ALBERTO MATANO

While we’re waiting for the Civil Protection Department to come on, I’d like to show you this important report produced by our very own Guido Schwarz.

There is a lot of talk at the moment about a possible vaccine and an Italian company, working in collaboration with the University of Oxford, is making a good progress.

But just so we understand where we really are, how much longer is needed, let’s take a look at this interview with Guido Schwarz Gigi Rezza.

VOICEOVER

Public and private laboratories the world over have mobilized and are trying to skip to the finish line.

Italy too is taking a leading role in this race, in fact the Pomezia-based company Advent IRBM ha announced that it will begin testing a new vaccine at the end of April.

GUIDO SCHWARZ

What are human trials for?

PIERO DI LORENZO

To assess how effective the candidate vaccine is.

GUIDO SCHWARZ

If the tests are positive, how long will it take to have a commercially available vaccine? Are there accelerated procedures in these cases?

PIERO DI LORENZO

At the end of April we’ll send the first batch of vaccines to Oxford so that they can begin the trial on 550 healthy volunteers.

In the meantime, the Jenner Institute in Oxford is recruiting these 550 volunteers.

I think vaccinations will begin by the end of May and so by early June they will all have been vaccinated. I think we’ll be able to get the results from this trial by the end of September, but for it to then reach pharmacies, because this is the question everyone is asking, will take many more months, and don’t forget we are talking about 8 billion people, so it will take years to vaccinate everyone.[/vc_column_text][/vc_column][/vc_row]

TG1 PRESENTER

We now have Piero Di Lorenzo on the line. He is the Managing Director of the company of Pomezia that developed the Coronavirus vaccine together with Oxford University. Good morning Mr. Di Lorenzo, what stage are we at with the trial?

PIERO DI LORENZO

Good morning. The pre-clinical phase has been completed, the results are quite good, in facts I’d say they are really good, so we have decided to proceed immediately with the human trial. To be specific, at the end of April, we will be sending off the first batch of vaccine that we have produced in the IRBM laboratories in Pomezia. In the meantime, the Jenner Institute in Oxford is selecting healthy volunteers to vaccinate, 550 in all. We think this vaccination process will begin by the end of May, early June, and we expect that as early as the end of September, there may be some convincing results. Assuming this all goes ahead as planned, we think the vaccine will be available by the end of the year. Bear in mind, just to be clear, that when we talk about the vaccine being available, we are not saying we are ready with a billion doses. We will start preparing the batches and get ready for mass vaccinations.

TG1 PRESENTER

OK, so the vaccine will be available by the end of the year and will then be distributed to the market. Thank you.

PIERO DI LORENZO

It will take time.

TG1 PRESENTER

OK, well thank you Mr. Di Lorenzo and keep up the good work.

ANDREA PANCANI

Right Claudia, I just need to ask you to be patient for a moment because next up I have Paolo Sottocorona and the commercial break, and then I want to talk to the man of the moment, as I see him, Piero Di Lorenzo from IRBM. The question everyone is asking Mr. Di Lorenzo, publicly and privately is: “Mr. Di Lorenzo, is there a vaccine against coronavirus, yes or no?”

DI LORENZO

The answer is fairly straightforward: there is a vaccine, the candidate vaccine, and the response from the pre-clinical phase of laboratory testing is definitely positive. So positive in fact, that the British regulatory authority is minded to, and has been moving forwards, drastically reducing the timescales for testing. Consequently, by the end of the month, we will be sending the first batch of vaccine to Oxford and in the meantime they are already recruiting 550 healthy volunteers. This means we will be virtually ready for clinical phase 3, the final clinical phase. As for the timescales: we are hopeful that vaccinations can start by end of May, early June, and that we will have a response from the vaccination of these healthy volunteers as early as the end of September. Then I will tell you afterwards what you want to know … So you can go ahead with the commercial break.

ANDREA PANCANI

Yes, then we’ll go into more detail, obviously.

In the meantime, let’s hope Professor Antinori arrives. Meanwhile, let’s go to Paolo.

Soon we will go back to Piero Di Lorenzo and the vaccine for coronavirus, let’s see if we now have Professor Antinori on the line. Let’s see if we have a good connection. Good morning and welcome back Professor.

PROFESSOR ANTINORI

Good morning to you.

