ReiThera’s Italian anti-Covid vaccine is effective. Indeed, after the second administration an antibody response against the Spike protein of the Sars-CoV-2 coronavirus is observed in over 93% of the volunteers enrolled in the experimentation, and it is reached 99% after the second administration. This is what emerges from the results of the preliminary analysis of the phase 2 clinical trial – randomized, double-blind and placebo-controlled – conducted on the GRAd-COV2 vaccine. The data from the Covitar trial were announced today by the biotech company based in Castel Romano.
Preliminary safety and immunogenicity data from the first 5 weeks of the study were reviewed by the Data Safety Monitoring Board, independent committee for safety evaluation, and by the Steering Committee, scientific committee for efficacy evaluation, during a joint meeting. . The two panels expressed themselves favorably on the data analyzed and recommended the continuation of the clinical development of the GRAd-COV2 vaccine.
The trial began on March 18 in 24 clinical centers distributed throughout the Italian territory, and involves 917 volunteers, 25% of whom are over 65 years of age and / or with conditions associated with an increased risk of severe disease in case of Sars-CoV-2 infection. The results after the first 5 weeks of vaccination confirm what was already observed in phase 1, explains ReiThera: the vaccine is “well tolerated at the first administration and even better tolerated at the second”.
Adverse events, mostly mild to moderate and of short duration, are mainly attributable to pain and tension at the injection site, fatigue, muscle aches and headaches, the note reads. There were no serious vaccine-related adverse events.