Italy is increasing COVID-19 vaccine production on Monday when local biotechnology company ReiThera said its vaccine showed a strong immune response on the candidate and no heavy side effects in intermediate Phase II clinical trials.
The vaccine, called GRAd-COV2, provoked an antibody response against the spike protein SARS-CoV-2 in more than 93% of candidates three weeks after the first dose, reaching 99% after the second dose, the company said in a report. communicated.
However, ReiThera needs at least 60 million euros ($71 million) to fund final Phase III testing and suffered a blow in May when a state audit court rejected a plan to inject public funds into the company.
ReiThera said on Monday that two independent advisory boards suggested raising GRAd-COV2 in Phase III studies but did not provide an update on funding.
The company held initial negotiations on the potential of supplying its vaccine to the European Union, which is seeking to diversify supplies and increase vaccine production within the bloc.
“Our candidate vaccine confirmed its excellent safety and good immunogenicity profile in a large cohort,” said ReiThera Medical Director Roberto Camerini, adding that the company hopes to start Phase III trials as soon as possible.
The Phase II study, which was conducted at 24 clinical centers in Italy, involved 917 volunteers over the age of 18, 25% of whom were over 65 and had conditions linked with an increased risk of severe disease in the case of SARS. CoV-2 infection.
Candidates were randomized into three regimens, receiving a single dose of vaccine followed by a dose of placebo, or two doses of vaccine, or two doses of placebo, with three weeks between the two administrations, the company said.
Adverse events, mainly mild to moderate and of short duration, were mainly related to pain and stiffness at the injection site, fatigue, muscle pain, and headache. There were no serious vaccine-related events, he added.