Agorà

SERENA BORTONE

Wait, we have a call on the line and then we’ll continue, because we finally have some good news: it seems that there are 5 vaccines around the world, but one of them has been developed in Italy in collaboration with the Jenner Institute at Oxford University. On the line I have Piero Di Lorenzo, President of the Company, that is working on this vaccine. He tells us that accelerated tests on 550 healthy volunteers will begin in England at the end of April. The vaccine could be ready by September. Mr Di Lorenzo, please tells us more.

PIERO DI LORENZO

Good morning, well the news is quite positive; positive in the sense that the laboratory tests carried out have been convincing enough for us to speed things up significantly. Sarah Gilbert, who is the director of the Jenner Institute and leads the project, has taken the appropriate decisions in England and so things have sped up. At the end of this month we will be sending the first batch of vaccines produced here at IRBM in Pomezia, to England, after which testing on healthy volunteers will begin quite quickly

SERENA BORTONE

So, let me see if I understand, Mr Di Lorenzo, sorry, who are the people coming forward to test the vaccine? You said they are healthy volunteers, what does that means?

PIERO DI LORENZO

So, a call is put out. Many ordinary individuals respond and then, using a statistical method, those who, statistically speaking, can provide the best response on the effectiveness of the vaccine, are selected. Bear in mind that…

SERENA BORTONE

Sorry, perhaps it’s a silly question, but just so I understand. It’s a question everyone at home is asking: Can I, Serena Bortone, be tested, in other words what do you do? Do you make the vaccine for me and then inject me with Covid?

PIERO DI LORENZO

No, the people chosen are those who come into contact with potential infection, and so statistically they allow us to draw conclusions.

SERENA BORTONE

So doctors?

PIERO DI LORENZO

No, not only doctors. They could be doctors, the supermarket cashier, people who have been selected using an actual statistical system.

SERENA BORTONE

Ok

PIERO DI LORENZO

The aim is to speed it up a lot, as I have said previously, the protocols require 3 clinical phases. The first phase with 10 or 15 healthy volunteers, a second phase with around 150 and a third phase with 500, 600 or 700. The vaccine we are talking about, and which has been developed, draws on 2 particularly proven strands of expertise. The first is that of the Jenner Institute, which has been studying the family of Coronaviruses for the past 17 years and has already developed the MERS vaccine.

SERENA BORTONE

The line is very bad, stop right here because I can hardly hear you, there is a lot of buzzing,

PIERO DI LORENZO

I’ve stopped, promise.

SERENA BORTONE

Honestly, here it sounds like, I don’t know, a swarm of wasp under the microphone. Alright so you were saying, you and England together. Why is the testing being done in England and not in Italy?

PIERO DI LORENZO

The trial is being done in England because their regulatory authority is considering merging the 3 vaccine stages; the 3 phases of clinical trials. This is why we are already starting tests on 550 healthy volunteers, this will mean we significantly reduce timescales, in fact we expect we hope and are confident that by the end of September, we will already have concrete reliable results.

SERENA BORTONE

So September, just to be clear on the dates because I didn’t hear you. In September you will have the first results and, in theory having had the first results will you then bring it to markets? How does it work?

PIERO DI LORENZO

No, absolutely not, in Spetember we will have the results of this overall test that has been done. Now I can also hear the buzzing

SERENA BORTONE

Go on, go on. Life is complicated.

PIERO DI LORENZO

I was saying that in September we will have these results, after which we will be ready with good batch of vaccine, so at that point the regulatory authorities could authorize us to use those doses on a compassionate bases, i.e. not in a commercial way, but entrusting the distribution of it to state organizations, approved hospitals, etc. In the meantime, we proceed with the legal approval that is expected to be given. When, perhaps this is something I should clarify, when this approval arrives, we will then start discussing where the vaccine doses will go, because there are 8 billion of us and it will take years to vaccinate 8 billion people. So I envisage that dividing up these batches of vaccines will be carried out at government level.

SERENA BORTONE

Ok right, so a certain amount will go to Italy. Hoping that this is, obviously, the winning vaccine, does the fact that we are the ones producing it help us at all? I am asking Ms Lorenzin who was the Minister for Health. What timescales do you envisage?

