Italian Covid-19 vaccine shows strong immune response in mid-term trial
MILAN (Reuters) – Italy’s hopes of producing its own Covid-19 vaccine were boosted on Monday when local biotech company ReiThera said its vaccine candidate exhibited a strong immune response and no major side effects in patients. interim phase II clinical trials.
The vaccine, called GRAd-COV2, elicited an antibody response against the SARS-CoV-2 spike protein in more than 93% of volunteers three weeks after the first dose, reaching 99% after the second dose, the vaccine said. company in a press release.
However, ReiThera needs at least 60 million euros ($ 71 million) to fund the latest Phase III trials and suffered a heavy blow in May when a state audit office rejected a plan. aimed at injecting public funds into the company.
ReiThera said Monday that two independent advisory boards had recommended advancing GRAd-COV2 into Phase III studies, but did not provide an update on funding.
The company has had preliminary discussions on the potential supply of its vaccine to the European Union, which is seeking to diversify its supplies and increase vaccine production within the bloc.
“Our vaccine candidate has confirmed its excellent safety and good immunogenicity profile in a large cohort,” said ReiThera medical director Roberto Camerini, adding that the company hoped to start phase III trials as soon as possible.
The phase II study, which was conducted in 24 clinical centers in Italy, recruited 917 volunteers over the age of 18, 25% of whom were over 65 and had conditions associated with an increased risk of severe disease in SARS case – CoV-2 infection.
The volunteers were randomized to three regimens, receiving either a single dose of vaccine followed by a dose of placebo, or two doses of vaccine, or two doses of placebo, with an interval of three weeks between the two administrations, the study said. society.
Adverse events, mostly mild to moderate and of short duration, were mainly related to pain and induration at the injection site, fatigue, muscle pain and headache. There were no serious adverse events related to the vaccine, he added.