Italy’s dreams of developing its own COVID-19 vaccine have been dashed after the state audit court dismissed a bid to invest public funds in local biotech firm ReiThera, according to two sources related to the matter who spoke to Reuters on Friday.
According to a source at the audit court, the court ruled this week against a contract drafted by state agency Invitalia to spend approximately 50 million euros ($60.62 million) as part of an agreement with ReiThera to finance the production of the new vaccine.
“The investment scheme is illegitimate, and therefore void,” the source said, without providing any details.
The court normally adjudicates on whether state agencies have followed correct procedures and not on the merits of a project.
The company’s vaccine has concluded stage-2 trials and the firm is in early talks with Brussels to supply the European Union. However, it needs public funding to start stage-3 trials.
Invitalia didn’t immediately reply to a Reuters request for comment. The state audit court declined to comment on the case.
Stefano Colloca, a senior director at ReiThera, said he had not heard from the court.
“We’re waiting to hear the official news, to find out if it’s true and (if so) why this decision was made, which, as far as we know, would be unprecedented,” he told Reuters.
The audit court ruling was verified by a source from the industry ministry, which had signed the investment contract alongside Invitalia and ReiThera, and a decision on what to do will be taken in the coming weeks.
The government of Prime Minister Mario Draghi, which took over the project from the previous administration headed by Giuseppe Conte, must either rewrite the contract in an attempt to resolve the court objections or abandon the initiative.
Alternatively, it could proceed anyway, but such a defiance of the court would be very rare.
ReiThera – whose aim is to produce some 100 million shots of a single-dose vaccine at a production site close to Rome this year – has been developing the project in partnership with Germany’s Leukocare and Belgium’s Univercells.
Following promising phase 1 trial results, the former government agreed to invest in the business in order to grant Italy more flexibility in vaccine procurement, which is currently reliant solely on a joint EU project.
The ReiThera vaccine is based on a non-replicating adenoviral vector, and is the same technology used by AstraZeneca (AZN.L) and Johnson & Johnson (JNJ.N) in their vaccines.
Vaccinations for both brands are only approved for people above the age of 60 in Italy, after the country and other European countries temporarily suspended AstraZeneca inoculations in March due to extremely rare cases of blood clots.
Due to related reasons, J&J deliveries were also briefly halted.
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