The Government approves funding to Hipra laboratories for its serum to advance to the final stages of clinical trials before its commercialisation.
The Centre for the Development of Industrial Technology (CDTI), a state body that supports knowledge-based innovation by providing advice and public aid, has approved funding for phase IIb/III clinical trials of the covid vaccine being developed by the Hipra laboratories in Amer (Girona), with an allocation of 14.7 million euros.
As confirmed by the Minister of Science and Innovation, Diana Morant, at the Trobada Empresarial al Pirineu, which is being held in the Lleida town of La Seu d’Urgell, the funding is part of the Final phases of the development of a vaccine against covid-19 project, which has a total budget of 17.3 million euros, of which 14.7 million will be provided by the CDTI in the form of partially reimbursable aid (APR).
In this way, and at the expense of the Spanish Agency for Medicines and Health Products (AEMPS) approving the continuation of the trials after phase 1, Hipra will have the necessary funds to advance in the final stages of the vaccine before its commercialisation.
Morant said: “With all due caution, we are hopeful that this vaccine will go ahead and be the first Spanish vaccine on the market. Hipra has already received approval from the AEMPS this summer to be the first Spanish vaccine to enter phase 1 clinical trials, and the results are currently being evaluated by the Agency.
The minister also stressed that there are currently four vaccines approved by the European Union, and just over 20 worldwide, hence the relevance of the Spanish vaccine. For the Government, Hipra is “an example of an innovative company”, which has had to reconvert itself in the context of a global emergency, going from being a leader in veterinary vaccines to the design and production of vaccines for humans.
The project for which the CDTI grant was requested materialises in the execution of clinical trials phases IIb and III of the vaccine and was carried out after a process of reflection and debate in collaboration with the AEMPS and the Spanish hospitals that will participate in the trials for “an effective design of the protocol to be applied”.
Science and Innovation stress that, as it is not necessary to have the trial completed in order to include the data in the registration dossier and speed up the process before the EMA, the vaccine could be authorised to be marketed without having completed phase III.
For Morant, Hipra’s vaccine is an example of public-private collaboration, as the government has accompanied the company in the development of the vaccine since July last year with a budget of almost 3 million euros.
Source www.levante-emv.com Translated with www.DeepL.com/Translator photo EU Brussels