The dream of the Italian vaccine stops. Hopefully only temporarily. No problem in scientific experimentation which, on the contrary, is progressing well. The stop to the project comes from the Court of Auditors which blocks the approval decree signed on 17 February last by the Ministry of Economic Development, by Invitalia spa and by the ReiThera company. A fundamental document to unlock funding and get the made in Italy vaccine off the ground.
The reasons for the red card have not yet been communicated to the Ministry of Economic Development but that decree was the key to approve the industrial development program at the Castel Romano plant and to support the scientific research project, including the clinical trial underway at the Spallanzani hospital in Rome. And above all it was the way to access the 81 million euros that the Government had decided to invest in the project through Invitalia. On this figure, the concessions granted, in compliance with the rules on state aid, amount to approximately 49 million euros: 41.2 million in non-repayable funds and 7.8 million in subsidized loans. The remaining 32 million will instead be funds allocated by ReiThera.
But the Court of Auditors did not consider it to be able to declare the provision legitimate and stopped the funding. One step away from the finish line, Italy finds itself paying the price of a formal defect that dates back to months ago, when the extraordinary commissioner Domenico Arcuri was in charge and which now hopefully can be corrected quickly.
While waiting to «know the findings of the Court of Auditors», the will of ReiThera is in any case to get to present the work to the EMA and to start phase three of the study as soon as possible. In fact, the feeling is not that of a definitive no but of a “freeze for revision”. At this very moment the company has completed phase two of the experimentation «also hiring staff» and is awaiting the results.
«I hope that a real investment will be made to increase the country’s production capacity. There may be different forms and sources of funding but it is important that we go back to developing experiments and research »says the scientific director of the Spallanzani institute in Rome, Giuseppe Ippolito. “Phase 2 of the trial – he points out – has been successfully completed on 900 patients and within two months we will have the first results. If they go in the right direction we will move on to phase three ».
While the Minister for Economic Development Giancarlo Giorgetti is being asked to report to Parliament on several fronts, the Higher Institute of Health also intervenes on the matter. “It is very important that this type of experimentation in the country can be conducted and developed – explains Silvio Brusaferro, president of Iss – then we know that some pass the screening of all phases, others perhaps in the various phases may find evidence that is not sufficient they suggest directing that type of technology or knowledge to other directions. But the assumption is that there is in the country the potential, the desire and the economic support to conduct these experiments. This is true for the current pandemic and for the future ».
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