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We asked Professor Maria Rita Gismondo, director of the Laboratory of Clinical Microbiology, Virology and Bioemergency Diagnosis of the Sacco Hospital in Milan, how she values the suspension of the tests.
“I must admit that the company has been very serious in the investigation and unfortunately I have to underline ‘I said so’, although it is very sad when it comes to people’s hopes for health. The vaccine will probably be there (although we are not sure if it will), but it takes time. The fact that such a significant case with regard to side effects occurred in Phase 3 means that we must follow the traditional paths of clinical research. For a vaccine to be not only effective but also safe, it takes 3 to 4 years. We can also have a vaccine in a year and a half, but we will never be sure of the absolute absence of side effects or even its effectiveness.
What happens now?
“At this point we stop, we analyze the effects caused and what the relationship may be between the undesirable effect and the composition of the vaccine, so that either something changes, or the number of volunteers is expanded to be more sure about the side effects, or again, as with drugs, it was decided to close the investigation and concentrate on another formulation.
Does it mean starting from Phase 3?
“If you had 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: you cannot propose a serious vaccine, in the sense of completeness of knowledge regarding efficacy and side effects, before 3-4 years. I do not exclude that in 3-4 years, when we have it and if we have it, we may not need it anymore. I want to emphasize that apart from a vaccine against Ebola (which, moreover, has only been partially tested), there are no vaccines against Rna viruses: we remember HIV and other coronaviruses. I do not say 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 think we should focus a lot on living with this virus, adopting the measures that governments have also indicated.
Will countries that have sped up the times, like Russia and China, come first in the “vaccine race”?
“I can’t say. Many countries overlook this basic concept, but current science is designed in such a way that results are made available to the global scientific community precisely to prevent others from making the same mistakes and to move forward synergistically. Unfortunately, expecting everyone to adopt the same rules in today’s world is a utopia, especially for some nations that are willing to lie and hide data. ”
What do you think of the so-called “deniers” of the virus?
“I am completely against those who have been called ‘deniers’ (which is a rather inappropriate term). To those who say that the virus does not exist I say: “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 scaremongering: I am based on an objective analysis of the data and I am not influenced either by the minimizers or by the various catastrophists.
Will there be the second wave?
“We cannot know. We will certainly never have a wave like the March-April wave: not so much because the virus has changed, but because we have changed. We have a health organization that has improved a lot, we have doubled the number of beds in the ICU, we have learned about the virus and how to manage therapy in the different stages of the disease. This is the most important reason why we are not now having the deaths that we have had.
Do you agree with the idea of shortening the quarantine to seven days as they will in France?
“I agree perfectly: because we have seen that this is the security period, we do not need to be blocked for 14 days, which has various repercussions on social and work life. On the other hand, I would invite scientists and the Scientific Technical Committee (CTS) to a discussion about the usefulness of quarantine for asymptomatic people who have low viral load: the “weak positives” that we have seen for some months. They are people who have very little virus and it has been shown that they are not capable of infecting (we also have data on this): they are people who are very well and from time to time they 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“ collateral effect ”: now we must reopen because children have to bridge the cultural but also psychological gap. That it is then possible, despite the teachers’ efforts, to keep the distances and the masks on correctly, I doubt it. We will try our best and some schools will be closed, but with this we cannot say that the reopening plan has been a failure. Of course, if we continue with these restrictive measures (blocking the entire class for a child with a fever, detaining the family, blocking all contacts) all work areas will become difficult: in this situation, with a content increase in infections I think we could slightly widen the mesh, while still being 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 necessary to comply with the measures “.
Are we prepared for the next few months at the health management level?
«If they ask me if we are prepared to face the flu season in conjunction with a virus that is still circulating, I answer ‘neither’, in fact perhaps I have some perplexities. It does not depend only on the health organization, but also on the response capacity of the citizen because the only help that can come to us to alleviate those who have access to first aid and health services is that the population is widely vaccinated against the flu. We need to get (and we are already late) quick text messages that allow us a quick response and we are behind in providing the number of vaccines available. Information campaigns must also be carried out immediately so that people understand how important it is to get vaccinated against the flu this year.
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