BEATRICE LORENZIN

It would be more helpful to us if the trial could take place in our cities, this would help us a lot more.

SERENA BORTONE

So let’s do it then. Why are we not doing it?

BEATRICE LORENZIN

So this is an issue for the regulatory authorities, but I think it would certainly be important, we also have the capability to do it.

SERENA BORTONE

So let’s say that to AIFA, is it AIFA who should be offering to have it tasted in Italy?

PIERO DI LORENZO

Both AIFA and the hospitals are already available to do this. I spoke it to the Minister for Research who totally agrees and the decision has now been referred to the Prime Minister

SERENA BORTONE

Perfect, so Conte could announce that the trial will be carried out here. We’ve made some news. Do you have any questions Dr Cattaneo, Ms Lorenzin, Professor Richeldi? If not, then I’ll say goodbye to our guest. Are you optimistic about this vaccine Professor Richeldi? Do you know of any others?

PROFESSOR RICHELDI

Yes, there are others; certainly this vaccine is very promising because as my colleague has already said, it utilizes a technology that is quite well known and above all, the expertise of the Jenner Institute in Oxford which is one of the most famous, most prestigious institute in the world so I have full confidence in them.

SERENA BORTONE

Ok, thank you Mr Di Lorenzo, there’s no point in wishing you good luck because obviously the whole of Italy is with me on the score

PIERO DI LORENZO

Thank you

Canale 5 TG5 – 14 Aprile 2020

TG 5 PRESENTER

Meanwhile, progress on treatment is (also) being made: the end of April sees the starts of human trials of a new vaccine which has been developed by a company in Pomezia together with Oxford University

REPORTER

The search for a vaccine against Covid-19 moves forward apce; one of the fastest in the trial process is the Jenner Institute at Oxford University in the UK, which will begin accelerated trials on humans in England at the end of April and is already looking for 550 healthy volunteers.

The vaccine is being produced in collaboration with a company in Pomezia: Advent IRBM, which will initially produce 1.000 doses for the first clinical trials.

PIERO DI LORENZO

The Jenner Institute has been working on Coronaviruses and has been researching them, with significant financial investment, for 17 years. We developed our expertise with the anti-Ebola vaccine 7 years ago and so we are more than up to the task.

REPORTER

If human trials are successful, the vaccination of British police and national health workers could begin as early as September.

PROFESSOR REZZA

This vaccine uses a platform which has already been used for the Ebola vaccine, the advantage here would be in being able to speed up the timescales.

REPORTER

There are dozens of public and private laboratories working on a vaccine. Professor Rezza stresses that, in times of emergency, regulatory agencies are more generous and speed up the timescales weighing up the risks and advantages of faster testing always on the understanding that going into entire world population, with billions of doses, will take many more months.

PIERO DI LORENZO

When an emergency arises, everyone immediately asks: “When will the vaccine be ready?” “ When wil the treatment be ready?” We need to remember that these studies should be funded when there is no emergency. Once the emergency is here, time has already run out.

TG5 PRESENTER

A collaboration between an Italian company from Pomezia and an institute of Oxford University promises to give great results on the vaccine front. In facts human trials are due to begin soon, so what’s new? The new development is that it’s based on a system previously tested for the Ebola vaccine. This allows times to be significantly shortened at all stages of the trial.

REPORTER

The search for a vaccine against Covid-19 is moving forward apace; one of the fastest in the trial process is the Jenner Institute at Oxford University in the UK, which will begin accelerated trials on humans in England at the end of April and is already looking for 550 healthy volunteers. The vaccine is being produced in collaboration with the Pomezia-based company Advent I.R.B.M., which will initially produce 1000 doses for the first clinical trials.

PIERO DI LORENZO

The Jenner Institute has been working on Coronaviruses and researching them, with significant financial investment, for 17 years. We developed our expertise with the Ebola vaccine 7 years ago, so we are more than up to the task.

REPORTER

If human trials are successful, the vaccination of the British police and national health workers could begin as early as September.

PROF. GIANNI REZZA

The vaccine uses a platform which has already been used for the Ebola vaccine, the advantage here would be in being able to speed up the timescales.

