We’re in the corridor leading to the production plant.
The production process for the potential Coronavirus vaccine.
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.
Today, a team of researchers are one step away from producing the vaccine for
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.
The exclusive images you are seeing were supplied by the researchers.
Access to this part of the laboratory is forbidden.
This room, called PASS-BOXS, is where the first 1000 doses of the potential vaccine will be produced and held in containers like this.
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]
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.
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.
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.
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.
The epidemic in Italy is already happening, but what are your timings?
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.
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]
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…
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.
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.
I could see Purgatori and Sansonetti…I don’t know if you had any questions for Di Lorenzo…
Meanwhile the nasty one is called Spike, as I understand it, right?
Yes. It seems interesting but it means that we…
Before the end of the year…
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.
Yes, at home.
I would like to ask…
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…
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.
So we have a question for Di Lorenzo from Scotti, the FIMMG Secretary, go ahead.
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.
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.
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?
And let us know as soon as… the five of us…
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.
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.
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.
A million doses of the Ebola vaccine were made here and now we’re going to start producing the Coronavirus vaccine.
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.
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.
This is where the vaccine is developed.
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.
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]
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.
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?
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.
From here, it will come out the Coronavirus vaccine.
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.
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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