Covid, Crisanti: “The vaccine? I can’t do it without data.” Aifa: “Unfounded claims that harm the country”

On the one hand there is him, the man with the swabs: the microbiologist who carried out the study on Vo ‘Euganeo, the first scientific frontier in the analysis of the coronavirus epidemic, on the other the astonished scientific community. Andrea CrisantI unleashed a storm of controversy with a phrase about the first vaccine that will arrive in January (probably the one from Pfizer, ed), “No data, I don’t, because I want to have the peace of mind that it has been tested and meets all the criteria of safety and efficacy. As a citizen I have the right to do so, I am not willing to accept shortcuts. ”The director of microbiology and virology at the University of Padua said this yesterday at Focus Live, the“ Focus ”scientific popularization festival. chain reaction came the aftershocks that forced the scientist himself to clarify his thoughts. It is worth mentioning that a vaccine cannot be approved by anyone in the absence of data of all phases of the trial, that there are independent scientific committees of the manufacturers that evaluate the safety and that the data of the candidate vaccines are already under review – continuous review – as they are acquired.

“Vaccines work, I am very much in favor of it, but these vaccines were developed skipping the sequence of phases 1, 2 and 3 – continues – Doing phases 1, 2 and 3 in parallelin fact, all the problems of the different phases come together. It is true that this is how you get there first, but then you need a whole review process behind it, which is not very easy to do ”. At this time “we have nothing available, we have to create the weapon (against Covid ed), we have to create a national surveillance system that overcomes regional differences, both by initiative and to equalize differences between regions. This epidemic has revealed and brought to light a series of problems related to state-regional relations for health ”.

Crisanti “about the upcoming vaccines against Covid-19 is” an irresponsible and intolerable statement by a person who should know the rules before declaring certain things, “he says. Guido Rasi, former executive director of the European drug agency EMA, who says he is “stunned”. “If Crisanti has doubts about the vaccine approval process – says Rasi, who has just finished his second term at the head of the EMA – pyou can make a phone call to the Italian Medicines Agency Aifa or the EMA, like all citizens who ask us how and why we approve vaccines and at what time. Crisanti explains to us what are the shortcuts used – urges the former executive director of the EU regulatory body – what impact they have and on what other considerations his irresponsible statement is based. I challenge Chrysanti to provide me with proof of what you are saying. Affirmations from which we call you to assume all social and ethical responsibilities “.

And, in fact, the AIFA also responds to the virologist: “It is wrong to spread unfounded claims on the safety “of anti-Covid vaccines. The” most serious, as false, refers to the phases of clinical studies that may have been skipped: clinical studies on Covid-19 vaccines have carried out all phases of validation and evaluation “writes the CEO of the Italian drug agency Nicola Magrini, who accuses Crisanti of causing” a serious damage to the countryas well as himself. “Magrini also announces that” Aifa will soon establish an international scientific committee to promote active surveillance studies on all the vaccines that will be available, to validate their safety even with regard to rare or very rare side effects. Some of the largest and most credible experts in the field will be summoned to form part of this Committee. “

“Beware of communication” about the Covid vaccine, “I even offered to be part of the trial. So it’s out of the question that I won’t get the vaccine, ”he says. Pierluigi lopalco, epidemiologist and health counselor from Puglia, guest of L’aria che tira su La7. “If in January I was called to get vaccinated with the Pfizer vaccine, I would have no doubts and I would be very happy to get vaccinated. And not because he is unconscious or unconscious, for exactly the opposite reason: hor I studied the vaccine, I know how it is made and how it worksI went through the experimentation and I know the strict rules that will lead (hopefully) to approval. Knowledge frees you from the fear of the unknown, ”he says. Antonella Viola, immunologist and Senior Lecturer in General Pathology at the University of Padua, in a Facebook post. “We remind you that the vaccine, when it arrives, will have concluded a phase III with more than 40,000 people involved and will be approved only if it has not caused significant side effects in these people. So – he warns – do not listen to those who insinuate doubts about vaccines: science accepts no shortcuts and is open to data verification“In the long post, the scientist explains why he can be trusted.

“When the regulatory authorities and publications give the green light to the safety and efficacy of the Covid vaccine, I will get vaccinated,” says Inmi Spallanzani’s health director, Francesco Vaia. “I got vaccinated against influenza and pneumococcus because I have always trusted in the effectiveness of vaccines, I am not obliged to do so, but I think we have to convince people and explain the goodness of vaccines with data. We must be sure that they are safe and effective. ” “The only way, other than blocking, to get rid of sarsCov2 is to create herd immunity. For this reason – said the president of the Superior Council of Health Franco Locatelli at a press conference at the Ministry of Health – vaccination is essential, since moral duty towards oneself and towards others. If today there were the first vaccine in Italy, Franco locatelli would do it without the slightest hesitation. All the more this moral sense should permeate professional staff on the front line ”.

Today in an interview with Corriere Crisanti, he seems to correct himself and defends himself: “I just said that to do this I would like to see the data first. That is to say, I would like to be convinced of this and to be so I have to read a publication that is certified by the scientific community, the only guarantee of validity, which does not exist at this time. Validity cannot be decided by a company or a policy. And then they complain that people are cautious. I’m not a no-vax, but I think such unorthodox behavior in the distribution of an important product can encourage the rapprochement of those who are against vaccines. Look, let’s do this, when a scientific publication comes out I’m going to get vaccinated and they even take a picture of me ”. To the Adnkronos he then says: “I am amazed. No one was outraged that nothing was done and we arrived unprepared for the second wave of Covid-19. So I say the obvious about the vaccine and become a no-vax. In fact, I speak from the position of an absolute and staunch supporter of vaccines. It is legitimate to want to see the efficacy and safety data. This is a demonization that helps non-vaxes. It was enough to read the question, which was dry: would the vaccine do it today? And I said no, for the simple reason that I don’t know the data yet. My words have been manipulated or misunderstood. You will understand if you read the interview with ‘Focus’ ”.