REPORTER

There are dozens of public and private laboratories working on a vaccine. In emergencies, Professor Rezza points out, regulatory agencies are more generous and speed up the timescales, weighing up the risks and benefits of faster testing. You must bear in mind, however, that undertaking mass production and making it available to the entire world population, with billions of doses, will take many more months.

PIERO DI LORENZO

When an emergency arises, everyone immediately asks: when will the vaccine be ready? When will the treatment be ready? We need to remember that these studies should be funded when there is no emergency. Once the emergency is here, time has already run out.

TGCOM 24 12th April 2020

Because we were hoping that, once reached the peak, having got the famous plateau, the downward trajectory would be quite steady and fast. Instead we are whilst the numbers are falling each day, they are not all that comforting. Piero Di Lorenzo, we’re back with you again, welcome and Happy Easter

PIERO DI LORENZO

Happy Easter to you too and to your viewers

LUCA RIGONI

Thank you. I wanted to ask you having spoken earlier with Professor Massimo Galli on the subject of vaccines, he didn’t seem particularly optimistic, he was saying “ Hopefully they will find one, but it has to be done for the whole world and there will be those who want to get hold of it first. It won’t be available to the whole world of mankind the very next day. Right but I would like to ask you: what point are you at in the studies you are doing with the British in Oxford?

PIERO DI LORENZO

Well, I agree with Professor Galli 100%, what he said is sacrosanct; that is, we are in a race against time to get to an approved vaccine but no one should be under any illusion that this…will be, so to speak “implementable” for the entire population. Time is needed and in this respect, on Easter day, I want to give a message of hope. We are very optimistic about our vaccine. Even as regards the timescales involved. But then…once the vaccine is confirmed as being non-toxic and effective, then time is needed for large scale production and distribution. Professor Galli was right, because we are feeling the pressure form governments that are hurrying to get hold of the first hundred thousand or so doses. And it is recognized that vaccinating all healthcare workers and law enforcement agencies makes a difference. Therefore…Therefore

LUCA RIGONI

There is a strategic difference, too…I am thinking here of a major power such as the United States, rather than China or Russia.  They are differences in terms of global control.

PIERO DI LORENZO

I would also say one specific thing: you should realize that, for a government to tell its citizens that it has managed to get hold of the first doses that’s not a small thing, you know. So let’s just say, as I said before, that we are already feeling the pressure as we get closer to our goal.

LUCA RIGONI

Let me ask you this: you said that timescales are not too long. I was quoting this Israeli scientist earlier…La Stampa wrote about it yesterday. He was interviewed yesterday by La Stampa. Using a vaccine that is not injected… In fact, a simpler system is used to take it.  Are you in competition? Are you two working together? Are they different pathways?

PIERO DI LORENZO

Look, let me tell you something we’re finding out every day that someone is competing to reach the goal in this competition. All those who actually succeed in making the vaccine aside from planting their flag on the Moon to say they got there first…all of those who make it, whether a month before or a month after the others, will end up in the pharmacies and will have…and they’ll have plenty of financial reward, no problem at all.  May I just say that, among all those who are doing press releases, there may be the odd show-off.

LUCA RIGONI

I understand…

PIERO DI LORENZO

But right now there are 4-5 definite players, in the Netherlands and Germany. In the United States. And then there’s ourselves with the Jenner Institute at Oxford University. I think that within a few months, maybe within a few days, we will be able to say what month it will be. There will be a vaccine within the space of a few months.

LUCA RIGONI

Excuse me may I say something? Because people are wondering: What does “a few months” mean? October or February? Because there’s quite a big difference.

PIERO DI LORENZO

Look there is quite a big difference from a media point of view, from the population’s point of view…the difference is minimal…because even if the vaccine is ready by October, and that is not an impossibility, before all those steps that Professor Galli has listed can be taken, in terms of production and distribution, many more months will go by. However, as far as we are concerned, we think that, by the end of the year the vaccine will be here.

LUCA RIGONI

By the end of the year? We’ll make a note of that Dr. Di Lorenzo! The vaccine by the end of the year, then the tests, the approvals and so on. But we’ll keep this news very much in mind. Thank you!

