The first anti-coronavirus vaccine produced in Italy Rete 4 – Stasera Italia – 29th March

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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.

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Piero Di Lorenzo – IRBM fights the Coronavirus in its labs La7 Di Martedì – 17th March

[vc_row][vc_column][vc_video link=”https://youtu.be/VSaIRs7n8XY”][/vc_column][/vc_row][vc_row][vc_column][vc_text_separator title=”ENGLISH TRANSCRIPT” color=”sky”][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]GIOVANNI FLORIS:

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]

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Piero Di Lorenzo – IRBM produced the first batch of vaccines La7 Coffee Break – 17th March

[vc_row][vc_column][vc_video link=”https://youtu.be/Lvs_615RN48″][/vc_column][/vc_row][vc_row][vc_column][vc_text_separator title=”ENGLISH TRANSCRIPT” color=”sky”][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]PRESENTER

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]

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Piero Di Lorenzo – Kicks offthe vaccine manufacturing against Covid-19 Sky TG 24 – 15th March

[vc_row][vc_column][vc_video link=”https://youtu.be/FiUSek1snxk”][/vc_column][/vc_row][vc_row][vc_column][vc_text_separator title=”ENGLISH TRANSCRIPT” color=”sky”][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]PRESENTER:

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]

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IRBM is close to a vaccine TG Com 24 – 13th March

[vc_row][vc_column][vc_video link=”https://youtu.be/bzYYuzDHRRs”][/vc_column][/vc_row][vc_row][vc_column][vc_text_separator title=”ENGLISH TRANSCRIPT” color=”sky”][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]REPORTER

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]

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IRBM working tirelessly to produce a vaccine Rete 4 – Stasera Italia – 6th March

[vc_row][vc_column][vc_video link=”https://youtu.be/9aIMuR643vo”][/vc_column][/vc_row][vc_row][vc_column][vc_text_separator title=”ENGLISH TRANSCRIPT” color=”sky”][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]RESEARCHER

We’re in the corridor leading to the production plant.

The production process for the potential Coronavirus vaccine.

REPORTER

We’re in Pomezia, 30 km from Rome. The drug used to prevent the spread of Ebola was first developed in these laboratories in 2014.

IRBM PRESIDENT DR. DI LORENZO

The experience we gained with Ebola was very valuable and it allows us to use the same platform that was so successful with Ebola.

REPORTER

Today, a team of researchers are one step away from producing the vaccine for

Coronavirus

RESEARCHER

We’re entering the controlled access production area. Every operator enters a personal code and then dons additional clothes because we’re entering a protected environment where we’re working with the virus, with the cells.

REPORTER

The exclusive images you are seeing were supplied by the researchers.

Access to this part of the laboratory is forbidden.

RESEARCHER

This room, called PASS-BOXS, is where the first 1000 doses of the potential vaccine will be produced and held in containers like this.

RESEARCHER

We are working on developing a potential vaccine for Coronavirus that uses a carrier, which is a system for conveying a message to the patient’s cells containing instructions to teach our immune system, the patient’s immune system, how to recognize the virus and defend us from it.

IRBM PRESIDENT DR. DI LORENZO

We expect to start production in one or two weeks at most, so that animal trials on mice can start in June.

If all goes well, by July we’ll have produced enough doses to start human trials.

Out of every 100 research projects that are launched, statistically 1 or 2 reach their goal.

Those 1 or 2 have to cover the costs of the other 98 or 99 that went wrong. The costs range between 1 and 1.3 billion dollars.[/vc_column_text][/vc_column][/vc_row]

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IRBM the Factory of the vaccine La7 Tagadà – 25th February

[vc_row][vc_column][vc_video link=”https://youtu.be/vCg7mxq7tsY”][/vc_column][/vc_row][vc_row][vc_column][vc_text_separator title=”ENGLISH TRANSCRIPT” color=”sky”][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]IN STUDIO

Here we are back in the studio and we still have Daniela Preziosi and Professor Pierluigi Lopalco with us answering your calls, so keep calling because we’ll be opening the lines again soon. Massimo De Manzoni is on the line from Milan. So we’re talking about the Coronavirus, pandemics and epidemics, but there is one magic word, which is the word “vaccine”. When is the vaccine coming? Who is working on the vaccine? Maria Grazia Gerina isn’t working on it but can tell us about it.

