The Spanish Agency for Medicines and Health Products (AEMPS) has authorized Hipra's Spanish vaccine against COVID-19 to go to phase three —the last— of the clinical trial, according to Cadena SER and confirmed by elDiario.es . This is a necessary step prior to submitting an authorization request to the European Medicines Agency.
Diana Morant: "If the Spanish vaccine comes out, it will be better than the ones on the market"
The clinical trial will include approximately 3,000 adults over 16 years of age who will receive the Hipra vaccine as a booster dose to other primary vaccination schedules that include different combinations. This phase will be carried out in twenty hospitals in Spain, Italy and Portugal. The patients included in the trial will be followed up for 52 weeks until the end of the trial, although data will be obtained for the purposes of the study in a shorter period of time.
The Minister of Science and Innovation, Diana Morant, already explained this Monday that it was "a matter of hours" before the resolution of Hipra's request to move on to the next phase of the trial with more volunteers, the last before its commercialization, was known. The estimate of the pharmaceutical company based in Amer (Girona) is that the vaccine is ready before the summer.
The Catalan company is working on a vaccine of two recombinant proteins of the Alpha and Beta variants of the coronavirus that would induce an immune response to the so-called protein S orspike of SARS-CoV-2, a technology similar to that used in the American Novavax. In addition, another notable feature of the project is that it is a product that can be stored between 2 and 8 degrees, which would facilitate its distribution and logistics.