clinical safety it is one of the crucial aspects of evaluation by pharmacovigilance agencies. Beyond what is being done in the United States, they are planned for Europe two main criteria: the first is that the vaccine has been tested in “Many thousands” from the peoplewhere in fact the lower limit is imposed by effectiveness evaluations, which require very robust statistics. The other criterion is the I pass the time of the administration. In a document to this prepared for the Covid-19 vaccines, the EMA explained that most of the eventual Adverse reactions to a vaccine occur in general (based on all vaccines studied in history) by first 4-6 weeks injection. For this reason it is required that the clinical details of all patients included in clinical trial for a period of at least 6 weeks. A time, however, much longer than that usually indicated by the Emma itself for vaccines, barely 5-7 days.
However, the same document also specifies that the requirements for each vaccine formulation may vary according to the composition. The more the vaccine is biologically different compared to others already marketed and safe, more will be needed analyze data, just to rule out unknown side effects. Last but not least, the approval protocol provides specific procedures and analysis to give the green light for details. categories of people, including not only pregnant and immunosuppressed women, but mostly (due to the ongoing pandemic) to Old people. Even if it is scientifically impossible to absolutely exclude that a vaccine can generate adverse reactions, especially if they are minor, authorization for the vaccine can only come if “The benefits greatly exceed the risks “.
At least according to the media, it seems that the evaluation ofeffectiveness in itself does not represent a particularly delicate point of the vaccines already announced: for the EMA it is enough that the vaccine formulation has aeffectiveness more than 30% (with a degree of security of this statement of at least 95%), while as we know based on the preliminary results declared by the companies we speak of effectiveness 70%, 90% or even more.
Continuous review and security
Quick and good don’t go together, the saying goes. However, one must understand what is meant by presto. The expedited procedure continuous review (continuous review) that was activated to respond to the health emergency does not alter neither the phases nor the criteria analysis, but it’s getting experts to start evaluating the data as soon as they are availableeven partially so that you don’t have all the work to do when the last documents arrive.
The idea, therefore, is not to loosen the control meshes or to make a hasty assessment, but in fact parallelize operations, examining scientific information I hand arriving. A emergency procedure me wasteful (because it requires a greater amount of human work than usual), considered necessary in a period like the one we are facing. However, it should be reiterated: criteria me Steps they have not been modified with respect to what normally occurs.
Efficacy and safety are tested even after authorization
In case of Vaccine for COVID-19 receives approval and authorization to trade, the so-called Step 4 of experimentation. The one in which they occur with still Greater precision the characteristics of the vaccine. But beware: this does not mean that a massive experiment is being carried out in the conspiracy sense of the term. It simply means that the more the stat is expanded, the more capable it is of refine quantitative assessments on the efficacy and safety of the vaccine.
Talking about safety, specifically, as is obvious all the Adverse effects of varying severity occurring in one in 10, one in 100 or one in 1,000 patients already emerge clearly during step 3, which involves tens of thousands of volunteers. What remains to be determined? For example, if in populations of millions or tens of millions of people they can manifest extremely rare reactions, possibly linked to specific clinical conditions.
And then, in parallel, they remain look special the people who participated in the first three phases of the trial. About them it is important to understand in detail what also happens to them longer timescales, in this case mainly as a matter of effectiveness. If, as already anticipated, we know that adverse reactions generally concentrate immediately after administration of the vaccine and are effectively depleted within a few weeks, it is interesting instead to understand whether the protection offered by the vaccine persists on time, also to set the frequency with which reminders should be given.
Security and trust
It is useless to surround him: the moment a person accepts take a drug it’s because you trust the system to work. Where with system means the scientific investigation public and private, with its achievements, the world ofpharmaceutical industry, which develops new therapeutic proposals, the scientific method, with its ability to discriminate experimental evidence from simple hypotheses, the Scientific community, from which arises the agreement on the meaning of the results obtained, the control agencies, which certify the efficacy and safety of the treatments, and then of all production, distribution and supply chain Drugs
If you trust this system there isn’t, so the whole vaccine race doesn’t make sense that it exists. If instead there is, to date everything suggests that the expected vaccine against Covid-19 – once approved regulatory agencies and once the consent of the scientific community has been obtained, both Of course like everyone else. For now, we know, neither the commercial authorization nor the confirmation from the scientific community has arrived, so the only thing that can be done is suspend consent, and wait for the data to be delivered and then for Ema, Aifa and the scientific community in the broadest sense to speak out.
As already mentioned, to date we have many announcements that bode well and preliminary data that pharmaceutical companies have presented as excellent. There is only one last step, but a fundamental one, before we can say that we have an effective and safe vaccine against the new coronavirus. Fingers crossed.
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