We asked Professor Maria Rita Gismondo, Director of the Laboratory of Clinical Microbiology, Virology and Bioemergency Diagnostics at the Sacco hospital in Milan, how she assesses the suspension of the tests.
«I must admit that the company has shown a lot of seriousness in the investigation and unfortunately I have to underline ‘I said so’, even if it is very sad when it comes to people’s health hopes. The vaccine will probably be there (although we’re not sure if it will), but it needs its time. The fact that such an important case with regard to side effects occurred in Phase 3 means that we need to follow the traditional paths of clinical research. For a vaccine to be not only effective but also safe, 3-4 years must pass. We can also have a vaccine in a year a year and a half, but we will never be sure of the absolute absence of side effects or even of its effectiveness ».
What happens now?
“At this point we stop, we analyze the effects caused and what can be the relationship between the undesirable effect and the composition of the vaccine, so either something changes, or the number of volunteers is expanded in order to be safer on side effects, or again, as happens with drugs, it was decided to close the research and concentrate on another formulation ».
Does it mean starting from Phase 3?
“If you were to choose to change the formulation, you start from scratch because it is a new vaccine, if instead you decide to investigate this side effect, maybe you will try to change something in the formula and proceed with an advanced Phase 2-3”.
How many months have they lost?
«I said it months ago: a serious vaccine, in the sense of completeness of knowledge regarding efficacy and side effects, cannot be proposed before 3-4 years. I do not exclude that in 3-4 years, when we will have it and if we will have it, we may no longer need it. I want to emphasize that apart from a vaccine against Ebola (which, moreover, has been only partially tested), there are no vaccines against Rna viruses: we remember HIV and other coronaviruses. I am not saying this to demoralize, but not to deceive people and not to delegate the solution of our problems only to the vaccine because it may not arrive. I believe that we should focus a lot on coexistence with this virus, adopting the measures that the governments have also indicated ».
Will the countries that have accelerated the times, such as Russia and China, arrive first in the “vaccine race”?
“I can not say it. Many countries bypass this basic concept, but current science is designed in such a way that the results are made available to the world scientific community precisely to prevent others from making the same mistakes and to move forward synergistically. Unfortunately, hoping that everyone will adopt the same rules in today’s world is a utopia, especially for some nations that are ready to lie and hide data ”.
What do you think of the so-called “deniers” of the virus?
“I am completely averse to those who have been called ‘deniers’ (which is a rather inappropriate term). To those who say that the virus does not exist I said: “Come to the laboratory and I will show you the virus in cell cultures, so you will have tangible proof”. The virus exists, the virus has killed, the virus continues to circulate and infect. Another thing is my position against alarmism: I rely on an objective analysis of the data and I do not allow myself to be influenced by either the minimizers or the various catastrophists ».
Will there be the second wave?
“We can’t know. We will certainly never have a wave like in March-April: not so much because the virus has changed, but because we have changed. We have a health organization that has been greatly improved, we have doubled the number of beds in the ICU, we have learned about the virus and to manage therapy in the various stages of the disease. This is the most important reason why now we are not having the deaths we have had ».
Do you agree with the idea of shortening the quarantine to seven days as they will do in France?
«I agree perfectly: because we have seen that this is the safety period, we do not need to be blocked for 14 days, which has various repercussions on social and working life. On the other hand, I would invite scientists and the Technical Scientific Committee (CTS) to a discussion on the usefulness of quarantine for asymptomatic people who have a low viral load: the “weakly positives” we have seen for some months. They are people who have a very low amount of virus and it has been shown that they are not able to infect (we also have data on this): they are people who are very well and occasionally discover that they have a slight positivity “.
Will schools and closed environments encourage contagion?
«Schools must be reopened because the closure was an unwanted but necessary“ side effect ”: now they must reopen because the children have to bridge the cultural gap but also the psychological one. That it is then possible, despite the teachers’ efforts, to keep distances and masks worn correctly, I doubt. We will try to do the best possible and some schools will be closed, but with this we cannot say that the reopening plan will have been a failure. Of course, if we continue with these restrictive measures (block the whole class for a child with a fever, stop the family, stop all contacts) all work areas will become difficult: in this situation, with a contained increase in infections, I think we could slightly widen the mesh, while remaining careful. Of course, in October-November the situation could worsen since we know that closed environments and crowded means of transport do not play against the virus and therefore a greater recommendation will be needed to comply with the measures “.
Are we ready for the next few months at the health management level?
«If you ask me if we are ready to face the flu season in conjunction with a virus that is still circulating, I answer” ni “, indeed perhaps I have some perplexities. It does not depend only on the health organization, but also on the responsiveness of the citizen because the only help that can come to us to lighten those who are access to the first aid and health services is that the population is vaccinated widely against the flu. We need to procure (and we are already late) quick texts that can allow us a quick response and we are late in providing the number of vaccines available. We must also immediately carry out information campaigns to make people understand how important this year is to get vaccinated against the flu ».
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