Interview with Piero Di Lorenzo ▪ Rai 3 Agorà – 14th April
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
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