PIERO DI LORENZO

Keep this news in mind and maybe we’ll talk again even sooner.

LUCA RIGONI

Well let’s hope so!

PIERO DI LORENZO

Happy Easter

LUCA RIGONI

We are heartened during this difficult Easter period by the words and deeds of Pope Francis. Thank you to Piero Di Lorenzo.

GIANLUIGI NUZZI:

Yes indeed my friends, just think, worldwide there are 400 drugs being worked on in different universities, different hospitals, by groups of academics, researchers, scientists, all working to find a solution. Now I am going to show you something important because, look, there are two small vials in this photo. I don’t want to oversell this, but it is perhaps from these vials that salvation may come for all of us, because they could be the vials that contain…none other than the vaccine. Or rather, that study, those molecules, that substance, they are all moving closer to becoming the vaccine that could save us one day soon. Let’s take a look.

REPORTER:

It is a real race against time, the hunt for the vaccine to stop Covid-19, and it is precisely in these laboratories in Pomezia, on the outskirts of Rome, that a pool of scientists have reached the finish line. Here is a preview photo of the first vial of vaccine; it will be trialed in the United Kingdom, despite the fact that hundreds of letters have been received from Italians wanting to volunteer themselves as guinea pigs for the vaccine.

PIERO DI LORENZO:

10 days ago we went into production. Our vaccine is the synthesis of 2 strands of expertise; the first relates to Coronavirus, which the Jenner Institute has had for 15 years now, and the second to the Adenovirus, which is our expertise, as 5 years ago the Ebola vaccine was produced by our laboratories.

REPORTER:

It is a vaccine that is predominantly born out of a combination of 2 others, but what was the starting point for the researchers to achieve this result? And how does the vaccine work?

PIERO DI LORENZO:

Our partners quickly synthesized the gene of the spike protein. We insert that weakened gene into the body, the body recognizes a foreign body and reacts by producing antibodies which will be vital if the real unweakened gene comes along.

VOICE OF DEPARTMENT NARRATOR

So it works like this: the Covid-19 gene, which has been weakened in the laboratory and injected into our body, prepares the body to counteract the real one that is in circulation. In Italy therefore, we are in the preliminary study phase, whereas in China a recombinant vaccine is already being tested on 108 volunteer patients who are in good health and range in age between 18 and 60. Their testimony shows how much the desire to combat the virus outweighs the fear of possible side effects.

CHINESE VOLUNTEER 1 VOICEOVER:

There are so many health workers all over the country fighting this outbreak on the front line. As a university student is there something I can do?

CHINESE VOLUNTEER 2 VOICEOVER:

Vaccination is a form of protection that we will need first. Being a guinea pig today can help launch the vaccine sooner and thus make a contribution to the country.

REPORTER:

But in which other countries is scientific research achieving a similar result?

PIERO DI LORENZO:

In the United States they have already tested the vaccine they have developed; in Israel there is already a biotech company that is familiar with the Coronavirus family and they are working on this. In Italy it is us, in partnership with the Jenner Institute at Oxford University in England. In the Netherlands there’s another company that has reached a good stage and in Germany there is another.

REPORTER:

In the biopharmaceutical company in Tubingen, Germany, and in the Research Institute of Galilee in northern Israel, the race to produce a vaccine is following different procedures but with the same urgency and tenacity.

DAVID ZIGDOM:

We still need a few more weeks to have the vaccine. After we’ve developed the vaccine it needs to go to pre-clinical trials; how long these take varies, depending on the regulations that establish how many tests are necessary. Only after that will it be possible to test the vaccine on humans. In all, this entire process will take a few months.

REPORTER:

This length of time seems endless during the emergency. But less if compared to 15 years, which is the average amount of time needed to produce a vaccine. From the study phase to reaching the pharmacy counter.

PIERO DI LORENZO:

In May we are thinking of experimenting on mice, by the end of June we’ll be ready to try it out on humans.

PIERO DI LORENZO:

Together with the Jenner Institute at Oxford University, we have perfected a vaccine against Covid-19 and the first batch went into production 10 days ago.

