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AstraZeneca Pharmaceutical Group announced a global suspension of clinical trials for its experimental Covid-19 vaccine, given the appearance of complications in a program participant. The group, associated withOxford University, knew the protocol stumbled in front of a adverse reaction serious and inexplicable and that, therefore, the suspension was decided autonomously to allow appropriate controls by an independent commission.
Sergio Abrignani, immunologist, professor of General Pathology at Milan State University, explains what can now happen on the path of the candidate vaccine that Italy had chosen.
Stop does not mean the vaccine is dead because it is normal, when the number of participants in a trial increases in the efficacy and safety phase (in this case Phase 3, ed), that adverse reactions not necessarily due to the vaccine may occur. What happened proves that efficacy and safety studies are needed. These shutdowns typically last 6 to 8 months, but if the problem is easily identified, even less.
Now the drug regulatory agency (EMA or FDA) will have to appoint a committee of independent experts that will have to review all the data and assess whether this unexplained adverse event is due to the vaccine or to chance.What are the possibilities?
In half the cases it starts again, because the experts conclude that it is not due to the vaccine, in the other half of the cases the doubt remains and therefore the study is stopped, due to a safety problem.
Even if it only involves one person, vaccine testing has very strict rules: is a single case of serious adverse reaction enough to block the entire process?
I regret this stoppage because it means that it is delayed, but it does not surprise me because those who have worked in the world of vaccines know that these things happen very often. I am “happy” because the demonstration that what was claimed, and that an unsafe vaccine would be administered to speed up times, is not true and this is the demonstration. The control mechanism works.
it was AstraZeneca itself that reported the problem of a serious adverse event and blocked the experimentation. Is this the correct procedure?
This is standard procedure because if a pharmaceutical company does not report such a thing and the regulatory agency finds out later, the license is withdrawn. Everyone knows they have to do their best and have a mechanism that works.
For approval of the reference regulatory agency, Phase 3 (the study in tens of thousands of healthy people demonstrating efficacy and safety, ed.) Must be completed in full or for serious risks to the community can be shortened times?
There is only one exception, which is emergency risk. Phase 3 is normally completed but if there were a new pandemic phase such as the one in March in Bergamo, it would be justified to administer the vaccine in the presence of partial data but that indicate that, at least until then, the drug is safe and works. . It cannot be excluded that the adverse event may occur at a later time, but it is a risk that can be taken if there is a real benefit. In a situation like the one now, it is not justified to administer the drug in Phase 3, unless you want to offer it to health professionals, as proposed by the minister, and they can accept, voluntarily, because they have a factor of significant risk, even if it is not an emergency situation.
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