In Italy, 12,016 Covid patients treated with mainly monoclonal, drugs intended for subjects at risk of progression to severe Covid-19 but with the recent appearance of the disease. In the last week, in particular, there were 554 prescription requests, equal to + 19% compared to the 465 of the previous week. This is highlighted by the 29th report of the Italian Medicines Agency (Aifa) relating to the period from 15 to 21 October.
Since the start of monitoring, the Veneto region has treated the most patients with these therapies, i.e. 2,022, followed by Lazio with 1,656 and Tuscany with 1,612. All the other regions are below 1,000 and in the last places Molise and the Autonomous Province of Bolzano, still at 16 and 3. The still monoclonals have not yet received the approval of the European Medicines Agency (EMA) but in Italy they have been temporarily authorized by Decree of the Minister of Health in February 2021 and are available starting from March.
Benedetta de Mattei interviewed the Prof. Francesco Vaia – Health Director of Spallanzani in Rome – to understand are the monoclonals, we are how it works and at what point in the fight against Covi-19.

What are monoclonals?
Often monoclonals are proteins produced in the laboratory, which simulate those produced naturally by our body as a response to vaccination or infection. I am the “soldiers” who bind the Spike protein, present on the surface of the virus, blocking its entry into our cells and preventing it from replicating.

How do second generation monoclonals work?
The peculiarity of these new lies in the fact that it is about fully engineered: after selecting the most powerful neutralizing individuals, products that get sick and are cured, they are cloned in vitro having made some changes that guarantee greater efficacy and safety.
These in fact, in addition to being more stable in the body than normal in a timely manner and therefore having a neutralizing effect longer life, do not interact with our immune system: yes thus the possible side effects of the classics.

At Spallanzani you are experimenting with them, what have been the results to date? How many other facilities in Italy administer them?
The results are extremely promising and we plan to arrive soon atauthorization from regulatory agencies. It is necessary to follow a path of rigorous validation and without this fundamental step we cannot of course reach clinical use on a large scale.
Until now, the neutralizing capacity of the new ones possible, that is the ability to bind the virus preventing its entry into the cells, has been shown to be even higher than that present in those who had the disease or in those who had received the vaccine.

What role could it play in this pandemic, could it replace the vaccine in the future?
Vaccines and monoclonals are a winning mix, but the vaccine remains indispensable to ensure lasting immunity. However, there are people who cannot be vaccinated or who do not respond to the vaccine (the so-called “responders”) and for many, they could receive directly which training.
At Spallanzani we are working precisely in this sense, for the eventual administration of stimuli prophylactically, since, until now, only for monoclonals have been used, with the aim of arresting the progression of the disease in patients already infected.
Second generation neutralizer releases have an additional advantage: they can be administered intramuscularly, directly at the patient’s home and possibly also by the nursing staff and will therefore be an important weapon in the prevention of Covid-19, especially for the most fragile.

Spallanzani has always been at the forefront of the fight against Covid-19, what is the current situation in your opinion and how do you foresee the coming months?
We are at an important turning point: the numbers, which never lie, paint the picture of a pandemic that is now nearing its end. Even in our Institute, admissions have dropped considerably and comparing the situation to that of a year ago, it is clear that the vaccination strategy worked, despite some minority voices persisted in saying the opposite, despite the pessimism staged by the virus speculators.
In addition to vaccines add new weapons, not substitutes, but complementary, like the new monoclonals, which there. We are able to prevent contagion and intervene, with tools that are increasingly capable of arresting the course of the disease, in cases where greater complexity of treatment is required: this will allow us to look at Covid-19 as one disease among others. Now the right way is that of gradualness and common sense, avoiding hasty reopening, as well as vaccination strategies whose usefulness is not supported by scientific studies.
However, this response, provided by Science, must also be followed by a system response, which agrees to us to come out really better, as a society, from the pandemic. I am not thinking only of Italian issues, but of international ones, such as vaccination fairness, which as I have said many times is not just an ethical issue. In fact, to avoid the development and spread of new variants, it is not enough to hide behind the high percentages of vaccinated in Western countries: the challenge is rather to look beyond, to developing countries and in particular to the continent of Africa, which with its meager 4% of vaccinated it could be an incubator for new outbreaks and variants.
I am confident that governments understand the importance of a moral suasion against pharmaceutical companies, so that prices do not rise, but accessibility to the vaccine is favored. It is a problem that affects us all.

Benedetta de Mattei