“The vaccine will arrive, but Italy is in danger of being left without.” Interview with Silvio Garattini

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No to hydroxychloroquine or chloroquine. Evidence on the effect of plasma treatment. Advanced state in vaccine research and danger that without prompt government intervention, Italy risks remaining in line to take advantage of it. To better understand where we are both from the point of view of curative and preventive therapies (read vaccine) against Coranavirus, we asked Professor Silvio Garattini, pharmacologist and founder of the Mario Negri Institute for Pharmacological Research, to update Milan.

“If we want to proceed in order, I believe that one of the first indications has practically passed, that of using the Lopinavir-Ritonavir combination, a treatment that is good for AIDS. The data showed no efficacy, but a significant form of toxicity “, explains the Professor, who reiterates and endorses the recent rejection by WHO of the treatment with hydroxychloroquine or chloroquine, that taken in” preventive “form by President Trump , to avoid the risk of contagion.

“Products snapped up and deemed very important. In fact, it has been seen that there has been an increase in mortality and not a decrease as was hoped to happen. Other possibilities remain, such as anti-inflammatory drugs such as Tocilizumab. ”

The one against arthritis.

A controlled clinical trial is going on, indeed more than one also here in Italy. A drug that is used against artitis which, however, due to its anti-inflammatory properties, can be useful in the excess of inflammation that develops in Covid lung disease. It is still under discussion, because we have no results yet. There is a WHO study in this regard and there are studies approved by AIFA that go on here in Italy.

Then there is the heparin.

It is used to counteract the forms of capillary coagulation that are formed in various organs, including the lung. This seems reasonable, however with risks of bleeding, even if we do not yet have a controlled clinical study that allows us to establish its effectiveness on a scientific basis.

The plasma cure deserves a separate discussion.

The effect of the administration of plasma of the healed subjects and plasma of convalescents appears the most probable. In reality it is an old type of treatment that has been in use for 100 years, already used for many diseases: rabies, tetanus, Mers and Sars and from which other studies are starting. The idea is to isolate the neutralizing antibodies for the virus and avoid administering all the other proteins. This, if successful, will generate a whole series of other studies and once known how antibodies are, they can be redone industrially. But we must not confuse this type of treatment with antibodies which is curative with the effect instead of vaccines, which are preventive: they generate antibodies that should remain stable in memory, while those we administer for curative purposes pass very quickly because the organism metabolizes them.

About vaccine. Where are we at?

As we progress, we have made progress on the news we receive. There are at least 8 in the world for which the part of animal experimentation has ended and human experimentation has begun, the so-called Phase 1 and some have also completed Phase 1. For example, what is being studied in England in collaboration with the ‘Irbm di Pomezia which is the vaccine of AstraZeneca, and what is being studied in America which is the vaccine of the Modern firm: having passed Phase 1 and found the neutralizing antibodies for the virus, Phase 2 begins, which is to establish both tolerability and the most suitable doses. Then there is Phase 3 that is done on large numbers of healthy people to establish how many are actually sensitive to the effect of the vaccine, how many develop antibodies and how many have side effects. If all goes well, I am optimistic, I think that at the end of the year there should be at least one vaccine, but I also think more than one, which shows an efficacy to justify its use. But here the problems do not end, but begin.

Explain us better.

For about a month, with Doctors Without Borders, we have appealed to the government to deal with the vaccine without waiting for the last minute. There are already positions that many have tried to take: the United States government has allocated one billion for the development of the vaccine, has put many others for the development of an internal vaccine, the British government has already ordered 30 million doses. We must try to intervene because we must be sure that there is also the possibility for Italy to have it and if we do not move in time we will find ourselves with all the reservations already made and the inability to purchase it.

But technically how does it work? Is there a single vaccine?

There can be many types of vaccines because it depends on what they use. The American one uses the RNA of the virus, to make sure that the body produces the proteins that are seen as foreign. Vaccines that use neutralized virus, vaccines that use virus proteins carried by a virus that is not contagious. There are at least a dozen variations on how these vaccines can be prepared and there are more than 100 groups around the world that are researching this.

Does the first country crossing the line produce the vaccine?

