How’s Reithera’s vaccine testing going? Facts, data and unknowns
Reithera's second-phase vaccine trial has provided positive results, but the company needs funds to continue with the clinical trial. Facts, numbers, problems and controversies
The second dose of the coronavirus vaccine developed by the Italian biotech company ReiThera induces an antibody response against the SARS-CoV-2 spike protein in 99 percent of the volunteers who underwent the second phase of the clinical trial. The response induced by the first dose of the vaccine – called GRAd-COV2 – is more than 93 percent, three weeks after administration.
These are positive results for ReiThera, also considering the absence of significant side effects in vaccno volunteers: only pain at the injection site, a sense of fatigue, muscle aches and headaches, writes the AGI agency .
NEED FOR REITHERA VACCINE FUNDS
The problem is that the company needs at least 60 million euros to finance the third and final part of the study. But last May the Court of Auditors rejected the plan of Invitalia (the government agency wholly owned by the Ministry of Economy and Finance) to invest around 50 million euros of public funds in ReiThera to support the development of the vaccine, deeming it illegitimate.
THE COURT OF AUDITORS QUESTION-INVITALIA
As explained by Start Magazine , the Court of Auditors judged the Invitalia investment project led by the CEO, Domenico Arcuri, "irreconcilable with the legal conditions, according to which the project cannot concern the entire company complex but only determined 'production units' in the field of vaccine development ".
Specifically, the court opposed the purchase of the property where the ReiThera operational headquarters are located, in Castel Romano, because it does not concern the single production unit (i.e. the vaccine filling and packaging plant), but precisely the entire headquarters, where the company carries out all its activities.
WHAT (NOT) REITHERA SAYS
In the statement published yesterday regarding the results of the second phase of the study, ReiThera said that the continuation of the trial "has received a positive opinion from important regulatory agencies including the EMA", or the European Medicines Agency, "and we hope to be able to start it as soon as possible ". However, no statements were made regarding the funding.
THE PERPLESSITIES OF SON
Francesco Paolo Figliuolo, extraordinary commissioner for combating the COVID-19 emergency, had expressed doubts about the ReiThera project: as Paolo Russo recalls in La Stampa , the general declared that "there was a stop to financing because the company is waiting for EMA's scientific advice , a sine qua non to enter phase 3 of the experimentation ".
Russo also writes that the GRAd-COV2 vaccine is “a viral vector, which Europe will stop using next year”: in short, Italy would have bet on the wrong vaccine. Stefania Capone of ReiThera claims, however, that "adenoviral vector vaccines induce powerful and persistent cell-mediated responses due to the activation of T lymphocytes against the Spike protein better than other vaccine platforms, as we confirmed for GRAd-COV2 in the Phase 1 study "We and others have shown that, unlike antibody immunity, T lymphocyte responses do not lose potency against the SARS-CoV-2 variants of concern."
THE OBJECTIVES OF REITHERA
ReiThera would like to supply its GRAd-COV2 vaccine to the European Union, which in turn intends to diversify supplies and enhance the development and production of doses within the bloc: AstraZeneca is based in the UK; while Johnson & Johnson, Pfizer and Moderna are from the United States.
VACCINE TESTING
Roberto Camerini, medical director of ReiThera, said that "our vaccine confirmed the excellent safety and immunogenicity profile in a large sample of volunteers" and that "we are very satisfied with the preliminary results of the Phase 2 COVITAR study, for to which we thank the volunteers and the 24 experimentation centers ”.
The study began on March 18 in twenty-four clinical centers throughout Italy. 917 volunteers participated, of which 25 percent are over the age of 65 and / or conditions associated with an increased risk of severe disease in case of coronavirus infection.
The three study regimens involve comparing a single-dose vaccine regimen plus a placebo dose, a repeat-dose vaccine regimen, and a repeat-dose placebo, with a three-week interval between the two administrations.
ALL THE MOST RECENT INSIGHTS FROM START MAGAZINE ON THE REITHERA VACCINE:
Corte dei Conti on Reithera: papocchio by Invitalia di Arcuri?
Italian vaccine, the Corte dei Conti crushes the intervention of Invitalia (Mef) for Retheira
Who funded Pfizer-Biontech, Moderna and Astrazeneca vaccines
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/vaccino-reithera-sperimentazione-fase-2-fondi/ on Tue, 13 Jul 2021 09:21:23 +0000.