ANDREA PANCANI

Excuse me, let me quickly ask you one thing. You lost the thread but you are well informed on this matter. We were speaking before with Piero Di Lorenzo, the CEO of IRBM in Pomezia; as you know they are developing a vaccine for coronavirus, you were telling us something earlier. Should we take this as good news or not Professor Antinori?

PROFESSOR ANTINORI

It certainly is good news, I mean, everything that is being done and all the work that is being developed by the scientists to ensure that a vaccine is produced that will, let’s be honest, be the only real definitive solution to this issue, I’d say that it’s excellent news in any case.

ANDREA PANCANI

I want to ask you another thing, because there is an endless debate going on here which I understand is also very complex. With regard to lifting the lockdown, the scientists and the experts disagree to some extend about this too. We have understood, for example, that wearing a mask is essential, we have understood that social distancing is essential, but perhaps we have understood something else and so my question is this: can we only really lift the lockdown when the intensive care wards and hospital system overall are less congested? That way, if there were new and sudden outbreaks, we’d be ready to react?

PROFESSOR ANTINORI

I would definitely say so. This is something very important. I wouldn’t underestimate also the fall in the number of new infections, because in order to get to the point of lifting the lockdown, we need greater certainty about what is going on with the epidemic, i.e. how many new transmissions, how many new cases there are. To be honest, at the moment, I see a lot more work needing to be done in this respect.

ANDREA PANCANI

But shouldn’t the regions take some responsibility for this? I’m asking whether there is an open debate about this too. For example, Professor Rezza, from the National Health Institute has said: “The Regions must provide us with much more information, otherwise we can’t get a complete and comparable picture.”

PROFESSOR ANTINORI

I don’t want to get into these issues which are typical of the relationship between the State and the Regions. I think that the comment that could be made by someone with a technical background, like myself, is that there should be maximum cooperation between the various organizations. The health care system today has been decentralized to regional level for many years, the State retains certain prerogatives. This epidemic has taught us that centralization is still a very important aspect, as is coordination between the various powers within the whole government of the country. I think the principle of collaboration is fundamental.

ANDREA PANCANI

But let me ask you something, because it is something of a more political nature but it directly involves experts as you are. Yesterday, in a long interview, Minister Boccia said: The scientific community must provide irrefutable certainties and not 3 or 4 options for each subject”. He was saying, for example, that someone who has had the virus can get it again. Do we know whether the antibody tests are useful or not? Otherwise, according to the Minister, we don’t have the knowledge. What do you say to that?

PROFESSOR ANTINORI

I think that is a strong statement which I personally do not agree with. I would like to remind everyone that this illness first appeared a little under two months ago, therefore I believe that in the history of medicine, there has never been another phenomenon that has produced so much research. There are already thousands of studies published on international databases and indexed listings of scientific journals, there has been an impressive mobilization of the whole international scientific community, within the space of a few weeks we have come up with highly developed diagnostic tools. A RT-PCR test is no ordinary test, it is an extremely important test which, in the case of other diseases, has been developed over a period of years. We have antibody tests, we have tested drugs, there are 25 drugs being studied, there are randomized studies taking place. Every day, the CTS at Aifa examines a dozen or so protocols. I don’t’ think we’ve ever seen anything on this scale. Look, I had front line experience of the AIDS epidemic, over thirty years ago, I was a young doctor just starting out, I remember very clearly what happened then. I think that what we have seen with this illness, in terms of the scientific initiative is extraordinary, but we shouldn’t think that science can come up with definitive answers within the space of a few weeks.

ANDREA PANCANI

You have been very clear, I want to go back for a moment to Piero Di Lorenzo, after which we’ll also take up the finer political points of the discussion with both the Undersecretary Mrs. Guerra and Daniela Santanchè. Mr. Di Lorenzo, you were saying that we are ready to send a first batch of the vaccine to Oxford, so to the UK. But what does it mean? What about Italy?

