The European Medicines Agency is finishing reviewing clinical trials before marketing authorization
The Hipra covid-19 vaccine —the first injection designed and manufactured in Spain to deal with coronavirus infections— could achieve the definitive approval in November. As reported by pharmaceutical executives at a press conference held this Tuesday in Brussels, the European Medicines Agency (EMA) is finalizing the revision of the clinical trials made to date with this vaccine to authorize its marketing. Everything indicates that the entity will pronounce on the subject In the next weeks. Probably well into November.
The company believes that as soon as the covid-19 vaccine achieves final approval could be marketed “immediately”. In this sense, it is estimated that Hipra injections against the coronavirus could take only a week to reach the outpatient clinics of the countries that have acquired it. In principle, these immunizations would be used as booster dose for people previously vaccinated with other pharmaceuticals.
Related news
According to the company’s R&D director, Elia Torroellain an interview with EL PERIÓDICO, the pharmacist also is preparing to close a purchase agreement with Europe. “Many European countries are interested in buying the Hipra vaccine. We are also in talks with countries in Latin America, Southeast Asia and the Middle East,” she explained.
New generation vaccine
Hipra’s covid-19 vaccine is the only Spanish vaccine that it has completed the clinical trial process and that it is ready for final authorization. As clinical trials to date have shown, this injection has shown high rates of effectiveness against all variants detected to date of the coronavirus responsible for covid-19: from the one originating in Wuhan to the most widespread variations during the pandemic, as is the case with beta, delta and omicron. Recently, it has also been observed high effectiveness against the subvariants BA.2, BA.4 and BA.5 of omicron: the lineages that are marking the course of the pandemic in practically the whole world.