Rottapharm’s anti-Covid vaccine is still missing the green light from the Istituto Superiore di Sanità and the start of the clinical study on the first volunteers is delayed. “In an emergency situation we need more speed, we are losing precious time,” is the concern of Lucio Rovati, president and scientific director of Rottapharm Biotech that together with Takis, a Roman biotechnology company, has developed an innovative vaccine based on the DNA of the virus. However, he said that: “I remain optimistic because I know the great work they are facing at the Istituto Superiore di Sanità.”
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The request for authorization was filed on November 30th
Only yesterday, on January 24th, – almost two months later – have formally arrived from Rome the technical applications for further study related to the dossier Rottapharm. Twenty-three questions and many dozens of pages of detailed and clarifying answers. Questions to which “we have responded immediately and we hope to receive feedback in the next few days,” said Rovati. Also because “if we do not manage to start testing by mid-February will be a problem, we will overlap with the many existing vaccinations.”
Without forgetting the fact that in the meantime some volunteers have been infected and therefore can no longer participate in the study, others were doctors who therefore received the Pfizer vaccine, others belong to the categories close to receiving the first booster and therefore could withdraw their willingness to participate in the Rottapharm-Takis trial. Although at the moment it remains a ‘marginal’ problem since the recruitment campaign of volunteers carried out at Asst of Monza has received over a thousand applications.
The only thing missing is the authorization of the Istituto Superiore di Sanità and the Italian Drug Agency
Once the green light is obtained, however, it will be necessary to ask for the approval of the Ethics Committee of Spallanzani in Rome and then sign contracts with the three hospitals involved in Phase 1 – San Gerardo in Monza, Spallanzani in Rome (which will also deal with all laboratory evaluations) and Pascale in Naples – which according to Rottapharm Biotech-Takis plans should have started at the beginning of January. As soon as the bureaucratic process is completed, the first grams of vaccine will be injected to 80 volunteers. One milligram per dose, but with four different ‘concentrations’ for four groups of 20 people so as to identify the best two able to give the most effective immune response. A phase that will last about three months.
Then, in Phase 2, the result achieved will be ‘expanded’ on a larger number of volunteers, up to 100, to find the best dose and start with Phase 3 on tens of thousands of subjects. The goal remains to be able to go into production at the end of 2021 and then start mass administration in 2022: if for Phase 1 a few grams of vaccine are enough, for about 30 thousand people involved in Phase 3 will require a few ounces, in the next phase, however, will be available tens of pounds for hundreds of millions of vials.
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First published in IL GIORNO, a third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.
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