IRBM RESEARCHER

We’re coming into the controlled area where the vaccine will be produced.

We’re walking along this corridor that looks in on the production rooms. This is where the operators get dressed, we wear an additional layer of protection over these overalls we’re wearing now. This is the door to the room that leads to the laboratories, so from here there is another level of security and operators enter using an access code, but we’re going to stop here today.

REPORTER

We’re at the laboratories in Pomezia where production is about to start of an experimental Coronavirus vaccine on which ADVENT  IRBM researches are working with Oxford University’s Jenner Institute.

IRBM RESEARCHER

We’re now entering the laboratories where the vaccine will be tested once produced. This is the laboratory where we also made the Ebola vaccine, using the same platform we’ll now be using for the Coronavirus vaccine. The vaccine is based on an adeno-virus, a common virus that causes the cold, which is deactivated and modified so that the piece of DNA that corresponds to the surface protein of the Coronavirus can be inserted into it. The host’s immune system senses this protein, recognizes it as foreign and generates antibodies.

We’ll be going in there to produce it shortly.

REPORTER

The epidemic in Italy is already happening, but what are your timings?

IRBM RESEARCHER

The vaccine is being built. We’ll need to see first how it responds to animal and then human trials.

We’ll need to test its safety and effectiveness.

IRBM PRESIDENT

We think we’ll have the first 1000 doses by June and they’ll be used for tests on animals. By July we’ll be ready to move on to the human phase. The timings will then be set by the national and international regulatory authorities. To give you an example, when we produced the doses for the Ebola vaccine, for the human trials, they authorized us within a day, instead of months or years, as normally happens.

I hope there will be no need given the extreme urgency.[/vc_column_text][/vc_column][/vc_row]

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Piero Di Lorenzo – The road map to get a vaccine La7 – Coffee Break – 25th February

[vc_row][vc_column][vc_video link=”https://youtu.be/tmsa1nf_T2o”][/vc_column][/vc_row][vc_row][vc_column][vc_text_separator title=”ENGLISH TRANSCRIPT” color=”sky”][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]ANDREA PANCANI

So let’s go to Piero di Lorenzo. Mr Di Lorenzo you’re working on a long-awaited goal, which is to develop a Coronavirus vaccine.

Can you tell us where you started and what the road map is to getting a vaccine?

PIERO DI LORENZO

Yes, good morning. We’re about to start production of the first 1000 doses of the Covid-19 vaccine. We’re about to start producing it now that two centers of expertise have joined together, the University of Oxford and the Jenner Institute of the University of Oxford, which has a… sorry, can we stop the audio feedback…

ANDREA PANCANI

There’s some feedback, we’ll sort it out for you now, go ahead.

PIERO DI LORENZO

Thank you. If you can. As I was saying, the Jenner Institute of the University of Oxford has isolated… after the Chinese isolated and sequenced the Coronavirus gene in question, they immediately started synthesizing the “Spike” protein in December. What does that mean?

The Jenner Institute in Oxford is an international center of excellence for the study of vaccines and has been monitoring the Coronavirus since the Sars outbreak. In fact it developed a vaccine for Sars and is currently running tests for the Mers vaccine in Saudi Arabia.

Therefore it knows the Coronavirus better than anybody. And this expertise is combined with ours, as we have well-established experience in the field of adeno-viruses, since we developed and produced the Ebola vaccine. We have continued to work with Oxford since then.

This collaboration is proving invaluable today, because the work they have done on the Spike protein, which is the crown of the virus, the bad part, will now allow our laboratories to find the shuttle, the vehicle which, suitably weakened, can carry it into the human body so that the vaccinated person can produce antibodies if the real Spike protein, the bad one, I repeat, should enter their body, and would thus be immunized.

So, to be accurate, we have characterized the adeno-virus,

i.e. the Shuttle, and we have created the conditions for it to receive the Spike protein synthesized at Oxford and now we are completing the process of purifying the adeno-virus to start producing the first 1000 doses from next week and we expect, as I assume the question is on everyone’s lips, we expect to be ready with these 1000 doses in June, at the end of June, so that we can immediately move on animal trials.