DI LORENZO

This partnership came about in order to take advantage of 2 very important areas of expertise. The Jenner Institute is, I’d say, the repository of very important knowledge about the family of coronaviruses, because it has already studied SARS, it has developed the anti-MERS vaccine and within a fortnight of the sequencing of the virus, they synthesized the gene of the Spike protein. Our expertise on the other hand, relates to the vehicle, the shuttle, which is the adenovirus that is used to insert the synthesized gene of the protein into the human body. It is therefore a very important collaboration. You need to bear 2 things in mind: the first is that all the operational and research funding comes from the CEPI, which is a supranational organization funded by the British, Dutch and Norwegian governments. So, as I was also saying to one of your colleagues yesterday evening, the ones who pay get to make the decisions. Then there is another thing: the Jenner Institute, which is in constant contact with the British regulatory authority, has managed to get these tests under way very quickly, which is something we are now preparing to do in Italy. So the whole thing first started in England. A am not ruling out anything; I have discussed this matter with Minister Manfredi and Minister Speranza, they are both very proactive on the subject. I should add that this is now being reviewed by the President so, as a country we are not holding back, in other words we are ready to take all possible initiatives. Bear in mind, I’d like to underline this point; earlier I told you that the first batch will be leaving for Oxford at the end of April, the phase 3 tests on 550 healthy volunteers will get under way  in June … we expect that by September there will be already be some significant and conclusive scientific  evidence on the table. Let me be very clear though: this does not mean that by Christmas we will all be vaccinated. The thing is that once the tests are approved, hopefully, in the autumn, the vaccine will, I hope, be approved, and then there are the technical timescales to deal with. So, whilst the official approval is being processed, etc., the doses of vaccine that have been produced in the meantime will be available to be used on a compassionate basis. But then we need to move onto an industrial scale and there are technical timescales that cannot be shortened.

ANDREA PANCANI

How long? What are we looking at, how long, technically, does it take to produce in on a worldwide scale? How long will it take?

1. DI LORENZO

In order to produce it on an industrial scale we are looking at the new year, we’re talking spring next year; but don’t forget that there are 8 billion people to cater for, no industry can say “we can make 8 billion doses of vaccine in a year”.

ANDREA PANCANI

You have been very clear.

CLAUDIA FUSANI

I just want to make 2 short points. First of all, with regard to what Professor Antinori was saying, politicians must show courage now, because science can never give answers that are entirely precise or unequivocal. It’s become a bit of a game, if I can use the term, and that isn’t OK. At some point, politicians need to take a decision and show courage that’s the first point. Secondly, with regard to the EMS, I am referring to the last discussion on vaccines. If released, this EMS would immediately give us 36 or 37 billion to invest directly or indirectly in healthcare. To rebuild in Italy the chemical and pharmaceutical supply chain for vaccines, serums … that we are lacking, because we dismantled it. That money should be used now because the Corona bond and the Recovery bond will be discussed months down the line. We need money right now, to rebuild the laboratories, we aren’t able to make swabs because we don’t have the reagents, that’s because they are produced elsewhere. We have to bring that supply chain back to Italy.

ANDREA PANCANI

I want to end by talking to Mrs. Santanchè and Undersecretary Mrs. Guerra. Undersecretary, I gather that Mr. Laforgia, who is a major figure in your party, has said that healthcare in Lombardy should be put under external administration. Do you really believe that? Is that what you are asking for?

UNDERSECRETARY GUERRA

Well, Mr. Laforgia is from Lombardy so his assessment will have been made on the basis of information that I do not have. I don’t think there is a need to put it under external administration. We certainly have a problem generally with strengthening the network, the public health department in central government, so that the conditions for essential levels of care are guaranteed across the entire country. I think the Lombardy health model has its limitations, especially as regards its relationship with the private sector, which has perhaps been given too much room, but I am not personally in a position to back up this claim.

ANDREA PANCANI

I’d like to hear from Daniela Santanchè on this.

DANIELA SANTANCHÈ

Thank you, and thank you Undersecretary, because now I shall immediately issue a press release saying that companies with more than 5 employees don’t need to notify the union to request funds from the business interruption scheme.

UNDERSECRETARY GUERRA

If they’ve been closed by the Prime Ministerial Decree. I want to be clear about this,

DANIELA SANTANCHÈ

No, look

UNDERSECRETARY GUERRA

If they’ve been closed by the Prime Ministerial Decree.

DANIELA SANTANCHÈ

I believe what you are now saying, I’ll issue a press release right away because until now we hadn’t understood a thing and I’d remind you that I continue to make the claim, but thank you for refuting the fact, that companies with more than 15 employees don’t have to send an electronic communication to the union and that there is no need to await a reply because it is done by default. This is a huge simplification. Today I’ll say that you have made this very important clarification on air for which I thank you. As regards putting health care under external administration and the banks we’ll see you again.

