What the first phase 2 data say about the Italian Reithera vaccine

What the first phase 2 data say about the Italian Reithera vaccine

Data on 917 volunteers indicate a good antibody response. Furthermore, the vaccine is well tolerated. But the funds, blocked by the Court of Auditors in May, are still standing

(photo: Willfried Wende via Pixabay) The development of new vaccines against Covid-19 does not stop. Today we return to talk about the Italian vaccine with a troubled history Grad-Cov, developed by the biotech company Reithera, based in Castel Romano, together with the Spallanzani Institute in Rome. The Court of Auditors has recently blocked funding for the study of the vaccine in phase 3, the last step of the clinical trial (here the reasons). Beyond the economic and bureaucratic aspects of the story, however, today new favorable data arrive on the efficacy in generating an immune response and on the safety of Reithera in phase 2, an intermediate stage in which tests are still carried out on a small sample of volunteers. br>
According to preliminary data released, 3 weeks after the first dose, the researchers detected an antibody response (part of the immune response) in 93% of the participants and after the second administration it would reach 99%. These results derive from a preliminary analysis, carried out by Reithera and not yet published, so we will have to wait for the official publication to get all the details. In any case, the funds are still firm and to date we do not know if and how the experimentation will continue.

The study is in phase 2

Currently the clinical study, called Covitar, has included 917 volunteers in 24 Italian centers and hospitals throughout the country. The research is in phase 2, remembering that only later, in phase 3, tens of thousands of participants are generally involved. The researchers compared different vaccination regimens, including one that involved a single administration and another that included a booster. Reithera's vaccine is also based on the use of a viral vector, a harmless adenovirus, such as the vaccines from AstraZeneca and Johnson & Johnson. This virus carries the information necessary to produce the coronavirus spike protein against which our immune system will activate.

Reithera Grad-Cov is well tolerated

From the data the safety profile it is favorable, and the vaccine is well tolerated at the first dose and even more so at the second. This is similar to what happens somewhat like for the vaccines of AstraZeneca and Johnson & Johnson, the side effects occur more on the first administration - on the contrary with Pfizer-BioNTech and Moderna the booster is associated with more reactions (we always talk about mild and moderate effects ). The most frequent reactions concern pain at the injection site, fatigue, headache and muscle aches, and there have been no serious adverse events - always remembering that the sample is still small and that more extensive evidence on this aspect will be obtained. only with phase 3.

How the immune system is activated

From the first data, the activation of the immune system to the vaccine is also good. The Reithera company reports that three weeks after the first dose, an additional antibody response against the coronavirus spike protein is observed in 93% of the volunteers. It reaches 99% after the second administration. To understand the extent of this immune response, the scientists add that 5 weeks after the first vaccination, the level of antibodies that bind the spike protein and neutralize the coronavirus is comparable to that measured in a reference group of patients recovering from Covid infection. -19.

The specialists of Reithera also point out that there is also an activation of T lymphocytes. And that it is precisely the action of these cells, as is the case for other vaccines, that it is important to counteract the action of variants such as the delta, in which the spike protein is mutated (and also the antibodies, which are directed specifically against the spike. , are less efficient).

But there are practical problems

But the continuation of clinical trials could be challenged by funding problems. The funds - 81 million euros - promised by Invitalia never reached the company, stopped by the Court of Auditors. And the Spallanzani institute, which coordinates the tests, has not yet enrolled the new volunteers for the larger study. In short, we will have to wait to understand if the situation of the Reithera Grad-Cov vaccine will unlock or not.

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