Italy hopes to produce its own Covid-19 vaccine. Those hopes received a boost on Monday. Results from Phase II of the clinical trial by biotech firm ReiThera show a strong immune response and no major side effects.
The vaccine, called GRAd-COV2, induced an antibody response against the SARS-CoV-2 spike protein in over 93% of volunteers three weeks after the first dose. That reached 99% after the second dose, the company said in a statement.
Phase III trial may not go ahead
However, Phase III is in the balance. ReiThera needs at least €60million to fund the final Phase III trials. In May, a state audit court rejected a plan to pump public funds into the company.
On Monday, ReiThera said two independent advisory boards recommended advancing GRAd-COV2 into Phase III studies. The company did not give an update on funding.
ReiThera has also held early stage talks with the European Union regarding potential supplies to member states. The EU is looking to diversify supplies of Covid-19 vaccine and increase production within the bloc.
“Our vaccine candidate confirmed its excellent safety and good immunogenicity profile in a large cohort,” ReiThera medical director Roberto Camerini said. He added the company hoped to be able to start Phase III trials as soon as possible.
How was Phase II conducted?
The Phase II study took place in 24 clinical centres in Italy. It enrolled 917 volunteers over the age of 18. 25% of them were over the age of 65 and had conditions associated with an increased risk of severe disease in case of SARS-CoV-2 infection.
There was randomisation of the volunteers into three regimens. One group received a single vaccine dose followed by a placebo dose. Another group received two vaccine doses, and the control group received two doses of placebo. There was a three-week gap between the administration of the two doses, the company said.
Recorded adverse events were mostly mild to moderate and of short duration. They related mainly to pain and induration at the site of injection, fatigue, muscle pain and headache. There were no serious vaccine-related adverse events.
