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The Italian Reithera vaccine successfully concluded Phase 1

Phase 1 has been completed without any problem. In six months Italy could have its vaccine. It seems a long time, in terms of vaccination strategy it is not too much and the availability of the company’s doses Reithera of Castel Romano, near the capital, could prove essential to proceed within the year to a rapid coverage of the population towards that 75/95% range of vaccinated persons deemed necessary to trigger herd immunity. This is because the group, which the state is supporting, claims it can produce 100 million doses per year.

Meanwhile, the first step of the experiments of the group co-founded and led by Antonella Folgori, already working in the past on vaccines for Ebola and for respiratory syncytial virus then purchased by Glaxo Smith & Kline, it has been surpassed: the data of the first phase, started on 24 August last on one hundred volunteers, they would seem comforting. No adverse reactions of the preparation named GRAd-CoV2 e activation of the immune system both in terms of antibodies capable of blocking the virus in circulation and on the fundamental one T lymphocytes, which come into play by destroying already infected and compromised cells. The second and third phases will investigate other aspects of the vaccine, such as efficacy in subjects more at risk, increasing the number of volunteers.

“We have enlisted a hundred people and 45 were vaccinated with different doses and all came to an end for the safety assessment: the vaccine had no serious adverse events in the first 28 days after vaccination, a better result than Moderna and Pfizer who had side effects. The peak of antibody production at 4 weeks remains constant and the vaccine is a a single dose“. The scientific director of the Spallanzani Institute Giuseppe Ippolito explained this during the presentation of the results: the Roman center collaborates in the experiments. To this it must be added that the vials can be kept a temperatures between 2 and 8 degrees centigrade: the single-dose and the simplicity of distribution could therefore do Reithera the Italian protagonist of the second phase of the year or at least putting the turbo at the end of the vaccination campaign. The third phase should be closed by the summer, in September the vaccine could be in the pool of solutions available to leave the pandemic behind.

At this stage the vaccine «has proven to be sure, to have the ability to induce immune response in adults and the response is similar to that of other two-dose vaccines. 92.5% of the vaccinees had detectable antibody levels and with a single dose we have results in line with Moderna and Pfizer ». Now we need a hand from the state and the commissioner intervened on this Domenico Arcuri: «We have arranged for the company to have the resources to carry out the trials. Today we see how much we are fighting to import vaccines from other countries. We know how valuable it is to equip ourselves with a production directly in Italy. For this we have provided aequity injection and public entry into the capital of Reithera, development contracts will be used to finance research and incremental stabilization of production. We must try to be independent with vaccines as we managed to be for the fans and other devices, which we imported in full in March, and which today we are able to manufacture ourselves ».

As for the neutralizing antibodies, precisely the T lymphocytes that give immune memory and persist for a long time, “we found them on 42 of the 44 volunteers who obtained the vaccine,” added Ippolito. The two people with no answer had had the lowest dose of the three tested but, in fact, the experiments are used precisely to identify the right balance. Reithera received 5 million euros from the Lazio region, three from the ministry of university and research and invested 12 on its own. Now a deeper commitment is needed to speed up and sustain phases two and three.

Like the others, GRAd-CoV2 carries a fragment of the genetic code into the cells mRNA but it does so through a adenovirus di gorilla, that is, using an attenuated cold virus, devoid of the genes that serve for its replication replaced with those that encode the proteina spike, as a vector of the information necessary to trigger the production of the notorious protein and therefore the antibody reaction. «There are various types of vaccines, the genetic ones are extremely rapid in their development. We will therefore be able to produce one hundred million doses of the vaccine every year. A vaccine that will remain stable at a temperature between 2 and 8 degrees – said Folgori – the virus is coated by the spike protein and the vector that our vaccine uses is the adenovirus: the immune system will recognize it and produce antibodies. killing infected cells. The vaccine, consisting of a single intramuscular injection, was well tolerated ».

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