On 18 October, the Ema authorized the filling of the vaccine produced by Pfizer-BioNTech at a plant in Monza, managed by Patheon Italia SpA, and one in Anagni, managed by Catalent Anagni SRL. It also approved a new formulation that provides better storage, transport and logistics options for vaccine distribution and administration. It is an important step for the Italian pharmaceutical production. We talked about it with the ex-president of Ema and scientific advisor to Commissioner Figliuolo, prof. Guido Rasi , who explained to us how far Italy still has to go (a long way) and what changes, if something changes, from now on.Prime Minister Draghi has expressed himself several times on the need to increase the production of vaccines, also through a direct commitment of the pharmaceutical industry in Italy. The efforts of Minister Giorgetti and former Minister Tria, in collaboration with Farmindustria, record another important result. What does it mean for Italy that Ema has approved the filling of Pfizer-BioNTech vaccines in the Patheon (Monza) and Catelent (Anagni) plants
What changes, if something changes, for the Italian and European vaccination campaign

The Italian vaccination campaign is now consolidated, even as regards Europe the number of doses is widely guaranteed. In the short term we could say that it does not change too much. Instead, it would change for the future, and certainly substantially, if this virus were to become endemic. So, having at home the possibility of closing the entire production arc would certainly be decisive. Of course we are still talking about a first step, if we want to see it that way. We comment on a step that signals the goodness of Italian production and that makes us remain the first producers of finished products – always and only one step away from France and Germany – but certainly there is still a lot to do. It is certainly positive news, but it is a first step, which however tells us that we are starting to move in the right direction. Dialogue is moving in the right direction, which was not the case before. Today finally all the parties recognize the urgency to strategically intervene on drug production policies, changing the regulatory context, streamlining bureaucracy, optimizing controls.What Italy should do to implement the technological power necessary to support the entire vaccine supply chain
At least four or five structural steps are missing. In the pharmaceutical field, as far as Italy is concerned, we need an “organic” industrial plan. Starting with encouraging research and experimentation, and up to making competition in the field of production attractive, it is a question of investing globally in the drug. It is certainly a good thing that the final phase of production is carried out in Italian factories, but if our researchers have to go outside because research is discouraged in Italy, we will never solve the problem. The same goes for the pharmaceutical company, which needs to be relaunched in all its dimensions. We can say that our ambition must be to see the production of the finished product as the last link in a chain that moves the Italian pharmaceutical industry,And for the competition / collaboration between the companies that produce the vaccines
It makes sense to think of a reconversion of the structures, and therefore a differentiation and functional extension of the plants, mediated by European organizations
What are the main obstacles to such a strategy

A European strategy must inevitably pass through the laws of competitiveness and the market. I think that the challenge does not consist in hypothesizing a sort of European direction in private production, which is, among other things, impossible as well as improbable, and ultimately counterproductive. Competition fuels innovation. Even and above all in the face of important competitors, closure in a pseudo-egalitarian model is not a solution, but the solution is instead to make what we said for Italy valid for Europe, that is to make the European market attractive. Let’s think about China or India …
Precisely. We focus on excellence. Europe and Italy are already a very fruitful context from this point of view, but the real challenge is to become more pragmatic. This is the point. There is a need to change course on some crucial issues. A lot in reality. Let’s think about the use and management of data, or privacy, just to name a few. The regulation needs to be strongly rethought, and somehow we are starting to move in this direction. The key point is to encourage research and competition to be an increasingly attractive market, which produces innovation and generates vision. But for this it is necessary to lighten the bureaucratic processes and not to stiffen them. This is why it is necessary to promote winning initiatives and not to become fossilized in five-year plans (or something like that) in which each country is told who does what, and how. Then there is a purely pragmatic, common sense discourse. For Europe, for example, encouraging research and optimizing controls means understanding when to opt for a bottom-up approach and when for a top-down approach compared, to say, to research. It is clear that if we are faced with an emergency that requires a rapid solution, the funds destined for research will have to be channeled in an optimal way, otherwise we are dispersing. Or again, sometimes you can select a product through a public tender, other times you don’t have time to go through a public tender and you need to be able to start negotiating faster with producers or research institutes (as has happened). It is always about pragmatically assessing.As far as research is concerned, some leading companies in the production of vaccines, such as Pfizer, are currently experimenting with a more effective vaccine against the Delta variant (phase III and IV). What are, to date, the timing of any access to this resource
How to reduce them
What critical issues characterize access to experimental vaccines

Some clarifications. The Delta variant is not our priority right now. The same applies to pharmaceutical companies. For better or worse, existing vaccines represent adequate protection. The real urgency, which we cannot underestimate in any way, would occur when we were faced with a variant that is completely beyond our control. So yes, a truly impressive vaccine production capacity would be at least a necessary prerequisite. As for the approval times, it must be said that in the face of such an emergency they would be very fast. The bureaucratic machine has already been deeply lightened in this sense. The real stumbling block is not the administrative one, the real problem would be production itself. That’s where we have to work.The EMA Committee for Human Medicines (CHMP) has also approved – in the same note – a formulation of Comirnaty that does not require dilution prior to administration, which will be available in packs of 10 vials (60 doses) and can be stored at 2-8 ° C for up to 10 weeks. What impact on the timing of vaccination
In Italy, and in Europe in general, where the vaccination campaign is already well established, this does not actually imply major upheavals. Certainly, the reduction in distribution times and greater ease in logistics can mean a great advantage for the future, for example if we have to face an annual recall of the vaccine against Covid. But above all, they facilitate access to vaccines in those areas of the world that have important logistical problems. They will cost a little more
. Maybe yes. But it will certainly cost less than what we would face if the virus continued to circulate, and in an even more immediate way, of course, it would reduce logistics costs.

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