Not exactly. It will take billions of doses to satisfy the whole world, therefore more than one vaccine will be needed, because it is difficult for one to be enough for everyone at the same time. This is why we must be present on the scene and possibly resort to the compulsory license provided by international bodies to produce it in our offices. When there is a public interest, it can be requested by skipping the patent. But in the case of the vaccine it is not as simple as making a chemical synthesis, it is much more complex so to be able to do it you have to prepare in time.

Are we back in Italy?

We have no news that there are any interventions. Hopefully they are moving. We have tried to make this present, I believe it is necessary to repeat it to be sure that the Government interacts with the governments of the countries in which the vaccines are being developed, the most advanced ones (there are a couple in China, a couple in the United States, the English one, which has Italy as its base, one in Holland, one in Israel) so as not to be displaced.

When is it likely to be available to the whole population?

It will take months. Initially it will serve for those most at risk: health workers, older people with polypathologies, people exposed for work to the public.

Months, not years …

Yes, because then production can be increased through replication in structures that can produce the vaccine with the compulsory license, in fact.

Are we also preparing for any virus mutations?

Fortunately for what we know to date, and several months have passed and more than a thousand determinations have been made in various countries, the virus has not changed substantially. If it changed after the arrival of the vaccine we would be in the same situation we are in as regards the flu: every year there is a new vaccine, but it is easy to do it because it is a variation of a vaccine that already exists.

So even if it changes for the worse, shouldn’t we worry?

If we already have a vaccine it is much easier to adapt it as it does for the flu, although unfortunately for now we do not know how things will go, we do not know if there will be a seasonality or if it will end abruptly as happened with Sars.

Professor Arnaldo Caruso says that the virus is “losing strength”.

There is no scientific evidence, what may have happened is certainly that as many say there is an attenuation, but it is not said that the virus has attenuated. Meanwhile, unfortunately, the more fragile ones have died, probably there are fewer old people with more pathologies; there has been the lockdown, there is less crowding in hospitals and therefore you can take care of the sick directly, the oxygenation system is more available, there is more attention to what must be done. A series of improvements occurred for the ability to better treat not by exaggerating in the administration of drugs, but by dealing more with oxygenation.

A health improvement, therefore. But Professor Caruso says he has isolated a variant of Sars-CoV-2 virus that “contacted in vitro with good cells to attack, could not even kill all of them”. In fact, even just “to start attacking them it took at least 6 days”.

It must be confirmed, I have not seen publications. He may be right, but the virus hasn’t changed according to what we know from all the available data.

The data are positive, there is a decrease in infections and deaths. Would you bet more on drug therapy or vaccines in the near future?

Medicines and vaccines must go hand in hand. We need to have therapy because we can continue to have disease. The vaccine is a preventive aspect, it acts on the long-term. We still have a long time before there is a generalized vaccination, so the two things must be pursued simultaneously, one cannot be abandoned for the benefit of the other.

The impression is that there has been a timely response from the scientific community in both cases.

There is no doubt that scientific research has reacted in a systematic way, practically most of the people have abandoned everything else to devote themselves to the emergency. But this must make you think. We don’t have to think that all the other diseases are resolved because we have to deal with the emergency. And this wants to be once again a call to political authority, to the Government: research is not an expense, it is an investment, it needs support.

In Italy research is not in excellent health …

We have a number of very important deficiencies. In Italy we have half (for every thousand workers) of the average of European researchers, we spend 1.2% of our GDP on research, when the European average is 2.2%, even Germany spends 3, 5%, the number of doctorates is less than half of the other countries. We have great difficulties in animal experimentation because of the animal rights movements that condition government decisions, universities do not respond to the new needs of culture, schools are still at the level of literary, philosophical and artistic training, in fact science does not enter and does not exerts its effect on general culture. We have many things to do and we must be realistic: we send (but it is not true because the money is not distributed if not very slowly) about 22 billion a year for research, but almost 50 spend France. Not to mention the latest decree.

Conte’s “mighty 55 billion maneuver”?

Exactly. Add 600 million, which will arrive in it is not known how many years, to be devoted to research is nothing, does not change the situation. Billions of investments must be thought of to try to reach the level of other countries. If they spend it is because they understood that without research the development of a country has slowed down a lot, it is difficult to make innovation. We must take significant measures, not the usual rain that satisfies everyone, but that in fact does not satisfy anyone and does not solve any problem.





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