ANDREA PANCANI

After that we’ll have to carry out clinical trials on humans, won’t we?

The next step.

PIERO DI LORENZO

Yes. I would say that if, as we expect, no particularly significant toxicities or side effects are found in animals, we can move on to this by the end of July, because in the meantime we will continue to produce the vaccine, Human trials at the end of July, then there is a discussion to be had about the spread of the epidemic.

ANDREA PANCANI

I could see Purgatori and Sansonetti…I don’t know if you had any questions for Di Lorenzo…

ANDREA PANCANI

Meanwhile the nasty one is called Spike, as I understand it, right?

ANDREA PURGATORI

Yes. It seems interesting but it means that we…

ANDREA PANCANI

Before the end of the year…

ANDREA PURGATORI

At best we won’t have a vaccine before autumn or even the end of the year. So the problem is containing the epidemic, containing the outbreaks and avoiding… because if it turned into a very aggressive epidemic that infected thousands and thousands of people the healthcare facilities equipped to manage it would be unable to… they would be insufficient. This is the real point.

PAOLO CIRINO POMICINO

However, I should say that, as we have seen in Veneto, some infected people are in self-isolation at home.

ANDREA PANCANI

Yes, at home.

ANDREA PURGATORI

I would like to ask…

ANDREA PANCANI

OK let’s do this, as we have a commercial break now, after the break if Silvestro Scotti has any questions to ask Piero di Lorenzo…

SILVESTRO SCOTTI

Absolutely, absolutely

ANDREA PANCANI

Because clearly he is very curious and justifiably interested in the development of a vaccine, as we all are. See you in a couple of minutes.

ANDREA PANCANI

So we have a question for Di Lorenzo from Scotti, the FIMMG Secretary, go ahead.

SILVESTRO SCOTTI

We’re also trying to find some positive sides to the Coronavirus panic effect. It will be possible, if things go well and can be completed within the expected time,

to consider a joint flu jab and Coronavirus vaccination next November, this would be a positive outcome,

given that Italians tend to vaccinate very little or not at all, perhaps the scare we are having now… So having a single product in which the flu vaccine can be administered together with the Coronavirus one.

ANDREA PANCANI

Let’s hear what Di Lorenzo has to say.

PIERO DI LORENZO

What Andrea Purgatori was saying just now is completely right. Going by the time take by regulators to issue authorizations, an authorization for mass vaccination using this vaccine would not come quickly at all.

Let’s hope this is not the case because as the lesser evil principle applies in scientific research, and therefore implementation, if the pandemic were to become as big as many newspaper headlines have suggested, the regulators would probably be convinced to cut the implementation times drastically. I should point out that in the case of the Ebola vaccine

we submitted an application for authorization to the US NIH in the morning and we were given the authorization by the evening. It normally takes a year.

So clearly it is all an ongoing process and all in one… it all has to be verified in the field, based on what happens. As for your question, I would rule out this possibility. Because we are working on a specific vaccine and all our energies are focused on finding a remedy to the epidemic that is happening at the moment.

I cannot rule out general discussions being held in future.

I want to say something about this. We need to say things as they are. In 2016, the Lazio Region, very bravely in my opinion, earmarked significant funds for research into the Zika virus, because a person had fallen ill in the region, in Anzio I think, so very quickly the regional council decided to allocate money for this research to be done.

Some people joked that the Lazio Region was funding research on a virus that was creating an epidemic in Brazil. I think these jokes were unwarranted because since then we have been doing research in this very field as part of a public/private consortium, the CNCCS. And I think this advance preparation can lead to a quick remedy being found in the unfortunate event of it being needed.

I say this to underline that what the doctor is saying the studio is definitely desirable. But we need to think about it when there isn’t an ongoing emergency, we need to think about it in normal circumstances.

ANDREA PANCANI

Very clear. I don’t know whether you have any other questions for Mr Di Lorenzo, otherwise we can say goodbye as he has to be somewhere. Anyway thank you, it’s important to know that an excellent company in Italy is working to develop… huh?

