"For the ReiThera vaccine it should be enough to inject a single dose, even if we are still experimenting with alternatives." The Policy Maker interview with Antonella Folgori, president of ReiThera, the Castel Romano company is producing a 100% Italian anti Covid vaccine developed together with Spallanzani
The biotechnology company ReiThera di Castel Romano is working on a 100% Italian anti Covid vaccine, developed together with Spallanzani, to accelerate the end of the pandemic and which could allow Italy to achieve vaccination autonomy.
Unlike many other companies, in fact, the ReiThera vaccine was born and is completely produced in the Castel Romano headquarters, from laboratory research to filling. Policy Maker interviewed the president of ReiThera, Antonella Folgori who first of all reassured us: "We do not yet know for sure, but at present we believe that the mutations in progress should not affect the effectiveness of the vaccine".
What is the timing of the ReiThera vaccine?
To date, we plan to obtain the necessary data from Phase 2/3 studies for eventual approval in the summer and then, if large-scale production takes place as planned, begin vaccinating the most exposed subjects in the second half of 2021.
What are Phase 2 and Phase 3?
The Phase 2 and 3 studies that we intend to start as soon as possible consist of expanding the number of volunteers to demonstrate the safety of the vaccine by enrolling thousands, if not tens of thousands of people. In addition, a placebo group is introduced to demonstrate the efficacy of the vaccine.
If successful and approved by the EMA, will we be able to meet internal needs? If so, by when, even with a rough estimate?
Production of the first batch of 100,000 doses has been completed for clinical trials. We are expanding our internal capabilities to reach the production capacity of millions of doses. Large-scale production will need to happen in parallel with clinical development so that the vaccine can be distributed soon after its approval.
Are you planning to get third party support to increase production?
Yes, through the collaboration established with other production companies, such as Univercells in Belgium, we aim to increase our production capacities and, in parallel, we are exploring innovative platforms based on multi-dose containers to ensure rapid production and safe and economical delivery of millions of doses of the vaccine.
What are the methods of administering your vaccine? Are there any recalls?
For the ReiThera vaccine it should be sufficient to inject a single dose, although we are still experimenting with alternatives. The single-dose choice, logically, allows to halve the time: since the injection of the second dose is not foreseen, it is possible to proceed directly with the administration of the vaccine to new subjects, significantly accelerating the immunization process.
What are the transport and storage methods?
As for conservation, the vaccine, properly formulated, is stable at a temperature between 2 and 8 degrees.
What are the main differences with the Pfizer / BioNTech vaccine? Can you explain the difference between vaccines that use DNA or Rna and others?
Both the technology used by Pfizer / BioNTech and those based on technologies that use viral vectors, fall into the category of genetic vaccines. In the case of ReiThera we use an adenoviral vector to carry the coronavirus spike protein gene, while Pfizer and Moderna use a messenger RNA encapsulated in lipid droplets.
In case of mutations in the virus, would the vaccine still be effective?
We do not know for sure yet, but at present we believe that the mutations in place should not affect the effectiveness of the vaccine.
Regarding funding, the ReiThera project is the result of investments by the Lazio Region and the Ministry of University and Research, combined with your company funds, can it be defined as a public-private cooperation model? Did other parties participate with other investments?
The Phase 1 experimentation and the production of the clinical material necessary for the study was funded by the Ministry of Scientific Research and the Lazio Region for a total of 8 million euros . We are in dialogue with institutions and partners to obtain those funds that would ensure continuity to the experimentation and we are optimistic that this can happen.
Interview deals with Policy Maker, here the full version.
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/vi-spiego-come-sara-il-vaccino-italiano-di-reithera/ on Sat, 16 Jan 2021 15:35:48 +0000.