REPORTER:

Piero Di Lorenzo, Director and President of IRBM, is feeling confident: within a few weeks it will be possible to try out the first anti-coronavirus vaccine produced in Italy; but this won’t be the first time the finish line has been reached in the war against viruses, because 5 years ago, the team of researchers working in Pomezia reached another one.

PIERO DI LORENZO

In 2015 we perfected and produced a million doses of the vaccine against Ebola: it was a wonderful, thrilling experience.

REPORTER:

And while Coronavirus continues to claim victims around the world, in this laboratory, researchers of different nationalities are doing their utmost to find a solution.

EMANUELE MINUTELLO:

During these days of emergency, the laboratory has become our home. Given the current situation, we are working in the laboratory with maximum commitment and quality, even for 11 hours at a time, in order to guarantee maximum productivity in the shortest possible time.

REPORTER:

The security system here is stringent: in fact you can’t enter this part of the laboratory you can see here unless you’re wearing several layers of sterile overalls.

PIERO DI LORENZO:

The timescale is set….By May we will be ready to start using it on mice, and by the end of June we’ll be ready to test it on humans.

REPORTER:

The timescales for being able to use the vaccine vary; after human testing we will still have to await the decision of the scientific community before being able to supply it on a large scale.

PIERO DI LORENZO:

We are optimistic because this vaccine that we are producing is a synthesis of two important strands of expertise; that of the Jenner Institute, which has already developed the anti-MERS vaccine, and our own, as the people who tested the anti-Ebola vaccine.

It’s coming, this one isn’t on Skype, it should be coming

PIERO DI LORENZO:

The bad one is this red one, […] the corona, after which it is named, and which is the contagious part, the one that causes the harm.

REPORT NARRATOR

Here at the IRBM in Pomezia they are fighting the Coronavirus in laboratories like these, where they created the Ebola vaccine and the one for Covid-19 is almost ready.

PIERO DI LORENZO:

This is the first corridor of the isolated laboratory.

INTERVIEWER:

Can’t we go in to do some filming?

PIERO DI LORENZO:

No, absolutely not, it takes an hour to go in and an hour to come out.

INTERVIEWER:

Because that’s where you’re developing what will then be tested?

PIERO DI LORENZO:

That’s where the vials with the vaccine come from.

REPORT NARRATOR

Here are the vials, the vaccine is working in vitro, antibodies are produced. But it needs to be tested on living beings.

PIERO DI LORENZO:

We’re starting by producing 1000 doses to be used for animal testing on mice. We’ll be ready by June, we hope there will be no need to skip the protocols established by the authorities.

INTERVIEWER:

Because it would mean the situation is bad?

PIERO DI LORENZO:

It would mean that the epidemic is becoming more dangerous than we thought.[/vc_column_text][/vc_column][/vc_row]

OK I’ll go to Piero di Lorenzo straight away, meanwhile I’ll pass on two bits of news: “Authorities in Germany have said that from today the infection risk is very high; in France, as a clear illustration of what is happening, the Lourdes Shrine has closed. So there is a total lockdown of everything. Prime Minister Conte also spoke a little while ago and reiterated that this is obviously a very difficult time and that Italy must show itself more united than ever before. So, Piero Di Lorenzo, Pomezia, on the outskirts of Rome, IRBM Science Park: you’re working on a vaccine. We’re speaking to you a couple of weeks on to find out what the situation is now. How is the work of your researchers going?

PIERO DI LORENZO

Yesterday we started producing the first batch of vaccines. Having characterized the adeno-virus and completed the related purification process, we started producing the vaccine. We expect to be ready by the end of May with the first doses to be used for the trials on mice. By the end of June, if the mice trials have not shown any toxicities or negative things, as we hope and expect, we are hopeful and optimistic that we can move on to humans.

PRESENTER

What does this mean? Once you get to the human trials, which, as Professor Vella and Di Lorenzo know very well, is divided into several stages, how long does this phase last?

PIERO DI LORENZO

The protocols require 3 clinical phases: 1, 2 and 3. Each of these 3 phases, according to the rules and the validated protocols, can last up to twelve or eighteen months. Obviously if the epidemic should become more worrying, if the situation should degenerate, the regulatory authorities may consider the need to shorten this time drastically.