ANDREA PANCANI

Of course we’ll talk about it again, in the coming days! In facts, we will invite you as of now to come back again.

DANIELA SANTANCHÈ

Fine, see you next week. Hurray, hurray, the money is finally on its way, as I recall we’ve been talking about it since March 6^th no less and it’s now April 15^th.

UNDERSECRETARY GUERRA

These things aren’t easy, nobody is saying it is easy to do, there’s no point in using fake irony.

DANIELA SANTANCHÈ

Undersecretary, you have clarified certain things that I …

ANDREA PANCANI

I have to end there, you must excuse me but I have to wrap things up. There is no doubt that this situation is extremely difficult and that things are complicated and everyone has their own opinion on how the government is responding. But we’ll back again with Undersecretary Guerra, with Daniela Santanchè. Thanks as always to Professor Antinori and our best wishes and thanks to everyone for the great work being done

PROFESSOR ANTINORI

Thanks and best wishes to you too

ANDREA PANCANI

At the Spallanzani Institute. I’ll say goodbye to Piero Di Lorenzo, thank you and don’t forget to give us the latest good news on the vaccine. Meanwhile it’s over to Myrta. Hi Myrta.

BRUNO VESPA

We have with us the CEO of Advent IRBM. There has been a lot a noise about this company that is based near Rome, in Pomezia, because together with a prestigious institute in Oxford, it has developed a vaccine. It is a vaccine that will be tried out on humans in the UK from the end of April. Good evening Mr. Di Lorenzo. How did this idea come about? Was it first developed in Pomezia or in Oxford?

DI LORENZO

Good evening.

BRUNO VESPA

You have 200 researchers, how do they coordinate with their colleagues in England?

DI LORENZO

We’ve been working with Oxford for 10 years: the collaboration between us is well-established and in this ground-breaking area they have synthesized the gene of the Spike protein. Once the Chinese had published the sequencing of the virus, on January 10^th, within a few days Oxford sent us the synthesized gene of the Spike protein so that we could characterize the adenovirus, i.e. the vehicle within which the disabled gene of the protein has to be placed. It is this protein, the small red corona of the virus, that causes contagion, enabling it to enter the body and create the conditions for the body to react by creating antibodies. Obviously, the original idea for the study came from Oxford, then we were called on to collaborate on this project, as we have done with many other projects. Our contribution is, as I always put it, as if we had been called upon by Ferrari to supply tires for the Grand Prix: so we are grateful for this recognition from what, for us, is the biggest institute in the world for the study of vaccines.

BRUNO VESPA

So you are providing the tires, and you will be sending them to Ferrari within a couple of weeks. Will human trials begin right away?

DI LORENZO

Yes, by the end of April we’ll be sending the first batch we’ve produced in our laboratories in Pomezia. They, in the meantime, are selecting 550 healthy volunteers to take part in the tests … I think that by May they will have selected the 500 volunteers and will vaccinate them right away. We anticipate being able to understand the actual effectiveness of the vaccine by the autumn.

BRUNO VESPA

So will we also have some doses to start with, if all goes to plan, to vaccinate health care and law enforcement workers, basically those who are a bit more exposed?

DI LORENZO

So the vaccine is being tested in England because, as I was saying, it was there that Sarah Gilbert, the internationally-recognized, highly-esteemed giant in the world of vaccines, first set up this research. Those tests will be carried out in England, once the scientific tests have provided a response, according to the official standards of approval of the British regulatory authority. During this time the batches that have been produced by then will be made available to qualifying hospitals, in other words they will be freely distributed during that period as another test.

BRUNO VESPA

Sorry, but does that include Italy too?

DI LORENZO

This whole project was set up with financing from the CEPI, which is a supranational body financed by the British and Norwegian governments, so, as we know, the ones who pay are entitled to take precedence. But I haven’t lost hope of Italy being involved. I have spoken about it to the relevant Ministers, with Minister Manfredi and Minister Speranza, they are also very committed to doing whatever it takes to involve Italy in this distribution.

BRUNO VESPA

Well thank you Mr. Di Lorenzo, well done and good luck. Let’s hope we can get some too. In the meantime, let’s hope it actually works and we can benefit from it.