PIERO SANSONETTI

And let us know as soon as… the five of us…

ANDREA PANCANI

Yes, of course, let us know immediately, but it isn’t ready. Thanks to Piero Di Lorenzo and good luck with your work, and thanks to all the researchers and employees of the IRBM SCIENCE PARK.

PIERO DI LORENZO

Thank you.[/vc_column_text][/vc_column][/vc_row]

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Covid-19: how a vaccine is produced. IRBM fights against Coronavirus RAI 1 UnoMattina, 14/02/2020

[vc_row][vc_column][vc_video link=”https://youtu.be/vcz3WGZ8RBg”][/vc_column][/vc_row][vc_row][vc_column][vc_text_separator title=”ENGLISH TRANSCRIPT” color=”sky”][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]REPORTER IN STUDIO

The first Coronavirus could be ready in 18 months. At least that is what the WHO is hoping. According to the US Infectious Disease Research Institute, an initial trial on a small number of people cannot be ruled out within two to three months. But to understand how close these hopes and forecasts are to reality, we decided to go and see how a vaccine is born. As you’ll see in the report by Claudio Antinoro, we didn’t have to go far.

VFC

Pomezia, just a few miles from Rome, is home to the Molecular Biology Research Institute, a center of excellence in the search for new drugs and vaccines. 200 researchers work here, including biologists and chemists, mostly women, with a large contingent of young people.

REPORTER AT IRBM

This is a controlled contamination environment, it’s where you produced the Ebola vaccine.

DI LORENZO

A million doses of the Ebola vaccine were made here and now we’re going to start producing the Coronavirus vaccine.

RESEARCHER

We have a team of 9 people on production. There are 7 production rooms, each of them performing a specific step in the process.

REPORTER AT IRBM

This project is a collaboration with the University of Oxford.

DI LORENZO

They discovered the protein to be used to immunize people. Our expertise lies in creating the vehicle, the adeno-virus, which loads this protein and carries it into the body of the person being vaccinated.

VFC

This is where the vaccine is developed.

IRBM RESEARCHER

This is where we carry out all the tests to characterize the vaccine and essentially to test this vial. This is the vial that will contain the vaccine once produced, to see if it fulfils the quality and safety requirements.

DI LORENZO

We hope the batch for animal trials will be ready by the end of June and the batch for human trials will follow by the end of July.[/vc_column_text][/vc_column][/vc_row]

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TG1 News interview Pietro Di Lorenzo & Stefania Di Marco RAI1 TG1 12th February 2020

[vc_row][vc_column][vc_video link=”https://youtu.be/4jDQBPCahng”][/vc_column][/vc_row][vc_row][vc_column][vc_text_separator title=”ENGLISH TRANSCRIPT” color=”sky”][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]GIORNALISTA IN STUDIO

This is how a vaccine is produced.  Tg1 cameras went to the Pomezia Research Centre where the antidote to fight Codiv-19 will be produced. Our news correspondent is Giorgia Cardinaletti.

INVIATA

The level of protection is very high, 1 hour to get dressed before entering, 1 hour to get undressed to exit. We are in Pomezia, at the Research Center that will produce the vaccine for Codiv 2019.

The vaccine preparation, the viral inoculum, which is currently being developed at the Oxford University, will arrive here shortly.

What is coming from Oxford?

DI LORENZO

It is coming the Adeno-virus, that is a engineered virus, a non-threatening virus, the cold, on which it is inserted the gene of the spike protein which is the protein that covers, the bad one, the Coronavirus. The spike protein inserted into the human organism, allows a reaction to make possible the production of antibodies.

GIORNALISTA

From here, it will come out the Coronavirus vaccine.

RICERCATRICE IRBM

Exactly. This is the vial of the vaccine that will come out from here, onceproduced. Then, a part will be frozen and another part will be sent to our laboratories to test safety, quality andpotency.

VFC

At the end of June we will have 1000 doses for animal testing. By July we will start the one on human Procedures can be speeded up according to the severity of the situation. In 2014, we produced the vaccine for Ebola virus and the authorization to switch from animal testing to human testing came in just one day.[/vc_column_text][/vc_column][/vc_row]

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