PRESENTER

Yes.

PIERO DI LORENZO

Stefano Vella is well aware of how this works because he has experienced it first hand. I want to underline one thing: it’s a pleasure to see a scientist on a television broadcast. It means that finally the era when “anyone who has read a newspaper article can pontificate” is over and we’re putting science first in every field: particularly in the field of biomedical science. Finally we have rediscovered the pleasure of listening to people who have studied all their lives to work on something rather than people who just talk drivel.

PRESENTER

Yes, you’re right to underline it Piero Di Lorenzo, let’s hope that even after the emergency is over, which we hope will happen as soon as possible, we’ll continue to keep this firmly in our minds, not only because of how our national health service works and is working, thanks to everyone’s self-sacrifice, and, making a quick foray into Stefano Vella’s field, remember the importance of research, which is so mistreated in our country.

STEFANO VELLA

I am sure about one thing: this virus is no doubt a nasty creature. It is transmitted very quickly. It won’t go away. We are trying to give it a clobbering. Doctors, nurses and ordinary people are trying to defeat it. People will be saved by research. It will save us because technologies have progressed. Many teams are working on drugs and vaccines. Remember AIDS? Drugs were eventually developed. They will come for this as well, and they’ll save us. As I said, we need to be optimistic, this virus has now come between us.

PRESENTER

Do we have to learn to live with it?

STEFANO VELLA

Absolutely, this virus won’t go back to where it came from, it is now one of our common germs.

PRESENTER

Yes, that’s very clear.

STEFANO VELLA

So this virus will come back, it will be here. How do we suppress it? With the vaccine. There are many groups, including IRBM, that are famous for having produced lots of vaccines. Di Lorenzo is right. Remember the Ebola vaccine? It was made and deployed in a very short time. Objectively, while ensuring total safety for people, by shortening the timescale, a vaccine was fielded in a very short time. In fact the latest epidemic in the Democratic Republic of Congo was contained. I am sure that, and I say this to reassure people, while we have to stay strong because the situation is dramatic, and there are too many deaths, too many injured people, so we have to stay strong, I am sure that research, and I represent Italy in the European research program, has deployed… almost 500 million immediately through public tenders, and there are many European research institutions working together, in fact, as we have always hoped, collaboration is starting between the public and private sectors.  Because this is the method that will work.

PRESENTER

This collaboration is crucial in every area of our lives, because otherwise…

STEFANO VELLA

In research above all, because there is a lot of academic research, which has to work with industrial research, which is where things are developed. If this collaboration works, that is what will ultimately save us from future problems.

PRESENTER

So I want to say goodbye to Piero Di Lorenzo pointing out that…

PIERO DI LORENZO

I’m sorry…

PRESENTER

Go ahead.

PIERO DI LORENZO

I’m sorry, I’d like to add something to what Stefano Vella said, because I feel it is very important. Yesterday and today, many newspapers reminded us of a speech given by Bill Gates four years ago in which he envisaged that: The next war won’t be against an enemy with missiles, but against viruses. That’s where we are now, unfortunately we didn’t listen to him enough. In this respect I would like you file one piece of news in your memory bank. Three years ago there was a Zika epidemic in Lazio, only one person was infected after being stung by a mosquito. This caused a massive state of alarm. Commendably and bravely, Governor Zingaretti, together with Vice President Smeriglio, took steps to launch a research program and, with a public-private consortium, going back to what Vella was saying earlier, research into the Zika virus started. We worked as part of this consortium for the Zika virus and viruses in the same family for 2 years. The newspapers engaged in an idiotic controversy, saying that: “The virus was in Brazil and the Lazio Region is wasting money from Lazio’s taxpayers to do the research”. The Zika virus might be in Brazil but it doesn’t need a passport to come to Italy and Europe…

PRESENTER

We realized this, and how!

PIERO DI LORENZO

If something happens, God forbid, remember that the funding ends in June. That research will not be funded again, I’m sure about that, because of the controversy in the press. Pull out this bit of the broadcast when, God forbid, this happens.

PRESENTER

No, no, let’s hope not. We already have our hands full with the Coronavirus. So thank you to Piero Di Lorenzo. Good luck of course to you and all the IRBM researchers in your work.[/vc_column_text][/vc_column][/vc_row]

We have a guest now, we’re with the President of IRBM, Piero di Lorenzo. [IRBM is] an Italian company in Pomezia that works in the molecular biotechnology sector and has been working with Oxford University to develop a potential coronavirus vaccine. Good evening, President, and of course thank you for being with us.

PIERO DI LORENZO:

Good evening.

PRESENTER:

Let’s just take stock with you of where we are with this potential vaccine.

PIERO DI LORENZO:

We’ll be starting production tomorrow morning and, just to let you know how things have developed, when in December the Chinese isolated and sequenced the virus and… our partner the Jenner Institute at Oxford University immediately synthesized the “spike” protein gene. The spike protein is the one that covers the Covid-19 virus, the bad protein that creates the contagion, and once the University of Oxford had synthesized this gene we were brought in because we joined two forms of expertise together, the Jenner Institute’s expertise, as it is familiar with the whole family of adeno-viruses, having developed the vaccine 10 years ago for the MERS Coronavirus, for which it is currently carrying out phase 3 tests, therefore the final tests, on healthy volunteers in Saudi Arabia… and we have contributed our expertise in adeno-viruses. The adeno-virus is a vehicle, known as shuttle, that is loaded with the Spike protein gene synthesized in Oxford and, thus deactivated, has to introduce it into the body. This way the body recognizes it as a foreigner entering the body and creates antibodies. It therefore creates antibodies to react against the false infection and, if the active gene of the spike protein should arrive, the one that actually causes the disease, the body would be prepared with the antibodies to fight it. We have therefore characterized the adeno-virus, this shuttle, which is a common cold virus, further deactivated, and following the purification process we are ready to start production of the first 1000 doses, we’re starting tomorrow morning, and for the tests on mice. We expect to start with the mice by the beginning of May and expect to complete this phase within a month so we’ll then be ready to move onto healthy volunteers.

PRESENTER:

You foresaw my question, but just to understand what you were saying, to help me and our viewers understand, essentially I get the feeling that you are particularly optimistic and that we might see results within a couple of months, a month and a half therefore.

PIERO DI LORENZO:

Let’s say two and half to three months, we aren’t “particularly” optimistic, just “moderately” optimistic, because we’re starting to produce a vaccine that has already been tested in two protocols, already tested on 2 platforms, because the synthesization part has already been tested by the Jenner Institute in the context of the MERS vaccine, and the use of the adeno-virus characterized by us, in this specific case, simply replicates what we did five years ago when we developed the Ebola vaccine and produced it in our laboratories.

PRESENTER:

So you said two and a half to three months? Obviously if all goes well. What will the next steps be after that? Will it be made available to hospitals if tested? How will this vaccine be marketed or used after that?

PIERO DI LORENZO:

The animal testing is followed by three phases: phase 1, phase 2, phase 3 of clinical trials on humans. Phase 1 (with 10, 15 patients. 10-15 healthy volunteers); phase 2, after that, with 150-200, and the last phase with 700, 800, 1000 tests. Normally, according to the protocols validated by regulatory agencies, each of these phases can take over a year. One complete phase from animal testing to the end of phase 3 can take 5 or 6 years. However, these protocols, these timings, can be shortened, even drastically, by national and international regulatory authorities in the event that a pandemic, like the one we’re having now, is perceived to be out of control, at which point the regulatory authorities could intervene and order us to avoid certain tests to start commercial production immediately.

PRESENTER:

Perfect.

PIERO DI LORENZO:

We hope this will happen. We hope we won’t get to that point.

PRESENTER:

Of course, thank you for your contribution and explanations. I wish you and your team good luck in your work, let’s hope things turn out for the best. Thank you President, keep up the good work and good evening.

PIERO DI LORENZO:

Good evening to you[/vc_column_text][/vc_column][/vc_row]

Good evening Piero Di Lorenzo, Molecular Biology Research Institute.

You say you’re very close to a vaccine, how close?

PIERO DI LORENZO

Good evening. Yes, very close, because, as I said in another interview, we have combined our expertise with that of Oxford University’s Jenner Institute. They have…

REPORTER

In the meantime we’re just seeing images of your Institute and of the work you’re doing. I’m just saying this for the benefit of the people watching us of course. Go ahead.

PIERO DI LORENZO

Yes. As I was saying, Oxford University has great expertise in the Coronavirus family because it studied Sars for a long time and has developed and now tested the Mers vaccine. We have quite a major expertise, the platform to inoculate the human body with the modified gene we have synthetized, the one for the existing Coronavirus, which is Covid19.

So we are quite optimistic that this vaccine will be effective and won’t be toxic.

We’re going to start producing on Monday and we expect to make a thousand or so doses,

which will be enough to…

REPORTER

Now, Mr Di Lorenzo, I just want to understand this point. Next Monday you’ll be able to produce a thousand or so doses, what does that mean?

PIERO DI LORENZO

Next Monday we’re going to start producing the vaccine and we expect to have a thousand or so doses ready by May, which are sufficient for the trials on mice. By…

REPORTER

How long do animal trials of the vaccine take?

PIERO DI LORENZO

About a month. So by June we’ll have started and will be well advanced in the trials on mice and we hope to move on to humans by the end of June.

REPORTER

So can we just try to make the necessary procedures clear for someone who isn’t an expert? You’re saying that you’ll be starting animal trials in May. In June, once these trials are over, if everything has gone well and is convincing and satisfactory, the human trials can begin, is that right?

So what happens at that point?

PIERO DI LORENZO

The trials on humans start on quite a small number of healthy volunteers, maybe 10, 12, 15 people, and at the end of this initial trial phase we’ll move on to phase 2, when there will be 150/200…

REPORTER

How long does this trial take?

PIERO DI LORENZO

According to the protocols and regulations, each of the three phases can take twelve to eighteen months.

But clearly the times set by the regulations are the prescribed times.

REPORTER

Yes, of course.

PIERO DI LORENZO

Not in the presence of such a contagious epidemic.

REPORTER

In the presence of such a widespread, alarming and global epidemic, what kind of plausible and acceptable acceleration could there be, based on previous history?

PIERO DI LORENZO

The process can be accelerated a very great deal.

REPORTER

Meaning?

PIERO DI LORENZO

I mean that if the effectiveness and non-toxicity can be demonstrated in animals,

in the presence of a very dangerous epidemic which is, I dare say, out of control, national and international regulatory authorities can authorize the vaccine immediately.

REPORTER

What would the risks be Mr Di Lorenzo? What would the risks be?

PIERO DI LORENZO

There is a whole discussion to be had about that.

REPORTER

Let’s summarize it.

PIERO DI LORENZO

Very briefly, one has to determine which is the lesser evil. Like any drug, vaccines can have side effects. The side effects are…

REPORTER

This is behind the endless and fierce controversies there have been in recent months.

PIERO DI LORENZO

Precisely. I was referring to…

REPORTER

In recent years, although, given the emergency, they aren’t as fierce now…

PIERO DI LORENZO

Yes, that’s right…

REPORTER

…And, I should point out, the fear caused by the Coronavirus.

PIERO DI LORENZO

I want to stress that this is wrong… because it turns people into fans of one side or the other. It’s wrong to say that there are no problems with vaccines. Like any drug, vaccines can and do have side effects. It’s always important to apply the lesser evil principle. If a vaccine has a relatively minor side effect, in terms of the practical effect, and its extent, as a percentage, then…

REPORTER

Very clear. Mr Di Lorenzo, you have been very clear. I’d like to summarize further because we don’t have an endless amount of time…

PIERO DI LORENZO

Let’s summarize it in a word: please, get vaccinated. For everything.

REPORTER

Yes, but I wanted to summarize another point too. Of course, in that respect, I think many people can’t wait for the vaccine. To summarize, let’s say that by the end of June, end of July, we might already expect to be using a vaccine.

PIERO DI LORENZO

Yes.

REPORTER

Then it will be up to national and international authorities to say yes or no.

PIERO DI LORENZO

If the regulatory authorities consider it useful, and can’t see any contraindications, they can even start using it in July.[/vc_column_text][/vc_column][/vc_row]